[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"AbbVie\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":588},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,147,0,25,[9,44,71,100,124,150,171,198,225,247,278,306,331,350,372,400,424,448,468,490,501,512,523,545,566],{"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":25,"conditions":26,"keywords":29,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100053345",false,"NCT07160179","Study to Assess the Adverse Events and How Intravitreal ABBV-6628 Moves Through the Body of Adult Participants With Geographic Atrophy Secondary to Age-Related Macular Degeneration","Safety, Tolerability, Pharmacokinetics, and Exploratory Efficacy of ABBV-6628 in Subjects With Geographic Atrophy Secondary to Age-Related Macular Degeneration","Inclusion Criteria:\n\nStage 1 and Stage 2\n\n-Diagnosed with Geographic atrophy (GA) secondary to age-related macular degeneration (AMD) in the study eye.\n\nStage 1\n\n* Foveal or non-foveal GA with total GA lesion area ≥ 0.5 DA (1.25 mm2) in the study eye, as assessed by the investigator at Screening and confirmed by the central reading center prior to Baseline\u002FDay 1\n* Absence of choroidal neovascularization (CNV) in the study eye as assessed by the investigator at Screening and confirmed by the central reading center prior to Baseline\u002FDay 1. In addition, investigators should confirm eligibility prior to treatment administration on Baseline\u002FDay 1.\n\nStage 2\n\n* Non-foveal GA with total lesion area of 1 to 7 DA (2.5 to 17.5 mm2); within 0.5 to 1.5 mm from fovea center in the study eye, as assessed by the investigator at Screening and confirmed by the central reading center prior to Baseline\u002FDay 1.\n* Absence of CNV in both eyes as assessed by the investigator at Screening and confirmed by the central reading center prior to Baseline\u002FDay 1. In addition, investigators should confirm eligibility prior to treatment administration on Baseline\u002FDay 1.\n\nExclusion Criteria:\n\nStage 1 and Stage 2\n\n* History of recurrent or currently active ocular or intraocular inflammation (e.g., uveitis, endophthalmitis) in at least one eye at Screening and Baseline\u002FDay 1.\n* Active periocular, ocular, or intraocular infection in at least one eye at Baseline\u002FDay 1.\n* History or clinical signs of diabetic retinopathy, diabetic macular edema (DME), or any retinal vascular disease other than AMD in at least one eye at Screening and Baseline\u002FDay 1.","ALL","50 Years",{"count":19,"type":20},66,"ESTIMATED","INTERVENTIONAL",[23,24],"PHASE1","PHASE2","Age-related macular degeneration (AMD) is the abnormal growth of new blood vessels in the light-sensitive tissue at the back of the eye called the retina. Geographic Atrophy (GA) is an advanced form of dry AMD. The purpose of this study is to assess the adverse events and how intravitreal ABBV-6628 moves through the body of adult participants with secondary to age-related macular degeneration\n\nABBV-6628 is an investigational monoclonal antibody fragment being developed for the treatment of geographic atrophy (GA) secondary to (AMD) age-related macular degeneration. Participants in the Stage 1 part will be placed in 1 of 4 groups, called treatment arms. Participants in Stage 2 will be placed into 1 of 2 groups. Each group receives different treatment. Adult participants aged 50 and older years with a diagnosis GA secondary to age-related macular degeneration will be enrolled. Around 66 participants will be enrolled in the study at approximately 27 sites across the US.\n\nParticipants in Stage 1 will be given ABBV-6628 as an intravitreal injection (injection into the jelly-like tissue that fills the eyeball injection) with dose escalation. Participants in Stage 2 will receive ABBV-6628 or SYFOVRE, an approved treatment for geographic atrophy, administered as per the FDA-approved label. The treatment duration is approximately 22 months and 3 months of follow-up.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular weekly visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.",[27,28],"Geographic Atrophy","Age-Related Macular Degeneration",[27,28,30],"ABBV-6628","RECRUITING","2026-07-10",{"date":34,"type":35},"2026-07-13","ACTUAL",{"date":37,"type":35},"2025-08-13",{"date":39,"type":20},"2029-10",{"name":41,"class":42},"AbbVie","INDUSTRY",5,{"id":45,"slug":4,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":21,"phases":54,"briefSummary":56,"conditions":57,"keywords":59,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":64,"startDateStruct":65,"completionDateStruct":67,"leadSponsor":69,"locationsCount":70},"100054198","NCT07525206","A Study to Access Intravenous (IV) Telisotuzumab Adizutecan in Combination With IV Bevacizumab Compared to Standard of Care IV Bevacizumabin Combination With Oral Trifluridine and Tipiracil in Adult Participants With Refractory Metastatic Colorectal Cancer","An Open-Label, Randomized, Controlled, Global Phase 3 Study Comparing Telisotuzumab Adizutecan (ABBV-400) Plus Bevacizumab to LONSURF (Trifluridine and Tipiracil) Plus Bevacizumab in Subjects With Refractory Metastatic Colorectal Cancer","AndroMETa-CRC","Inclusion Criteria:\n\n* Must voluntarily sign and date an informed consent, approved by an Ethics Committee (IEC)\u002F Institutional Review Board (IRB), prior to the initiation of any screening or study-specific procedures. Participants must have the capacity to consent in the opinion of the investigator.\n* Life expectancy \\>= 12 weeks per investigator assessment\n\nExclusion Criteria:\n\n* Prior systemic regimen containing c-Met targeting agent (e.g., antibody, antibody drug conjugate, bispecific) or any other unapproved investigational agent.\n* History of allergic reactions or hypersensitivity to bevacizumab or any of its excipients, or to compounds similar to trifluridine\u002Ftipiracil.\n* History of hypersensitivity to Chinese Hamster Ovary cell products or other recombinant human or humanized antibodies.\n* History of clinically significant (per investigator's judgment) drug or alcohol abuse within the last 6 months.","18 Years",{"count":53,"type":20},700,[55],"PHASE3","Colorectal cancer (CRC) is the third most common type of cancer diagnosed worldwide. The purpose of this study is to assess the adverse events and change in disease activity of telisotuzumab adizutecan plus bevacizumab compared to standard of care (SOC) of LONSURF (trifluridine and tipiracil) plus bevacizumab in adult participants with c-Met over-expressed refractory metastatic colorectal cancer (mCRC).\n\nTelisotuzumab adizutecan is an investigational drug being developed for the treatment of CRC. Participants will then be randomized into 2 groups called treatment arms. One group will receive telisotuzumab adizutecan with bevacizumab in different doses. Another group will receive standard of care (SOC), trifluridine and tipiracil (LONSURF), with Bevacizumab. Up to approximately 700 adult participants with refractory mCRC, will be enrolled in the study in approximately 125 sites globally.\n\nIn this Phase 3, one of two groups will receive doses of Intravenous (IV) telisotuzumab adizutecan + bevacizumab and other group will receive oral SOC of trifluridine\u002Ftipiracil (LONSURF)+ Intravenous (IV) bevacizumab. The study will run for a duration of approximately of 36 months.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.",[58],"Colorectal Cancer",[58,60,61,62,63],"Telisotuzumab Adizutecan","Bevacizumab","Trifluridine and Tipiracil","AndroMETa-CRC-560",{"date":34,"type":35},{"date":66,"type":35},"2026-05-22",{"date":68,"type":20},"2030-03",{"name":41,"class":42},16,{"id":72,"slug":4,"hasResults":11,"nctId":73,"briefTitle":74,"officialTitle":75,"acronym":76,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":4,"enrollmentInfo":78,"targetDuration":4,"studyType":80,"phases":4,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":93,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":99},"100053355","NCT03342144","Study of the Use of Venetoclax in Participants With Chronic Lymphocytic Leukemia (CLL) Under Real-Life Setting","Observational Study of the Use of Venetoclax in Patients With Chronic Lymphocytic Leukemia (CLL) Under Real-Life Setting in Austria, Germany and Switzerland","VeRVe","Inclusion Criteria:\n\n\\- Participant with chronic lymphocytic leukemia (CLL) who start venetoclax therapy can be included in the study if treated as specified in the local label for any specific line of treatment.