[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"countryName\":\"Sweden\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":625},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,1434,0,25,[9,40,62,91,113,133,154,196,222,244,268,289,311,342,372,392,414,437,460,483,511,538,558,581,602],{"id":10,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":29,"startDateStruct":32,"completionDateStruct":34,"leadSponsor":36,"locationsCount":39},"100054056",false,"NCT07355296","PODOMOUNT-Basket, a Study to Test Whether BI 764198 Helps Adults and Adolescents With Different Types of Kidney Disease","PODOMOUNT-Basket, a Phase II, Multicentre, Randomised, 2-arm Parallel-group, Double-blind, Placebo-controlled Basket Trial to Assess Safety, Tolerability, PK, and Efficacy of BI 764198 in Four Proteinuric Kidney Diseases","Inclusion Criteria:\n\n* Male or female participants ≥18 years of age (≥12 years of age for Treatment resistant primary Minimal Change Disease (TR-pMCD)) on the day of signing informed consent\u002Fassent (Visit 1)\n* Body Mass Index (BMI) of ≤40 kg\u002Fm2 at screening visit (Visit 1)\n* Weight of ≥40 kg at screening\n* Estimated glomerular filtration rate (eGFR) ≥25 mL\u002Fmin\u002F1.73 m2 (chronic kidney disease (CKD) EPI formula based on serum cystatin C) at screening visit\n\n  * For adult participants (≥18); ≥25 mL\u002Fmin\u002F1.73 m2 (CKD-EPI formula based on serum cystatin C) at the screening visit\n  * For adolescent participants (\\\u003C18); ≥25 mL\u002Fmin\u002F1.73 m2 (chronic kidey disease under 25 years (CKiD U25) formula using height and serum cystatin C) at the screening visit\n* Seated blood pressure (mean of 3 values) systolic blood pressure (SBP) ≤160 mmHg (adult participants ≥18) or SBP ≤140 mmHg (participants \\\u003C18) at the screening visit (Visit 1). A participant with a documented history of white coat hypertension may be included as long as the participant is considered medically stable by the investigator and \"true\" blood pressure can be considered to be ≤160 mmHg (adult participants ≥18) or ≤140 mmHg (adolescent participants \\\u003C18)\n* Participants should be treated with angiotensin converting enzyme (ACE) inhibitors or angiotensin receptor blockers (ARBs), at a stable optimised dose for at least 8 weeks prior to the screening visit (Visit 1), with no plan to change the dose until the end of the randomised treatment period (i.e. end of trial (EoT), Week 20) unless not tolerated or indicated as per the discretion of the investigator\n* If treated with (non-steroidal) mineralocorticoid receptor antagonist (MRA), endothelin receptor antagonists (ERA), glucagon-like peptide-1 (GLP-1) or Sodium-glucose co-transporter-2 (SGLT2) inhibitors (SGLT2i), participants must be on a stable dose for at least 8 weeks prior to the screening visit (Visit 1), preferably with no plan to change the dose until the end of the randomised double-blind treatment period (i.e. EoT, Week 20)\n* Participants treated with oral immunosuppressive therapy except glucocorticoids (e.g. Calcineurin inhibitor(s) (CNI), mycophenolate mofetil\u002F-sodium, cyclophosphamide) must be on a stable dose for at least 12 weeks prior to the screening visit (Visit 1) with no plans to change their dose during the trial treatment period\n* Patients treated\u002Fto be treated with oral glucocorticoids have to be at a dose ≤10 mg\u002Fd prednisolone or equivalent for ≥4 weeks prior to screening with no plan to increase the dose during the treatment period.\n\nFurther inclusion criteria apply.\n\nExclusion Criteria:\n\n* A history of organ transplantation or planned transplantation during the course of the study\n* Use of intravenous immunosuppressive agents (e.g. cyclophosphamide, rituximab, obinutuzumab) in the past 6 months prior to screening visit (Visit 1)\n* Participants in whom initiation of oral or IV immunosuppression is anticipated during the course of the trial\n* Treatment with metformin or dofetilide (multidrug and toxin extrusion protein 1 (MATE1) substrates) within one week prior to randomisation visit (Visit 2) through 5 days after the EoT visit\n* Treatment with strong inhibitors or strong inducers of cytochrome P450 3A4\u002F5 (CYP3A4\u002F5) within one week or 5 half-lives (whichever is longer) prior to randomisation visit (Visit 2)\n* Alanine aminotransferase (ALT)\u002Faspartate aminotransferase (AST) \\>3X the upper limit of normal (ULN) at screening visit (Visit 1)\n* Clinically significant laboratory abnormalities or medical conditions which pose a safety risk for the participant or may interfere with the trial objectives in the investigator's opinion (except for renal function tests or deviation of clinical laboratory values that are related to the podocytopathy in question) at screening visit\n* QTc intervals (QTcF) greater than 450 ms in males or greater than 470 ms in females, or any other clinically relevant ECG findings (at the investigator's discretion) at screening visit (Visit 1) Further exclusion criteria apply.","ALL","12 Years",{"count":19,"type":20},132,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","This study is open to adults with certain kidney conditions, including secondary focal segmental glomerulosclerosis (sFSGS), treatment-resistant primary minimal change disease (TR-pMCD), Alport Syndrome (AS), and treatment-resistant primary membranous nephropathy (TR-pMN). Adolescents with treatment-resistant primary MCD can also participate in this study. The purpose of this study is to find out whether a medicine called BI 764198 helps people with these kidney conditions.\n\nParticipants are put into 2 groups randomly, which means by chance. One group takes BI 764198 tablets, and the other group takes placebo tablets. Placebo tablets look like BI 764198 tablets but do not contain any medicine. Participants take a tablet once a day for 20 weeks. All participants also continue their standard medication for their kidney condition during the study. Participants have twice the chance of being placed in the BI 764198 group than in the placebo group.\n\nParticipants are in the study for about 7 months. During this time, they visit the study site 6 times and have 3 phone calls. Doctors regularly test the protein levels in participants' urine by collecting urine samples. They also check kidney function by taking blood samples. The results are compared between the two groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.",[26],"Proteinuric Kidney Diseases","RECRUITING","2026-07-10",{"date":30,"type":31},"2026-07-13","ACTUAL",{"date":33,"type":31},"2026-03-23",{"date":35,"type":20},"2028-02-17",{"name":37,"class":38},"Boehringer Ingelheim","INDUSTRY",161,{"id":41,"slug":4,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":11,"sex":16,"minAge":46,"maxAge":4,"enrollmentInfo":47,"targetDuration":4,"studyType":21,"phases":49,"briefSummary":51,"conditions":52,"keywords":4,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":55,"startDateStruct":56,"completionDateStruct":58,"leadSponsor":60,"locationsCount":61},"100054317","NCT07544654","DAREON®-NEC-1: A Study in People With Advanced Extrapulmonary Neuroendocrine Cancer (epNEC) to Compare Obrixtamig Plus Carboplatin and Etoposide Treatment With Standard Chemotherapy","A Phase III, Multi-center, Open-label, Randomised, Controlled Trial of Intravenous Obrixtamig in Combination With Carboplatin and Etoposide vs. Carboplatin and Etoposide as First-line Therapy in DLL3-positive Patients With Unresectable Locally Advanced or Metastatic Extrapulmonary Neuroendocrine Carcinomas","Inclusion Criteria:\n\n1. Patients with poorly differentiated unresectable locally advanced or metastatic extrapulmonary neuroendocrine carcinoma (epNEC) with Ki-67 \\>20% or mitotic rate mitotic rate with number of mitoses \\>20 per 2 mm2, regardless of primary site (including site of unknown origin)\n2. Patients with tumours with mixed histologies are eligible only if neuroendocrine carcinoma component is predominant and represents more than 70% of the overall tumour tissue\n3. No prior systemic treatment for unresectable locally advanced or metastatic epNEC (except for the completed one cycle of standard platinum + etoposide). Prior peri-operative chemotherapy or -radiation for curative intention is allowed if at least 6 months have elapsed between completion of this therapy and diagnosis of unresectable locally advanced or metastatic disease\n4. Patients who have finished one cycle of standard platinum + etoposide regimen as first-line treatment (Cycle 0: etoposide with carboplatin or cisplatin, administered at a minimum dose of cisplatin 75 mg\u002Fm2 or carboplatin area under the curve (AUC) 5 and etoposide 80 mg\u002Fm2) prior to randomisation\n5. Patients must comply with criteria for receiving further chemotherapy treatment as first-line standard of care (SoC) treatment within 28 days after the start of the initial chemotherapy (Cycle 0)\n6. Adequate archival Formalin-Fixed Paraffin-Embedded (FFPE) tumour tissue, as specified in the Laboratory Manual, must be available for central laboratory analysis of Delta-like ligand 3 (DLL3) expression status. Tumours must be positive (as defined in the diagnostic study protocol) for DLL3 expression status assessed by investigational VENTANA DLL3 (SP347) RxDx Assay\n7. Eastern Cooperative Oncology Group (ECOG) score of 0 or 1\n8. Male or female participants ≥18 years old and at least at the legal age of consent in countries where it is greater than 18 years at the time of signature of the informed consent form (ICF) Further inclusion criteria apply.\n\nExclusion Criteria:\n\n1. Presence of leptomeningeal disease and\u002For carcinomatous meningitis\n2. Patients with diagnosis of Merkel cell carcinoma or medullary thyroid carcinoma\n3. Patients with neuroendocrine prostate cancer\n4. Patients with well-differentiated neuroendocrine tumours of any grade according to the world health organization (WHO) classification, 5th edition\n5. Patients with a history of well differentiated Neuroendocrine tumour (NET) tumour that transformed into poorly differentiated Neuroendocrine carcinoma (NEC)\n6. Previous treatment with obrixtamig or other DLL3-targeting therapies (e.g. T-cell engager (TcEs), cell therapies, antibody-drug conjugates, or radiopharmaceuticals)\n7. Previous treatment with anti-PD-1 or programmed death ligand 1 (PD-L1) therapies during the one cycle of standard platinum + etoposide first-line chemotherapy (Cycle 0)\n8. Toxicity from previous treatments that has not resolved to ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 or grade prior to Cycle 0. Participants with alopecia any grade, CTCAE ≤Grade 2 asthenia\u002Ffatigue, amenorrhea\u002Fmenstrual disorders any grade, CTCAE ≤Grade 2 peripheral neuropathy, and\u002For CTCAE ≤Grade 2 endocrinopathies controlled by replacement therapy, and toxicities, which are considered irreversible but stable for at least 4 weeks, per Investigator judgement may be eligible Further exclusion criteria apply.","18 Years",{"count":48,"type":20},390,[50],"PHASE3","This study is open to adults with advanced extrapulmonary neuroendocrine cancer. The purpose of this study is to find out if a study medicine called obrixtamig plus standard chemotherapy (carboplatin and etoposide) improves survival when compared to standard chemotherapy (carboplatin and etoposide) alone. Obrixtamig is an antibody-like molecule that may help the immune system fight cancer. Another purpose of the study is to test a medical device being developed to measure levels of the tumour marker delta-like ligand 3 (DLL3).\n\nParticipants are put into 2 groups randomly, which means by chance. One group (treatment arm) receives obrixtamig and standard chemotherapy followed by obrixtamig alone for up to 3 years. The other group (control arm) receives standard chemotherapy without obrixtamig for about 4 months. All treatments are given as infusions into a vein.