[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Hoffmann-La Roche\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":534},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,100,0,25,[9,40,63,84,106,126,145,167,193,214,233,251,271,290,312,331,358,379,400,420,438,456,475,496,514],{"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},"100053422",false,"NCT07405801","A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus Ribociclib Plus Fulvestrant in Participants With Advanced Breast Cancer","A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus Ribociclib Plus Fulvestrant in Patients With Endocrine- Resistant Hormone-Receptor-Positive, HER2-Negative Advanced Breast Cancer With Chromosome 8P Loss and Without a PIK3CA Mutation","Inclusion Criteria:\n\n* Women or men with histologically or cytologically confirmed carcinoma of the breast that is locally advanced or metastatic and is not amenable to surgical or radiation therapy with curative intent\n* Documented estrogen receptor (ER)-positive and\u002For progesterone receptor (PR)-positive tumor according to American Society of Clinical Oncology\u002FCollege of American Pathologists (ASCO\u002FCAP) guidelines, defined as \\>=1% of tumor cells stained positive based on the most recent tumor biopsy and assessed locally (Allison et al. 2020)\n* Participants must not have received any prior systemic therapy for locally advanced unresectable or metastatic breast cancer (mBC) and must have progressed during adjuvant endocrine-based treatment or within 12 months after completing adjuvant endocrine-based therapy with an aromatase inhibitor or tamoxifen\n* Confirmed biomarker eligibility as documented through central laboratory testing of a tumor tissue sample documenting both the lack of a phosphatidylinositol-4,5-biphosphate 3-kinase catalytic subunit alpha gene (PIK3CA) mutation and the presence of heterozygous loss of chromosome 8p (i.e., PIK3CAnmd and chr8p loss)\n* Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)\n\nExclusion Criteria:\n\n* Metaplastic breast cancer\n* Radiotherapy within 2 weeks before randomization\n* Appropriate for treatment with cytotoxic chemotherapy at time of entry into the study, as per national or local treatment guidelines (e.g., participants with visceral crisis)\n* Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes\n* Known and untreated, or active Central nervous system (CNS) metastases (progressing or requiring anticonvulsants or corticosteroids for symptomatic control). Participants with a history of treated CNS metastases are eligible\n* Any history of leptomeningeal disease or carcinomatous meningitis","ALL","18 Years",{"count":19,"type":20},80,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","A study to evaluate the efficacy and safety of triplet combination of inavolisib plus ribociclib and fulvestrant versus placebo plus ribociclib and fulvestrant in the first-line setting in participants with endocrine-therapy-resistant hormone receptor (HR)-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC).",[26],"Breast Cancer","RECRUITING","2026-07-10",{"date":30,"type":31},"2026-07-13","ACTUAL",{"date":33,"type":31},"2026-04-07",{"date":35,"type":20},"2030-02-26",{"name":37,"class":38},"Hoffmann-La Roche","INDUSTRY",49,{"id":41,"slug":4,"hasResults":11,"nctId":42,"briefTitle":43,"officialTitle":44,"acronym":4,"eligibilityCriteria":45,"healthyVolunteers":46,"sex":16,"minAge":17,"maxAge":47,"enrollmentInfo":48,"targetDuration":4,"studyType":21,"phases":50,"briefSummary":52,"conditions":53,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":56,"startDateStruct":57,"completionDateStruct":59,"leadSponsor":61,"locationsCount":62},"100053851","NCT07495813","A Study to See How RO7763505 Works and How Safe it is When Given to Healthy People and People With Stable Heart Disease","A Phase I, Randomized, Double-Blind, Adaptive, Placebo-Controlled, Single- Ascending Dose and Multiple-Ascending Dose, Parallel Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Food Effect of RO7763505 Following Oral Administration in Healthy Participants and Patients With Stable Coronary Artery Disease","Inclusion Criteria:\n\nPart 1:\n\n* Healthy biologically male and female participants of nonchildbearing potential or childbearing potential with no clinically relevant findings on physical examination at screening or baseline (assessed either on Day -2 or Day -1), including detailed medical and surgical history, vital signs, 12-lead electrocardiogram (ECG), hematology, blood chemistry, serology, and urinalysis\n* No suspicion of cognitive impairment\u002Fdementia as judged by the Investigator\n\nPart 2:\n\n* Myocardial infarction before the screening visit\n* Objective imaging evidence (coronary computed tomography \\[CT\\] angiography or invasive angiography) of coronary atherosclerosis Participants who underwent percutaneous coronary intervention (PCI) or coronary artery bypass graft (CABG) are eligible if the procedure was done \\>6 months prior to screening\n* A diagnosis of stable CAD, defined as being on stable guideline-directed medical therapy (GDMT) if tolerated for at least 90 days prior to screening with no planned changes or scheduled interventions during the study\n* QTc of \\\u003C= 450 milliseconds (ms) as determined by a single 12-lead ECG recording. If the initial ECG result of the triplicate is exclusionary, consecutive repeat ECG results must be within the acceptable limits. In participants with a stable bundle branch block where the QRS duration is \\> 120 ms, the QTcF will be calculated as: QTcF - (QRS - 100 ms)\n\nExclusion Criteria:\n\nPart 1:\n\n* Any condition or disease detected during the medical interview\u002Fphysical examination that would render the participant unsuitable for the study, place the participant at undue risk, or interfere with the ability of the participant to complete the study in the opinion of the Investigator\n* Vaccination within 28 days prior to Day 1 (non-live vaccines including influenza vaccination are permitted 14 days prior to Day 1) or planned before the end of the study. Investigators are advised to review the immunization status of participants who are considered for treatment with RO7763505 and follow local\u002Fnational guidance for adult vaccination against infectious disease as they deem relevant\n* Positive result on human immunodeficiency virus (HIV)-1 and HIV-2, hepatitis B virus (HBV) (either hepatitis B surface antigen \\[HBsAg\\] or hepatitis B core antibody \\[HBcAb\\]), hepatitis C virus (HCV) antibody test, or tuberculosis (TB)\n\nPart 2:\n\n* Individuals with New York Heart Association (NYHA) Class III or IV heart failure\n* Known or suspected immunocompromised state\n* Treatment with any investigational therapy within 28 days or within five drug-elimination half-lives (whichever is longer; or longer than either if required by local regulations; if the half-life is unknown, the 90-day period applies) prior to Day 1, calculated from the day of the follow-up from the previous study",true,"75 Years",{"count":49,"type":20},196,[51],"PHASE1","This study will evaluate safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of single ascending doses (SAD) (Part 1a), multiple ascending doses (MAD) (Part 1b), and the food effect (Part 1c) of RO7763505 in healthy adult participant. In Part 2, the safety, tolerability, PK and PD of multiple doses of RO7763505 in participants with stable coronary artery diseases (CAD).",[54,55],"Stable Coronary Artery Disease","Healthy Volunteers",{"date":30,"type":31},{"date":58,"type":31},"2026-03-31",{"date":60,"type":20},"2028-02-15",{"name":37,"class":38},1,{"id":64,"slug":4,"hasResults":11,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":4,"eligibilityCriteria":68,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":69,"targetDuration":4,"studyType":21,"phases":71,"briefSummary":73,"conditions":74,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":77,"startDateStruct":78,"completionDateStruct":80,"leadSponsor":82,"locationsCount":83},"100053771","NCT06704672","Clinical Study to Evaluate the Impact of the Accu-Chek SmartGuide CGM Solution on the Mean Change in Time in Range Compared With Self-Monitoring of Blood Glucose in Participants With Type 1 and Type 2 Diabetes Mellitus","Clinical Study to Evaluate the Impact of the Accu-Chek SmartGuide CGM Solution on the Mean Change in Time in Range of 70 - 180 mg\u002Fdl Compared to SMBG","Inclusion Criteria:\n\n* Type 1 Diabetes mellitus (T1D) or Type 2 Diabetes mellitus (T2D) diagnosed at least 12 months prior to screening, using multiple daily injection (MDI) regime for at least six months prior to screening\n* Performing SMBG, no CGM\u002Fflash glucose monitoring (FGM) use during the last six months prior screening\n* HbA1c ≥8% and ≤10% based on analysis from a local laboratory\n\nExclusion Criteria:\n\n* Untreated adrenal or thyroid insufficiency\n* Severe visual impairment\n* Significant renal impairment: eGFR \\\u003C30 ml\u002Fmin within last one year\n* Serious acute or chronic concomitant disease or an anamnesis which might, in the opinion of the investigator, pose a risk to the subject\n* Hematocrit greater than 10% below the lower limit of normal\n* Pregnancy (lack of negative pregnancy test - except in case of menopause, sterilization or hysterectomy - self-reported), planned pregnancy, or breast feeding\n* Allergic to the adhesive (glue or tape)\n* Skin diseases (e.g. psoriasis vulgaris, bacterial skin diseases) at the sensor application sites\n* Sickle cell disease, or hemoglobinopathy\n* Elective surgery planned that requires general anesthesia during study participation\n* Current or anticipated acute uses of glucocorticoids (oral, injectable, or intravenous)\n* Medical conditions that, per investigator determination, make it inappropriate or unsafe to target an HbA1c of \\\u003C7%. Conditions may include but are not limited to: heart failure, unstable cardiovascular disease, recent myocardial infarction, ventricular rhythm disturbances, recent transient ischemic attack or cerebrovascular accident, significant malignancy\n* Chronic use of opiates, opioids, morphinomimetics more than three times per week, which has not stopped at least 30 days prior to screening and any other medication interfering with the assessment of pain, as per investigator's discretion\n* Intake of hydroxyurea (hydroxycarbamide), levodopa, methyldopa, ascorbic acid, acetylsalicylic acid (≥300mg), which has not stopped at least 30 days prior to screening\n* Magnetic resonance tomography (MRT), computed tomography (CT), X-ray, radiofrequency ablation, high-frequency electrical heat or high intensity focused ultrasound planned during the course of the study\n* Planned flight or high-altitude hike (\\>3000 m) during baseline and assessment periods\n* Shift-worker (night-shifts)\n* On or planning to start a diet intended for weight change\n* Currently abusing illicit and\u002For prescription drugs or alcohol as judged by the investigator\n* Any other physical or psychological disease or psychiatric disorder that could limit adherence to the required study tasks and interfere with the normal conduct of the study as judged by the investigator\n* Dependency (e.g., employee, co-worker or family member) on sponsor, investigator or companies active in the field of CGM (e.g. Dexcom, Abbott, Menarini, Medtronic) or their subsidiaries\n* Participation in another clinical study at the same time",{"count":70,"type":20},270,[72],"NA","This is an open label, two-arm, randomized multi-center clinical device study in adult subjects with Type 1 diabetes (T1D) or insulin-dependent Type 2 diabetes (T2D) on a multiple daily injection (MDI) regime.