\n\nExclusion Criteria:\n\n\\- None",{"count":79,"type":20},500,"OBSERVATIONAL","An observational study to assess the effectiveness, health economic-relevant costs and participant reported outcomes in participants with Chronic lymphocytic leukemia (CLL) receiving venetoclax as a monotherapy or in combination with rituximab, obinutuzumab, ibrutinib, or acalabrutinib as prescribed at the discretion of the physician and in accordance with local clinical practice and label.",[83],"Chronic Lymphocytic Leukemia (CLL)",[83,85,86,87,88,89,90,91,92],"Cancer","Leukemia","venetoclax","rituximab","obinutuzumab","ABT-199","venclexta","venclyxto",{"date":34,"type":35},{"date":95,"type":35},"2017-12-04",{"date":97,"type":20},"2030-12",{"name":41,"class":42},70,{"id":101,"slug":4,"hasResults":11,"nctId":102,"briefTitle":103,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":107,"minAge":51,"maxAge":4,"enrollmentInfo":108,"targetDuration":4,"studyType":21,"phases":110,"briefSummary":111,"conditions":112,"keywords":114,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":117,"startDateStruct":118,"completionDateStruct":120,"leadSponsor":122,"locationsCount":123},"100053966","NCT07059845","A Study to Assess Adverse Events and Change in Disease Activity of Multiple Treatment Combinations With Intravenous Mirvetuximab Soravtansine in Adult Participants With Ovarian Cancer","A Phase 2, Open-Label, Randomized, Master Protocol Dose Optimization Study to Evaluate Safety and Efficacy of Multiple Treatment Combinations With Mirvetuximab Soravtansine in Subjects With Ovarian Cancer","FLORENZA","Inclusion Criteria:\n\nSubstudy 1\n\n* Participants must be willing to provide an archival tumor tissue block or slides or must undergo a procedure to obtain a new tumor biopsy using a low-risk, medically routine procedure for immunohistochemistry (IHC) confirmation of FRα expression as defined by the central VENTANA FOLR1 (FOLR1-2.1) assay. Tumors must have FRα-expression in \\>= 50% of viable tumor cells with \\>= 2+ staining intensity.\n* Participants must have an Eastern Cooperative Oncology Group performance status of 0 or 1.\n* 1L participants must have a confirmed diagnosis of Federation of Gynecology and Obstetrics (FIGO) Stage III or IV high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer.\n\n  2L participants must have platinum-sensitive high-grade serous epithelial ovarian, primary peritoneal, or fallopian tube cancer. Participants must have platinum-sensitive disease defined as radiographic progression greater than 183 days from the last dose of most recent platinumbased chemotherapy. Note: Progression should be calculated from the date of the last administered dose of platinum therapy to the date of the radiographic imaging showing progression.\n* Participant has a local homologous recombination deficient (HRD) or breast cancer susceptibility gene (BRCA) test result available. Participants with BRCA wild-type will need to have a local HRD test result available.\n\nSubstudy 2\n\n* Participants must be willing to provide an archival tumor tissue block or slides or must undergo a procedure to obtain a new tumor biopsy using a low-risk, medically routine procedure for immunohistochemistry (IHC) confirmation of FRα expression as defined by the central VENTANA FOLR1 (FOLR1-2.1) assay. Tumors must have FRα-expression in \\>= 50% of viable tumor cells with \\>= 2+ staining intensity.\n* Participants must have an Eastern Cooperative Oncology Group performance status of 0 or 1.\n* Participants must have a confirmed diagnosis of high-grade serous ovarian, primary peritoneal, or fallopian tube cancer.\n* Participants must have relapsed after 1 or 2 prior lines of platinum-based chemotherapy.\n* Participants must have platinum-sensitive disease defined as radiographic progression greater than 183 days from the last dose of platinum-based chemotherapy.\n* Participants must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (assessed by the investigator) at baseline.\n\nSubstudy 3\n\n* Participants must be willing to provide an archival tumor tissue block or slides or must undergo a procedure to obtain a new tumor biopsy using a low-risk, medically routine procedure for immunohistochemistry (IHC) confirmation of FRα expression as defined by the central VENTANA FOLR1 (FOLR1-2.1) assay. Tumors must have FRα-expression in \\>= 50% of viable tumor cells with \\>= 2+ staining intensity.\n* Participants must have an Eastern Cooperative Oncology Group performance status of 0 or 1.\n* Participants must have a confirmed diagnosis of high-grade serous ovarian, primary peritoneal, or fallopian tube cancer.\n* Participants must have relapsed after 1 or 2 prior lines of platinum-based chemotherapy.\n* Participants must have platinum-sensitive disease defined as radiographic progression greater than 183 days from the last dose of platinum-based chemotherapy.\n* Participants must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 (assessed by the investigator) at baseline.\n\nExclusion Criteria:\n\nSubstudy 1\n\n* Participants with progressive disease (PD) while on triplet therapy or after the first day of their last triplet therapy cycle and before randomization.\n* Participants who receive an intervening dose of bevacizumab after the first day of their last triplet therapy cycle and before randomization.\n* Participants who received prior treatment with mirvetuximab soravtansine (MIRV), any FRα-targeting agent, or Poly(ADP-ribose) polymerase inhibitor (PARPi).\n\nSubstudy 2\n\n* More than 2 prior lines of chemotherapy. Lines of prior anticancer therapy are counted with the following considerations:\n\n  * Neoadjuvant +\u002F- adjuvant therapies are considered 1 line of therapy if the neoadjuvant and adjuvant correspond to 1 fully predefined regimen; otherwise, they are counted as 2 prior regimens.\n  * Maintenance therapy (e.g., bevacizumab, PARPi) will be considered part of the preceding line of therapy (i.e., not counted independently).\n  * If a chemotherapeutic agent in a regimen is substituted with another during a course of treatment due to toxicity, it will be considered part of the same line of therapy\n  * Prior hormonal therapy will not be counted as a separate line of chemotherapy (it will be counted as part of the prior systemic therapy regimen)\n* Participants who received prior treatment with mirvetuximab soravtansine or other FRα-targeting agents.\n\nSubstudy 3\n\n* More than 2 prior lines of chemotherapy. Lines of prior anticancer therapy are counted with the following considerations:\n\n  * Neoadjuvant +\u002F- adjuvant therapies are considered 1 line of therapy if the neoadjuvant and adjuvant correspond to 1 fully predefined regimen; otherwise, they are counted as 2 prior regimens.\n  * Maintenance therapy (e.g., bevacizumab, PARPi) will be considered part of the preceding line of therapy (i.e., not counted independently).\n  * If a chemotherapeutic agent in a regimen is substituted with another during a course of treatment due to toxicity, it will be considered part of the same line of therapy\n  * Prior hormonal therapy will not be counted as a separate line of chemotherapy (it will be counted as part of the prior systemic therapy regimen)\n* Participants who received prior treatment with mirvetuximab soravtansine or other FRα-targeting agents.","FEMALE",{"count":109,"type":20},400,[24],"Ovarian cancer is a lethal disease with an estimated 310,000 new cases and 200,000 deaths experienced worldwide in 2020. The purpose of this study is to assess the adverse events and change in disease activity of mirvetuximab soravtansine with carboplatin, or bevacizumab (Bev), or bev alone in participants with ovarian cancer (OC). Participants must have confirmation of folate receptor alpha (FRa) positivity by the Ventana folate receptor 1 (FOLR1) Assay.\n\nMirvetuximab Soravtansine (MIRV) is an investigational drug for the treatment of OC. Participants will be assigned to 1 of 3 substudies and further into groups called treatment arms. In substudy 1, arms A-C, participants will receive 1 of 2 doses of MIRV with Bev, or Bev alone. In substudy 2, arms D and E, participants will receive 1 of 2 doses of MIRV with carboplatin, followed by MIRV alone. In substudy 3, arms F and G, participants will receive one of two doses of MIRV with BEV and carboplatin, followed by MIRV with BEV. Approximately 400 participants will be enrolled in the study at 100 sites around the world.\n\nParticipants will receive intravenously (IV) infused MIRV with IV infused carboplatin, or IV infused Bev, or IV infused carboplatin and Bev, or IV infused Bev alone. The total study duration will be approximately 40 months.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and scans.",[113],"Ovarian Cancer",[113,115,61,116],"Mirvetuximab Soravtansine","Carboplatin",{"date":34,"type":35},{"date":119,"type":35},"2025-11-13",{"date":121,"type":20},"2029-01",{"name":41,"class":42},77,{"id":125,"slug":4,"hasResults":11,"nctId":126,"briefTitle":127,"officialTitle":128,"acronym":129,"eligibilityCriteria":130,"healthyVolunteers":11,"sex":16,"minAge":131,"maxAge":132,"enrollmentInfo":133,"targetDuration":4,"studyType":21,"phases":135,"briefSummary":136,"conditions":137,"keywords":139,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":143,"startDateStruct":144,"completionDateStruct":146,"leadSponsor":148,"locationsCount":149},"100054201","NCT06012240","A Study to Evaluate the Safety and Effectiveness of Upadacitinib Tablets in Adult and Adolescent Participants With Severe Alopecia Areata","A Phase 3 Randomized, Placebo-controlled, Double-blind Program to Evaluate Efficacy and Safety of Upadacitinib in Adult and Adolescent Subjects With Severe Alopecia Areata","Up-AA","Inclusion Criteria:\n\n* Adult individuals must be \\\u003C 64 years old at Baseline Visit. Where permitted outside United States (US)\u002FEuropean Union (EU), adolescent individuals who are at least 12 years old at Screening may participate in Study 1 and Study 2. Adolescent individuals in the US who are at least 12 years old at Screening may participate in Study 4.