\n\nDuring the study, participants in both groups visit the study site regularly. Participants in the treatment arm stay overnight at the study site following the first 2 obrixtamig treatments. The doctors regularly check participants' health and take note of any unwanted effects. At some of the visits, doctors check the size of the tumour(s). The results are compared between the 2 groups to see whether the treatment works.",[53],"Extrapulmonary Neuroendocrine Cancer (epNEC)","NOT_YET_RECRUITING",{"date":30,"type":31},{"date":57,"type":20},"2026-07-07",{"date":59,"type":20},"2031-03-11",{"name":37,"class":38},165,{"id":63,"slug":4,"hasResults":11,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":11,"sex":16,"minAge":69,"maxAge":4,"enrollmentInfo":70,"targetDuration":4,"studyType":21,"phases":72,"briefSummary":73,"conditions":74,"keywords":76,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":83,"startDateStruct":84,"completionDateStruct":86,"leadSponsor":88,"locationsCount":90},"100053313","NCT05712200","Study to evaLuate the effIcacy and Safety of abeLacimab in High-risk Patients With Atrial Fibrillation Who Have Been Deemed Unsuitable for Oral antiCoagulation (LILAC-TIMI 76)","A Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to evaLuate the effIcacy and Safety of abeLacimab in High-risk Patients With Atrial Fibrillation Who Have Been Deemed Unsuitable for Oral antiCoagulation (LILAC-TIMI 76)","LILAC-TIMI 76","Inclusion Criteria:\n\n* Patient is able to understand and has provided written informed consent to participate in the trial\n* Diagnosed Atrial Fibrillation (AF) or atrial flutter (documented on an electrocardiogram (ECG) or monitor recording)\n* Age 65-74 and a CHA2DS2VASc ≥4 OR age ≥75 and a CHA2DS2VASc ≥3\n* Patient is judged by the responsible physician to be unsuitable for oral anticoagulation because the risks outweigh the benefits or the patient is unwilling to take oral anticoagulation AND this determination was made prior to and independent of the study\n* At least 1 bleeding risk factor such as severe renal insufficiency, planned daily use of antiplatelet medication for the duration of the trial, history of bleeding from a critical area, or other conditions associated with increased risk of bleeding such as chronic nonsteroidal anti-inflammatory drug (NSAID) use, frailty or multiple falls\n* Patient is judged by the responsible physician to be unsuitable for left atrial appendage (LAA) closure or occlusion device, an approved device is not available, or the patient is unwilling to undergo the procedure AND this determination was made prior to and independent of the study\n\nExclusion Criteria:\n\n* AF due to an ongoing acute reversible cause (e.g., cardiac surgery, pulmonary embolism (PE), untreated hyperthyroidism, alcohol use)\n* Patients who within 60 days prior to randomization (1) received a vitamin K antagonists (VKA) (e.g., warfarin, phenprocoumon, acenocoumarol) or a direct oral anticoagulant (DOAC) such as, dabigatran, rivaroxaban, apixaban, or edoxaban or (2) were newly diagnosed with AF\n* Patients with an intracranial or intraocular bleed within the 3 months prior to screening or any history of spontaneous intracerebral hemorrhage at any time in the absence of antithrombotic treatment\n* Any stroke within 14 days before randomization or transient ischemic attack (TIA) within 3 days before randomization\n* Mechanical heart valve or valve disease that is expected to require mechanical valve replacement intervention (surgical or invasive) during the course of the study\n* Patients on dialysis at screening or who are planned to start dialysis within 6 months\n\nOther protocol defined Inclusion\u002FExclusion criteria may apply","65 Years",{"count":71,"type":20},2500,[50],"A study to evaluate the effect of abelacimab relative to placebo on the rate of ischemic stroke or systemic embolism (SE) in patients with Atrial Fibrillation (AF) who have been deemed by their responsible physicians or by their own decision to be unsuitable for oral anticoagulation therapy.",[75],"Atrial Fibrillation (AF)",[77,78,79,80,81,82],"abelacimab","randomized","placebo-controlled","double-blind","endpoint evaluation","atrial fibrillation",{"date":30,"type":31},{"date":85,"type":31},"2022-12-27",{"date":87,"type":20},"2027-12-30",{"name":89,"class":38},"Anthos Therapeutics, Inc.",789,{"id":92,"slug":4,"hasResults":11,"nctId":93,"briefTitle":94,"officialTitle":95,"acronym":4,"eligibilityCriteria":96,"healthyVolunteers":11,"sex":97,"minAge":46,"maxAge":4,"enrollmentInfo":98,"targetDuration":4,"studyType":21,"phases":100,"briefSummary":101,"conditions":102,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":105,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":112},"100054324","NCT06925737","A Clinical Study of Ifinatamab Deruxtecan (I-DXd) in People With Metastatic Prostate Cancer (MK-2400-001)","A Phase 3, Open-label Study of Ifinatamab Deruxtecan Versus Docetaxel in Participants With Metastatic Castration-Resistant Prostate Cancer (mCRPC) (IDeate-Prostate01)","Inclusion Criteria:\n\nThe main inclusion criteria include but are not limited to the following:\n\n* Has histologically- or cytologically-confirmed adenocarcinoma of the prostate without small cell histology\n* Has prostate cancer progression while on androgen deprivation therapy (ADT) (or post bilateral orchiectomy) within 6 months prior to Screening\n* Has current evidence of distant metastatic disease (M1 disease) documented by either bone lesions on bone scan and\u002For soft tissue disease by computed tomography (CT)\u002Fmagnetic resonance imaging (MRI)\n* Has received prior treatment with 1 or 2 androgen receptor pathway inhibitors (ARPIs) and progressed during or after at least 8 weeks of treatment\n* Has provided tumor tissue from a core or excisional biopsy from soft tissue not previously irradiated and obtained after disease progression on the most recent prior therapy\n* Has recovered from adverse events (AEs) due to previous anticancer therapies\n\nExclusion Criteria:\n\nThe main exclusion criteria include but are not limited to the following:\n\n* Is unable to swallow tablets\u002Fcapsules\n* Has any of the following indicators of interstitial lung disease (ILD)\u002Fpneumonitis:\n\n  1. Has any history of ILD\u002Fpneumonitis that required steroid use, except for a history of radiation pneumonitis that did not require steroids\n  2. Has current ILD\u002Fpneumonitis\n  3. Has a clinical or radiographic suspicion of ILD for which the diagnosis of ILD cannot be ruled out\n* Has clinically severe pulmonary compromise resulting from intercurrent pulmonary illnesses\n* Has uncontrolled or significant cardiovascular disease\n* Has received prior treatment with a taxane-based chemotherapy agent for metastatic castration-resistant prostate cancer (mCRPC)\n* Has had prior discontinuation of an antibody drug conjugate (ADC) that consists of an exatecan derivative (eg, trastuzumab deruxtecan) due to treatment-related toxicities\n* Has a \"superscan\" bone scan","MALE",{"count":99,"type":20},1440,[50],"Researchers are looking for new ways to treat metastatic castration-resistant prostate cancer (mCRPC). Researchers have designed a study medicine called ifinatamab deruxtecan (also called I-DXd or MK-2400) to treat mCRPC. The goal of this study is to learn if people who receive I-DXd live longer overall and live longer without the cancer growing or spreading than people who receive chemotherapy.",[103,104],"Prostate Cancer","Prostatic Neoplasms",{"date":30,"type":31},{"date":107,"type":31},"2025-05-13",{"date":109,"type":20},"2031-01-06",{"name":111,"class":38},"Merck Sharp & Dohme LLC",290,{"id":114,"slug":4,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":16,"minAge":46,"maxAge":4,"enrollmentInfo":119,"targetDuration":4,"studyType":121,"phases":4,"briefSummary":122,"conditions":123,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":125,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":132},"100054181","NCT01550575","Patient Retrospective Outcomes (PRO)","PRO","Key Inclusion Criteria:\n\n* Previously treated with or eligible for use with Boston Scientific Systems\n* 18 years of age or older at the start of Baseline",{"count":120,"type":20},15000,"OBSERVATIONAL","This study will evaluate de-identified (anonymous) data in subject medical charts to review the clinical outcomes of various treatment approaches in the treatment of chronic pain.",[124],"Chronic Pain",{"date":30,"type":31},{"date":127,"type":31},"2012-04-03",{"date":129,"type":20},"2030-12",{"name":131,"class":38},"Boston Scientific Corporation",144,{"id":134,"slug":4,"hasResults":11,"nctId":135,"briefTitle":136,"officialTitle":137,"acronym":138,"eligibilityCriteria":139,"healthyVolunteers":11,"sex":16,"minAge":46,"maxAge":4,"enrollmentInfo":140,"targetDuration":4,"studyType":21,"phases":142,"briefSummary":143,"conditions":144,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":146,"startDateStruct":147,"completionDateStruct":149,"leadSponsor":151,"locationsCount":153},"100053627","NCT06290141","A Study to Test the Efficacy and Safety of Riliprubart Against the Usual Treatment of Intravenous Immunoglobulin (IVIg) in People With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)","A Phase 3, Randomized, Double-blind, Study Evaluating Efficacy and Safety of Riliprubart Versus Intravenous Immunoglobulin (IVIg) in Participants With Chronic Inflammatory Demyelinating Polyneuropathy","VITALIZE","Inclusion Criteria:\n\nParticipants are eligible to be included in the study only if all of the following criteria apply:\n\n* Participant must have CIDP or possible CIDP criteria, based on European Academy of Neurology (EAN)\u002FPeripheral Nerve Society (PNS) Task Force CIDP guidelines, second revision (2021).\n* Participant must have either typical CIDP, or one of the following 2 CIDP variants: motor CIDP, multifocal CIDP (also known as Lewis Sumner Syndrome). Diagnosis must be confirmed by the study adjudication committee.\n* Participants must have responded to IVIg in the past 5 years.\n* Participant must be on a stable maintenance dosage of IVIg.\n* Participant must have residual disability, defined as an INCAT score of 2 to 9 at Screening that is confirmed at baseline (a score of 2 should be exclusively from leg disability component of INCAT).\n* Participant must be receiving treatment with IVIg within a standard maintenance dosing regimen, defined as per EAN\u002FPNS 2021 CIDP guidelines.\n* Participants receiving IVIg infusions at home are eligible, as long as IVIg infusions are switched to a hospital or infusion center setting at least 1 cycle prior to baseline.\n* Participant must have active disease, defined by a CIDP disease activity score (CDAS) of ≥2 points at Screening.\n* Participant must have documented vaccinations against encapsulated bacterial pathogens given within 5 years prior to Day 1 or initiated a minimum of 14 days prior to first dose of study intervention.\n* Contraception for sexually active male or female participants; not pregnant or breastfeeding; no sperm donating for male participant\n* Participant must have a body weight at Screening of 35 kg to 154 kg (77 to 340 lbs) inclusive.\n* Evidence of at least one clinically meaningful deterioration within 2 years, or at least 2 clinically meaningful deteriorations within 5 years prior to screening which occurred during period of interrupted dosing, reduced dosage, or extended intervals between doses of immunoglobin therapy, as verified by clinical examination or medical records.\n\nExclusion Criteria:\n\nParticipants are excluded from the study if any of the following criteria apply:\n\n* Polyneuropathy of other causes, including but not limited to acute demyelinating polyneuropathies (eg, Guillain-Barré syndrome), hereditary demyelinating neuropathies, neuropathies secondary to infection or systemic disease, diabetic neuropathy, drug- or toxin-induced neuropathies, multifocal motor neuropathy, polyneuropathy related to IgM monoclonal gammopathy, POEMS syndrome, lumbosacral radiculoplexus neuropathy.\n* Sensory CIDP, distal CIDP and focal CIDP variants.\n* Any other neurological or systemic disease that can cause symptoms and signs interfering with treatment or outcome assessments.\n* Poorly controlled diabetes\n* Serious infections requiring hospitalization within 30 days prior to Screening, any active infection requiring antimicrobial treatment during Screening, or presence of a condition that may predispose the participant to increased risk of infection (eg, medical history such as known immunodeficiency or history of recurrent infections).\n* Clinical diagnosis of Systemic Lupus Erythematosus (SLE) or family history of SLE. For a participant with an antinuclear antibody (ANA) titer ≥1:160 and a positive anti double-stranded DNA (anti-dsDNA) at Screening, SLE diagnosis must be ruled out prior to enrollment.\n* Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator, contraindicates participation in the study. Specifically, history of any hypersensitivity reaction to riliprubart or its components or of a severe allergic or anaphylactic reaction to any humanized or murine monoclonal antibody.\n* Any contraindication related to the administration of immunoglobulins (eg hypersensitivity, chronic kidney disease, thromboembolic diseases or recent thromboembolic event, known history of IgA deficiency at the time of Screening).\n* Any other clinically meaningful medical history or ongoing medical condition (as determined by the Investigator at Screening) that might impact the benefit-risk assessment, jeopardize the safety of the participant, or compromise the quality of the data collected in this study; or history or presence of other significant concomitant illness that would adversely affect participation in this study, per the Investigator's judgment.