\n\nThe goal of the study is to investigate the impact of the Accu-Chek SmartGuide CGM solution on the change in overall time in range (TIR) of blood glucose concentrations of 70-180 mg\u002Fdl compared with that using self-monitoring of blood glucose (SMBG).",[75,76],"Type 1 Diabetes Mellitus","Type 2 Diabetes Mellitus",{"date":30,"type":31},{"date":79,"type":31},"2025-04-14",{"date":81,"type":20},"2027-05-30",{"name":37,"class":38},18,{"id":85,"slug":4,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":89,"eligibilityCriteria":90,"healthyVolunteers":11,"sex":16,"minAge":91,"maxAge":92,"enrollmentInfo":93,"targetDuration":4,"studyType":21,"phases":94,"briefSummary":96,"conditions":97,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":99,"startDateStruct":100,"completionDateStruct":102,"leadSponsor":104,"locationsCount":105},"100053821","NCT07298421","A Study to Assess the Pharmacokinetics, Effectiveness and Safety of Afimkibart for Induction and Maintenance Therapy in Children With Moderately to Severely Active Crohn's Disease","A Phase III Randomized Double-Blind Multi-Center Treat-Through Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Induction and Maintenance Therapy With Afimkibart (RO7790121) in Children Aged 2-17 Years With Moderately to Severely Active Crohn's Disease","SIBERITE-PEDS","Inclusion Criteria:\n\n* Body weight \\>= 10 kilogram (kg)\n* Active CD confirmed by endoscopy (ileocolonoscopy)\n* Moderately to severely active CD, defined as a Pediatric Crohn's Disease Activity Index (PCDAI) score \\>= 30, and Simple Endoscopic Score Crohn's Disease (SES-CD) \\>=6 (or \\>=4 for isolated ileal disease) confirmed through centrally-read ileocolonoscopy\n* Inadequate response, loss of response, and\u002For intolerance to at least one of the following conventional therapies (aminosalicylates, corticosteroids and\u002For immunosuppressants) or advanced therapies (including anti-tumor necrosis factor, anti-interleukin, anti-integrin, or Janus Kinase (JAK) inhibitors)\n\nExclusion Criteria:\n\n* Monogenic disorder pertaining to infant onset Inflammatory Bowel Disease (IBD)\n* History of \\>= 3 bowel resections: \\> 2 missing segments of the following five segments: terminal ileum, right colon, transverse colon, sigmoid and left colon, and rectum\n* Current diagnosis of ulcerative colitis (UC), abdominal\u002Fintraabdominal\u002Fperianal fistula and\u002For abscess, indeterminant colitis, IBD-unclassified, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, or active diverticular disease.\n* Symptomatic bowel strictures, fulminant colitis, or toxic megacolon\n* Presence of abdominal or perianal abscess\n* Current diagnosis or suspicion of primary sclerosing cholangitis","2 Years","17 Years",{"count":5,"type":20},[95],"PHASE3","This phase III, double-blind, multi-center treat-through study will evaluate the efficacy and safety of Afimkibart (also known as RO7790121) in children with moderately to severely active Crohn's Disease (CD).",[98],"Moderately to Severely Active Crohns Disease",{"date":30,"type":31},{"date":101,"type":20},"2026-08-31",{"date":103,"type":20},"2031-05-30",{"name":37,"class":38},7,{"id":107,"slug":4,"hasResults":11,"nctId":108,"briefTitle":109,"officialTitle":110,"acronym":111,"eligibilityCriteria":112,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":113,"targetDuration":4,"studyType":21,"phases":115,"briefSummary":116,"conditions":117,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":119,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":125},"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":114,"type":20},320,[51,23],"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).",[118],"Non-Small Cell Lung Cancer",{"date":30,"type":31},{"date":121,"type":31},"2023-06-20",{"date":123,"type":20},"2032-01-29",{"name":37,"class":38},71,{"id":127,"slug":4,"hasResults":11,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":4,"eligibilityCriteria":131,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":132,"targetDuration":4,"studyType":21,"phases":134,"briefSummary":135,"conditions":136,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":28,"lastUpdatePostDateStruct":138,"startDateStruct":139,"completionDateStruct":141,"leadSponsor":143,"locationsCount":144},"100053642","NCT05169515","A Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab or Glofitamab in Combination With CC-220 and\u002For CC-99282 in Participants With B-Cell Non-Hodgkin Lymphoma","A Phase Ib, Open-Label, Multicenter Study Evaluating the Safety, Pharmacokinetics, and Efficacy of Mosunetuzumab or Glofitamab in Combination With CC-220 and\u002For CC-99282 in Patients With B-Cell Non-Hodgkin Lymphoma","Inclusion Criteria:\n\n* Age \\>\u002F= 18 years\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2\n* History of one of the following histologically documented hematologic malignancies that are expected to express the CD20 antigen: In the Dose Escalation phase, participants must have relapsed after or failed to respond to at least two prior lines of systemic therapy. In the Dose Expansion phase, participants with FL Grades 1-3a must have relapsed after or failed to respond to at least one prior line of systemic therapy and must require systemic therapy. Participants with DLBCL\u002Ftransformed FL must have relapsed after or failed to respond to at least one prior systemic treatment regimen.\n* Participants with DLBCL\u002Ftransformed FL who have received only one prior line of therapy must: Not be considered a candidate for autologous stem cell transplantation (ASCT) due to age, performance status, comorbidities and\u002For insufficient response to prior treatment, or have refused ASCT; or be ineligible for or unable to receive chimeric antigen receptor T-cell (CAR-T) therapy due to reasons defined by the protocol\n* Fluorodeoxyglucose-avid lymphoma (i.e. PET-positive lymphoma)\n* At least one bi-dimensionally measurable nodal lesion (\\> 1.5 cm in its largest dimension by diagnostic quality CT or PET\u002FCT scan), or at least one bi-dimensionally measurable extranodal lesion (\\> 1.0 cm in its largest dimension by diagnostic quality CT or PET\u002FCT scan)\n* Availability of a representative tumor specimen and the corresponding pathology report for confirmation of the diagnosis of NHL\n* A fresh pretreatment biopsy during screening period, excisional or incisional, is preferred\n* Adequate hematologic function without growth factors or blood product transfusion within 14 days of first dose of study drug administration\n* Normal laboratory values\n* All participants and health care providers will be trained and counseled on pregnancy prevention. For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception during the treatment period and for 3 months after the final dose of mosunetuzumab, at least 18 months after pre-treatment with obinutuzumab or 2 months after the last dose of glofitamab, 28 days after the last dose of CC-220, 28 days after the last dose of CC-99282, 3 months after the last dose of tocilizumab (if applicable), whichever is longer\n* For male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom, and agree to refrain from donating sperm during the treatment period and for at least 3 months after pre-treatment with obinutuzumab or 2 months after the last dose of glofitamab, 28 days after the last dose of CC-220, 28 days after the last dose of CC- 99282, 2 months after the final dose of tocilizumab (if applicable), whichever is longer\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding, or intention of becoming pregnant during the study (female participants of childbearing potential must have a negative serum pregancy test result within 14 days prior to initiation of the study treatment) or within 3 months after the final dose of mosunetuzumab, at least 3 months after pre-treatment with obinutuzumab or 2 months after the last dose of glofitamab, whichever is longer, 28 days after the last dose of CC-220, 28 days after the last dose of CC-9282, 3 months after the final dose of tocilizumab, whichever is longer\n* Participant has received prior therapy with cereblon (CRBN)-modulating drug (e.g., lenalidomide, avadomide\u002FCC-122, pomalidomide) \\\u003C\u002F= 4 weeks prior to starting CC-220 and\u002For CC-99282\n* Inability to swallow pills, or persistent diarrhea or malabsorption \\>= Grade 2 National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), despite medical management\n* QTc interval of \\> 470 ms\n* The following treatments prior to study entry: mosunetuzumab, glofitamab, or other CD20\u002FCD3-directed bispecific antibodies; allogenic stem cell therapy (SCT); solid organ transplantation\n* Treatments (investigational or approved) within the following time periods prior to initiation\u002Ffirst dose of study treatment: radiotherapy within 2 weeks; autologous SCT within 100 days; chimeric antigen receptor (CAR) T-cell therapy within 30 days; prior anti-lymphoma treatment with monoclonal antibodies or antibody-drug conjugates within 4 weeks; use of radioimmunoconjugates within 12 weeks; systemic immunosuppressive medications within 2 weeks; any other anti-cancer therapy, whether investigational or approved, including but not limited to chemotherapy, within 4 weeks or 5 half-lives of the drug, whichever is shorter\n* Live, attenuated vaccine within 4 weeks before first dose of study treatment, or in whom it is anticipated that such a live attenuated vaccine will be required during the study period or within 5 months after the final dose of study treatment\n* Current or past history of central nervous system (CNS) lymphoma or leptomeningeal infiltration\n* History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibody therapy (or recombinant antibody-related fusion proteins)\n* History of autoimmune disease, including but not limited to myocarditis, pneumonitis, myasthenia gravis, myositis, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, vascular thrombosis associated with antiphospholipid syndrome, granulomatosis with polyangiitis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vasculitis, or glomerulonephritis\n* Major surgery or significant traumatic injury \\\u003C 28 days prior to enrollment (excluding biopsies) or anticipation of the need for major surgery during study treatment\n* Clinically significant toxicities from prior treatment have not resolved to Grade \\\u003C\u002F= 1 (per US national cancer institute (NCI) common terminology criteria for adverse events (CTCAE) v5.0) prior to the first study drug administration with exceptions defined by the protocol\n* Evidence of any significant, concomitant disease (e.g. cardiovascular, pulmonary, liver, CVA or stroke, ILD, PML, infection, HLH etc) that could affect compliance with the protocol or interpretation of results\n* For participants enrolled into glofitamab cohort: documented refractoriness to an obinutuzumab monotherapy-containing regimen (defined as disease that did not achieve response (PR or CR) or progressed within 6 months of the last dose of an obinutuzumab-containing regimen)",{"count":133,"type":20},121,[51],"This study will evaluate the safety, efficacy, and pharmacokinetics