\n* Diagnosis of severe alopecia areata (AA) with Severity of Alopecia Tool (SALT) score \\>= 50 scalp hair loss at Screening and Baseline.\n* Severe AA with no spontaneous scalp hair regrowth over the past 6 months.\n* Current episode of AA of less than 8 years.\n\nExclusion Criteria:\n\n* Current diagnosis of primarily diffuse type of AA.\n* Current diagnosis of other types of alopecia that would interfere with evaluation of AA, including but not limited to female pattern hair loss, male pattern hair loss (androgenetic alopecia) Stage III or greater based on Hamilton-Norwood classification, traction alopecia, lichen planopilaris (LPP), discoid lupus, frontal fibrosing alopecia (FFA), central centrifugal cicatricial alopecia (CCCA), folliculitis decalvans, trichotillomania, and telogen effluvium.\n* Diagnosis of other types of inflammatory scalp, eyebrow, or eyelash disorders that would interfere with evaluation of AA as determined by the investigator, including but not limited to seborrheic dermatitis, scalp psoriasis, atopic dermatitis (AD), and tinea capitis.","12 Years","63 Years",{"count":134,"type":20},1500,[55],"Alopecia areata (AA) is a disease that happens when the immune system attacks hair follicles and causes hair loss. AA usually affects the head and face, but hair loss can happen on any part of the body. The purpose of this study is to assess how safe, effective, and tolerable upadacitinib is in adolescent and adult participants with severe AA.\n\nUpadacitinib is an approved drug being investigated for the treatment of AA. In Study 1 and Study 2 and Study 4 Period A, participants are placed in 1 of 3 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 5 chance that participants will be assigned to placebo. In Study 1 and Study 2 and Study 4 Period B, participants originally randomized to upadacitinib dose group in Period A will continue their same treatment in Period B. Participants originally randomized to Placebo in Period A will either remain on placebo in Period B, or be randomized in 1 of 2 groups, based off of their Severity of Alopecia Tool (SALT) score. Participants who complete Study 1, Study 2 or Study 4, can join Study 3 and may be re-randomized to receive 1 of 2 doses of upadacitinib for up to 108 weeks. Around 1500 participants with severe AA will be enrolled in the study at approximately 280 sites worldwide.\n\nParticipants will receive oral tablets of either upadacitinib or placebo once daily for up to 160 weeks with the potential of being re-randomized into a different treatment group at Weeks 24 and 52. Participants will be followed up for up to 30 days after last study drug dose.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.",[138],"Alopecia Areata",[138,140,141,142],"Upadacitinib","Rinvoq","ABT-494",{"date":34,"type":35},{"date":145,"type":35},"2023-10-11",{"date":147,"type":20},"2030-04",{"name":41,"class":42},281,{"id":151,"slug":4,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":49,"eligibilityCriteria":155,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":4,"enrollmentInfo":156,"targetDuration":4,"studyType":21,"phases":158,"briefSummary":159,"conditions":160,"keywords":162,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":164,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":170},"100053954","NCT06820463","A Study to Evaluate the Adverse Events, and Efficacy of Intravenous (IV) of Telisotuzumab Adizutecan in Combination With IV Oxaliplatin, Fluorouracil, Folinic Acid\u002FLeucovorin, Bevacizumab, Panitumumab in Adult Participants With Metastatic Colorectal Cancer","A Phase 2, Open-Label, Randomized, Master Protocol Study to Evaluate Safety and Efficacy of Multiple Treatment Combinations With Telisotuzumab Adizutecan in Subjects With Metastatic Colorectal Cancer","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.\n* Laboratory values meeting the criteria within the protocol.\n* Has measurable disease per response evaluation criteria in solid tumors (RECIST) v1.1.\n\nExclusion Criteria:\n\n* Prior systemic regimen containing c-Met targeting agent(s) (e.g., antibody, antibody drug conjugate, bispecific) and\u002For any topoisomerase inhibitor(s) (e.g., irinotecan).\n* History of other malignancies within 5 years prior to screening, except for malignancies with a negligible risk of metastasis or death.",{"count":157,"type":20},390,[24],"CRC is the third most common type of cancer diagnosed worldwide with developed countries at highest risk. The purpose of this study is to assess adverse events and change in disease activity when telisotuzumab adizutecan is given in combination with oxaliplatin, fluorouracil (5FU), leucovorin (LV) (FOLFOX), and bevacizumab or panitumumab.\n\nTelisotuzumab adizutecan is an investigational drug being developed for the treatment of mCRC. Fluorouracil and leucovorin are drugs approved for the treatment of mCRC. This study will be divided into two stages, with the first stage treating participants with increasing doses of telisotuzumab adizutecan with FOLFOX and bevacizumab or 5FU\u002FLV and panitumumab until the dose reached is tolerable and expected to be efficacious. Participants will then be randomized into 3 groups called treatment arms where one group will receive one of two optimized doses of telisotuzumab adizutecan from the dose escalation phase with FOLFOX and bevacizumab or 5FU\u002FLV and panitumumab, or a comparator of FOLFOX and bevacizumab or panitumumab. Approximately 390 adult participants with mCRC will be enrolled in the study in 100 sites worldwide.\n\nIn the dose escalation stage participants will be treated with increasing intravenous (IV) doses of telisotuzumab adizutecan with FOLFOX and bevacizumab or 5FU\u002FLV and panitumumab until the dose reached is tolerable and expected to be efficacious. In the dose optimization stage participants will be receive FOLFOX or receive 5FU\u002FLV, but with one of two optimized doses of telisotuzumab adizutecan, or a comparator of FOLFOX and bevacizumab\u002Fpantitumumab. The study will run for a duration of approximately 6 years.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.",[161],"Metastatic Colorectal Cancer",[161,163,60],"AndroMETa-CRC-533",{"date":34,"type":35},{"date":166,"type":35},"2025-04-24",{"date":168,"type":20},"2028-04",{"name":41,"class":42},56,{"id":172,"slug":4,"hasResults":11,"nctId":173,"briefTitle":174,"officialTitle":175,"acronym":4,"eligibilityCriteria":176,"healthyVolunteers":11,"sex":16,"minAge":177,"maxAge":178,"enrollmentInfo":179,"targetDuration":4,"studyType":21,"phases":181,"briefSummary":182,"conditions":183,"keywords":185,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":192,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":196,"locationsCount":197},"100053318","NCT07306832","A Study to Assess Adverse Events and How Intravenous (IV) Pivekimab Sunirine Moves Through the Body in Pediatric Participants With Relapsed or Refractory Acute Myeloid Leukemia (AML)","A Phase 1b Study of the Safety and Pharmacokinetics of Pivekimab Sunirine in Pediatric Subjects With Relapsed or Refractory Acute Myeloid Leukemia (AML)","Inclusion Criteria:\n\n* Must have histologically confirmed acute myeloid leukemia (AML) meeting one of the following disease criteria:\n\n  * Second or greater relapse. OR\n  * Disease refractory to second or subsequent line of therapy (defined as resistant disease after at least one cycle of each treatment regimen).\n* Must have myeloid leukemic blasts that are CD123-positive by flow cytometry as determined by the treating institution.\n* Has \\>= 5% myeloid leukemic blasts in bone marrow at time of relapse or refractory disease and prior to Screening for this study.\n* Performance status by Lansky (\\\u003C 16 years old at evaluation) or Karnofsky (\\>= 16 years old at evaluation) score \\>= 50 or ECOG score \\\u003C= 2.\n* May have status of central nervous system (CNS)1, CNS2, or CNS3 disease without clinical signs or neurologic symptoms suggestive of CNS leukemia, such as facial nerve palsy, brain\u002Feye involvement or hypothalamic syndrome. Participants receiving intrathecal therapy and no additional CNS-directed systemic therapy at study entry are eligible and may continue treatment as clinically indicated in accordance with institutional practice.\n* For those participants who have not reached the age of consent, parent or legal guardian with the willingness and ability to provide informed consent and participant willing and able to give assent, as appropriate for age and country.\n\nExclusion Criteria:\n\n* Known clinically significant cardiac disease.\n* Down syndrome.\n* Acute promyelocytic leukemia (APL) or juvenile myelomonocytic leukemia (JMML).\n* Symptomatic central nervous system (CNS3) disease\n* Prior history of any severity veno-occlusive disease\u002Fsinusoidal obstructive syndrome (VOD\u002FSOS) of the liver.