\n* Documented history of attempted suicide over the 6 months prior to the Screening visit, presence of suicidal ideation of category 4 or 5 on the C-SSRS during Screening, OR if in the Investigator's judgment, the participant is at risk for a suicide attempt.\n* Evidence of CIDP worsening within the 6 weeks following a prior vaccination that, in the opinion of the Investigator, constituted a relapse.\n* Recent or planned major surgery that could confound the results of the trial or put the participant at undue risk.\n* Recent treatment with plasma exchange\n* Treatment within 3 months prior to dosing with immunosuppressive\u002F immunomodulator medication, or corticosteroids (with exception of maintenance dose, which is allowed), or prior treatment (at any time) with highly immunosuppressive\u002F chemotherapeutic medications with sustained effects (eg, mitoxantrone, alemtuzumab, or cladribine).\n* Prior treatment with riliprubart.\n* Recent use of any specific complement system inhibitor (eg, eculizumab).\n* Prior treatment (any time) with total lymphoid irradiation or bone marrow transplantation.\n* Prior treatment with B-cell depleting agents such as rituximab within 6 months.\n* Any vaccination received within 28 days prior to dosing (with few exceptions to be confirmed at screening).\n* Participation in another clinical trial with an investigational drug or receipt of an investigational product within 12 weeks or 5 times the half-life of the product (whichever is longer) prior to Screening.\n* Any Screening laboratory values outside normal limits or abnormal ECG considered in the Investigator's judgment to be clinically significant in the context of this trial.\n* Positive result of any of the following tests:\n\n  * hepatitis B surface antigen (HbsAg).\n  * anti-hepatitis B core antibodies (anti-HBc Ab) (unless anti-hepatitis B surface antibodies \\[anti-HBs Ab\\] are also positive, indicating natural immunity).\n  * anti-hepatitis C virus (anti-HCV) antibodies. Participants with positive hepatitis C antibody due to prior resolved disease can be enrolled, only if a confirmatory negative Hepatitis RNA test is obtained.\n  * anti-human immunodeficiency virus 1 and 2 (anti-HIV1 and anti-HIV2) antibodies.\n* Pregnancy, defined as a positive result of a highly sensitive urine or serum pregnancy test, or lactation.\n* Accommodation in an institution because of regulatory or legal order; imprisoned or legally institutionalized.\n* Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures.\n* Participants are employees of the clinical study site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals.\n* Any country-related specific regulation that would prevent the participant from entering the study as defined by the protocol.\n* Recent treatment with efgartigimod.\n\nThe above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.",{"count":141,"type":20},160,[50],"The purpose of the study is to evaluate efficacy of riliprubart compared to IVIg in adult participants with CIDP who are receiving maintenance treatment with IVIg. The study duration will be for a maximum of 109 weeks including screening, treatment phases, and follow-up.",[145],"Chronic Inflammatory Demyelinating Polyneuropathy",{"date":30,"type":31},{"date":148,"type":31},"2024-08-21",{"date":150,"type":20},"2029-01-12",{"name":152,"class":38},"Sanofi",129,{"id":155,"slug":4,"hasResults":11,"nctId":156,"briefTitle":157,"officialTitle":158,"acronym":159,"eligibilityCriteria":160,"healthyVolunteers":11,"sex":16,"minAge":46,"maxAge":161,"enrollmentInfo":162,"targetDuration":4,"studyType":21,"phases":164,"briefSummary":165,"conditions":166,"keywords":168,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":188,"startDateStruct":189,"completionDateStruct":191,"leadSponsor":193,"locationsCount":195},"100053904","NCT07555483","A Non-inferiority Pharmacokinetic and Safety\u002FTolerability Study of Two Different Doses of Weekly SC Alpha1-PI 15% Compared With Corresponding Standard IV Alpha1-PI in Participants With Alpha1-Antitrypsin Deficiency (AATD)","An Open-Label, Multicenter, Randomized, Non-Inferiority Pharmacokinetic and Safety\u002FTolerability Study of Two Different Weekly Doses of Alpha1-Proteinase Inhibitor Subcutaneous (Human) 15% in Patients With Alpha1-Antitrypsin Deficiency Compared to Corresponding Standard 60 mg\u002Fkg\u002FWeek and 120 mg\u002Fkg\u002FWeek Doses of Intravenous Alpha1-Proteinase Inhibitor (5%)","SWIFT-SC","Inclusion Criteria:\n\n* Have a diagnosis of congenital AATD with an allelic combination of ZZ, SZ, Z(null), (null)(null), S(null), or \"at-risk\" alleles (patients with \"at-risk\" alleles must be individually evaluated for eligibility by the Medical Monitor). If the genotype has yet to be documented, a blood draw for genotyping (i.e., allelic discrimination) and phenotyping will be obtained at the Screening Visit.\n* Participants may be naïve to alpha1-PI augmentation therapy or may be currently receiving alpha1-PI augmentation therapy or received alpha1-PI augmentation therapy in the past. If the total alpha1-PI serum (alpha-1 antitrypsin \\[AAT\\]) level has yet to be documented as in a treatment-naïve patient, a blood draw for total alpha1-PI serum level will be obtained at the Screening Visit. For participants currently receiving alpha1-PI augmentation, a pre-alpha1-PI augmentation AAT level must be documented in the participant's medical history\u002Frecords.\n* All participants must have a documented total alpha1-PI serum level \\\u003C11 μM (80mg\u002FdL if measured by radial immunodiffusion or 50 mg\u002FdL if measured by nephelometry) which is documented pre-alpha1-PI augmentation for participants receiving AAT augmentation.\n* At the Screening Visit, have post-bronchodilator Forced Expiratory Volume in 1 second (FEV₁) ≥25% and \\\u003C80% predicted of predicted FEV₁\u002FForced Vital Capacity (FVC) \\\u003C70% (Global Initiative for Chronic Obstructive Lung Disease \\[GOLD\\] stage II-III, and some individuals are GOLD stage IV).\n* If the participant has received alpha1-PI augmentation therapy of any kind, he\u002Fshe must be willing to discontinue that treatment at the Week 1 (Baseline) Visit and remain off any kind of alpha1-PI treatment, other than the IPs of this study, while participating in the study.\n* Willing and able to provide written informed consent indicating that they understand the purpose of, and procedures required for the study and are willing to participate in it.\n\nExclusion Criteria:\n\n* Have had a moderate or severe chronic obstructive pulmonary disease (COPD) exacerbation during the 4 weeks before the Week 1 (Baseline) Visit.\n* Have history of lung or liver transplant or on transplantation waiting list.\n* Have any lung surgery during the past 1 year (excluding lung biopsy).\n* At screening, have elevated liver enzymes (aspartate aminotransferase \\[AST\\], alanine aminotransferase \\[ALT\\], and alkaline phosphatase \\[ALP\\]) ≥ 2.5 times the upper limit of normal (ULN).\n* Have severe concomitant disease (e.g., congestive heart failure, clinically significant pulmonary fibrosis, malignant disease \\[except for skin cancers other than melanoma\\], history of acute hypersensitivity pneumonitis reaction, or current chronic hypersensitivity pneumonitis).\n* Females who are pregnant, breastfeeding or, if of child-bearing potential†, unwilling to practice a highly effective method of contraception (oral, injectable, or implanted hormonal methods of contraception, placement of an intrauterine device (IUD) or intrauterine system (IUS), condom or occlusive cap with spermicidal foam\u002Fgel\u002Ffilm\u002Fcream\u002Fsuppository, male sterilization, or true abstinence\\*) throughout the study. †Women of childbearing potential are defined as premenopausal and not surgically sterile, post tubal ligation, nor documented as infertile due to a concurrent medical condition.\n\n  \\*True abstinence: When this is in line with the preferred and usual lifestyle of the participant. (Periodic abstinence \\[e.g., calendar, ovulation, symptothermal, post-ovulation methods\\], declaration of abstinence for the duration of a study, and withdrawal are not acceptable methods of contraception.)\n* Have known previous infection with or clinical signs and symptoms consistent with current Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV) infection.\n* Have smoked during the past 6 months (this includes electronic\u002Fvapor cigarettes) or a positive urine cotinine test at the Screening Visit that is due to smoking.\n* Received IP in another study within 30 days prior to the Week 1 (Baseline) Visit or received any recombinant human AAT-Fc fusion protein (e.g., INBRX-101) or other extended half-life AAT products within 5 half-lives of the product relative to the Screening Visit date.\n* Have history of anaphylaxis or severe systemic response to any plasma-derived alpha1- PI preparation or other blood product(s).\n* Use systemic steroids above a stable dose equivalent to 5 mg\u002Fday prednisone (i.e., 10 mg every 2 days) within the 4 weeks prior to the Week 1 (Baseline) Visit (Note: inhaled steroids are not considered systemic steroids). It is recommended to maintain the same dose throughout the study.\n* Use systemic or aerosolized antibiotics for a COPD exacerbation within the 4 weeks prior to the Week 1 (Baseline) Visit.\n* Have known selective or severe Immunoglobulin A (IgA) deficiency based on prior medical records.\n* In the opinion of the Investigator, the participant may have compliance problems or any medical condition that may place them at safety risk with the protocol and the procedures of the protocol, or because of unstable health be unable to come to the study site for in-person clinic visits required by the protocol.","80 Years",{"count":163,"type":20},40,[50],"This study is designed to compare two different weekly doses of a medicine called Alpha1-Proteinase Inhibitor given by injection under the skin with the standard doses of the same medicine given through a vein.\n\nAdults with Alpha-1 Antitrypsin Deficiency will take part. Participants will be randomly assigned to one of the treatment groups, and both the study doctors and participants will know which treatment is being given.\n\nThe main goals of the study are to understand how the body processes the medicine (pharmacokinetics) and to assess how safe and well tolerated the different weekly doses are.",[167],"Alpha 1 Antitrypsin Deficiency",[169,170,171,172,173,174,175,176,177,178,179,180,181,182,183,184,185,186,187],"Phase 3","Clinical Trial","Alpha1-Proteinase Inhibitor (Human)","Alpha 1-Antitrypsin","Subcutaneous","Intravenous","Pulmonary Emphysema","Emphysema","Pathologic Processes","Pulmonary Disease, Chronic Obstructive","Lung Diseases, Obstructive","Lung Diseases","Respiratory Tract Diseases","Genetic Diseases, Inborn","Subcutaneous Emphysema","Serine Proteinase Inhibitors","Protease Inhibitors","Enzyme Inhibition","Molecular Mechanisms of Pharmacological Action",{"date":30,"type":31},{"date":190,"type":31},"2026-05-05",{"date":192,"type":20},"2027-09-30",{"name":194,"class":38},"Grifols Therapeutics LLC",22,{"id":197,"slug":4,"hasResults":11,"nctId":198,"briefTitle":199,"officialTitle":200,"acronym":201,"eligibilityCriteria":202,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":203,"enrollmentInfo":204,"targetDuration":4,"studyType":21,"phases":206,"briefSummary":207,"conditions":208,"keywords":210,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":214,"startDateStruct":215,"completionDateStruct":217,"leadSponsor":219,"locationsCount":221},"100054201","NCT06012240","A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants With Severe Alopecia Areata","A Phase 3 Randomized, Placebo-controlled, Double-blind Program to Evaluate Efficacy and Safety of Upadacitinib in Adult and Adolescent Subjects With Severe Alopecia Areata","Up-AA","Inclusion Criteria:\n\n* Adult individuals must be \\\u003C 64 years old at Baseline Visit. Where permitted outside United States (US)\u002FEuropean Union (EU), adolescent individuals who are at least 12 years old at Screening may participate in Study 1 and Study 2. Adolescent individuals in the US who are at least 12 years old at Screening may participate in Study 4.\n* Diagnosis of severe alopecia areata (AA) with Severity of Alopecia Tool (SALT) score \\>= 50 scalp hair loss at Screening and Baseline.\n* Severe AA with no spontaneous scalp hair regrowth over the past 6 months.\n* Current episode of AA of less than 8 years.\n\nExclusion Criteria:\n\n* Current diagnosis of primarily diffuse type of AA.