of mosunetuzumab or glofitamab in combination with CELMoDs (CC-220 and\u002For CC-99282) in participants with B-cell NHL.",[137],"Non-Hodgkin Lymphoma",{"date":30,"type":31},{"date":140,"type":31},"2022-10-26",{"date":142,"type":20},"2029-09-15",{"name":37,"class":38},26,{"id":146,"slug":4,"hasResults":11,"nctId":147,"briefTitle":148,"officialTitle":149,"acronym":150,"eligibilityCriteria":151,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":152,"targetDuration":4,"studyType":154,"phases":4,"briefSummary":155,"conditions":156,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":159,"startDateStruct":161,"completionDateStruct":163,"leadSponsor":165,"locationsCount":166},"100608347","NCT07200375","An Observational Study of Glofitamab in Chinese Adult Participants With 2L Diffuse Large B-Cell Lymphoma","Evaluating Effectiveness and Safety of Glofitamab Based Second-Line Therapy in Chinese Adult Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma: A Prospective, Observational, Multicenter, Cohort Study","GlofitReal","Inclusion Criteria:\n\n* Histologically confirmed R\u002FR DLBCL after one line of systemic therapy\n* Will be treated with Glofit-based regimen (known as being recommended and having the intention to be treated with Glofitamab at the time of signing ICF) or have initiated Glofit-based regimen treatment within three months (90 days) prior to enrollment\n\nExclusion Criteria:\n\n* Participants who currently participate in or plan to participate in any interventional clinical trial",{"count":153,"type":20},300,"OBSERVATIONAL","This study will investigate how well glofitamab-based therapy works and how safe it is in Chinese adult participants with relapsed or refractory diffuse large B-cell lymphoma (R\u002FR DLBCL).",[157],"Diffuse Large B-Cell Lymphoma","2026-07-01",{"date":160,"type":31},"2026-07-02",{"date":162,"type":31},"2025-09-29",{"date":164,"type":20},"2029-09-29",{"name":37,"class":38},19,{"id":168,"slug":4,"hasResults":11,"nctId":169,"briefTitle":170,"officialTitle":171,"acronym":172,"eligibilityCriteria":173,"healthyVolunteers":11,"sex":16,"minAge":174,"maxAge":175,"enrollmentInfo":176,"targetDuration":4,"studyType":21,"phases":178,"briefSummary":179,"conditions":180,"keywords":182,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":186,"startDateStruct":187,"completionDateStruct":189,"leadSponsor":191,"locationsCount":192},"100605979","NCT07169578","A Study of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease","A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Efficacy and Safety Study of Trontinemab in Participants With Early Symptomatic Alzheimer's Disease (MCI to Mild Dementia Due to AD)","TRONTIER 1","Inclusion Criteria:\n\n* Willingness and ability to complete all aspects of the study (including MRI, clinical genotyping, and PET imaging or CSF as applicable) for the duration of the study. The participant should be capable of completing assessments either alone or with the help of the study partner\n* Adequate visual and auditory acuity, in the investigator's judgment, sufficient to perform the neuropsychological testing (eyewear and hearing aids are permitted)\n* Evidence of AD pathological process, as confirmed on amyloid PET scan. A CSF tau181\u002FAβ42 ratio may be used as an alternative option if amyloid PET is not available\n* Probable AD dementia or MCI due to AD, also known as an Alzheimer's clinical syndrome clinical Stage 3 or Stage 4\n* Screening MMSE score ≥ 22 and CDR-GS of 0.5 or 1.0\n* Participant- and\u002For Informant-reported history of cognitive decline with gradual onset and progression over the last 1 year before screening\n* A Repeatable Battery for the Assessment of Neuropsychological Status Delayed Memory Index (RBANS DMI) score of 85 or order\n* Availability of a \"study partner\" as defined by the protocol\n\nExclusion Criteria:\n\n* Any evidence of a condition other than AD that may affect cognition\n* History or presence of clinically significant cerebrovascular disease\n* History of severe, clinically significant (persistent neurologic deficit or structural brain damage) central nervous system (CNS) trauma\n* History or presence of clinically significant intracranial mass\n* MRI evidence of significant cerebral abnormalities or inability to tolerate MRI procedures or contraindication to MRI\n* Any other medical conditions (e.g., cardiovascular, hepatic, renal disease) which are not stable and adequately controlled or which in the opinion of the investigator could affect the participant's safety in the study or interfere with the study assessments\n* History of malignancy with the following exceptions: if considered to be cured; malignancies with a negligible risk of metastasis or death","50 Years","90 Years",{"count":177,"type":20},800,[95],"The purpose of this study is to assess the efficacy and safety of trontinemab in participants with early symptomatic Alzheimer's disease (AD) (mild cognitive impairment \\[MCI\\] to mild dementia due to AD).",[181],"Alzheimers Disease",[183,184,185],"Early Alzheimers Disease","Mild Cognitive Impairment","Mild Dementia",{"date":160,"type":31},{"date":188,"type":31},"2025-09-17",{"date":190,"type":20},"2028-06-07",{"name":37,"class":38},143,{"id":194,"slug":4,"hasResults":11,"nctId":195,"briefTitle":196,"officialTitle":197,"acronym":198,"eligibilityCriteria":199,"healthyVolunteers":11,"sex":16,"minAge":200,"maxAge":201,"enrollmentInfo":202,"targetDuration":4,"studyType":21,"phases":204,"briefSummary":205,"conditions":206,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":207,"startDateStruct":208,"completionDateStruct":210,"leadSponsor":212,"locationsCount":213},"100579098","NCT06819878","A Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy With Afimkibart (RO7790121) in Participants With Moderately to Severely Active Crohn's Disease","A Phase III, Multicenter, Double-Blind, Placebo-Controlled, Treat-Through Study to Assess the Efficacy and Safety of Induction and Maintenance Therapy With RO7790121 in Patients With Moderately to Severely Active Crohn's Disease","SIBERITE-1","Inclusion Criteria:\n\n* Confirmed diagnosis of CD\n* Moderately to severely active CD\n* Bodyweight \\>= 40 kilogram (kg)\n* Demonstrated inadequate response, loss of response and\u002For intolerance to at least one protocol-specified conventional or advanced CD therapy\n* Males and females of childbearing potential must meet protocol criteria for contraception requirements\n\nExclusion Criteria:\n\n* Current diagnosis of ulcerative colitis (UC) or indeterminate colitis, ischemic colitis, infectious colitis, radiation colitis, microscopic colitis\n* Participant with a history of \\>= 3 bowel resections (\\> 2 missing segments of the 5 following segments: terminal ilelium, right colon, transverse colon, sigmoid and left colon, and rectum)\n* Diagnosis of short gut or short bowel syndrome\n* Presence of an ileostomy, colostomy or ileoanal pouch\n* Participants with symptomatic bowel strictures, fulminant colitis, or toxic megacolon\n* Presence of abdominal or perianal abscess\n* Presence of rectovaginal, enterovaginal, high output enterocutaneous fistula, enterovesical fistulas or perianal fistulas with \\>3 openings\n* Current diagnosis or suspicion of primary sclerosing cholangitis\n* Pregnancy or breastfeeding, or intention of becoming pregnant during the study\n* Any past or current evidence of cancer of gastrointestinal tract, definite low-grade or high-grade colonic dysplasia\n* History of non-gastrointestinal cancer, with the exception of adequately treated non-metastatic basal cell or squamous cell skin cancer or in situ cervical cancer\n* Evidence of infection with Clostridioides difficile (C. difficile; formerly known as Clostridium difficile), cytomegalovirus (CMV), human immunodeficiency virus (HIV), Hepatitis B (HBV), Hepatitis C (HCV) during screening\n* Has evidence of active tuberculosis (TB), latent TB not successfully treated (per local guidance) or inadequately treated TB\n* Has received protocol-specified prohibited medicines, including known exposure to any type of anti-TL1A therapy","16 Years","80 Years",{"count":203,"type":20},600,[95],"This Phase III, multicenter, double-blind, placebo-controlled treat-through study will evaluate the efficacy and safety of induction and maintenance therapy with Afimkibart (also known as RO7790121) in participants with moderately to severely active Crohn's disease (CD).",[98],{"date":160,"type":31},{"date":209,"type":31},"2025-03-17",{"date":211,"type":20},"2033-12-31",{"name":37,"class":38},372,{"id":215,"slug":4,"hasResults":11,"nctId":216,"briefTitle":217,"officialTitle":218,"acronym":219,"eligibilityCriteria":220,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":221,"targetDuration":4,"studyType":21,"phases":223,"briefSummary":224,"conditions":225,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":226,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":232},"100576853","NCT06790693","A Study Evaluating the Efficacy and Safety of Inavolisib Plus CDK4\u002F6 Inhibitor and Letrozole vs Placebo + CDK4\u002F6i and Letrozole in Participants With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer","A Phase III, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Efficacy and Safety of Inavolisib Plus a CDK4\u002F6 Inhibitor and Letrozole Versus Placebo Plus a CDK4\u002F6 Inhibitor and Letrozole in Patients With Endocrine-Sensitive PIK3CA-Mutated, Hormone Receptor-Positive, HER2-Negative Advanced Breast Cancer","INAVO123","Inclusion Criteria:\n\n* Women or men with histologically or cytologically confirmed carcinoma of the breast\n* Documented ER-positive and\u002For progesterone receptor-positive tumor according to American Society of Clinical Oncology\u002FCollege of American Pathologists (ASCO\u002FCAP) guidelines\n* Documented HER2-negative tumor according to ASCO\u002FCAP guidelines\n* De-novo HR+ , HER2- ABC, or, alternatively, relapsed HR+ , HER2- ABC after at least 2 years of standard neoadjuvant\u002Fadjuvant endocrine therapy without disease progression during that treatment and disease-free interval of at least 1 year since the completion of that treatment\n* Participants who have bilateral breast cancers which are both HR-positive and HER2-negative\n* Confirmation of biomarker eligibility\n* Consent to provide fresh or archival tumor tissue specimen\n* Measurable disease per Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST v1.1)\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1\n* Adequate hematologic and organ function within 14 days prior to initiation of study treatment\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding, or intention of becoming pregnant during the study or within the time frame in which contraception is required\n* Metaplastic breast cancer\n* Any prior systemic therapy for locally advanced unresectable or metastatic breast cancer\n* Type 2 diabetes requiring ongoing systemic treatment at the time of study entry; or any history of Type 1 diabetes\n* Any history of leptomeningeal disease or carcinomatous meningitis\n* Known and untreated, or active CNS metastases. Participants with a history of treated CNS metastases are eligible\n* Active inflammatory or infectious conditions in either eye or history of idiopathic or autoimmune-associated uveitis in either eye\n* Symptomatic active lung disease\n* History of or active inflammatory bowel disease\n* Any active bowel inflammation\n* Prior hematopoietic stem cell or bone marrow transplantation\n* Treatment with strong cytochrome P450 (CYP) 3A4 inhibitors or strong CYP3A4 inducers within 4 weeks or 5 drug-elimination half-lives, prior to initiation of study treatment",{"count":222,"type":20},450,[95],"This study will evaluate the efficacy and safety of the combination of inavolisib plus a cyclin-dependent kinase 4 and 6 inhibitor (CDK4\u002F6i) and letrozole versus placebo plus a CDK4\u002F6i and letrozole in the first-line setting in participants with endocrine-sensitive PIK3CA-mutated hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-), advanced breast cancer (ABC).",[26],{"date":160,"type":31},{"date":228,"type":31},"2025-04-09",{"date":230,"type":20},"2032-05-30",{"name":37,"class":38},232,{"id":234,"slug":4,"hasResults":11,"nctId":235,"briefTitle":236,"officialTitle":237,"acronym":4,"eligibilityCriteria":238,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":239,"targetDuration":4,"studyType":21,"phases":241,"briefSummary":242,"conditions":243,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":245,"startDateStruct":246,"completionDateStruct":248,"leadSponsor":250,"locationsCount":83},"100564047","NCT06624085","A Study Evaluating the Safety and Efficacy of Glofitamab + Gemcitabine + Oxaliplatin in U.S. Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma","A Phase Ib Study Evaluating the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of Glofitamab in Combination With Gemcitabine Plus Oxaliplatin in U.S. Patients With Relapsed or Refractory Diffuse Large B-Cell Lymphoma","Inclusion Criteria:\n\n* Histologically confirmed DLBCL, not otherwise specified (NOS)\n* Relapsed (disease that has recurred following a response that lasted ≥ 6 months after completion of the last line of therapy) or refractory ( disease that did not respond to or that progressed \\\u003C 6 months after completion of the last line of therapy) disease\n* At least one prior line of systemic therapy\n* Participants who have failed only one prior line of therapy must not be a candidate for high-dose chemotherapy followed by autologous stem cell transplant (ASCT)\n* At least one bi-dimensionally measurable (\\> 1.5 cm) nodal lesion, or one bi-dimensionally measurable (\\> 1 cm) extranodal lesion, as measured on CT scan\n* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, or 2\n\nExclusion Criteria:\n\n* Prior enrollment in Study GO41944 (STARGLO; NCT04408638)\n* Participant has failed only one prior line of therapy and is a candidate for stem cell transplantation\n* History of transformation of indolent disease to DLBCL\n* High-grade B-cell lymphoma with MYC and BCL2 and\u002For BCL6 rearrangements, and high-grade B-cell lymphoma NOS, as defined by 2016 WHO guidelines\n* Primary mediastinal B-cell lymphoma\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* Prior treatment with glofitamab or other bispecific antibodies targeting both CD20 and CD3\n* Prior treatment with gemcitabine or oxaliplatin\n* Peripheral neuropathy or paresthesia assessed to be Grade \\>\u002F= 2 according to NCI CTCAE v5.0 at enrollment\n* Treatment with radiotherapy, chemotherapy, immunotherapy, immunosuppressive therapy, or any investigational agent for the purposes of treating cancer within 2 weeks prior to first study treatment\n* Treatment with monoclonal antibodies for the purposes of treating cancer within 4 weeks prior to first study treatment\n* Primary or secondary CNS lymphoma at the time of recruitment or history of CNS lymphoma\n* Prior CNS involvement that has been definitively treated and confirmed via MRI or cerebrospinal fluid analysis to be in complete remission is permissible\n* Current or history of CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease\n* History of other primary malignancy, with exceptions defined by the protocol\n* Significant or extensive cardiovascular disease, or significant pulmonary disease\n* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (exclusing fungal infections of nail beds) at study enrollment or any major episode of infection within 4 weeks prior to the first study treatment\n* Documented severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection within 6 months of first study treatment, or positive SARS-CoV-2 test within 7 days prior to enrollment\n* Suspected or latent tuberculosis\n* Positive test results for hepatitis B (HBV) or hepatitis C (HCV)\n* Known or suspected chronic active Epstein-Barr viral infection\n* Known or suspected history of hemophagocytic lymphohistiocytosis (HLH)\n* Known history of progressive multifocal leukoencephalopathy\n* Prior solid organ transplantation\n* Prior allogenic stem cell transplant\n* Active autoimmune disease requiring treatment\n* Prior treatment with systemic immunosuppressive medications within 4 weeks prior to first dose of study treatment\n* Ongoing systemic corticosteroid use which, in the opinion of the investigator, puts the patient at increased risk of steroid-related iatrogenic adrenal insufficiency\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":240,"type":20},50,[51],"The purpose of the study is to evaluate glofitamab + gemcitabine + oxaliplatin in participants in the United States, including under-represented racial and ethnic populations, that have relapsed or refractory (R\u002FR) diffuse large B-cell lymphoma (DLBCL).",[244],"Lymphoma",{"date":160,"type":31},{"date":247,"type":31},"2025-04-28",{"date":249,"type":20},"2030-03-31",{"name":37,"class":38},{"id":252,"slug":4,"hasResults":11,"nctId":253,"briefTitle":254,"officialTitle":255,"acronym":256,"eligibilityCriteria":257,"healthyVolunteers":11,"sex":16,"minAge":200,"maxAge":201,"enrollmentInfo":258,"targetDuration":4,"studyType":21,"phases":260,"briefSummary":261,"conditions":262,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":264,"startDateStruct":265,"completionDateStruct":267,"leadSponsor":269,"locationsCount":270},"100561337","NCT06588855","A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (Also Known as RO7790121) in Participants With Moderately to Severely Active Ulcerative Colitis","A Phase III, Multicenter, Double-Blind, Placebo-Controlled Study to Assess the Efficacy and Safety of Induction Therapy With RO7790121 in Patients With Moderately to Severely Active Ulcerative Colitis","Ametrine-2","Inclusion Criteria:\n\n* Confirmed diagnosis of UC\n* Moderately to severely active UC assessed by mMS\n* Bodyweight \\>= 40 kilogram (kg)\n* Up to date with colorectal cancer (CRC) screening performed according to local standards\n* Demonstrated inadequate response, loss of response and\u002For intolerance to at least one protocol-specified conventional or advanced UC therapy\n* Males and females of childbearing potential must meet protocol criteria for contraception requirements\n\nExclusion Criteria:\n\n* Currently known complications of UC (e.g. fulminant colitis, toxic megacolon)\n* Current diagnosis of Crohn's disease (CD) or indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis\n* Presence of an ostomy or ileoanal pouch\n* Current diagnosis or suspicion of primary sclerosing cholangitis\n* Pregnancy or breastfeeding, or intention of becoming pregnant during the study\n* Past or current evidence of definite low-grade or high-grade colonic dysplasia or adenomas or neoplasia not completely removed\n* History of malignancy within 5 years, with the exception of malignancies adequately treated with resection for non-metastatic basal cell or squamous cell cancer or in situ cervical cancer\n* Evidence of infection with Clostridioides difficile (C. difficile; formerly known as Clostridium difficile), cytomegalovirus (CMV), human immunodeficiency virus (HIV), Hepatitis B (HBV), Hepatitis C (HCV)\n* Has evidence of active tuberculosis (TB), latent TB not successfully treated (per local guidance) or inadequately treated TB\n* Has received protocol-specified prohibited medicines, including known exposure to any type of anti-TL1A therapy",{"count":259,"type":20},350,[95],"This Phase III, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of induction therapy with Afimkibart (RO7790121) compared with placebo in participants with moderately to severely active ulcerative colitis (UC).",[263],"Moderately to Severely Active Ulcerative Colitis",{"date":160,"type":31},{"date":266,"type":31},"2024-12-11",{"date":268,"type":20},"2031-01-30",{"name":37,"class":38},200,{"id":272,"slug":4,"hasResults":11,"nctId":273,"briefTitle":274,"officialTitle":275,"acronym":276,"eligibilityCriteria":277,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":278,"targetDuration":4,"studyType":21,"phases":280,"briefSummary":281,"conditions":282,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":283,"startDateStruct":284,"completionDateStruct":286,"leadSponsor":288,"locationsCount":289},"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":279,"type":20},182,[95],"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).",[244],{"date":160,"type":31},{"date":285,"type":31},"2023-10-22",{"date":287,"type":20},"2028-03-31",{"name":37,"class":38},77,{"id":291,"slug":4,"hasResults":11,"nctId":292,"briefTitle":293,"officialTitle":294,"acronym":4,"eligibilityCriteria":295,"healthyVolunteers":11,"sex":16,"minAge":296,"maxAge":175,"enrollmentInfo":297,"targetDuration":4,"studyType":21,"phases":299,"briefSummary":300,"conditions":301,"keywords":303,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":305,"startDateStruct":306,"completionDateStruct":308,"leadSponsor":310,"locationsCount":311},"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",{"count":298,"type":20},2000,[95],"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.",[302],"Chronic Obstructive Pulmonary Disease",[304],"chronic obstructive pulmonary disease, COPD",{"date":160,"type":31},{"date":307,"type":31},"2023-06-28",{"date":309,"type":20},"2034-07-01",{"name":37,"class":38},486,{"id":313,"slug":4,"hasResults":11,"nctId":314,"briefTitle":315,"officialTitle":316,"acronym":317,"eligibilityCriteria":318,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":319,"targetDuration":4,"studyType":21,"phases":320,"briefSummary":321,"conditions":322,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":324,"startDateStruct":325,"completionDateStruct":327,"leadSponsor":329,"locationsCount":330},"100484098","NCT05583617","A Study Evaluating the Safety and Efficacy of Multiple Treatments in Participants With Multiple Myeloma","A Platform Study Evaluating the Safety and Efficacy of Multiple Treatments in Patients With Multiple Myeloma","PLYCOM","Inclusion Criteria:\n\n* Diagnosed with MM per International Myeloma Working Group (IMWG) criteria\n* Eastern Cooperative Oncology Group Performance Status of 0, or 1, or 2\n* Resolution of AEs from prior anti-cancer therapy to Grade \\\u003C=1\n* Agreement to undergo scheduled assessments and procedures\n\nAdditional Inclusion Criteria for SS2:\n\n* Completion of planned induction therapy and achievement of at least a partial response (PR)\n* Autologous Stem Cell Transplant (SCT) within 100 days prior to first study treatment and the absence of progressive disease\n* Cytogenetic high-risk features at diagnosis\n* Treatment with any investigational medicinal products, systemic cancer therapies, immunotherapies received previously in CO43923 (any arms) within 5 half-lives or 3 weeks whichever is the shortest\n* Agreement to comply with all local requirements of the lenalidomide