\n* Prior history of hematopoietic stem cell transplant within 6 months prior to Screening without evidence of active GvHD at the time of screening and the participant is off medications to treat or prevent either post-transplant graft-versus-host disease (GvHD) or post-transplant rejection (except for a stable dose of corticosteroids).\n* Have received prior Chimeric Antigen Receptor T-cell (CAR-T) therapy.\n* Any other known current malignancy requiring therapy.\n* Currently receiving anticancer therapy with antineoplastic intent, including radiotherapy, systemic therapy small molecules, monoclonal antibodies, other investigational agents, or high-dose chemotherapy with the exception of intrathecal therapy.","6 Months","17 Years",{"count":180,"type":20},18,[23],"Acute myeloid leukemia (AML) is an aggressive blood cancer, withwith few options for participants who relapse after treatment or who don't respond to treatment. This study will assess the adverse events and how pivekimab sunirine moves through the body in pediatric participants with relapsed or refractory (R\u002FR) AML.\n\nPivekimab sunirine is a drug being evaluated in the treatment of AML. This is an open label, single arm study, participants will be enrolled in 1 of the 3 cohorts based on their age and will receive pivekimab sunirine at a dose based on their weight. Around 18 pediatric participants with a diagnosis of AML will be enrolled in the study at approximately 30 sites around the world.\n\nParticipants will receive intravenous (IV) pivekimab sunirine alone. The total study duration is approximately 28 months.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, and checking for side effects.",[184],"Acute Myeloid Leukemia",[184,186,187,188,189,190],"Relapsed","Refractory","Pivekimab Sunirine","PVEK","Pediatric","2026-07-09",{"date":34,"type":35},{"date":194,"type":35},"2026-05-20",{"date":68,"type":20},{"name":41,"class":42},8,{"id":199,"slug":4,"hasResults":11,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":4,"eligibilityCriteria":203,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":4,"enrollmentInfo":204,"targetDuration":4,"studyType":21,"phases":206,"briefSummary":207,"conditions":208,"keywords":210,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":218,"startDateStruct":219,"completionDateStruct":221,"leadSponsor":223,"locationsCount":224},"100053684","NCT06772623","Study to Evaluate Adverse Events and Efficacy of Intravenous (IV) Telisotuzumab Adizutecan in Combination With a PD-1 Immune Checkpoint Inhibitor in Adult Participants With Advanced or Metastatic Non-Squamous NSCLC With No Prior Treatment for Advanced Disease, and No Actionable Genomic Alterations","An Open-label Multi-Cohort Phase 1b\u002F2 Study to Evaluate the Safety, Efficacy, and Optimal Dose of Telisotuzumab Adizutecan in Combination With a PD-1 Immune Checkpoint Inhibitor in Advanced or Metastatic Non-Squamous NSCLC With No Prior Treatment for Advanced Disease and No Actionable Genomic Alterations","Inclusion Criteria:\n\n* Must have histologically documented non-squamous (NSq) non small cell lung carcinoma (NSCLC) that is locally advanced or metastatic will be enrolled into the study.\n* Must have measurable disease per response evaluation criteria in solid tumors (RECIST) v1.1.\n* For Part 1, participants must have had no more than 1 systemic therapy for advanced disease including platinum-based chemotherapy or an immune checkpoint inhibitor (as monotherapy or in combination with chemotherapy), or appropriate targeted therapy for an actionable gene alteration, if applicable, for epidermal growth factor receptor (EGFR) wild-type (WT) NSq NSCLC.\n* For Part 2, participants must have no prior systemic therapy for advanced disease, no known actionable genomic alteration.\n* Must have documented programmed death ligand 1 (PD-L1) status.\n* For Part 2, participant must have evaluable c-Met immunohistochemistry (IHC) result per central testing prior to randomization.\n* Must have adequate organ function.\n\nExclusion Criteria:\n\n* Known uncontrolled metastases to the central nervous system.\n* History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, or any evidence of active ILD or pneumonitis on screening chest computed tomography (CT) scan.",{"count":205,"type":20},252,[23,24],"Non small cell lung carcinoma (NSCLC) is the most frequently occurring histologic subtype of lung cancer and is the leading cause of cancer-related deaths worldwide. The purpose of this study is to assess adverse events and change in disease activity when Telisotuzumab Adizutecan (ABBV-400) is given in combination with a programmed cell death receptor 1 (PD1) immune checkpoint inhibitor to adult participants to treat NSCLC.\n\nTelisotuzumab Adizutecan (ABBV-400) and budigalimab are investigational drugs being developed for the treatment of NSCLC. This study will be divided into two stages, with the first stage treating participants with several doses of telisotuzumab adizutecan in combination with budigalimab within the dose escalation regimen until the dose reached is tolerable and expected to be efficacious. In Stage 2 there will be 3 treatment groups. Two groups will receive pembrolizumab with different optimized doses of telisotuzumab adizutecan (to allow for the best dose to be studied in the future). One group will receive the standard of care (SOC) - pembrolizumab, pemetrexed, and investigator's choice of carboplatin or cisplatin, followed by pembrolizumab and pemetrexed. Approximately 252 adult participants with NSCLC will be enrolled in the study in 132 sites worldwide.\n\nIn the dose escalation stage participants will be treated with increasing intravenous (IV) doses of Telisotuzumab Adizutecan in combination with budigalimab until the dose of Telisotuzumab Adizutecan reached is tolerable and expected to be efficacious. In the dose optimization stage participants will be receive IV optimized doses of Telisotuzumab Adizutecan in combination with IV pembrolizumab, or IV SOC - pembrolizumab, pemetrexed, and investigator's choice of carboplatin or cisplatin, followed by pembrolizumab and pemetrexed. The study will run for a duration of approximately 33 months.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.",[209],"Non Small Cell Lung Carcinoma",[209,211,212,116,213,60,214,215,216,217],"Pembrolizumab","Pemetrexed","Cisplatin","ABBV-400","ABBV-181","Budigalimab","AndroMETa-Lung-536",{"date":34,"type":35},{"date":220,"type":35},"2025-03-06",{"date":222,"type":20},"2027-11",{"name":41,"class":42},106,{"id":226,"slug":4,"hasResults":11,"nctId":227,"briefTitle":228,"officialTitle":229,"acronym":4,"eligibilityCriteria":230,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":4,"enrollmentInfo":231,"targetDuration":4,"studyType":21,"phases":233,"briefSummary":234,"conditions":235,"keywords":237,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":191,"lastUpdatePostDateStruct":240,"startDateStruct":241,"completionDateStruct":243,"leadSponsor":245,"locationsCount":246},"100054075","NCT05650632","A Study to Assess Adverse Events of Intravenously (IV) Infused Etentamig (ABBV-383) in Adult Participants With Relapsed or Refractory Multiple Myeloma","A Multicenter, Phase 1b, Open-label Study to Evaluate Dose Optimization Measures and Safety of Etentamig (ABBV-383) in Subjects With Relapsed or Refractory Multiple Myeloma","Inclusion Criteria:\n\n* Must have measurable disease as outlined in the protocol.\n* Eastern Cooperative Oncology Group (ECOG) performance of \\\u003C= 2. Arm C and Arm D: ECOG performance of \\\u003C= 1.\n* Relapsed\u002Frefractory (R\u002FR) multiple myeloma (MM) with documented evidence of progression during or after the participant's last treatment regimen based on the investigator's determination of the International Myeloma Working Group (IMWG) 2016 criteria.\n* Must be naïve to treatment with etentamig (ABBV-383).\n* Arm A: Must have received at least 3 or more lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory imide drug (IMiD), and an anti-CD38 monoclonal antibody.\n* Arm B: Must have received at least 2 or more lines of therapy, including exposure to a PI, an IMiD, an anti-CD38 monoclonal antibody, and a prior B-cell maturation antigen (BCMA)-targeted therapy (must be an anti-drug conjugate \\[ADC\\] or chimeric antigen receptor T-cell \\[CAR-T\\] directed against BCMA).\n* Arm C: Must have received at least 2 or more lines of therapy, including exposure to a PI, an IMiD, and an anti-CD38 monoclonal antibody. Must be suitable for outpatient administration of etentamig (ABBV-383).\n* Arm D: Must have received at least 1 and no more than 3 prior lines of therapy, including exposure to a PI, an IMiD, or an anti-CD38 monoclonal antibody. Must be suitable for outpatient administration of etentamig (ABBV-383).\n\nExclusion Criteria:\n\n* Arm A: Received BCMA-targeted therapy.\n* Arm C and Arm D: Rapidly progressing disease per investigator.",{"count":232,"type":20},210,[23],"Multiple Myeloma (MM) is a cancer of the blood's plasma cells ( blood cell). The cancer is typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can cause bone pain, fractures, infections, weaker bones, and kidney failure. Treatments are available, but MM can come back (relapsed) or may not get better (refractory) with treatment. This is a study to determine adverse events and change in disease symptoms of etentamig (ABBV-383) in adult participants with relapsed\u002Frefractory (R\u002FR) MM.