\n* Current diagnosis of other types of alopecia that would interfere with evaluation of AA, including but not limited to female pattern hair loss, male pattern hair loss (androgenetic alopecia) Stage III or greater based on Hamilton-Norwood classification, traction alopecia, lichen planopilaris (LPP), discoid lupus, frontal fibrosing alopecia (FFA), central centrifugal cicatricial alopecia (CCCA), folliculitis decalvans, trichotillomania, and telogen effluvium.\n* Diagnosis of other types of inflammatory scalp, eyebrow, or eyelash disorders that would interfere with evaluation of AA as determined by the investigator, including but not limited to seborrheic dermatitis, scalp psoriasis, atopic dermatitis (AD), and tinea capitis.","63 Years",{"count":205,"type":20},1500,[50],"Alopecia areata (AA) is a disease that happens when the immune system attacks hair follicles and causes hair loss. AA usually affects the head and face, but hair loss can happen on any part of the body. The purpose of this study is to assess how safe, effective, and tolerable upadacitinib is in adolescent and adult participants with severe AA.\n\nUpadacitinib is an approved drug being investigated for the treatment of AA. In Study 1 and Study 2 and Study 4 Period A, participants are placed in 1 of 3 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 5 chance that participants will be assigned to placebo. In Study 1 and Study 2 and Study 4 Period B, participants originally randomized to upadacitinib dose group in Period A will continue their same treatment in Period B. Participants originally randomized to Placebo in Period A will either remain on placebo in Period B, or be randomized in 1 of 2 groups, based off of their Severity of Alopecia Tool (SALT) score. Participants who complete Study 1, Study 2 or Study 4, can join Study 3 and may be re-randomized to receive 1 of 2 doses of upadacitinib for up to 108 weeks. Around 1500 participants with severe AA will be enrolled in the study at approximately 280 sites worldwide.\n\nParticipants will receive oral tablets of either upadacitinib or placebo once daily for up to 160 weeks with the potential of being re-randomized into a different treatment group at Weeks 24 and 52. Participants will be followed up for up to 30 days after last study drug dose.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.",[209],"Alopecia Areata",[209,211,212,213],"Upadacitinib","Rinvoq","ABT-494",{"date":30,"type":31},{"date":216,"type":31},"2023-10-11",{"date":218,"type":20},"2030-04",{"name":220,"class":38},"AbbVie",281,{"id":223,"slug":4,"hasResults":11,"nctId":224,"briefTitle":225,"officialTitle":226,"acronym":4,"eligibilityCriteria":227,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":228,"targetDuration":4,"studyType":121,"phases":4,"briefSummary":230,"conditions":231,"keywords":233,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":236,"startDateStruct":237,"completionDateStruct":239,"leadSponsor":241,"locationsCount":243},"100053391","NCT05376891","Met Non Small Cell Cancer Registry (MOMENT)","Disease Registry on Patients With Advanced NSCLC Harboring METex14 Skipping Alterations (MOMENT)","Inclusion Criteria:\n\n* Participants who signed ICF\n* Participants with advanced stage (stages IIIB-IV) NSCLC (all histologies) and Confirmed METex14 skipping alterations (by valid assay)\n* Participants who are starting or are already being treated with systemic therapy\n\nExclusion Criteria:\n\n* Participants who are enrolled in a clinical trial",{"count":229,"type":20},700,"The purpose of this multi-national disease registry is to collect prospectively (with longitudinal follow-up) high-quality, standardized, and contemporaneous data to capture changes in the non-small cell lung cancer (NSCLC) treatment landscape and outcomes over time.\n\nThe registry will capture data on participants; demographic, clinical characteristics (including biomarker data), treatment patterns, and effectiveness and safety outcomes for advanced NSCLC with mesenchymal-epithelial transition exon 14(METex14) participants treated with systemic therapy.",[232],"Cancer",[234,235],"Disease Registry","METex14 Skipping Alterations",{"date":30,"type":31},{"date":238,"type":31},"2022-10-04",{"date":240,"type":20},"2028-04-28",{"name":242,"class":38},"EMD Serono Research & Development Institute, Inc.",66,{"id":245,"slug":4,"hasResults":11,"nctId":246,"briefTitle":247,"officialTitle":248,"acronym":4,"eligibilityCriteria":249,"healthyVolunteers":11,"sex":16,"minAge":46,"maxAge":4,"enrollmentInfo":250,"targetDuration":4,"studyType":21,"phases":252,"briefSummary":253,"conditions":254,"keywords":256,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":261,"startDateStruct":262,"completionDateStruct":264,"leadSponsor":266,"locationsCount":267},"100054110","NCT06456346","Bomedemstat vs Hydroxyurea for Essential Thrombocythemia (MK-3543-007)","A Phase 3, Randomized, Double-blind, Active-Comparator-Controlled Clinical Study to Evaluate the Efficacy and Safety of Bomedemstat (MK-3543) Versus Hydroxyurea in Cytoreductive Therapy Naïve Essential Thrombocythemia Participants","Inclusion Criteria:\n\n* Diagnosis of Essential Thrombocythemia (ET) based on World Health Organization Criteria for myeloproliferative neoplasms, and an indication for cytoreductive therapy regardless of age or risk status\n* Has a centrally assessed bone marrow fibrosis score of Grade 0 or Grade 1, as per a modified version of the European Consensus Criteria for Grading Myelofibrosis\n* Has received no prior cytoreductive treatment for their ET\n* Human Immunodeficiency Virus (HIV)-infected participants have well controlled HIV on antiretroviral therapy\n* Participants who are Hepatitis B surface antigen (HBsAg) positive are eligible if they have received Hepatitis B Virus (HBV) antiviral therapy for at least 4 weeks and have undetectable HBV viral load\n* Participants with history of Hepatitis C Virus (HCV) infection are eligible if HCV viral load is undetectable\n\nExclusion Criteria:\n\n* History of any illness\u002Fimpairment of gastrointestinal function that might interfere with drug absorption\n* History of a malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 2 years\n* HIV-infected participants with a history of Kaposi's sarcoma and\u002For Multicentric Castleman's Disease\n* Has an active infection requiring systemic therapy\n* Has had a major surgery \\\u003C4 weeks prior to first dose of study intervention or has not recovered from side effects of major surgery \\>4 weeks prior to first dose",{"count":251,"type":20},300,[50],"The purpose of this study is to evaluate the efficacy and safety of bomedemstat compared with hydroxyurea in cytoreductive therapy naïve essential thrombocythemia (ET) participants for whom cytoreductive therapy is indicated. Its primary objective is to compare bomedemstat to hydroxyurea with respect to durable clinicohematologic response (DCHR). The primary hypothesis is that bomedemstat is superior to hydroxyurea with respect to DCHR.",[255],"Essential Thrombocythemia",[257,258,259,260],"essential thrombocythemia","ET","bomedemstat","IMG-7289",{"date":30,"type":31},{"date":263,"type":31},"2024-07-16",{"date":265,"type":20},"2028-03-24",{"name":111,"class":38},171,{"id":269,"slug":4,"hasResults":11,"nctId":270,"briefTitle":271,"officialTitle":272,"acronym":273,"eligibilityCriteria":274,"healthyVolunteers":11,"sex":16,"minAge":46,"maxAge":161,"enrollmentInfo":275,"targetDuration":4,"studyType":21,"phases":277,"briefSummary":278,"conditions":279,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":282,"startDateStruct":283,"completionDateStruct":284,"leadSponsor":286,"locationsCount":288},"100054145","NCT07672236","A Clinical Study to Compare BupiZenge With Lidocaine for Pain Due to Oral Mucositis in Patients With Head and Neck Cancer.","A Randomized, Open-label, Phase III Trial to Assess the Efficacy and Safety of BupiZenge Compared to Lidocaine for Pain Associated With Oral Mucositis in Head and Neck Cancer","BEAM-Pain","Inclusion Criteria:\n\n* Participant must provide signed written informed consent prior to trial participation and must be willing and able to comply with all requirements and restrictions of the trial.\n* Male or female aged ≥ 18 on the day of consent and ≤ 80 on the first day of dosing.\n* Pathologically confirmed diagnosis of squamous cell carcinoma of the oral cavity, oropharynx, hypopharynx, or nasopharynx.\n* About to start IMRT with curative intent with daily fractions of 2.0 Gy to 2.2 Gy to a cumulative intended dose of at least 60 Gy and a maximum of 72 Gy. Proton therapy given at equivalent biological doses is allowed.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status 0-2.\n* Female participants of childbearing potential (WOCBP) must agree to use a highly effective contraceptive measure or practice total sexual abstinence from the time of giving informed consent until at least 24 hours after last dose of IMP.\n\nExclusion Criteria:\n\n* Participation in another investigational interventional clinical trial within 3 months prior to first dosing, or for a longer period if required by local regulations, or within 5 half-lives of the investigational agent taken (whichever is longer). An exception is studies where patients are randomized to different radiotherapy settings, e.g. participation in DAHANCA 35 is allowed.\n* Previous radiation therapy to the head and\u002For neck area.\n* Pre-existing OM, active herpes simplex virus (HSV) infection, or untreated or uncontrolled oral candidiasis.\n* Receiving high-dose (\\> 15 mg per day prednisolone), corticosteroids (for any indication).\n* Known allergy or intolerance to bupivacaine, lidocaine, or any of the excipients in the products.\n* Significant cardiac disease such as AV block II-III or requiring treatment with antiarrhythmic drugs in class III (e.g., amiodarone).\n* Inability to eat or drink, or dependence on an enteral feeding tube (percutaneous endoscopic gastrostomy \\[PEG\\] or nasogastric tube) for any reason.\n* Moderate\u002Fsevere liver or kidney disease defined as:\n\n  1. AST\u002FALT \\> 3 × upper limit of normal (ULN) or bilirubin \\> 1.5 × ULN (unless related to Gilbert's syndrome)\n  2. glomerular filtration rate (GFR) \\\u003C 30 mL\u002Fmin\u002F1.73 m2\n* Known diagnosis of epilepsy.\n* Known phenylketonuria (PKU).\n* Pregnancy or breastfeeding.\n* Any condition or circumstance-based on the investigator's assessment-that could increase risk to the participant, confound trial results, or interfere with compliance \u002F participation (including inability or unwillingness to follow trial procedures, or any clinically significant physical or psychiatric condition).",{"count":276,"type":20},150,[50],"Most patients who receive radiation therapy for head and neck cancer develop painful sores in the mouth called oral mucositis. For many of them, these sores are severe and result in debilitating pain. The sores usually start in the third week of radiation and last aboutfive weeks, often continuing for two weeks after treatment ends. Current pain treatments, for instance lidocaine solution, only give short-lasting pain relief.\n\nBupiZenge is a lozenge that dissolves slowly in the mouth and contains bupivacaine. Bupivacaine is a long-acting pain-relieving medicine and has been safely used for many years for both children and adults, and its safety profile is well understood. The BupiZenge lozenge is designed to give longer and more reliable pain relief for patients with mucositis in their mouth.\n\nThis study will check if BupiZenge works better to reduce pain than lidocaine, and if better pain control improves quality of life and reduces the need for strong pain medicines like opioids.\n\nThe main goal is to see how much mouth pain decreases after taking BupiZenge compared to lidocaine. This is measured by asking the patients to rate their pain score on a scale from 0 (no pain) to 10 (worst possible pain). This is done at different time-points, from before the dose until three hours after dose on the last day of radiotherapy.\n\nThe study will include 150 adults, both women and men, aged 18 to 80 years, who have head and neck cancer and are scheduled to receive radiotherapy, with or without chemotherapy. These patients will be randomly assigned to one of the treatment groups. The first is BupiZenge, which is a lozenge containing bupivacaine, which dissolves slowly in the mouth. The second is lidocaine, which is a liquid solution for use in the mouth that you gurgle or swish around in the mouth.\n\nThe study begins with a combined screening and run-in period that can last up to five weeks. During radiotherapy, patients record their mouth pain each day using a number scale from 0 (no pain) to 10 (worst possible pain). If the pain score is at least 4 (moderate pain) and they have developed mucositis in the mouth within 5 weeks, patients are randomly assigned to receive either BupiZenge or Lidocaine.