risk minimization plan, which includes the global pregnancy prevention program\n* For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception\n* For male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use a condom even if they have had a prior vasectomy, and agreement to refrain from donating sperm\n\nAdditional Inclusion Criteria for SS4:\n\n* Previously exposed to at least a PI, an IMiD, and an anti-CD38 antibody for the treatment of R\u002FR MM for whom no suitable SOC therapy options are available\n\nExclusion Criteria:\n\n* Inability to comply with protocol-mandated hospitalization and procedures\n* History of confirmed progressive multifocal leukoencephalopathy\n* History of other malignancy within 2 years prior to screening\n* Current or past history of central nervous system (CNS) disease\n* Significant cardiovascular disease that may limit a participant's ability to adequately respond to a CRS event\n* Symptomatic active pulmonary disease or requiring supplemental oxygen\n* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection at study enrollment, or any major episode of infection requiring treatment with IV antibiotics where the last dose of IV antibiotics was given within 14 days prior to first study treatment\n* Known or suspected chronic active Epstein-Barr virus (EBV) infection\n* Positive serologic or PCR test results for acute or chronic hepatitis B virus (HBV) infection\n* Acute or chronic hepatitis C virus (HCV) infection\n* Known history of HIV seropositivity\n* Administration of a live, attenuated vaccine within 4 weeks prior to initiation of study treatment or anticipation that such a live, attenuated vaccine will be required during the study\n* Any medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the participant's safe participation in and completion of the study, or which could affect compliance with the protocol or interpretation of results\n\nAdditional Exclusion Criteria for SS2:\n\n* Hypersensitivity reactions to lenalidomide or other immunomodulatory drugs\n* Harbor lesions at proximity of vital organs that may develop sudden decompensation\u002Fdeterioration in the setting of a tumor flare\n* Prior treatment with any investigational medicinal product, systemic cancer therapy, or immunotherapies in any arm of study CO43923 within 5 half-lives or 3 weeks, whichever is shorter\n* Known active bacterial, viral, fungal, mycobacterial, parasitic, or other infection (excluding fungal infections of nail beds) at study enrollment, or any major episode of infection requiring treatment with IV antimicrobials where the last dose of IV antimicrobial was given within 14 days prior to first study treatment\n* History of erythema multiforme, Grade \\>=3 rash, or blistering following prior treatment with immunomodulatory derivatives\n* Pregnant or breastfeeding, or intending to become pregnant during the study or within 5 months after the final dose of study treatment Exlcusion Criteria Applicable to SS2 and SS4\n* History of autoimmune disease\n* Known history of hemophagocytic lymphohistiocytosis (HLH) or macrophage activation syndrome (MAS)\n* History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins)\n* Received a cumulative dose of corticosteroids equivalent to \\>=140 mg of prednisone within the 14-day period before the first dose of the study drug (does not include pretreatment medication)\n* Active symptomatic COVID-19 infection at study enrollment or requiring treatment with IV antiviral where the last dose of IV antiviral treatment was given within 14 days prior to first study treatment. Participants with active COVID-19 infection must have clinical recovery and two negative antigen tests at least 24 hours apart prior to first study treatment.\n* Positive and quantifiable EBV PCR or CMV PCR prior to first study treatment\n\nAdditional Exclusion Criteria for SS4:\n\n* Treatment with any investigational medicinal products, systemic cancer therapies, immunotherapies within 5 half-lives or 12 weeks before starting pre-phase\n* History of anaphylaxis or hypersensitivity, including \\>=Grade 3 rash, during prior treatment with IMiDs, dexamethasone, any CELMoDs, or the excipients contained in the formulations\n* Known anaphylaxis, allergies, hypersensitivity, or intolerance to boron or mannitol, hyaluronidase, sorbitol, corticosteroids, monoclonal antibodies (or recombinant antibody-related fusion proteins), or human proteins, CRBN modulating agents or their excipients, or known sensitivity to mammalian-derived products\n* Administration of strong CYP3A modulators; administration of proton-pump inhibitors within 2 weeks of starting study treatment\n* Uncontrolled hypertension or uncontrolled diabetes within 14 days prior to enrollment\n* Concurrent administration of a strong inhibitor, modulator or inducer of cytochrome P450 (CYP3A4\u002F5) (including within 14 days of initiating study treatment)\n* History of malignancies, other than MM, unless the subject has been free of the disease for \\>=5 years\n* Peripheral neuropathy \\>Grade 2\n* Prior treatment with cevostamab or another agent targeting FcRH5 or iberdomide\n* Pregnant or breastfeeding, or intending to become pregnant during the study or within 5 months after the final dose of study treatment\n* History of Stevens-Johnson syndrome, toxic epidermal necrolysis, or drug rash with eosinophilia and systemic symptoms\n* Treatment with systemic immunosuppressive medications\n* Prior treatment with CAR T-cell therapy (autologous or allogeneic) within 12 weeks before starting pre-phase\n* Autologous SCT within 100 days prior to starting pre-phase\n* Prior allogeneic SCT\n* Plasmacytoma in proximity of vital organs that may develop sudden decompensation\u002Fdeterioration in the setting of a tumor flare",{"count":270,"type":20},[51,23],"CO43923 is a platform study that will evaluate the safety, efficacy, and pharmacokinetics (PK) of multiple treatment combinations, as monotherapy or in combination, in participants with multiple myeloma (MM). The study is designed with the flexibility to open new treatment substudies as new treatments become available. Information regarding the opened substudies are found below.",[323],"Multiple Myeloma",{"date":160,"type":31},{"date":326,"type":31},"2023-11-14",{"date":328,"type":20},"2028-07-31",{"name":37,"class":38},16,{"id":332,"slug":4,"hasResults":11,"nctId":333,"briefTitle":334,"officialTitle":335,"acronym":336,"eligibilityCriteria":337,"healthyVolunteers":11,"sex":16,"minAge":338,"maxAge":339,"enrollmentInfo":340,"targetDuration":4,"studyType":21,"phases":342,"briefSummary":343,"conditions":344,"keywords":346,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":351,"startDateStruct":352,"completionDateStruct":354,"leadSponsor":356,"locationsCount":357},"100480268","NCT05533775","A Study to Evaluate Glofitamab Monotherapy and Glofitamab + Chemoimmunotherapy in Pediatric and Young Adult Participants With Relapsed\u002FRefractory Mature B-Cell Non-Hodgkin Lymphoma","A Phase I\u002FII, Open-Label, Single-Arm, Two-Part Trial to Evaluate Safety, Tolerability, Pharmacokinetics, and Anti-Tumor Activity of Glofitamab in Monotherapy and in Combination With Chemoimmunotherapy in Pediatric and Young Adult Participants With Relapsed\u002FRefractory Mature B-Cell Non-Hodgkin Lymphoma","iMATRIX GLO","Inclusion Criteria:\n\n* Age 6 months to \\\u003C 18 years at the time of signing Informed Consent for Cohort A Part 1 and Cohort B of the study, and age 6 months to \\\u003C 30 years old at the time of signing Informed Consent for Cohort A Part 2 of the study\n* Histologically re-confirmed diagnosis, via tissue biopsy, or bone marrow aspirate, pleural effusion, or ascites, prior to study entry of aggressive mature B-NHL that expresses CD20 (reconfirmed by IHC or flow cytometry if IHC is not possible), including BL, BAL (mature B-cell leukemia FAB L3), DLBCL, and PMBCL, at the time of first R\u002FR disease for Cohort A and second or greater R\u002FR disease for Cohort B\n* Refractory or relapsed disease (i.e., prior treatment was ineffective or intolerable) following first-line standard-of-care chemoimmunotherapy for Cohort A and following at least two prior systemic chemoimmunotherapy regimens and who have exhausted all available established therapies for Cohort B\n* Measurable disease, defined as: At least one bi-dimensionally measurable nodal lesion, defined as \\> 1.5 cm in its longest dimension, or at least one bi dimensionally measurable extranodal lesion, defined as \\> 1.0 cm in its longest dimension; or percentage of bone marrow involvement with lymphoma cells defined by cytomorphological analysis of bone marrow aspirates\n* Adequate performance status, as assessed according to the Lansky or Karnofsky Performance Status scales: Participants \\\u003C 16 years old: Lansky Performance Status ≥ 50%; Participants ≥ 16 years old: Karnofsky Performance Status ≥ 50%\n* Adequate bone marrow, liver, and renal function\n* Negative test results for acute or chronic hepatitis B virus (HBV), hepatitis C virus (HCV)\n* Negative HIV test at screening, with the following exception: Individuals with a positive HIV test at screening are eligible provided they are stable on anti-retroviral therapy for at least 4 weeks, have a CD4 count ≥200\u002FuL, have an undetectable viral load, and have not had a history of opportunistic infection attributable to AIDS within the last 12 months\n* Negative SARS-CoV-2 antigen or PCR test within 7 days prior to enrollment\n* Participants and\u002For caregivers who are willing and able to complete clinical outcome assessments throughout the study using either paper or interviewer methods\n\nExclusion Criteria:\n\n* Isolated CNS disease of mature B-NHL without systemic involvement, and primary CNS lymphoma\n* Receipt of glofitamab prior to study enrollment\n* Ongoing adverse events from prior anti-cancer therapy that were not resolved to Grade ≤ 1 (exceptions: alopecia, Grade 2 peripheral neuropathy)\n* Grade ≥ 3 adverse events, with the exception of Grade 3 endocrinopathy managed with replacement therapy\n* Participants with active infections which are not resolved prior to Day 1 of Cycle 1\n* Prior solid organ transplantation\n* Known or suspected history of hemophagocytic lymphohistiocytosis (HLH), or chronic active Epstein-Barr viral infection (CAEBV)\n* Active autoimmune disease requiring treatment\n* History of severe allergic or anaphylactic reactions to monoclonal antibody therapy (or recombinant antibody-related fusion proteins) or known sensitivity or allergy to murine products, except if the participant was able to safely receive it after initial administration (consider consultation with Medical Monitor)\n* History of confirmed progressive multifocal leukoencephalopathy\n* Current or past history of uncontrolled non-malignant CNS disease, such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease\n* Evidence of significant and uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results\n* Major surgery or significant traumatic injury \\\u003C 28 days prior to the obinutuzumab pretreatment infusion (excluding biopsies) or anticipation of the need for major surgery during study treatment\n* Administration of a live, attenuated vaccine within 4 weeks before the start of study treatment (obinutuzumab pretreatment) or at any time during the study treatment period and within 12 months after end of study treatment\n* Participants with