\n\nEtentamig (ABBV-383) is an investigational drug being developed for the treatment of R\u002FR Multiple Myeloma (MM). This study is broken into 4 Arms; Arm A (Parts 1 and 2), Arm B and Arms C \\& D. Arm A includes 2 parts: step-up dose optimization (Part 1) and dose expansion (Part 2). In Part 1, different level of step-up doses are tested followed by the target dose of etentamig (ABBV-383). In Part 2, the step-up dose identified in Part 1 (Dose A) will be used followed by the target dose A of etentamig (ABBV-383). In Arm B a flat dose of etentamig (ABBV-383) will be tested. In Arms C \\& D, the step-up dose identified in Arm A will be used followed by the target dose of etentamig (ABBV-383) to investigate outpatient administration of etentamig (ABBV-383). Around 210 adult participants with relapsed\u002Frefractory multiple myeloma will be enrolled at approximately 50 sites across the world.\n\nParticipants will receive etentamig (ABBV-383) as an infusion into the vein in 28 day cycles for approximately 3 years.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and questionnaires.",[236],"Multiple Myeloma",[236,85,238,239],"ABBV-383","B-Cell Maturation Antigen",{"date":34,"type":35},{"date":242,"type":35},"2023-03-21",{"date":244,"type":20},"2029-08",{"name":41,"class":42},46,{"id":248,"slug":4,"hasResults":11,"nctId":249,"briefTitle":250,"officialTitle":251,"acronym":4,"eligibilityCriteria":252,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":253,"enrollmentInfo":254,"targetDuration":4,"studyType":21,"phases":256,"briefSummary":257,"conditions":258,"keywords":261,"overallStatus":269,"whyStopped":4,"lastUpdateSubmitDate":270,"lastUpdatePostDateStruct":271,"startDateStruct":272,"completionDateStruct":274,"leadSponsor":276,"locationsCount":277},"100053737","NCT07697456","Study of Advanced Therapies for the Treatment of Adult Participants With Moderately to Severely Active Crohn's Disease or Ulcerative Colitis","A Phase 2 Platform Basket Study Evaluating Advanced Therapies in Subjects With Moderately to Severely Active Crohn's Disease or Ulcerative Colitis","Inclusion Criteria:\n\nCD specific:\n\n* Crohn's Disease Activity Index (CDAI) score of ≥ 220\n* Confirmed diagnosis of CD at least 90 days prior to Baseline\n* Endoscopic evidence of mucosal inflammation as documented by an Simple Endoscopic Score for Crohn's Disease (SES-CD) of ≥ 6 for ileocolonic or colonic disease or SES-CD of ≥ 4 for isolated ileal disease.\n* Demonstrated failure of 1 or more therapy for CD\n\nUC specific:\n\n* Confirmed diagnosis of UC at least 90 days prior to Baseline\n* Active UC with a modified Mayo Score (mMS) of 5 to 9 points and endoscopic subscore (ESS) of 2 to 3\n* Demonstrated failure of 1 or more therapy for UC\n\nExclusion Criteria:\n\n* Participants with demonstrated intolerance to p19 IL-23 inhibitors (including risankizumab)\n* Participants treated with any investigational drug within 30 days or 5 half-lives of the study treatments (whichever is longer) prior to the first dose of study treatment\n* Participants who received any ATs (biologic or small molecules) prior to first dose of study treatment within the protocol specified time frame\n* Participants with surgical bowel resection within the past 3 months prior to Baseline\n\nCD specific:\n\n* Participants with \\>3 prior bowel resections\n* Participants with previous small bowel resection(s) of combined length \\>100 cm\n\nUC specific:\n\n* Participants with prior colectomy (total or subtotal)\n* Participants with extent of disease limited to \\\u003C 10 cm of rectum","75 Years",{"count":255,"type":20},2000,[24],"Crohn's disease (CD) and Ulcerative colitis (UC) are 2 types of inflammatory bowel diseases which cause long-lasting, severe inflammation (redness, swelling) in the digestive tract. CD can affect any part of the digestive tract causing many different symptoms including belly pain, diarrhea, tiredness, and weight loss. UC affects the lining of the rectum and colon (large intestine) and can cause bleeding, belly pain, and diarrhea. This platform basket study will evaluate how safe and effective advanced therapies are in adults with moderately to severely active Crohn's Disease (CD) or Ulcerative Colitis (UC).\n\nThis study currently includes 2 substudies evaluating different treatments in participants with CD or UC. Substudy 1 will evaluate the combination of risankizumab and trosunilimab (ABBV-466) and Substudy 2 will evaluate the combination of risankizumab and ABBV-701 (ABBV-7066). When adult participants with moderately to severely active CD or UC join the study, they will undergo a 2-step randomization within CD and UC substudies, respectively. The first unblinded randomization will assign participants into a substudy, and the second blinded randomization will assign participants to a treatment arm within the assigned substudy. Approximately 100 adult participants will be enrolled per treatment arm across both substudies at approximately 400 sites worldwide.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care treatment without participating in this study. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, stool tests, endoscopies, checking for side effects and completing questionnaires and a daily diary.",[259,260],"Crohn's Disease","Ulcerative Colitis",[262,263,264,265,266,267,268],"Crohn's disease","Ulcerative colitis","Risankizumab","ABBV-701","Trosunilimab","ABBV-466","ABBV-7066","NOT_YET_RECRUITING","2026-07-07",{"date":34,"type":35},{"date":273,"type":20},"2026-07-24",{"date":275,"type":20},"2031-10",{"name":41,"class":42},30,{"id":279,"slug":4,"hasResults":11,"nctId":280,"briefTitle":281,"officialTitle":282,"acronym":283,"eligibilityCriteria":284,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":4,"enrollmentInfo":285,"targetDuration":4,"studyType":21,"phases":287,"briefSummary":288,"conditions":289,"keywords":291,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":297,"lastUpdatePostDateStruct":298,"startDateStruct":300,"completionDateStruct":302,"leadSponsor":304,"locationsCount":305},"100604873","NCT07155174","A Study to Evaluate the Optimal Dose, Adverse Events and Change in Disease Activity of Intravenous ABBV-706 in Combination With Atezolizumab Versus Standard of Care as First-Line Treatment in Adult Participants With Previously Untreated Extensive Stage Small Cell Lung Cancer","A Phase 2 Randomized, Open Label, Multicenter Study to Evaluate the Optimal Dose, Safety, and Efficacy of ABBV-706 in Combination With Atezolizumab Versus Standard of Care as First-Line Treatment in Subjects With Previously Untreated Extensive Stage Small Cell Lung Cancer (ES-SCLC)","SEZanne","Inclusion Criteria:\n\n* Diagnosis of histologically or cytologically confirmed extensive stage small cell lung cancer (ES-SCLC) requiring treatment with first line therapy.\n* Have an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 to 1 during the screening period prior to the first dose of study treatment.\n* Have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST v1.1).\n* Suspected brain metastases at screening should have a computed tomography (CT)\u002F magnetic resonance imaging (MRI) of the brain prior to study entry.\n\nExclusion Criteria:\n\n* Have received any kind of treatment for limited stage small cell lung cancer (LS-SCLC).\n* Known active\u002Fsymptomatic central nervous system (CNS) metastases should be excluded.\n* History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, or any evidence of active ILD\u002Fpneumonitis on screening chest computed tomography (CT) scan should be excluded.\n* Have any clinically significant conditions that would adversely affect the participant's participation in the study, and the subject should have a life expectancy of at least 3 months.",{"count":286,"type":20},180,[24],"Small cell lung cancer (SCLC) is characterized by aggressive and rapid growth and a tendency to develop early spread to distant sites including mediastinal lymph nodes, liver, bones, adrenal glands, and brain. The purpose of this study is to assess safety, dose, change in disease activity of ABBV-706 given with atezolizumab, compared to standard of care (SOC) treatment (etoposide, carboplatin, atezolizumab, and optional lurbinectedin).\n\nABBV-706 is an investigational drug being developed for the treatment of SCLC. There are multiple treatment arms in this study. Participants will either receive ABBV-706 given with atezolizumab, at 1 of 2 doses, or SOC. Approximately 180 adult participants will be enrolled in the study across sites worldwide.\n\nIn the safety lead-in, participants with SCLC will receive intravenous (IV) ABBV-706 in 1 of 2 doses with IV atezolizumab, or IV SOC. In the expansion portion of the study, participants with SCLC will receive IV ABBV-706 in 1 of 2 doses with atezolizumab, or IV SOC, until the optimal dose of ABBV-706 is determined. The estimated duration of the study is up to 69.5 months.