\n\nTreatment continues at least until radiotherapy is completed. If the patient has pain and mouth sores, and the treatment is working well, it may continue after radiotherapy ends, but only until the sores heal or for a maximum of six weeks in total, whichever occurs first. After treatment ends, there is a 30-day follow-up period.",[280,281],"Head & Neck Cancer","Oral Mucositis",{"date":30,"type":31},{"date":57,"type":31},{"date":285,"type":20},"2027-01-31",{"name":287,"class":38},"OncoZenge AB",11,{"id":290,"slug":4,"hasResults":11,"nctId":291,"briefTitle":292,"officialTitle":293,"acronym":294,"eligibilityCriteria":295,"healthyVolunteers":11,"sex":16,"minAge":46,"maxAge":4,"enrollmentInfo":296,"targetDuration":4,"studyType":21,"phases":298,"briefSummary":300,"conditions":301,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":303,"startDateStruct":304,"completionDateStruct":306,"leadSponsor":308,"locationsCount":310},"100053298","NCT05789082","A Study Evaluating the Safety, Activity, and Pharmacokinetics of Divarasib as a Single Agent or in Combination With Other Anti-Cancer Therapies in Participants With Previously Untreated Advanced or Metastatic Non-Small Cell Lung Cancer With a KRAS G12C Mutation","A Phase Ib\u002FII, Open-Label, Multicenter Study Evaluating the Safety, Activity, and Pharmacokinetics of Divarasib as a Single Agent or in Combination With Other Anti-Cancer Therapies in Patients With Previously Untreated Advanced Or Metastatic Non-Small Cell Lung Cancer With a KRAS G12C Mutation","KRAScendo 170","Inclusion Criteria:\n\n* Confirmation of Biomarker eligibility\n* Pre-treatment tumor tissue along with an associated pathology report is required for all participants enrolled on study. Representative tumor specimens must be in formalin-fixed, paraffin embedded (FFPE) blocks (preferred) or 15 unstained, freshly cut, serial slides. Although 15 slides are required, if only 10 slides are available, the participant may be eligible for the study following consultation with the Sponsor.\n* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1\n* Histologically or cytologically documented locally advanced unresectable or metastatic NSCLC that is not eligible for curative surgery and\u002For definitive chemoradiotherapy\n* No prior systemic treatment for advanced unresectable or metastatic NSCLC\n* Measurable disease, as defined by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Additionally, for participants in cohort D, measurable brain metastases defined as at least 5 millimeters and twice the slice thickness, but less than 20 mm, that is asymptomatic and does not require local therapy at the time of enrollment.\n\nExclusion Criteria:\n\n* Known concomitant second oncogenic driver with available targeted treatment\n* Squamous cell histology NSCLC\n* Symptomatic, untreated, or actively progressing CNS metastases (Cohorts A, B, and C)\n* Prior treatment with a KRAS G12C inhibitor\n* Known hypersensitivity to any of the components of divarasib or pembrolizumab; or known hypersensitivity to pemetrexed, carboplatin, or cisplatin (Cohort B only)\n* History of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis, or evidence of active pneumonitis, active tuberculosis, significant cardiovascular disease within 3 months prior to initiation of study treatment\n* History of malignancy other than NSCLC within 5 years prior to initiation of study treatment, with the exception of malignancies with a negligible risk of metastasis or death (e.g., 5-year OS rate more \\>90%), such as adequately treated carcinoma in situ of the cervix, non-melanoma skin carcinoma, localized prostate cancer, ductal breast carcinoma in situ, or Stage I uterine cancer\n* Uncontrolled tumor related pain, pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures, uncontrolled or symptomatic hypercalcemia\n* Co-morbid condition that is an absolute contraindication to treatment with corticosteroids\n* Inability or unwillingness to take prophylactic treatments such as corticosteroids, anti-emetics, folic acid, or vitamin B12 supplementation.\n* Participants with brain metastases for whom complete surgical resections is clinically appropriate",{"count":297,"type":20},320,[299,23],"PHASE1","The purpose of this study is to evaluate the safety, pharmacokinetics (PK), and activity of single-agent divarasib or combined with other anti-cancer therapies in participants with previously untreated, advanced or metastatic non-small cell lung cancer (NSCLC).",[302],"Non-Small Cell Lung Cancer",{"date":30,"type":31},{"date":305,"type":31},"2023-06-20",{"date":307,"type":20},"2032-01-29",{"name":309,"class":38},"Hoffmann-La Roche",71,{"id":312,"slug":4,"hasResults":11,"nctId":313,"briefTitle":314,"officialTitle":315,"acronym":316,"eligibilityCriteria":317,"healthyVolunteers":11,"sex":16,"minAge":46,"maxAge":4,"enrollmentInfo":318,"targetDuration":4,"studyType":21,"phases":320,"briefSummary":321,"conditions":322,"keywords":326,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":334,"startDateStruct":335,"completionDateStruct":337,"leadSponsor":339,"locationsCount":341},"100054235","NCT07181109","Zilebesiran in Patients With Hypertension Not Adequately Controlled and With Either Established Cardiovascular Disease or High Risk for Cardiovascular Disease","ZENITH: A Phase 3 Global, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Zilebesiran in Addition to Standard of Care in Reducing Major Adverse Cardiovascular Events in Adult Patients With Hypertension Not Adequately Controlled and With Either Established Cardiovascular Disease or High Risk for Cardiovascular Disease","ZENITH","Inclusion Criteria:\n\n* Is 18 years or older for patients with established cardiovascular disease (CVD)\n* Is 55 years or older for patients with high risk for CVD\n* Has established CVD (defined as coronary, cerebrovascular, or peripheral artery disease) or high risk for CVD\n* Has treated hypertension on stable therapy with at least 2 standard of care antihypertensive medications, one of which must be a thiazide, thiazide-like, or loop diuretic\n\nExclusion Criteria:\n\n* Has known history of secondary hypertension\n* Has symptomatic orthostatic hypotension\n* Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \\>3×upper limit of normal (ULN)\n* Has total serum bilirubin \\>1.5×ULN\n* Has international normalized ratio (INR) \\>1.5\n* Has serum potassium \\>4.8 mEq\u002FL\n* Has estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002F1.73m\\^2",{"count":319,"type":20},11000,[50],"The purpose of this study is to evaluate whether zilebesiran versus placebo reduces the risk of cardiovascular (CV) death, nonfatal myocardial infarction (MI), nonfatal stroke, or heart failure (HF) events. This is an event-driven study that will continue until the targeted number of positively adjudicated primary endpoint clinical outcome events (COEs) have been reached.",[323,324,325],"High Risk Cardiovascular Disease","Hypertension","High Cardiovascular Risk",[327,328,329,330,331,332,333],"High blood pressure","siRNA","Angiotensinogen","AGT","Cardiovascular disease","Uncontrolled hypertension","RNAi",{"date":30,"type":31},{"date":336,"type":31},"2025-09-22",{"date":338,"type":20},"2030-09-30",{"name":340,"class":38},"Alnylam Pharmaceuticals",995,{"id":343,"slug":4,"hasResults":11,"nctId":344,"briefTitle":345,"officialTitle":346,"acronym":4,"eligibilityCriteria":347,"healthyVolunteers":11,"sex":16,"minAge":4,"maxAge":4,"enrollmentInfo":348,"targetDuration":4,"studyType":121,"phases":4,"briefSummary":350,"conditions":351,"keywords":353,"overallStatus":54,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":363,"startDateStruct":364,"completionDateStruct":366,"leadSponsor":368,"locationsCount":371},"100053597","NCT07678905","Management and Leadership in Healthcare: Expectations, Conditions, Skills, and Reflections in a Leadership Program","First- and Second-Line Healthcare Managers' Expectations, Skills, and Conditions for Practicing Management and Leadership Before, During, and After Participation in a Leadership Development Program, and Their Reflections on the Program","Inclusion Criteria:\n\n* Employed as a first- or second-line healthcare manager in Region Kronoberg and selected by the healthcare organization to participate in the leadership development program starting in September 2026.\n\nExclusion Criteria:\n\n* Not employed as a first- or second-line healthcare manager",{"count":349,"type":20},50,"This study follows first- and second-line healthcare managers who take part in an established leadership development program in a Swedish healthcare region. The study examines managers' expectations of the program and how they describe their skills and conditions for practicing management and leadership before, during, and after participation. It also explores their reflections on the program, including learning, new insights, application in everyday management practice, and conditions for taking part.\n\nParticipants complete questionnaires before the program, immediately after it ends, and one year later. During the program, they record reflections in structured diaries. After the program, participants are invited to focus group interviews to discuss their experiences in greater depth. The questionnaire, diary, and interview findings will be combined to provide a broader understanding of managers' development and experiences of the program.",[352],"Management and Leadership in Healthcare",[354,355,356,357,358,359,360,361,362],"Healthcare Managers","Leadership Development Program","Thriving at Work","Longitudinal Studies","Diary Method","Focus Group Interviews","Intention to Leave","Questionnaires","Leadership and Management Performance",{"date":30,"type":31},{"date":365,"type":20},"2026-09",{"date":367,"type":20},"2028-07",{"name":369,"class":370},"Kronoberg County Council","OTHER_GOV",1,{"id":373,"slug":4,"hasResults":11,"nctId":374,"briefTitle":375,"officialTitle":376,"acronym":4,"eligibilityCriteria":377,"healthyVolunteers":11,"sex":16,"minAge":378,"maxAge":161,"enrollmentInfo":379,"targetDuration":4,"studyType":21,"phases":381,"briefSummary":382,"conditions":383,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":385,"startDateStruct":386,"completionDateStruct":388,"leadSponsor":390,"locationsCount":391},"100053921","NCT06430801","A Study to Evaluate the Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderate to Severe Crohn's Disease (MK-7240-008)","A Phase 3, Randomized, Double-Blind, Placebo-Controlled Program to Evaluate the Efficacy and Safety of Tulisokibart in Participants With Moderately to Severely Active Crohn's Disease","The main inclusion and exclusion criteria include but are not limited to the following:\n\nInclusion Criteria:\n\n* Has had a diagnosis of CD at least 3 months before study.\n* Has moderately to severely active CD.\n* Demonstrated inadequate response, loss of response, or intolerance to one or more of the following categories of drugs: oral locally acting steroids, systemic steroids, immunomodulators, biologic and\u002For small molecule advanced therapies.\n* Adolescent participants ≥16 and \\\u003C18 years of age can participate if approved by the country or regulatory\u002Fhealth authority.\n\nExclusion Criteria:\n\n* Has diagnosis of ulcerative colitis (UC) or indeterminate colitis.\n* Has CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic and\u002For ileal involvement.\n* Currently has any of the following complications of CD: suspected or diagnosed with intra-abdominal or perianal abscess, known symptomatic stricture or colonic stenosis not passable in endoscopy, fulminant colitis, toxic megacolon, or any other manifestation that might require surgery while enrolled in the study.\n* Has current stoma or need for colostomy or ileostomy.\n* Is missing \\>2 segments of the following 5 segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum.\n* Has been diagnosed with short gut or short bowel syndrome, or any other uncontrolled chronic diarrhea besides Crohn's disease.\n* Has surgical bowel resection within 3 months of study.\n* Has prior or current gastrointestinal dysplasia.\n* Has chronic infection requiring ongoing antimicrobial treatment.\n* Has a history of cancer (except fully treated non-melanoma skin cell cancers or cervical carcinoma in situ after complete surgical removal) and is disease free for \\\u003C5 years.\n* Is infected with Hepatitis B virus (HBV), Hepatitis C virus (HCV), or human immunodeficiency virus (HIV).\n* Has active tuberculosis.\n* Has confirmed or suspected coronavirus disease of 2019 (COVID-19) infection.