any other diseases, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that would contraindicate the use of an investigational drug","6 Months","30 Years",{"count":341,"type":20},65,[51,23],"The purpose of this study is to evaluate the safety and efficacy of glofitamab, as monotherapy and in combination with a standard chemoimmunotherapy regimen: rituximab, ifosfamide, carboplatin, and etoposide (R-ICE) in pediatric and young adult participants with relapsed and refractory (R\u002FR) mature B-cell non-Hodgkin lymphoma (B-NHL).",[345],"Mature B-Cell Non-Hodgkin Lymphoma",[347,348,349,350],"Relapsed","Refractory","Pediatrics","B-NHL",{"date":160,"type":31},{"date":353,"type":31},"2022-11-16",{"date":355,"type":20},"2032-11-30",{"name":37,"class":38},30,{"id":359,"slug":4,"hasResults":11,"nctId":360,"briefTitle":361,"officialTitle":362,"acronym":363,"eligibilityCriteria":364,"healthyVolunteers":11,"sex":16,"minAge":365,"maxAge":92,"enrollmentInfo":366,"targetDuration":4,"studyType":21,"phases":368,"briefSummary":369,"conditions":370,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":158,"lastUpdatePostDateStruct":372,"startDateStruct":373,"completionDateStruct":375,"leadSponsor":377,"locationsCount":378},"100442302","NCT05039619","A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Obinutuzumab in Adolescents With Active Class III or IV Lupus Nephritis and the Safety and PK of Obinutuzumab in Pediatric Participants","A Phase II, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Obinutuzumab in Adolescent Patients With Active Class III or IV Lupus Nephritis, Including an Evaluation of Open Label Safety and PK in a Cohort of Pediatric Patients (Aged 5 to \u003C 12)","POSTERITY","Inclusion Criteria:\n\n* Participants who are age 12 to \\\u003C18 years at the time of randomization\n* Participants who are age 5 to \\\u003C12 years (younger participant cohort) at the time of randomization once recruitment is open. (Investigators will be notified by the Sponsor when recruitment is open to this younger population)\n* International Society of Nephrology and the Renal Pathology Society (ISN\u002FRPS) 2003 Class III or IV active LN demonstrated on renal biopsy performed in the 12 months prior to or during screening\n* Class V disease may be present in addition to Class III or IV LN, but participants with isolated Class V disease are not eligible\n* Diagnosis of SLE according to the Systemic Lupus International Collaborating Clinics (SLICC) 2012 criteria\n* Significant proteinuria defined by a UPCR above \\> 0.5 based on a first-morning void (FMV) collection at screening\n* During the 12 months prior to or during screening, all participants must have received at least one dose of pulse-range IV methylprednisolone (typically 30 mg\u002Fkg, maximum of 1000 mg per dose) or equivalent for the treatment of the current episode of active LN.\n\nExclusion Criteria:\n\n* Severe, active central nervous system (CNS) SLE, including retinitis, poorly controlled seizure disorder, acute confusional state, myelitis, stroke, cerebellar ataxia, or dementia\n* Sclerosis in \\>50% of glomeruli on renal biopsy\n* Purely chronic Class III(c) or Class IV(c) disease on renal biopsy, defined as the absence of any active lesions\n* Presence of rapidly progressive glomerulonephritis\n* Pure Class V LN\n* Intolerance or contraindication to study therapies\n* Active infection of any kind (excluding fungal infection of nail beds) or any major episode of infection requiring hospitalization or treatment with IV anti-infective medications within 4 weeks prior to screening, or completion of oral anti-infectives within 2 weeks prior to randomization\n* History of or currently active primary or secondary immunodeficiency, including known history of HIV infection and other severe Immunodeficiency blood disorders\n* History of serious recurrent or chronic infection\n* History of or current cancer, including solid tumors, hematological malignancies, and carcinoma in situ (except basal cell carcinoma and squamous cell carcinoma of the skin that have been excised and cured) within the past 5 years\n* Significant or uncontrolled concomitant medical disease which, in the investigator's opinion, would preclude participant participation\n* Currently active alcohol or drug abuse or history of alcohol or drug abuse","5 Years",{"count":367,"type":20},40,[23],"This phase II, randomized, double-blind, placebo-controlled study is designed to evaluate the safety, efficacy and pharmacokinetics (PK) of obinutuzumab in adolescent participants (AP) aged 12 to less than 18 with biopsy-confirmed proliferative lupus nephritis (LN). It will also evaluate open label safety and PK of obinutuzumab in pediatric participants (PP), aged 5 to \\\u003C12 with LN.",[371],"Lupus Nephritis",{"date":160,"type":31},{"date":374,"type":31},"2022-05-12",{"date":376,"type":20},"2030-06-14",{"name":37,"class":38},42,{"id":380,"slug":4,"hasResults":11,"nctId":381,"briefTitle":382,"officialTitle":383,"acronym":384,"eligibilityCriteria":385,"healthyVolunteers":11,"sex":16,"minAge":386,"maxAge":92,"enrollmentInfo":387,"targetDuration":4,"studyType":21,"phases":388,"briefSummary":389,"conditions":390,"keywords":4,"overallStatus":392,"whyStopped":4,"lastUpdateSubmitDate":393,"lastUpdatePostDateStruct":394,"startDateStruct":395,"completionDateStruct":397,"leadSponsor":399,"locationsCount":4},"100631642","NCT07503340","A Study to Evaluate Pharmacokinetics, Safety, Tolerability, Immunogenicity and Pharmacodynamic Effects of Subcutaneous Ocrelizumab Administration in Children and Adolescents With Relapsing-remitting Multiple Sclerosis (RRMS)","An Open-label Study to Evaluate Pharmacokinetics, Safety, Tolerability, Immunogenicity and Pharmacodynamic Effects of Subcutaneous Ocrelizumab Administration in Children and Adolescents With Relapsing-remitting Multiple Sclerosis","Operetta III","Inclusion Criteria:\n\n* Children and adolescents from 10 years to less than 18 years of age, at the time of baseline visit\n* Body weight ≥25 kg\n* Diagnosis of RRMS in accordance with the International Pediatric Multiple Sclerosis Study Group (IPMSSG) criteria for pediatric MS, Version 2012, or McDonald criteria 2017 or 2024\n* Neurologic stability for at least 30 days prior to screening, and between screening and baseline\n* Expanded Disability Status Scale (EDSS) score, 0-5.5, at screening\n* Must have received all childhood required vaccinations as per local\u002Fnational recommendations for childhood vaccination against infectious diseases\n\nExclusion Criteria:\n\n* Participants who are positive for aquaporin 4 (AQP4) or myelin oligodendrocyte glycoprotein (MOG) antibody are not eligible to participate in the study\n* Any known presence or suspicion of other neurologic disorders that may mimic multiple sclerosis (MS)\n* History or known presence of recurrent or chronic infection (e.g., human immunodeficiency virus \\[HIV\\], syphilis, tuberculosis \\[TB\\])\n* Contraindications against SC injections or other conditions not suitable for SC injections, e.g., extremely thin SC fat layer\n* History of a severe allergic or anaphylactic reaction to humanized or murine monoclonal antibody or known hypersensitivity to any component of ocrelizumab solution\n* Contraindications to mandatory premedications (i.e., corticosteroids and histamines), including closed-angle glaucoma for antihistamines\n* Participants who have previously received treatment with B cell-targeted therapies, including ocrelizumab\n* Any previous treatment with alemtuzumab, anti-CD4, cladribine, mitoxantrone, daclizumab, laquinimod, total body irradiation, or bone marrow transplantation\n* Treatment with any investigational agent within 24 weeks of screening or 5 half-lives, whichever is longer (or longer if indicated by the PD action of the drug)","10 Years",{"count":7,"type":20},[23],"The main purpose of this study is to evaluate the pharmacokinetics (PK) of ocrelizumab administered subcutaneously (SC) in children and adolescents aged 10 to \\\u003C18 years with RRMS. The study consists of a 48-week treatment period, an Optional Ocrelizumab Extension (OOE) period of at least 48 weeks, and Safety Follow-up (SFU) for 104 weeks.",[391],"Relapsing-remitting Multiple Sclerosis","NOT_YET_RECRUITING","2026-06-30",{"date":160,"type":31},{"date":396,"type":20},"2026-08-01",{"date":398,"type":20},"2031-08-01",{"name":37,"class":38},{"id":401,"slug":4,"hasResults":11,"nctId":402,"briefTitle":403,"officialTitle":404,"acronym":405,"eligibilityCriteria":406,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":407,"enrollmentInfo":408,"targetDuration":4,"studyType":21,"phases":409,"briefSummary":410,"conditions":411,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":393,"lastUpdatePostDateStruct":413,"startDateStruct":414,"completionDateStruct":416,"leadSponsor":418,"locationsCount":419},"100598699","NCT07074886","A Study to Assess Bioequivalence of Two Subcutaneous (SC) Formulations of Ocrelizumab in Participants With Multiple Sclerosis (MS)","A Phase II, Randomized, Open-label, Parallel Group, Multicenter Study to Assess Bioequivalence of Two Subcutaneous Formulations of Ocrelizumab in Patients With Multiple Sclerosis","PORTAMENTO","Inclusion Criteria:\n\n* Diagnosis of RMS or PPMS according to the revised McDonald 2017 criteria (Thompson et al. 2018) or the most current McDonald criteria at the time of study start\n* Expanded Disability Status Scale (EDSS) score, 0-6.5, inclusive, at screening\n\nExclusion Criteria:\n\n* Participants who have previously received anti-cluster of differentiation (CD) 20s (including ocrelizumab) less than 2 years before screening\n* Participants who have previously received anti-CD20s (including ocrelizumab) more than 2 years before screening if one of the following conditions is met: B-cell count is below lower limit of normal (LLN), or the discontinuation of the treatment was due to safety reasons\n* History of confirmed or suspected progressive multifocal leukoencephalopathy (PML)\n* History of cancer, including hematologic malignancy and solid tumors, within 10 years of screening\n* Immunocompromised state\n* Sensitivity or intolerance to any ingredient (including excipients) of ocrelizumab\n* History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies\n* Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study\n* Significant, uncontrolled disease, such as cardiovascular, pulmonary, renal, hepatic, endocrine or gastrointestinal, or any other significant disease that may preclude participation in the study\n* Lack of peripheral venous access\n* Previous treatment with cladribine, atacicept, and alemtuzumab\n* Any previous treatment with bone marrow transplantation and hematopoietic stem cell transplantation\n* Any previous history of transplantation or anti-rejection therapy\n* Positive screening tests for active, latent, or inadequately treated hepatitis B virus (HBV)","65 Years",{"count":279,"type":20},[23],"The main purpose of this study is to assess the bioequivalence of ocrelizumab SC test formulation to the marketed ocrelizumab SC reference formulation in participants with either relapsing multiple sclerosis (RMS) or primary progressive multiple sclerosis (PPMS). The study consists of 2 phases: a controlled phase, where participants in each group will receive one dose of test or reference formulation and a continuation phase, where all participants in both groups will receive ocrelizumab