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, questionnaires, and scans.",[290],"Small Cell Lung Cancer",[290,292,293,294,116,295,296],"SCLC","ABBV-706","Etoposide","Atezolizumab","Lurbinectedin","2026-06-30",{"date":299,"type":35},"2026-07-02",{"date":301,"type":35},"2025-11-25",{"date":303,"type":20},"2031-09",{"name":41,"class":42},57,{"id":307,"slug":4,"hasResults":11,"nctId":308,"briefTitle":309,"officialTitle":310,"acronym":311,"eligibilityCriteria":312,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":4,"enrollmentInfo":313,"targetDuration":4,"studyType":21,"phases":315,"briefSummary":316,"conditions":317,"keywords":319,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":322,"lastUpdatePostDateStruct":323,"startDateStruct":325,"completionDateStruct":327,"leadSponsor":329,"locationsCount":330},"100642444","NCT07592273","Surabgene Lomparvovec Administered in the Suprachoroidal Space in Adult Participants With Diabetic Retinopathy Without Center-Involved Diabetic Macular Edema","An Operationally Seamless Phase 2b\u002F3, Multicenter, Randomized, Masked, Sham-controlled Study to Evaluate the Efficacy and Safety of Surabgene Lomparvovec (Sura-vec) Delivered Via Suprachoroidal Space (SCS) Injection Targeting Subjects With Diabetic Retinopathy Without Center Involved-Diabetic Macular Edema (CI-DME) (NAAVIGATE)","NAAVIGATE","Inclusion Criteria:\n\nOcular (Study Eye for Phase 2b and Phase 3 Portions; Both Eyes for Bilateral Portion)\n\n* Moderately severe or severe nonproliferative diabetic retinopathy (NPDR) (early treatment diabetic retinopathy study-diabetic retinopathy severity scale \\[DRSS\\] level 47 or 53) for which panretinal photocoagulation (PRP) or anti- vascular endothelial growth factor (VEGF) can be safely deferred for at least 6 months after Screening Visit 1.\n* Best-corrected visual acuity (BCVA) in the study eye of \\>= 69 Early treatment diabetic retinopathy study letters (approximate Snellen equivalent 20\u002F40 or better) at Screening Visit 1.\n\nSystemic\n\n• Diabetic retinopathy (DR) secondary to diabetes mellitus Type 1 or 2 with a hemoglobin A1c (HbA1c)\\\u003C 12% within 60 days prior to Screening Visit 1.\n\nExclusion Criteria:\n\nOcular (Study Eye for Phase 2b and Phase 3 Portions; Both Eyes for Bilateral Portion)\n\n* Presence of active center involved-diabetic macular edema (CI-DME) in the study eye as determined by spectral domain optical coherence tomography (SD-OCT) evaluated by the central reading center (CRC), using the following threshold:\n\nCentral retinal thickness (CRT) \\>= 320 μm as measured by Heidelberg Spectralis SD-OCT (conversion to equivalent measurement is required and performed by the CRC if imaging is done with another SD-OCT instrument).\n\n* Active ocular inflammation including scleral inflammation (including episcleritis) or ocular\u002F periocular infection present in either eye at Screening Visit 1 or Screening Visit 2\n* Neovascularization from a cause other than DR, per investigator\n* Evidence or documented history of panretinal photocoagulation (PRP) or retinal laser therapy\n* History of intravitreal therapy, including anti-VEGF and long- or short-acting steroid therapy, within the prior 6 months and documentation of more than 10 prior anti-VEGF or short acting steroid intravitreal injections within 36 months of Screening Visit 1\n* Pregnant and breastfeeding individuals are excluded from this clinical study.\n\nSystemic\n\n* Initiation of intensive insulin treatment (pump or multiple daily injections) within the past 6 months or plans to do so within 52 weeks after Day 1\n* Initiation of any treatment containing a GLP-1 receptor agonist within the 3 months prior to Screening Visit 1 or plans to do so within 52 weeks after Day 1\n* Pregnant and breastfeeding individuals are excluded from this clinical study",{"count":314,"type":20},576,[24,55],"Diabetic Retinopathy (DR) is a common eye condition caused by diabetes, where high blood sugar levels damage the blood vessels in the back part of the eye (called the retina). Over time, this damage can lead to vision problems and even blindness if not treated. This study will assess surabgene lomparvovec (sura-vec) as a potential one-time gene therapy administered in the suprachoroidal space (SCS) for the treatment of diabetic retinopathy (DR) and prevention of vision-threatening events (VTEs) in participants with non-proliferative DR (NPDR) without center-involved diabetic macular edema (CI-DME).\n\nThis study will consist of 3 portions: a Phase 2b portion, a Phase 3 portion, and a bilateral treatment portion. Approximately 576 adult participants will be enrolled in the study across multiple sites in the United States and Puerto Rico.\n\nIn the Phase 2b and Phase 3 portions, participants will be randomized to different groups to receive sura-vec and prophylactic steroids or sham and artificial tears in their study eye. If assigned to sham, participants will be given an opportunity to cross over and receive treatment with sura-vec. In the bilateral treatment portion, participants will be enrolled to receive sura-vec and prophylactic steroids in both eyes. In all 3 portions, follow-up in the study will continue through 5 years following administration of sura-vec in each eye.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.",[318],"Diabetic Retinopathy",[318,320,321],"Severe Nonproliferative Diabetic Retinopathy","ABBV-RGX-314","2026-06-29",{"date":324,"type":35},"2026-07-01",{"date":326,"type":35},"2026-06-01",{"date":328,"type":20},"2036-01",{"name":41,"class":42},11,{"id":332,"slug":4,"hasResults":11,"nctId":333,"briefTitle":334,"officialTitle":335,"acronym":4,"eligibilityCriteria":336,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":253,"enrollmentInfo":337,"targetDuration":4,"studyType":21,"phases":338,"briefSummary":339,"conditions":340,"keywords":343,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":322,"lastUpdatePostDateStruct":344,"startDateStruct":345,"completionDateStruct":347,"leadSponsor":348,"locationsCount":349},"100641531","NCT07607964","A Study to Assess Adverse Events, How the Drug Moves Through the Body and Effectiveness of Intravenous Infusions and Subcutaneous Injections of ABBV-519 in Adult Participants With Systemic Lupus Erythematosus (SLE) or Rheumatoid Arthritis (RA)","A Phase 1, First-in-Human, Single Ascending Dose, Open-label, Non-randomized Study Evaluating the Pharmacokinetics, Pharmacodynamics, and Safety of ABBV-519 in Subjects With Systemic Lupus Erythematosus (SLE) or Rheumatoid Arthritis (RA)","Inclusion Criteria:\n\nKey Inclusion Criteria:\n\n* Individuals between 18 and 75 years of age inclusive at the time of Screening.\n* Minimum baseline B-cell count of 50 cells\u002FmcL.\n\nInclusion Criteria for SLE Participants:\n\n* Clinical diagnosis of SLE and fulfilling the 2019 EULAR\u002FACR classification criteria.\n* Positive ANA ≥ 1:80 and the presence of at least one of the following autoantibodies above the upper limit of normal (ULN): anti-double-stranded DNA (dsDNA), anti-Smith (Sm), anti-ribonucleoprotein (RNP), or anti-Sjogren's syndrome antigen A (SSA).\n* Hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) score of ≥ 4 (excluding anti-dsDNA and C3\u002FC4). Lupus headache or organic brain syndrome do not count towards the hSLEDAI points required for eligibility.\n* Participants must have an inadequate response to ≥ 1 immunosuppressant therapies, used for at least 3 months.\n\nInclusion Criteria for RA Participants:\n\n* Clinical diagnosis of RA and fulfilling the 2010 ACR\u002FEULAR classification criteria for RA.\n* Presence of rheumatoid factor (RF) or anti-citrullinated peptide antibodies (ACPA) above the ULN.\n* Presence of at least 6 swollen and 6 tender joints\n* High-sensitivity C-reactive protein (hs-CRP) ≥ 3 mg\u002FL.\n* Failed at least 1 conventional synthetic disease-modifying antirheumatic drug (DMARD) and ≥ 1 biological or targeted DMARDs of different classes.\n\nExclusion Criteria:\n\nKey Exclusion Criteria:\n\n* Participants with a history of infection.\n* Participants with uncontrolled hypertension\n\nExclusion for SLE Participants:\n\n* Active neuropsychiatric SLE, or signs or symptoms of neuropsychiatric SLE within the 6 months prior to Screening (lupus headache permissible).\n\n  \\- Unstable or progressive glomerulonephritis (active class III or IV).\n* SLE overlap syndromes including, but not limited to RA, Sjogren's disease (SjD), SSc, polymyositis, dermatomyositis, or mixed connective tissue disease.\n\nExclusion for RA Participants:\n\n\\-- History of RA overlap syndromes, including but not limited to SLE, SjD, scleroderma, mixed connective tissue disorder or polymyositis.",{"count":277,"type":20},[23],"Systemic lupus erythematosus (SLE) is a chronic, systemic autoimmune disease characterized by B cell hyperactivity.\n\nRheumatoid Arthritis (RA) is a chronic inflammatory disease causing pain, stiffness, swelling and loss of joint function. The purpose of this study is to assess the pharmacokinetics, pharmacodynamics and safety of ABBV-519 in adult participants with SLE or RA.\n\nThis is a single ascending dose study in an estimated 30 adult participants with moderate SLE or RA. The total duration of the study will be approximately 425 days (60-day Screening Period, 1-day Treatment Period, and a 52 week Follow-up Period) at approximately 15 to 20 sites globally.