\n* Prior exposure to tulisokibart (MK-7240, PRA023) or another anti-TL1A antibody.","16 Years",{"count":380,"type":20},1200,[50],"The purpose of this protocol is to evaluate the efficacy and safety of tulisokibart in participants with moderately to severely active Crohn's disease. Study 1's primary hypotheses are that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\\\u003C150, US\u002FFDA) or per stool frequency and abdominal pain score (EU\u002FEMA) and in the proportion of participants achieving endoscopic response at Week 52 (US\u002FFDA and EU\u002FEMA), and that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\\\u003C150, US\u002FFDA) or per stool frequency and abdominal pain score (EU\u002FEMA) and in the proportion of participants achieving endoscopic response at Week 12 (US\u002FFDA and EU\u002FEMA). Study 2's primary hypothesis is that at least 1 tulisokibart dose level is superior to placebo in the proportion of participants achieving clinical remission per Crohn's Disease Activity Index score (\\\u003C150, US\u002FFDA) or stool frequency and abdominal pain score (EU\u002FEMA) and in the proportion of participants achieving endoscopic response at Week 12 (US\u002FFDA and EU\u002FEMA).",[384],"Crohn's Disease",{"date":30,"type":31},{"date":387,"type":31},"2024-06-05",{"date":389,"type":20},"2029-11-12",{"name":111,"class":38},499,{"id":393,"slug":4,"hasResults":11,"nctId":394,"briefTitle":395,"officialTitle":396,"acronym":4,"eligibilityCriteria":397,"healthyVolunteers":11,"sex":16,"minAge":398,"maxAge":399,"enrollmentInfo":400,"targetDuration":4,"studyType":21,"phases":402,"briefSummary":403,"conditions":404,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":407,"startDateStruct":408,"completionDateStruct":410,"leadSponsor":412,"locationsCount":413},"100053407","NCT05714085","Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)","A Phase 2\u002F3 Randomized, Placebo-Controlled, Double-blind, Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Systemic Left Ventricular Systolic Dysfunction (VALOR)","Inclusion Criteria:\n\n* Has symptomatic chronic heart failure (HF) resulting from systemic left ventricular (LV) systolic dysfunction.\n* Has biventricular physiology with a morphologic systemic left ventricle.\n* Is currently receiving stable medical therapy for HF.\n* Has left ventricular ejection fraction (LVEF) \\\u003C45% assessed within 3 months before randomization.\n* Is of any sex\u002Fgender, from \\>28 days to \\\u003C18 years of age inclusive. Must weigh ≥3 kg to participate.\n* Female is eligible to participate if not pregnant or breastfeeding, and at least one of the following: is not a participant of childbearing potential (POCBP); or is a POCBP who uses a highly effective contraceptive method; has a negative highly sensitive pregnancy test; abstains from breastfeeding during the study intervention period and for at least 30 days after study intervention; and their medical history; their menstrual history, and recent sexual activity has been reviewed.\n* Extension Period: Was randomized, received at least 1 dose of study intervention (vericiguat or placebo), did not permanently discontinue study intervention, and completed the Week 52 visit and safety follow-up period of the Base Period\n\nExclusion Criteria:\n\n* Is clinically unstable-with at least one of the following: has symptomatic hypotension or is hypotensive for age, recent use of intravenous (IV) inotrope and\u002For IV vasodilator, or recent IV diuretic.\n* Has a known allergy or sensitivity to vericiguat, any of its constituents, or any other soluble guanylate cyclase (sGC) stimulator.\n* Has a history of single ventricle heart disease or has a morphologic systemic right ventricle.\n* Has undergone heart transplantation, is awaiting heart transplantation United Network for Organ Sharing (UNOS) Class 1A or equivalent, is receiving continuous IV infusion of an inotrope, or has an implanted ventricular assist device.\n* Has sustained or symptomatic dysrhythmia uncontrolled with drug or device therapy.\n* Has had recent cardiovascular (CV) surgical procedure or percutaneous intervention to palliate or correct congenital CV malformations.\n* Has unoperated or residual hemodynamically significant congenital cardiac malformations.\n* Has hypertrophic or restrictive cardiomyopathy.\n* Has active myocarditis or has been recently diagnosed with presumed or definitive myocarditis.\n* Has acute coronary syndrome, undergone recent coronary intervention, or indication for coronary revascularization.\n* Has symptomatic carotid stenosis or other symptomatic cerebrovascular disease\n* Has severe pulmonary hypertension.\n* Requires continuous home oxygen for significant pulmonary disease and\u002For has known interstitial lung disease.\n* Has severe chronic kidney disease.\n* Has hepatic disorder such as hepatic encephalopathy, hepatic laboratory abnormalities or Child Pugh Class C.\n* Has a gastrointestinal or biliary disorder that could impair absorption, metabolism, or excretion of medications.\n* Has significant bone disease (other than osteopenia) that in the assessment of the investigator can alter bone formation\n* Has concurrent or anticipated concomitant use of phosphodiesterase type 5 inhibitors or an sGC stimulator.\n* Has received a COVID-19 vaccination within 1 week before randomization.","29 Days","17 Years",{"count":401,"type":20},342,[23,50],"This study aims to compare the efficacy of vericiguat versus placebo on change in n-terminal pro-brain natriuretic peptide (NTproBNP) from baseline to Week 16 of the Base Period. The primary hypothesis is that vericiguat is superior to placebo in reducing NT-proBNP at Week 16 of the Base Period.",[405,406],"Heart Failure","Left Ventricular Systolic Dysfunction",{"date":30,"type":31},{"date":409,"type":31},"2023-05-31",{"date":411,"type":20},"2032-04-15",{"name":111,"class":38},107,{"id":415,"slug":4,"hasResults":11,"nctId":416,"briefTitle":417,"officialTitle":418,"acronym":4,"eligibilityCriteria":419,"healthyVolunteers":11,"sex":16,"minAge":420,"maxAge":421,"enrollmentInfo":422,"targetDuration":4,"studyType":21,"phases":424,"briefSummary":425,"conditions":426,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":428,"lastUpdatePostDateStruct":429,"startDateStruct":430,"completionDateStruct":432,"leadSponsor":434,"locationsCount":436},"100053332","NCT06842355","A Study of TYRA-300 in Children With Achondroplasia: BEACH301","A Multicenter, Phase 2, Dose-Escalation\u002FDose-Expansion Study of TYRA-300 in Children With Achondroplasia With Open Growth Plates: BEACH301","Inclusion Criteria:\n\n* Aged 3 to 10 years old (inclusive) at the time of consent.\n* Informed consent provided by parent(s) or legal guardian(s). As study participants are less than 18 years old, participants are willing and able to provide written assent (where applicable and required).\n* Molecular diagnosis of achondroplasia (FGFR3 G380R).\n* Radiographically confirmed open growth plates at Screening, as determined by bone age X-ray.\n* Able to stand and ambulate independently.\n* Able to take oral medication.\n* Sentinel Safety Cohort only: aged 5 to 10 years old (inclusive).\n* Cohort 1 only: aged 3 to 10 years old (inclusive) and are naive to prior growth accelerating therapy.\n* Cohort 2 only: aged 3 to 10 years old (inclusive) and have received prior growth accelerating therapy.\n\nExclusion Criteria:\n\n* Presence or history of any concurrent disease or condition that would interfere with study participation, safety evaluations, or any uncontrolled or untreated condition that could impact pediatric growth.\n* Diagnosis of endocrine condition that alters calcium\u002Fphosphate homeostasis.\n* Prior limb lengthening surgery or planned or expected to have limb lengthening surgery while enrolled in the study.\n* Taking medications that are strong inhibitors or inducers of cytochrome P450 (Cyp) 3A4.\n* History or current evidence of corneal or retinal disorder\u002Fkeratopathy.\n* Presence of guided growth hardware\u002F8 plates. Planned or anticipated orthopedic surgeries.","3 Years","10 Years",{"count":423,"type":20},92,[23],"The purpose of this study is to evaluate the safety, tolerability, and identify potentially effective dose(s) of TYRA-300 in children with achondroplasia with open growth plates.",[427],"Achondroplasia","2026-07-09",{"date":30,"type":31},{"date":431,"type":31},"2025-03-04",{"date":433,"type":20},"2030-06",{"name":435,"class":38},"Tyra Biosciences, Inc",19,{"id":438,"slug":4,"hasResults":11,"nctId":439,"briefTitle":440,"officialTitle":441,"acronym":442,"eligibilityCriteria":443,"healthyVolunteers":11,"sex":16,"minAge":46,"maxAge":161,"enrollmentInfo":444,"targetDuration":4,"studyType":21,"phases":446,"briefSummary":447,"conditions":448,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":450,"lastUpdatePostDateStruct":451,"startDateStruct":453,"completionDateStruct":455,"leadSponsor":457,"locationsCount":459},"100617698","NCT07322003","Pridopidine Phase 3 Study to Evaluate Efficacy and Safety in ALS","A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Pridopidine in Participants With Amyotrophic Lateral Sclerosis","PREVAiLS","Key Inclusion Criteria:\n\n* Definite ALS or Probable ALS using the El Escorial criteria.\n* Symptom onset of ≤18 months at screening.\n* Slow vital capacity (SVC) greater or equal to 60% predicted.\n* Treatment Research Initiative to Cure ALS (TRICALS) Risk Profile Calculator score, based on the European Network for the Cure of ALS (ENCALS) survival prediction model, in the range of -6 to -2, inclusive, at screening.\n* Able to swallow a capsule.\n\nKey Exclusion Criteria:\n\n* Presence of tracheostomy or permanent assisted ventilation.\n* Clinically significant heart disease, clinically significant history of arrhythmia, symptomatic or uncontrolled atrial fibrillation despite treatment, or asymptomatic sustained ventricular tachycardia, or presence of left bundle branch block.\n* Presence of unstable psychiatric disease, cognitive impairment, dementia or substance abuse that would impair ability of the participant to provide informed consent and participate in the study.\n* Clinically significant and\u002For unstable medical condition (other than ALS) that may either pose a clinically meaningful risk to the participant and\u002For to study completion.\n* Use of medications that prolong QT interval.\n* Previous treatment with pridopidine, gene therapy, or antisense oligonucleotides.\n* Confirmed mutation in the SOD1, FUS or C9orf72 gene.\n* Pregnancy.",{"count":445,"type":20},500,[50],"The goal of this clinical trial is to learn if the drug pridopidine works to treat amyotrophic lateral sclerosis in adults. It will also help to learn about the safety of pridopidine. The main question it aims to answer is:\n\nDoes pridopidine slow disease progression of ALS?\n\nResearchers will compare pridopidine to a placebo (a look-alike substance that contains no drug) to see if pridopidine works to treat ALS.\n\nParticipants will:\n\nTake pridopidine or a placebo by mouth every day for 48 weeks. Afterwards, all participants will take pridopidine for another 48 weeks.\n\nVisit the clinic once every 1-3 months for checkups and tests",[449],"Amyotrophic Lateral Sclerosis","2026-07-01",{"date":452,"type":31},"2026-07-02",{"date":454,"type":31},"2026-02-01",{"date":456,"type":20},"2029-03",{"name":458,"class":38},"Prilenia",32,{"id":461,"slug":4,"hasResults":11,"nctId":462,"briefTitle":463,"officialTitle":464,"acronym":465,"eligibilityCriteria":466,"healthyVolunteers":11,"sex":16,"minAge":46,"maxAge":4,"enrollmentInfo":467,"targetDuration":4,"studyType":21,"phases":469,"briefSummary":470,"conditions":471,"keywords":473,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":450,"lastUpdatePostDateStruct":475,"startDateStruct":476,"completionDateStruct":478,"leadSponsor":480,"locationsCount":482},"100592970","NCT07000357","A Phase III Study of AZD0780 on Major Adverse CV Events in Patients With a History of ASCVD Events or at High Risk for a First Event","A Phase III, Randomised, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Effect of AZD0780 on Major Adverse Cardiovascular Events in Patients With Established Atherosclerotic Cardiovascular Disease (ASCVD) or at High Risk for a First ASCVD Event","AZURE-Outcomes","Inclusion Criteria:\n\n* Meets one of the following:\n\n  1. Participants with history of an ASCVD event: Participants ≥ 18 years of age at the time of signing the ICF with a history of MI or ischaemic stroke suspected to be due to atherosclerotic vascular disease ≥ 1 month prior to randomisation (presumed lacunar or cardioembolic strokes are not qualifying events), or revascularisation for symptomatic lower limb PAD any time prior to screening\n\n     Additional risk factors based on the level of the LDL-C and timing of MI or stroke:\n\n     o Participants with an LDL-C ≥ 75 mg\u002FdL (≥ 1.9 mmol\u002FL) need to have at least one of the other additional risk factors (i to viii) below.