SC test formulation.",[412],"Multiple Sclerosis",{"date":160,"type":31},{"date":415,"type":31},"2025-11-13",{"date":417,"type":20},"2030-10-30",{"name":37,"class":38},56,{"id":421,"slug":4,"hasResults":11,"nctId":422,"briefTitle":423,"officialTitle":424,"acronym":4,"eligibilityCriteria":425,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":426,"targetDuration":428,"studyType":154,"phases":4,"briefSummary":429,"conditions":430,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":393,"lastUpdatePostDateStruct":431,"startDateStruct":432,"completionDateStruct":434,"leadSponsor":436,"locationsCount":437},"100512627","NCT05954910","A Study to Evaluate the Effectiveness and Safety of Polatuzumab in Real World Clinical Practice Among Adult Chinese Participants With Diffuse Large B-Cell Lymphoma","The Effectiveness and Safety of Polatuzumab in Real-World Clinical Practice Among Chinese Adult Patients With Diffuse Large B-Cell Lymphoma: A Prospective, Observational, Multicenter, Registry Study","Inclusion Criteria:\n\n* Be diagnosed as DLBCL\n* Cohort 1: diagnosed as unfit\u002Ffrail DLBCL. The unfit\u002Ffrail is defined as aged 80 years or older, or younger than 80 years but with comorbidity and not tolerant to the standardized dose of cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP) therapy according to investigator's judgment\n* Cohort 2: diagnosis as DLBCL but could not be classified into unfit\u002Ffrail\n* Cohort 3: relapse or refractory to previous treatment\n\nExclusion Criteria:\n\n* Participant who currently participates in or with plan to participate in any interventional clinical trial\n* Any other reason that, in the investigator's opinion, makes the participant unsuitable to participate in this study.",{"count":427,"type":20},1000,"3 Years","The purpose of this study is to assess the progression free survival (PFS) in the real-world settings of polatuzumab among Chinese diffuse large B cell lymphoma (DLBCL) participants.",[157],{"date":158,"type":31},{"date":433,"type":31},"2023-08-25",{"date":435,"type":20},"2027-05-31",{"name":37,"class":38},29,{"id":439,"slug":4,"hasResults":11,"nctId":440,"briefTitle":441,"officialTitle":442,"acronym":4,"eligibilityCriteria":443,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":407,"enrollmentInfo":444,"targetDuration":4,"studyType":21,"phases":446,"briefSummary":447,"conditions":448,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":393,"lastUpdatePostDateStruct":449,"startDateStruct":450,"completionDateStruct":452,"leadSponsor":454,"locationsCount":455},"100493377","NCT05704361","A Study to Investigate the Safety, Tolerability, and Processing by the Body of Intravenous and Subcutaneous RO7121932 Administration in Participants With Multiple Sclerosis","A Multiple-center, Non-randomized, Open-label, Adaptive, Single-ascending Dose (Part 1 and Part 2) and Multiple-ascending Dose (Part 3) Parallel, Phase IB Study to Investigate the Safety, Tolerability, Immunogenicity, Pharmacokinetics, and Pharmacodynamics of RO7121932 Following Intravenous (Parts 1) and Subcutaneous Administration (Parts 2 and 3) in Participants With Multiple Sclerosis","Inclusion Criteria:\n\n* Expanded Disability Status Scale (EDSS) score ≤7.0 at Screening\n* Participants with relapsing multiple sclerosis (RMS) or progressive multiple sclerosis (PMS) who fulfil international panel criteria for diagnosis (McDonald 2017 criteria)\n* Participants not treated with any approved MS treatment at Screening and not planning to start on any MS therapy during the study (including follow-up)\n* Female participants must practice abstinence or otherwise use contraception\n\nExclusion Criteria:\n\n* Evidence of clinical disease activity as defined by any clinical relapse within 3 months prior to screening, or by \\>1 clinical relapse within 12 months prior to screening\n* Evidence of magnetic resonance imaging (MRI) activity as defined by the presence of ≥ 1 Gadolinium (Gd)-enhancing T1 lesion in the screening MRI scan or by ≥ 4 new or enlarging T2 lesions in the screening scan as compared to a reference scan\n* Participants who have active progressive multifocal leukoencephalopathy (PML), have had confirmed PML, or have a high degree of suspicion for PML\n* Known presence of other neurological disorders that may mimic MS including but not limited to: neuromyelitis optica spectrum disease, Lyme disease, untreated Vitamin B12 deficiency, neurosarcoidosis, cerebrovascular disorders, and untreated hypothyroidism\n* Known active or uncontrolled bacterial, viral, fungal, mycobacterial infection or other infection, excluding fungal infection of nail beds, including participants exhibiting symptoms consistent with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) within 6 weeks prior to Day 1\n* Participants with a current diagnosis of epilepsy\n* Clinically significant cardiac, metabolic, hematologic, hepatic, immunologic, urologic, endocrinologic, neurologic, pulmonary, psychiatric, dermatologic, allergic, renal, or other major diseases\n* History of cancer, including hematologic malignancy and solid tumors, within 10 years of screening. Basal or squamous cell carcinoma of the skin that has been excised and is considered cured and in situ carcinoma of the cervix treated with apparent success by curative therapy \\>1 year prior to screening is not exclusionary\n* Any concomitant disease that may require treatment with systemic corticosteroids or immunosuppressants during course of the study\n* History of currently active primary or secondary (non-drug-related) immunodeficiency\n* History of hypersensitivity to biologic agents or any of the excipients in the formulation\n* Only for cohorts where CSF samples are planned to be collected: Participants with a history of spinal cord compression, raised intra-cerebral pressure, clinically significant vertebral joint pathology or any other current abnormalities in the lumbar region which could prevent the lumbar puncture procedure.\n\nPrior\u002FConcomitant Therapy:\n\n* Treatment with any approved MS treatment at Screening. Participants may become eligible after completion of a washout period prior to acquiring any screening laboratory tests but should not be withdrawn from therapies for the sole purpose of meeting eligibility for the trial\n* Previous treatment with RO7121932, alemtuzumab, cladribine, mitoxantrone, cyclophosphamide, total body irradiation, bone marrow transplantation, and hematopoietic stem cell transplantation. For the USA only, previous treatment with daclizumab\n* Previous treatment with anti-cluster of differentiation 20 (CD20) B-cell-depleting therapies (e.g., rituximab, ocrelizumab, or ofatumumab)\n\n  * \\\u003C12 months prior to acquiring any screening laboratory tests,\n  * ≥12 months prior to acquiring any screening laboratory tests, if B-cells are outside the normal range, or not back to individual baseline ± 20% (if data are available),\n  * If discontinuation of a prior B-cell depletion therapy was motivated by safety reasons\n* Current or prior treatment with natalizumab (if \\\u003C24 months prior to acquiring any screening laboratory tests)\n\nPrior\u002FConcurrent Clinical Study Experience:\n\n\\- Participation in an investigational drug medicinal product or medical device study within 30 days before Screening or within five times the pharmacodynamic (PD) or pharmacokinetic (PK) half-life (if known), whichever is longer\n\nDiagnostic Assessments:\n\n* Positive result on human immunodeficiency virus (HIV1) and HIV2, hepatitis C, or hepatitis B\n* Participants with SI or behavior within 6 months prior to Screening or participants who, in the Investigator's judgment, pose a suicidal or homicidal risk\n* Vaccination with a live or live-attenuated vaccine within 6 weeks prior to Day 1",{"count":445,"type":20},129,[51],"The primary purpose of the study is to evaluate the safety and tolerability of a single-ascending intravenous (IV) dose (Part 1), a single-ascending subcutaneous (SC) dose (Part 2), and multiple ascending SC doses (Part 3) of RO7121932 in participants with multiple sclerosis (MS).",[412],{"date":158,"type":31},{"date":451,"type":31},"2021-08-11",{"date":453,"type":20},"2027-07-08",{"name":37,"class":38},32,{"id":457,"slug":4,"hasResults":11,"nctId":458,"briefTitle":459,"officialTitle":460,"acronym":4,"eligibilityCriteria":461,"healthyVolunteers":11,"sex":16,"minAge":174,"maxAge":47,"enrollmentInfo":462,"targetDuration":4,"studyType":21,"phases":463,"briefSummary":464,"conditions":465,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":467,"lastUpdatePostDateStruct":468,"startDateStruct":469,"completionDateStruct":471,"leadSponsor":473,"locationsCount":474},"100611004","NCT07234942","A Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7812653 in Participants With Early Symptomatic Alzheimer's Disease (eAD)","A Phase I, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Single Ascending Dose Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RO7812653 Following Intrathecal Administration in Participants With Early Symptomatic Alzheimer's Disease","Inclusion Criteria:\n\n* Probable AD dementia (consistent with National Institute on Aging and Alzheimer's Association (NIA-AA) core clinical criteria for probable AD dementia) \\[McKhann et al 2011\\] or Mild Cognitive Impairment (MCI) due to AD (consistent with the NIA-AA core clinical criteria for mild cognitive impairment due to AD) \\[Albert et al 2011\\]).\n* Willingness and ability to complete all aspects of the study. The participant should be capable of completing assessments either alone or with the help of the study partner.\n* Fluency in the language of the tests used at the study site.\n* Adequate visual and auditory acuity, in the investigator's judgment, sufficient to perform the neuropsychological testing (eyewear and hearing aids are permitted).\n* If the participant is receiving symptomatic AD medications, a stable dosing regimen for at least 8 weeks prior to screening and until randomization is required.\n* Agreement not to participate in other research studies for the duration of this study.\n\nExclusion Criteria:\n\n* Any medical history or evidence of a condition other than AD that may affect cognition.\n* Presence of any significant cerebral abnormalities that would contraindicate lumbar puncture, as assessed on MRI\n* Any other significant cerebral abnormalities that the Investigator considers clinically significant\n* History of schizophrenia, schizoaffective disorder, major depression or bipolar disorder.'