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.",[341,342],"Systemic Lupus Erythematosus","Rheumatoid Arthritis",[341,342],{"date":324,"type":35},{"date":346,"type":35},"2026-05-28",{"date":121,"type":20},{"name":41,"class":42},10,{"id":351,"slug":4,"hasResults":11,"nctId":352,"briefTitle":353,"officialTitle":354,"acronym":4,"eligibilityCriteria":355,"healthyVolunteers":356,"sex":16,"minAge":51,"maxAge":357,"enrollmentInfo":358,"targetDuration":4,"studyType":21,"phases":360,"briefSummary":361,"conditions":362,"keywords":364,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":322,"lastUpdatePostDateStruct":365,"startDateStruct":366,"completionDateStruct":368,"leadSponsor":370,"locationsCount":371},"100628815","NCT07466550","A Study to Assess How Intravenous and Subcutaneous Administrations of Risankizumab Moves Through the Body of Healthy Adult Participants","A Phase 1 Study in Healthy Subjects to Assess Pharmacokinetics Following Intravenous and Subcutaneous Administration of Risankizumab","Inclusion Criteria:\n\n* Body weight between 40 kg and 100 kg inclusive at screening and upon initial confinement.\n* BMI is ≥ 18.0 to ≤ 32.0 kg\u002Fm2 after rounding to the tenths decimal at Screening. BMI is calculated as weight in kg divided by the square of height measured in meters.\n* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG.\n\nExclusion Criteria:\n\n* Exposure to any anti-interleukin-12\u002F23 or anti interleukin-23 treatment for at least one year prior to Screening.\n* Intention to perform strenuous exercise to which the subject is unaccustomed within one week prior to administration of first dose of study treatment or during the study.",true,"65 Years",{"count":359,"type":20},60,[23],"The purpose of this study is to compare how the drug moves through the body following risankizumab subcutaneous (SC) and risankizumab intravenous (IV) doses.",[363],"Healthy Volunteer",[363,264],{"date":324,"type":35},{"date":367,"type":35},"2026-06-04",{"date":369,"type":20},"2027-01",{"name":41,"class":42},2,{"id":373,"slug":4,"hasResults":11,"nctId":374,"briefTitle":375,"officialTitle":376,"acronym":377,"eligibilityCriteria":378,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":4,"enrollmentInfo":379,"targetDuration":4,"studyType":21,"phases":381,"briefSummary":382,"conditions":383,"keywords":384,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":322,"lastUpdatePostDateStruct":393,"startDateStruct":394,"completionDateStruct":396,"leadSponsor":398,"locationsCount":399},"100528290","NCT06158841","Study Assessing Activity of Intravenous (IV) Etentamig Monotherapy Versus Standard Available Therapies in Adult Participants With Relapsed or Refractory Multiple Myeloma","A Phase 3, Multicenter, Randomized, Open Label Study of Etentamig Compared With Standard Available Therapies in Subjects With Relapsed or Refractory Multiple Myeloma (3L+ RRMM Monotherapy Study)","CERVINO","Inclusion Criteria:\n\n* Eastern Cooperative Oncology Group (ECOG) performance of \\\u003C= 2.\n* Diagnosis of relapsed\u002Frefractory (R\u002FR) multiple myeloma (MM) during or after the participant's last treatment as stated in the protocol.\n* Must have measurable disease with at least 1 of the following assessed within 28 days of enrollment:\n\n  * Serum M-protein \\>= 0.5 g\u002FdL (\\>= 5 g\u002FL).\n  * Urine M-protein \\>= 200 mg\u002F24 hours.\n  * In participants without measurable serum or urine M protein, serum free light chain (FLC) \\>= 100 mg\u002FL (10 mg\u002FdL) (involved light chain)and an abnormal serum kappa lambda ratio.\n* Must have received at least 2 or more lines of therapy, including a proteasome inhibitor (PI), an immunomodulatory imide (IMiD), and an anti-CD38 monoclonal antibody (mAb).\n\n  \\-- US and Puerto Rico only: Participant must have received at least 1 or more line of therapy, including exposure to a PI, an IMiD, and an anti-CD38 mAb.\n* Must be eligible to receive the Investigator's choice standard available therapy (SAT) based on approved prescribing information, previous MM treatment history, and institutional guidelines.\n\nExclusion Criteria:\n\n* Clinically significant (per Investigator's judgment) drug or alcohol abuse within the last 6 months.\n* Clinically significant conditions such as but not limited to the following: neurologic, psychiatric, endocrine, metabolic, immunologic, cardiovascular, pulmonary, or hepatic disease within the last 6 months that would adversely affect the participant's participation in the study.\n* Central nervous system involvement of MM.\n* Has received B-cell maturation antigen (BCMA)-targeted therapy.",{"count":380,"type":20},380,[55],"Multiple myeloma (MM) is a cancer of the blood's plasma cells. The cancer is typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can cause bone pain, fractures, infections, weaker bones, and kidney failure. Treatments are available, but MM can come back (relapsed) or may not get better (refractory) with treatment. This is a study to determine change in disease symptoms of etentamig compared to standard available therapies in adult participants with relapsed\u002Frefractory (R\u002FR) MM.\n\nEtentamig is an investigational drug being developed for the treatment of R\u002FR MM. This study is broken into 2 Arms; Arm A and Arm B. In Arm A, participants will receive etentamig as a monotherapy. In Arm B, participants will receive the standard available therapy (SAT) identified by the Investigator during screening, in accordance with the local (or applicable) approved label, package insert, summary of product characteristics, and\u002For the institutional guidelines, as applicable. Around 380 adult participants with relapsed\u002Frefractory multiple myeloma will be enrolled at approximately 140 sites across the world.\n\nIn Arm A participants will receive etentamig as an infusion into the vein in 28 day cycles, during the 3.5 year study duration. In Arm B, participants will receive the SAT identified by the Investigator during screening, in accordance with the local (or applicable) approved label, package insert, summary of product characteristics, and\u002For the institutional guidelines, as applicable, during the 3.5 year study duration.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and questionnaires.",[236],[385,236,386,387,388,389,390,391,392],"Cervino","Etentamig","Carfilzomib","Pomalidomide","Elotuzumab","Selinexor","Bortezomib","Dexamethasone",{"date":297,"type":35},{"date":395,"type":35},"2024-05-19",{"date":397,"type":20},"2027-12",{"name":41,"class":42},166,{"id":401,"slug":4,"hasResults":11,"nctId":402,"briefTitle":403,"officialTitle":404,"acronym":4,"eligibilityCriteria":405,"healthyVolunteers":11,"sex":16,"minAge":406,"maxAge":178,"enrollmentInfo":407,"targetDuration":4,"studyType":21,"phases":409,"briefSummary":410,"conditions":411,"keywords":413,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":322,"lastUpdatePostDateStruct":417,"startDateStruct":418,"completionDateStruct":420,"leadSponsor":422,"locationsCount":423},"100523825","NCT06100744","A Study to Assess Adverse Events, Change in Disease Activity, and How the Drug Moves Through the Body in Children With Juvenile Psoriatic Arthritis (jPsA) Receiving Subcutaneously Injected Risankizumab or Adalimumab","Open-label, Randomized, Assessor-blinded, Efficacy, Safety, Tolerability, and Pharmacokinetics Study of Subcutaneous Risankizumab With an Adalimumab Reference Arm in Children With Active Juvenile Psoriatic Arthritis","Inclusion Criteria:\n\n* Diagnosis of juvenile psoriatic arthritis (jPsA) according to International League of Associations for Rheumatology criteria for at least 3 months prior to screening.\n* Active Disease in \\>= 3 joints at screening and at Baseline (swelling not due to deformity, or limitation of motion with pain, tenderness, or both) are eligible for inclusion in the study.\n* Have had an inadequate response (lack of efficacy after minimum 2-month duration of therapy at maximally tolerated dose), or intolerance to previous or current treatment with at least 1 of the following conventional synthetic disease-modifying antirheumatic drug (csDMARDs): methotrexate (MTX), sulfasalazine, leflunomide, or hydroxychloroquine.\n\nExclusion Criteria:\n\n* Have any other autoimmune disease, rheumatic disease (including systemic Juvenile idiopathic arthritis \\[JIA\\], rheumatoid factor-positive or rheumatoid factor-negative polyarticular JIA, extended oligoarticular JIA, persistent oligoarticular JIA, enthesitis-related arthritis, and undifferentiated JIA), or overlap syndrome.\n* Prior inadequate response to treatments in the anti-TNF or IL-23 inhibitor classes.","5 Years",{"count":408,"type":20},40,[55],"Psoriatic arthritis (PsA) is a type of arthritis that happens when the body's immune system attacks healthy cells and tissues causing joint pain, stiffness, and swelling. Symptoms can get worse and go away for periods of time. PsA that begins before a patient's 16th birthday is called juvenile PsA (jPsA).This study will evaluate how safe risankizumab is for the treatment of psoriatic arthritis and to assess change in disease symptoms.