\n\n     ii) T2DM requiring ongoing medical therapy iii) Age ≥ 65 years v) Previous above ankle amputation due to PAD vi) Previous diagnosis of non-end stage CKD\n  2. Participants at increased risk of a first ASCVD event: Male participant ≥ 50 years of age or female participant ≥ 55 years of age at the time of signing the ICF with LDL-C ≥ 100 mg\u002FdL (≥ 2.6 mmol\u002FL), with no prior history of MI, ischaemic stroke due to atherosclerotic disease, or leg revascularisation for symptomatic lower limb PAD, and with diagnostic evidence of at least one of the following disease categories (i, ii, or iii):\n\n  (i) Significant atherosclerotic artery disease (ii) High-risk Type 1 or Type 2 diabetes mellitus with manifestation of at least one of the following end-organ diseases:\n  1. Nephropathy - Persistent (≥ 2 readings) microalbuminuria (urine albumin\u002Fcreatinine ratio ≥ 30 mg\u002Fg) and\u002For persistent eGFR \\\u003C 60 mL\u002Fmin\u002F1.73 m2. At least one reading must come from the medical record within the last 12 months in addition to the reading from screening\n  2. Retinopathy - Treated diabetic retinopathy (surgical intervention or injectable therapy) or prior diagnosis made by a relevant healthcare specialist\n  3. Neuropathy - Treated neuropathy (medical therapy for pain relief or symptom alleviation) or prior diagnosis made by a relevant healthcare specialist\n  4. ABI \\\u003C 0.9 or \\> 1.4 - confirmed either in study during screening or randomisation, or from the medical record within the last 5 years (iii) Documented atherosclerosis of less significance\n\n     For (ii) and (iii), participants need to have at least one of the additional risk factors below:\n\n  \u003C!-- -->\n\n  1. CKD with eGFR x mL\u002Fmin\u002F1.73 m2\n  2. Current tobacco use\n  3. Age ≥ 65\n  4. T2DM (if included on the less significant atherosclerosis criterion iii)\n* Participants should receive a background lipid lowering regimen anticipated to achieve at least a \\~50% reduction in LDL-C. Except in cases of intolerance, the regimen should include a high intensity statin therapy or lower intensity statin therapy in combination with an oral agent with proven outcome benefit (eg, ezetimibe and\u002For bempedoic acid).\n\nParticipants must achieve a stable background lipid lowering therapy \\> 28 days before screening.\n\nExclusion criteria:\n\n* Any underlying known disease, or condition including homozygous familial hypercholesterolaemia, or LDL or plasma apheresis within 12 months prior to randomisation, that, in the opinion of the investigator, might interfere with the interpretation of the clinical study results.\n* Any revascularisation procedure planned within the next 3 months.\n* Available imaging assessment within the last 3 years showing either coronary calcium score of zero, or a coronary computed tomography angiography with no atherosclerosis.\n* Calculated eGFR \\\u003C 15 mL \u002Fmin\u002F1.73 m2 at screening.\n* Any laboratory values with the following deviations at screening:\n\n  * AST or ALT \\> 3 × ULN\n  * TBL \\> 2 × ULN (except for participants with Gilbert's syndrome where TBL 3 × ULN is acceptable provided direct bilirubin \\\u003C 1.5 × ULN)\n  * Fasting triglycerides ≥ 400 mg\u002FdL (≥ 4.52 mmol\u002FL).\n  * Creatine kinase \\> 5 × ULN\n  * Urine albumin\u002Fcreatinine ratio ≥ 500 mg\u002Fg\n* Uncontrolled T2DM defined as HbA1c ≥ 9.5% at screening.\n* Inadequately treated hypothyroidism defined as TSH \\> 1.5 × ULN at screening or participants whose thyroid replacement therapy was initiated or modified within the last 3 months prior to screening.\n* Use of mipomersen or lomitapide (cholesterol-lowering medications) within 12 months of screening or planned use during the study.\n* Use of gemfibrozil within one week prior to the Screening Visit or planned use during the study.\n* Use of PCSK9 inhibitors: evolocumab\u002Falirocumab within 12 weeks of the Screening Visit or planned use during the study, or inclisiran within 18 months of the Screening Visit or planned use during the study, or any other approved PCSK9 inhibitor use within 5 half lives prior to the Screening Visit or planned use during the study.",{"count":468,"type":20},15100,[50],"The purpose of this phase 3, randomized, placebo controlled, event-driven study is to assess the effect of AZD0780, an oral PCSK9 inhibitor, compared with placebo in reducing the risk of MACE-PLUS in patients with established ASCVD or at high risk for a first ASCVD event. The effect of AZD0780 vs placebo on the risk of MACE-PLUS will be evaluated from randomisation until the primary analysis censoring date (PACD). The Study Closure Visit will be scheduled to occur after the PACD and will be the final visit for each participant in the study.",[472],"Cardiovascular Disease",[474],"Atherosclerotic Cardiovascular Disease",{"date":452,"type":31},{"date":477,"type":31},"2025-06-04",{"date":479,"type":20},"2029-10-26",{"name":481,"class":38},"AstraZeneca",1365,{"id":484,"slug":4,"hasResults":11,"nctId":485,"briefTitle":486,"officialTitle":487,"acronym":488,"eligibilityCriteria":489,"healthyVolunteers":11,"sex":490,"minAge":46,"maxAge":4,"enrollmentInfo":491,"targetDuration":4,"studyType":21,"phases":493,"briefSummary":494,"conditions":495,"keywords":497,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":450,"lastUpdatePostDateStruct":503,"startDateStruct":504,"completionDateStruct":506,"leadSponsor":508,"locationsCount":510},"100579031","NCT06819007","Study of Trastuzumab Deruxtecan With Bevacizumab Versus Bevacizumab Monotherapy for First-line Maintenance in HER2-Expressing Ovarian Cancer (DESTINY-Ovarian01)","A Phase 3, Open-label, Multicenter, Randomized Trial of Trastuzumab Deruxtecan With Bevacizumab Versus Bevacizumab Monotherapy as First-line Maintenance Therapy in HER2-Expressing Ovarian Cancer (DESTINY-Ovarian01\u002FENGOT-ov89\u002FGEICO144- O\u002FGOG-3112\u002FAPGOT-OV13)","DO-01","Key Inclusion Criteria:\n\n1. Sign and date the tissue prescreening ICF, prior to HER2 central testing. Sign and date the Main ICF, prior to the start of any trial- specific qualification procedures. Consent to optional PGx prior to any PGx procedures.\n\n   \\*For participants in the safety run-in phase, a safety run-in ICF needs to be signed and dated prior to the start of any trial-specific qualification procedures.\n2. Adults ≥18 years of age on the day of signing the ICF. Follow local regulatory requirements if the legal age of consent for trial participation is \\>18 years old.\n3. Has histologically confirmed diagnosis of epithelial high-grade ovarian, fallopian tube or primary peritoneal carcinoma per local assessment (including but not limiting to serous, endometrioid, clear cell, carcinosarcoma, mucinous).\n4. Is newly diagnosed FIGO Stage III or IV.\n5. Has HER2 expression per 2016 ASCO-CAP gastric cancer IHC scoring (3+\u002F2+\u002F1+) guidelines1 by prospective central testing.\n\n   \\*For participants in the safety run-in phase, HER2 expression assessed by either local (require using ASCO-CAP gastric cancer IHC scoring \\[IHC 3+\u002F2+\u002F1+\\] guidelines) or central assessment (if available) is acceptable. Submission of the pathology report is required for participants enrolled based on local HER2 IHC results.\n6. Has adequate tumor tissue sample available for assessment of HER2 by central laboratory. Tumor tissue block or sufficient tissue slides are required for HER2 testing and retrospective HRD status determination.\n\n   \\*Participants in the safety run-in phase who are enrolled based on local HER2 IHC results are recommended to provide tumor tissue sample from the same specimen for central assessment.\n7. Has a local HRD or BRCA test result available. Participants with BRCA-wildtype will have a local HRD test results, as applicable.\n8. Has received up to 6 cycles of standard of care bevacizumab in combination with frontline platinum- based chemotherapy as per approved indication and clinical guidelines and is eligible to continue single agent bevacizumab maintenance per standard of care and investigator discretion.\n\nKey Exclusion Criteria:\n\n1. Has ovarian, fallopian tube, or peritoneal cancer of non-epithelial origin.\n2. Has a known or suspected deleterious BRCA alteration as per local test that makes the patient eligible for PARP inhibitor.\n3. Participant to receive PARP inhibitor as maintenance per standard of care and investigator discretion. Reasons for which the participant is not eligible for PARP inhibitor will be recorded in the eCRF as follows:\n\n   * HRD negative\n   * HRD positive with SD as best response after platinum\n   * HRD positive non-serous histology Note: For participants enrolled from the Republic of Korea\n   * HRD tested, but inconclusive\n   * HRD positive but safety concern (safety concern to be specified).\n4. Has a history of severe hypersensitivity reactions to either the drug substances or inactive ingredients in the drug products and other monoclonal antibodies.\n5. Previous Cerebral-Vascular Accident, Transient Ischemic Attack or Sub- Arachnoids Hemorrhage within 6 months prior to randomization.\n\n   \\*Note: For participants enrolled from the Republic of Korea,\n6. Has evidence of bleeding diathesis or significant coagulopathy (in the absence of anticoagulation therapy).\n7. Has a history of hemorrhagic disorders, abdominal fistula, gastrointestinal perforation, or active gastrointestinal bleeding within 6 months before randomization.\n8. Evidence of active or ongoing bowel obstruction.\n9. Has a medical history of myocardial infarction within 6 months before randomization, symptomatic congestive heart failure (New York Heart Association Class II to IV).\n\n   Participants with troponin levels above the upper limit of normal at Screening (as defined by the manufacturer), and without any myocardial infarction related symptoms should have a cardiologic consultation during the Screening Period to rule out myocardial infarction.\n10. Has a corrected QT interval prolongation to \\>480 msec based on average of the Screening triplicate 12-lead ECG.\n11. Has a history of (non-infectious) ILD\u002Fpneumonitis that required steroids, has current ILD\u002Fpneumonitis, or where suspected ILD\u002Fpneumonitis cannot be ruled out by imaging at Screening.","FEMALE",{"count":492,"type":20},582,[50],"This clinical trial is designed to evaluate the efficacy and safety of T-DXd in combination with bevacizumab versus bevacizumab monotherapy as first-line maintenance therapy, in participants with human epidermal growth factor 2 (HER2)-expressing (immunohistochemistry \\[IHC\\] 3+\u002F2+\u002F1+) advanced high-grade epithelial ovarian cancer.",[496],"Ovarian Cancer",[498,499,500,501,502],"Ovarian cancer","epithelial ovarian cancer","HER2","Trastuzumab Deruxtecan","Bevacizumab",{"date":452,"type":31},{"date":505,"type":31},"2025-03-19",{"date":507,"type":20},"2032-01-31",{"name":509,"class":38},"Daiichi Sankyo",208,{"id":512,"slug":4,"hasResults":11,"nctId":513,"briefTitle":514,"officialTitle":515,"acronym":516,"eligibilityCriteria":517,"healthyVolunteers":11,"sex":16,"minAge":46,"maxAge":4,"enrollmentInfo":518,"targetDuration":4,"studyType":21,"phases":520,"briefSummary":521,"conditions":522,"keywords":524,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":450,"lastUpdatePostDateStruct":530,"startDateStruct":531,"completionDateStruct":533,"leadSponsor":535,"locationsCount":537},"100535501","NCT06252649","Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb in Treatment-naïve Participants With Metastatic Colorectal Cancer With KRAS p.G12C Mutation","Phase 3 Multicenter, Randomized, Open-label, Active-controlled Study of Sotorasib, Panitumumab and FOLFIRI Versus FOLFIRI With or Without Bevacizumab-awwb for Treatment-naïve Subjects With Metastatic Colorectal Cancer With KRAS p.G12C Mutation (CodeBreaK 301)","CodeBreaK 301","Inclusion Criteria:\n\n* Pathologically documented metastatic colorectal adenocarcinoma with KRAS p.G12C mutation by a locally validated assay.\n* Central laboratory detection of KRAS p.G12C mutation.\n* Measurable metastatic disease per RECIST v1.1 criteria.\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of ≤ 1.\n* Adequate organ function.\n\nExclusion Criteria:\n\n* Active, untreated brain metastases.