\n* Presence of cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematological medical conditions which are not stable and adequately controlled or which in the opinion of the investigator could affect the subject's safety in the study or interfere with the study assessments",{"count":240,"type":20},[51],"This study aims to evaluate the safety, tolerability, immunogenicity, pharmacokinetics, and pharmacodynamics following administration of RO7812653 in participants with eAD.",[466],"Alzheimer's Disease","2026-06-28",{"date":393,"type":31},{"date":470,"type":31},"2026-01-27",{"date":472,"type":20},"2030-03-05",{"name":37,"class":38},10,{"id":476,"slug":4,"hasResults":11,"nctId":477,"briefTitle":478,"officialTitle":479,"acronym":480,"eligibilityCriteria":481,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":482,"targetDuration":4,"studyType":21,"phases":483,"briefSummary":484,"conditions":485,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":488,"lastUpdatePostDateStruct":489,"startDateStruct":490,"completionDateStruct":492,"leadSponsor":494,"locationsCount":495},"100640944","NCT07598396","A Study to Evaluate Mosunetuzumab in Participants With Systemic Lupus Erythematosus With or Without Active Lupus Nephritis","A Phase II Open-Label Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Mosunetuzumab in Patients With Systemic Lupus Erythematosus With or Without Active Lupus Nephritis","SOLUNA","Inclusion Criteria:\n\n* Diagnosis of SLE for ≥ 6 months as assessed using the 2019 European League Against Rheumatism\u002FAmerican College of Rheumatology (EULAR\u002FACR) Classification Criteria at screening\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding, or intention of becoming pregnant during the study or within the time frame in which contraception is required\n* Treatment with investigational therapy within 30 days or 5 drug-elimination half-lives (whichever is longer) prior to initiation of study treatment and during the study\n* Major surgery requiring hospitalization during the 4 weeks prior to screening or during screening, or any planned surgery or procedure requiring hospitalization during the 12 weeks following study drug administration\n* Alcohol or substance abuse within the 12 months prior to screening\n* Active infection of any kind, excluding fungal infection of the nail beds\n* Any major episode of infection as defined by the protocol\n* History of serious recurrent or chronic infection\n* History of progressive multifocal leukoencephalopathy (PML)\n* Tuberculosis (TB) infection\n* History of cancer, including solid tumors, hematological malignancies, and carcinoma in situ, within the past 5 years\n* Active overlap syndrome with mixed connective tissue disease or systemic sclerosis within the 12 months prior to screening or during screening\n* Catastrophic or severe antiphospholipid syndrome within the 12 months prior to screening or during screening. Antiphospholipid syndrome adequately controlled by anticoagulant therapy for at least 2 months prior to screening is acceptable\n* High risk for clinically significant bleeding or any condition requiring plasmapheresis, IV immunoglobulin, or acute blood product transfusions\n* Active severe or unstable lupus-associated neuropsychiatric disease or where, in the opinion of the investigator, it is likely to require treatment with protocol-disallowed therapies. Examples of neuropsychiatric SLE manifestations include, but are not limited to the following: meningitis, retinitis, cerebral vasculitis, myelopathy, demyelination syndromes, acute confusional state, psychosis, acute stroke or stroke syndrome, cranial neuropathy, status epilepticus or seizures, cerebellar ataxia, and mononeuritis multiplex\n* History of any non-SLE disease treated with oral, intravenous, or intramuscular corticosteroids for more than 14 days in total during the one year prior to Day 1\n* History of treatment with any T cell-engaging bispecific antibodies or CAR-T therapy within the past 2 years\n* Receipt of any live or attenuated vaccine in the 28 days prior to or during screening",{"count":357,"type":20},[23],"This study will assess how mosunetuzumab works in people who have systemic lupus erythematosus (SLE) who may or may not also have active lupus nephritis (LN).",[486,487,371],"Lupus","Systemic Lupus Erythematosus","2026-06-26",{"date":393,"type":31},{"date":491,"type":31},"2026-05-25",{"date":493,"type":20},"2028-08-31",{"name":37,"class":38},15,{"id":497,"slug":4,"hasResults":11,"nctId":498,"briefTitle":499,"officialTitle":500,"acronym":4,"eligibilityCriteria":501,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":502,"targetDuration":4,"studyType":154,"phases":4,"briefSummary":503,"conditions":504,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":488,"lastUpdatePostDateStruct":506,"startDateStruct":508,"completionDateStruct":510,"leadSponsor":512,"locationsCount":513},"100627938","NCT07455136","A Study to Develop a Blood-based Test for Aiding the Diagnosis\u002FPrognosis of Traumatic Brain Injury in Adults and for Monitoring the Development of Secondary Events in Patients Diagnosed With Traumatic Brain Injury","A Multicenter Prospective Study to Develop a Blood-based Biomarker Test for Aiding the Diagnosis\u002FPrognosis of Traumatic Brain Injury in Adult Subjects (CLIN12.1) and for Monitoring the Development of Secondary Events in Patients Diagnosed With Traumatic Brain Injury (CLIN12.2)","Inclusion Criteria:\n\n* Presenting to the Emergency Department with a biomechanically plausible mechanism of non-penetrating traumatic brain injury (TBI; direct impact: blow to the head, head against object, object against head; acceleration\u002Fdeceleration)\n* Acute brain CT completed for standard of care\n\nFurther Inclusion Criteria (specific for CLIN12.2):\n\n* Admitted to the hospital with radiographic evidence of acute TBI\n* Admitted to the intensive care unit at risk for decline related to TBI\n\nExclusion Criteria:\n\n* Prior neurosurgical intervention within the last 6 months\n* Major debilitating neurological disease (such as, but not limited to: stroke, CVA, mild cognitive impairment, Alzheimer's disease, Amyotrophic lateral sclerosis, Parkinson's disease, Huntington's disease, Frontotemporal dementia, tumor, epilepsy, unmanaged seizure disorder), impairing baseline awareness, cognition, or validity of outcomes assessments\n* Major debilitating baseline mental health disorders (such as but not limited to schizophrenia or bipolar disorder) that would interfere with follow-up and the validity of outcome assessments\n* Significant pre-existing conditions that would interfere with follow-up and outcome assessment (such as, but not limited to: chronic kidney disease, chronic cardiovascular comorbidities, alcohol or substance use disorder)\n* History of melanoma\n* Primary diagnosis of ischemic or hemorrhagic stroke\n* Any spinal Cord Injury (American Spinal Injury Association \\[ASIA\\] score of A-D)\n* Received chemotherapy or radiation currently or within the last year\n* Patients on psychiatric hold (e.g., 5150, 5250)\n* Current incarceration or in custody\n* Known inability to undergo an MRI\n* Currently receiving any interventional treatments as a part of an investigational study\u002Ftrial (drug, device, behavioral, treatment) at the time of enrollment and\u002For during the course of this study\n* Low likelihood of follow-up (e.g. participant or family indicating low interest, residence in another state or country, homelessness or lack of reliable contacts)\n* Any condition that, in the opinion of the investigator, could interfere in the proper execution of the study procedures and\u002For in their future permanence in the study",{"count":298,"type":20},"The study is intended to cover two purposes: first, to develop a blood-based biomarker test for aiding the diagnosis of traumatic brain injury (TBI) in adult participants and for prognosis of outcome of TBI (CLIN12.1); and second, for monitoring the development of secondary events in adult participants diagnosed with TBI (CLIN12.2).",[505],"Traumatic Brain Injury",{"date":507,"type":31},"2026-06-29",{"date":509,"type":31},"2026-02-09",{"date":511,"type":20},"2028-05-31",{"name":37,"class":38},13,{"id":515,"slug":4,"hasResults":11,"nctId":516,"briefTitle":517,"officialTitle":518,"acronym":519,"eligibilityCriteria":520,"healthyVolunteers":11,"sex":16,"minAge":521,"maxAge":407,"enrollmentInfo":522,"targetDuration":4,"studyType":21,"phases":523,"briefSummary":524,"conditions":525,"keywords":4,"overallStatus":27,"whyStopped":4,"lastUpdateSubmitDate":488,"lastUpdatePostDateStruct":527,"startDateStruct":528,"completionDateStruct":530,"leadSponsor":532,"locationsCount":533},"100611927","NCT07246941","A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of RG6496 in Huntington's Disease","A Phase I, 2-Part Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Single-ascending Doses of Intrathecally Administered RG6496 in a Randomized, Placebo-controlled, Investigator\u002FParticipant-blind Study With an Open-label Extension in Huntington's Disease Gene Expansion Carriers","POINT-HD","Inclusion Criteria:\n\nPart 1\n\n* Confirmation of HDGEC status with cytosine-adenine-guanine (CAG) expansion \\> 39.\n* Confirmation of SNP carrier status of the target SNP\n* Independence Scale (IS) score of ≥70, total functional capacity (TFC) ≥10, total motor score (TMS) \\>6.\n* Ability to read the words \"red,\" \"blue,\" and \"green\" and be fluent in the language of the informed consent form (ICF) and the tests used at the study site.\n* Ability to walk unassisted.\n* Total body weight \\> 40 kilogram (kg) and body mass index (BMI) within the range 18-32 kilogram per square meter (kg\u002Fm\\^2) (inclusive) at baseline.\n* Ability to undergo and tolerate MRI scans.\n\nPart 2\n\n* Completed the post-dose safety follow-up period in the Part 1 of the study.\n* In the opinion of the Investigator, the participant has not experienced a worsening in health that precludes their safe continued participation in the study.\n\nExclusion Criteria:\n\nPart 1\n\n* Concurrent or planned participation in any interventional clinical study, including current use of an ASO or any HTT-lowering therapy or treatment with investigational therapy within 90 days or 5 drug-elimination half-lives, whichever is longer prior to screening\n* Pregnant or breastfeeding, or with the intention of becoming pregnant during the study or within the timeframe in which contraception is required\n* Malignancy within 5 years prior to screening\n* Planned brain surgery during the study\n* Positive HIV test, hepatitis B surface antigen and hepatitis B surface antigen at screening\n* Active psychosis, confusional state, or violent behavior, including aggression that could cause harm to self or others, over the 12 weeks prior to screening.\n* Current or previous history of a primary independent psychotic disorder.\n* Scoliosis or spinal deformity or surgery making IT injection not feasible in an outpatient setting\n* History of attempted suicide or suicidal ideation with plan (i.e., active suicidal ideation) that required hospital visit and\u002For change in level of care within 12 months prior to screening.\n\nPart 2\n\n* Prematurely discontinued from Part 1 for any reason (i.e., before the completion of the postdose safety follow-up period of Part 1).\n* Pregnant or breastfeeding, or with the intention of becoming pregnant during the study or within the timeframe in which contraception is required.\n* Concurrent or planned participation in any interventional clinical study, including current use of an ASO or any HTT-lowering therapy\n* Received any active investigational treatment other than RG6496 during or since completion of Part 1 of the study.\n* Had confirmed Dose-Limiting Adverse Event (DLAE)(s) in Part 1 of the study.","25 Years",{"count":367,"type":20},[51],"This is a first-in-human (FIH) study of RG6496 that will assess the safety and tolerability of single-ascending doses of RG6496 administered to huntington's disease gene expansion carriers (HDGECs). The study consists of two parts: Part 1 \\[single-ascending dose\\] followed by Part 2 \\[open-label extension (OLE)\\].",[526],"Huntington's Disease",{"date":507,"type":31},{"date":529,"type":31},"2025-11-19",{"date":531,"type":20},"2029-05-23",{"name":37,"class":38},6,""]