\n* Leptomeningeal disease\n* Previous treatment with a KRAS p.G12C inhibitor\n* History of interstitial pneumonitis or pulmonary fibrosis or evidence of interstitial pneumonitis or pulmonary fibrosis on baseline CT scan",{"count":519,"type":20},450,[50],"The aim of this study is to compare progression free survival (PFS) in treatment-naïve participants with KRAS p.G12C mutated metastatic colorectal cancer (mCRC) receiving sotorasib, panitumumab and FOLFIRI vs FOLFIRI with or without bevacizumab-awwb.",[523],"Metastatic Colorectal Cancer",[525,526,527,528,529],"Sotorasib","Panitumumab","FOLFIRI","Bevacizumab-awwb","Oncology",{"date":452,"type":31},{"date":532,"type":31},"2024-07-17",{"date":534,"type":20},"2032-04-25",{"name":536,"class":38},"Amgen",292,{"id":539,"slug":4,"hasResults":11,"nctId":540,"briefTitle":541,"officialTitle":542,"acronym":543,"eligibilityCriteria":544,"healthyVolunteers":11,"sex":16,"minAge":46,"maxAge":4,"enrollmentInfo":545,"targetDuration":4,"studyType":21,"phases":547,"briefSummary":548,"conditions":549,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":450,"lastUpdatePostDateStruct":551,"startDateStruct":552,"completionDateStruct":554,"leadSponsor":556,"locationsCount":557},"100522616","NCT06084936","A Study to Evaluate Glofitamab as a Single Agent vs. Investigator's Choice in Participants With Relapsed\u002FRefractory Mantle Cell Lymphoma","A Phase III, Open-Label, Multicenter Randomized Study Evaluating Glofitamab as a Single Agent Versus Investigator's Choice in Patients With Relapsed\u002FRefractory Mantle Cell Lymphoma","GLOBRYTE","Inclusion Criteria:\n\n* Life expectancy at least 12 weeks\n* Histologically-confirmed MCL, with documentation of either overexpression of cyclin D1 or the presence of t(11:14) within 12 months of study entry\n* Relapsed (disease progression after the last treatment regimen) or refractory (failure to achieve a partial or complete response from the last treatment regimen) disease\n* At least 1 line of prior systemic therapy including a BTK inhibitor and additional systemic therapy option\n* Confirmed availability of tumor tissue, unless deemed unsafe per investigator assessment\n* At least one bi-dimensionally measurable (defined as at least 1.5 cm) nodal lesion, or one bi-dimensionally measurable (at least 1 cm) extranodal lesion, as measured on CT scan\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2\n* Negative HIV test at screening\n* Adequate hematological function\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding, or intention of becoming pregnant during the study or within 3 months after the final dose of tocilizumab, 2 months after the final dose of glofitamab, whichever is longer\n* Leukemic, non-nodal MCL\n* History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies (or recombinant antibody-related fusion proteins) or known sensitivity or allergy to murine products\n* Contraindication to obinutuzumab or rituximab, and either bendamustine or lenalidomide\n* Prior treatment with glofitamab or other bispecific antibodies targeting both CD20 and CD3\n* Prior treatment with CAR-T cell therapy\n* Treatment with systemic therapy or BTK inhibitors, or any investigational agent for the purposes of treating cancer within 2 weeks or 5 half-lives (whichever is shorter) prior to first study treatment\n* Primary or secondary CNS lymphoma at the time of recruitment or history of CNS lymphoma\n* Current or history of CNS disease, such as stroke, epilepisy, CNS vasculitis, or neurodegenerative disease\n* History of other malignancy that could affect compliance with the protocol or interpretation of results\n* Significant or extensive cardiovascular disease\n* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection at study enrollment or any major episode of infection within 4 weeks prior to the first study treatment\n* Suspected or latent tuberculosis\n* Positive test for hepatitis B virus (HBV) or hepatitis C virus (HCV)\n* Known or suspected chronic active Epstein-Barr viral infection (EBV)\n* Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)\n* Known history of progressive multifocal leukoencephalopathy (PML)\n* Adverse events from prior anti-cancer therapy that have not resolved to Grade 1 or better\n* Administration of a live, attenuated vaccine within 4 weeks before first study treatment administration or anticipation that such a live, attenuated vaccine will be required during the study\n* Prior solid organ transplantation or allogenic stem cell transplant\n* Eligibility for stem cell transplantation (SCT)\n* Active autoimmune disease requiring treatment\n* Prior treatment with systemic immunosuppressive medications within 2 weeks or five half-lives (whichever is shorter) prior to the first dose of study treatment\n* Corticosteroid therapy within 2 weeks prior to first dose of study treatment\n* Recent major surgery (within 4 weeks before the first study treatment) other than for diagnosis\n* Clinically significant history of cirrhotic liver disease",{"count":546,"type":20},182,[50],"The purpose of this study is to evaluate the efficacy of glofitamab monotherapy compared with an investigator's choice of either rituximab plus bendamustine (BR), or lenalidomide with rituximab (R-Len) in patients with relapsed or refractory (R\u002FR) mantle cell lymphoma (MCL).",[550],"Lymphoma",{"date":452,"type":31},{"date":553,"type":31},"2023-10-22",{"date":555,"type":20},"2028-03-31",{"name":309,"class":38},77,{"id":559,"slug":4,"hasResults":11,"nctId":560,"briefTitle":561,"officialTitle":562,"acronym":4,"eligibilityCriteria":563,"healthyVolunteers":11,"sex":16,"minAge":564,"maxAge":565,"enrollmentInfo":566,"targetDuration":4,"studyType":21,"phases":568,"briefSummary":569,"conditions":570,"keywords":572,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":450,"lastUpdatePostDateStruct":574,"startDateStruct":575,"completionDateStruct":577,"leadSponsor":579,"locationsCount":580},"100506775","NCT05878769","A Study to Evaluate the Long-Term Safety of Astegolimab in Participants With Chronic Obstructive Pulmonary Disease (COPD)","A Phase III Open-Label Extension Study to Evaluate the Long-Term Safety of Astegolimab in Patients With Chronic Obstructive Pulmonary Disease","Inclusion Criteria:\n\n* Completion of the 52-week treatment period in either parent GB43311 or GB44332\n\nExclusion Criteria:\n\n* Withdrawal of consent and\u002For premature discontinuation from parent study\n* Any permanent discontinuation of study drug in parent study\n* Significant non-compliance in the parent study, specifically defined as missing scheduled visits, per investigator's judgment\n* Any new diagnosis of asthma according to the Global Initiative for Asthma guidelines or other accepted guidelines since enrolling in the parent study\n* Any new clinically significant pulmonary disease other than COPD (e.g., pulmonary fibrosis, sarcoidosis, chronic pulmonary embolism or primary pulmonary hypertension, alpha-1-antitrypsin deficiency) since enrolling in the parent study\n* Any new unstable cardiac disease, myocardial infarction, or New York Heart Association Class III or IV heart failure since enrolling in the parent study","40 Years","90 Years",{"count":567,"type":20},2000,[50],"The purpose of this study is to assess the long-term safety and to explore the efficacy of astegolimab in participants with chronic obstructive pulmonary disease (COPD) who have completed the 52-week placebo-controlled treatment period in parent studies GB43311 or GB44332.",[571],"Chronic Obstructive Pulmonary Disease",[573],"chronic obstructive pulmonary disease, COPD",{"date":452,"type":31},{"date":576,"type":31},"2023-06-28",{"date":578,"type":20},"2034-07-01",{"name":309,"class":38},486,{"id":582,"slug":4,"hasResults":11,"nctId":583,"briefTitle":584,"officialTitle":585,"acronym":4,"eligibilityCriteria":586,"healthyVolunteers":11,"sex":16,"minAge":46,"maxAge":4,"enrollmentInfo":587,"targetDuration":4,"studyType":21,"phases":588,"briefSummary":589,"conditions":590,"keywords":591,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":450,"lastUpdatePostDateStruct":594,"startDateStruct":595,"completionDateStruct":597,"leadSponsor":599,"locationsCount":601},"100354763","NCT03899155","Pan Tumor Rollover Study","Pan-Tumor Study for Long-term Treatment of Cancer Patients Who Have Participated in BMS Sponsored Trials Investigating Nivolumab and Other Cancer Therapies","Inclusion Criteria\n\n* Signed Written Informed Consent.\n* Eligible to receive continued study treatment per the Parent Study, including treatment beyond progression per investigator assessment in the Parent Study.\n* On treatment hold in the Parent Study following long-lasting response or are eligible for treatment rechallenge as defined in the Parent Study.\n* WOCBP and male participants who are sexually active must agree to follow instructions for method(s) of contraception as described below and included in the ICF.\n\nExclusion Criteria\n\n* Participant is not eligible for study treatment per the Parent Study eligibility criteria.\n* Participants not receiving clinical benefit as assessed by the Investigator.\n* Any clinical adverse event (AE), laboratory abnormality, or intercurrent illness which, in the opinion of the Investigator, indicates that participation in the study is not in the best interest of the participant.\n* Other protocol-defined Inclusion\u002FExclusion Criteria apply",{"count":205,"type":20},[23],"Main Objective of this study is to examine long-term safety of nivolumab monotherapy including combinations and other cancer therapies in various tumor types.",[232],[592,593],"Rollover","pan-tumor",{"date":452,"type":31},{"date":596,"type":31},"2019-08-09",{"date":598,"type":20},"2029-08-25",{"name":600,"class":38},"Bristol-Myers Squibb",399,{"id":603,"slug":4,"hasResults":11,"nctId":604,"briefTitle":605,"officialTitle":606,"acronym":607,"eligibilityCriteria":608,"healthyVolunteers":11,"sex":97,"minAge":46,"maxAge":4,"enrollmentInfo":609,"targetDuration":4,"studyType":21,"phases":611,"briefSummary":612,"conditions":613,"keywords":615,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":617,"lastUpdatePostDateStruct":618,"startDateStruct":619,"completionDateStruct":621,"leadSponsor":623,"locationsCount":624},"100637445","NCT07611110","AZD2265 Compared With Standard of Care in PSMA-positive Metastatic Castration-resistant Prostate Cancer (VECTRA-01)","A Phase III, Multicentre, Randomised Controlled Study to Evaluate the Efficacy and Safety of AZD2265 (FPI-2265) ²²⁵Ac-PSMA-I&T Compared With Standard of Care in Patients With PSMA-positive Metastatic Castration-resistant Prostate Cancer (VECTRA-01)","VECTRA-01","Inclusion Criteria:\n\n* ≥ 18 years of age.\n* Diagnosis of adenocarcinoma of prostate.\n* Must have had prior orchiectomy and\u002For ongoing ADT and a castrate level of plasma\u002Fserum testosterone.\n* Progressive mCRPC following the most recent treatment at the time of study entry, with at least 1 metastatic lesion (measurable and\u002For non-measurable) that is suitable for repeated assessment by CT and\u002For MRI and\u002For bone scan.\n* Previously treated with at least 2 cycles of PSMA-directed β-emitting radioconjugate.\n* Previously treated with at least 1 taxane-based chemotherapy regimen for either metastatic hormone-sensitive prostate cancer or CRPC.\n* Previously treated with at least 1 ARPI (eg, enzalutamide, abiraterone, etc.).\n* Positive PSMA PET\u002FCT scans, obtained with PSMA ligands (⁶⁸Ga-PSMA-11 or ¹⁸F-DCFPyL).\n* ECOG performance status of 0 to 2.\n* Adequate organ and bone marrow function as described in study protocol.\n* Participants must not father children or donate sperm from signing ICF, during the study intervention and for 6 months after the last dose of study intervention.\n* Participants must use a condom from signing ICF, during study intervention, and for 6 months after the last dose of study drug, with all sexual partners.\n\nExclusion Criteria:\n\n* Prior treatment with an α-emitting molecular targeted therapeutic radioconjugate (prior treatment with radium-223 is permitted).\n* Progression on PSMA-directed β-emitting radioconjugate prior to the administration of Cycle 3.\n* Receipt of \\> 6 cycles of PSMA-directed β-emitting therapeutic RC.\n* History of another primary malignancy, with exceptions.\n* Persistent toxicities (CTCAE Grade ≥ 2) caused by previous anticancer therapy, with exceptions.\n* Spinal cord compression or brain metastases unless asymptomatic, stable, and not requiring steroids for at least 4 weeks prior to start of study intervention.\n* Clinically significant ECG abnormalities, with exceptions.",{"count":610,"type":20},670,[50],"The intention of the study is to demonstrate superiority of AZD2265 relative to standard of care treatments by assessment of radiographic progression-free survival (rPFS) and overall survival (OS) in participants with mCRPC.",[614],"Metastatic Castration-resistant Prostate Cancer",[616],"AZD2265; prostate cancer; mCRPC; PSMA; FPI-2265; 225Ac","2026-06-30",{"date":450,"type":31},{"date":620,"type":31},"2026-05-04",{"date":622,"type":20},"2029-12-20",{"name":481,"class":38},104,""]