\n\nRisankizumab is being studied for the treatment of jPsA and adalimumab is approved for the treatment of jPsA. Participants are placed in 1 of 2 groups, called treatment arms. Each group receives a different treatment. There is a 1 in 4 chance that participants will be assigned to receive adalimumab. Approximately 40 juvenile participants with jPsA will be enrolled at approximately 30 sites worldwide.\n\nParticipants will receive risankizumab and adalimumab as subcutaneous (SC) injections based on body weight. At the start of Period 1, participants are randomized to receive risankizumab or adalimumab for 24 weeks. Participants who respond to the study treatment received in Period 1, will continue to receive the same treatment in Period 2 for another 100 weeks. Those with worsening jPsA symptoms in Period 2 will be withdrawn from the study. Participants who receive adalimumab are followed for safety for 70 days after the last study treatment. Participants who receive risankizumab are followed for 140 days after the last study treatment.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care (due to study procedures). Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.",[412],"Juvenile Psoriatic Arthritis",[412,414,264,415,416],"Psoriatic Arthritis","ABBV-066","Adalimumab",{"date":297,"type":35},{"date":419,"type":35},"2024-07-08",{"date":421,"type":20},"2028-10",{"name":41,"class":42},33,{"id":425,"slug":4,"hasResults":11,"nctId":426,"briefTitle":427,"officialTitle":428,"acronym":4,"eligibilityCriteria":429,"healthyVolunteers":11,"sex":16,"minAge":430,"maxAge":178,"enrollmentInfo":431,"targetDuration":4,"studyType":21,"phases":433,"briefSummary":434,"conditions":435,"keywords":437,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":322,"lastUpdatePostDateStruct":441,"startDateStruct":442,"completionDateStruct":444,"leadSponsor":446,"locationsCount":447},"100493917","NCT05711394","A Study to Assess the Adverse Events and Change in Disease Activity of Oral Atogepant Tablets in Pediatric Participants (6-17 Years of Age) With Episodic Migraine","A Phase 3, Multicenter, 12-Week, Double Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Atogepant for the Preventive Treatment of Episodic Migraine in Pediatric Subjects 6-17 Years of Age.","Inclusion Criteria:\n\n* Weight is \\>= 20 kg (44 lbs) and \\\u003C 135 kg (298 lbs).\n* History of episodic migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders (ICHD) -3 (2018) for at least 6 months.\n* Participant has to have 4 to 14 migraine days and \\\u003C 15 headache days in the 28-day baseline period per eDiary.\n* To be eligible for the PK substudy, participants must be 6 to 11 years of age (inclusive), with a history of migraine (consistent with a diagnosis according to the ICHD-3 \\[2018\\]) and per investigator judgment is appropriate to receive preventive treatment for migraine.\n\nExclusion Criteria:\n\n* History of migraine brainstem aura, hemiplegic migraine, or retinal migraine as defined by ICHD-3 (2018).\n* Have a current diagnosis of chronic migraine as defined by ICHD-3 (2018).\n* Have a current diagnosis of new daily persistent headache, trigeminal autonomic cephalgia (e.g., cluster headache), or painful cranial neuropathy as defined by ICHD-3 (2018).","6 Years",{"count":432,"type":20},450,[55],"A migraine is a moderate to severe headache on one side of the head. A migraine attack is a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. A number of treatments are available for adults with migraine but there are limited approved treatments available for pediatric participants. The main goal of the study is to evaluate the safety and efficacy (how well treatment works) of a low-dose and high-dose of atogepant in pediatric participants between the ages of 6 and 17.\n\nAtogepant is a medicine currently approved to treat adults with migraine (0 to 14 migraine days per month) and is being studied in pediatric participants between the ages of 6 and 17 with a history of episodic migraine. This is a Phase 3, randomized, double-blind study of atogepant in participants with a history of episodic migraine with an open-label pharmacokinetic substudy. Eligible participants will be randomized into 6 different groups. Participants between the ages of 12 and 17 will be randomized to receive placebo, low-dose atogepant, or high-dose atogepant for 12 weeks. Participants between the ages of 6 and 11 will also be randomized to receive placebo, low-dose atogepant, or high-dose atogepant for 12 weeks. The specific atogepant doses to be used in participants between the ages of 6 and 11 will be determined after the PK substudy is complete. Around 450 participants will be enrolled in approximately 100 sites worldwide.\n\nPlacebo, low-dose atogepant, and high-dose atogepant are given as a tablet to take by mouth once a day. At the end of Week 12, participants will either undergo a follow-up visit 4 weeks after last study treatment or join an extension study where they can continue to receive atogepant for another 52 weeks.\n\nThere may be a bigger responsibility for participants in this study. Participants will attend regular visits during the study at a hospital or clinic. The effects of treatment will be checked by medical assessments, blood tests, checking for side effects, and completing questionnaires.",[436],"Episodic Migraine",[436,438,439,440],"Atogepant","QULIPTA","AGN-241689",{"date":324,"type":35},{"date":443,"type":35},"2023-05-01",{"date":445,"type":20},"2028-05",{"name":41,"class":42},98,{"id":449,"slug":4,"hasResults":11,"nctId":450,"briefTitle":451,"officialTitle":452,"acronym":4,"eligibilityCriteria":453,"healthyVolunteers":356,"sex":16,"minAge":51,"maxAge":454,"enrollmentInfo":455,"targetDuration":4,"studyType":21,"phases":457,"briefSummary":458,"conditions":459,"keywords":460,"overallStatus":269,"whyStopped":4,"lastUpdateSubmitDate":462,"lastUpdatePostDateStruct":463,"startDateStruct":464,"completionDateStruct":465,"leadSponsor":467,"locationsCount":4},"100645339","NCT07680686","Study to Assess How Different Oral Formulations of Ubrogepant Move Through the Body in Healthy Adult Participants","A Two-Part, Phase 1, Open-Label, Randomized Study to Evaluate the Relative Bioavailability (Versus Immediate Release Tablet) and Food Effect of a New Orally Disintegrating Tablet Formulation of Ubrogepant in Healthy Volunteers","Inclusion Criteria:\n\n* BMI is ≥ 18.0 to ≤ 32.0 kg\u002Fm2 after rounding to the tenths decimal at Screening. BMI is calculated as weight in kg divided by the square of height measured in meters.\n* A condition of general good health, based upon the results of a medical history, physical examination, vital signs, laboratory profile and a 12-lead ECG.\n\nExclusion Criteria:\n\n* History: of epilepsy, any clinically significant cardiac, respiratory (except mild asthma as a child), renal, hepatic, gastrointestinal, hematologic, neurologic, or psychiatric disease or disorder, history of Raynaud's Phenomenon, or any uncontrolled medical illness.\n* History of any clinically significant sensitivity or allergy to any medication or food.","55 Years",{"count":456,"type":20},52,[23],"This study will assess how different oral formulations of ubrogepant move through the body in healthy adult participants under fasting and fed conditions.",[363],[363,461],"Ubrogepant","2026-06-26",{"date":299,"type":35},{"date":297,"type":20},{"date":466,"type":20},"2026-10",{"name":41,"class":42},{"id":469,"slug":4,"hasResults":11,"nctId":470,"briefTitle":471,"officialTitle":472,"acronym":4,"eligibilityCriteria":473,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":4,"enrollmentInfo":474,"targetDuration":4,"studyType":21,"phases":476,"briefSummary":477,"conditions":478,"keywords":481,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":462,"lastUpdatePostDateStruct":483,"startDateStruct":484,"completionDateStruct":486,"leadSponsor":488,"locationsCount":489},"100630640","NCT07490301","A Study to Assess Intravenous (IV) Telisotuzumab Adizutecan in Combination With Fluorouracil, Folinic Acid, and Oxaliplatin (FOLFOX) Compared to Standard of Care in Adult Participants With First-Line Metastatic Pancreatic Ductal Adenocarcinoma","Phase 2\u002F3 Open Label Randomized Study of Telisotuzumab Adizutecan in Combination With FOLFOX Compared to Standard of Care in Subjects With First-Line Metastatic Pancreatic Ductal Adenocarcinoma - AndroMETa-PDAC-288","Inclusion Criteria:\n\n* Have unresectable, metastatic histologically- or cytologically-confirmed adenocarcinoma of the pancreas\n* Have an Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1\n* Must consent to provide archived or recently obtained tumor tissue during Screening\n* Have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1.\n\nExclusion Criteria:\n\n* Have prior systemic therapy, surgery, or radiation (except palliative radiation) in the unresectable, locally advanced or metastatic setting\n* Prior c-MET targeting therapy\n* History of interstitial lung disease (ILD) or pneumonitis that required treatment with systemic steroids, or any evidence of active ILD\u002Fpneumonitis on screening chest computed tomography (CT) scan, including a history of idiopathic pulmonary fibrosis, organizing pneumonia (e.g., bronchiolitis obliterans), drug-induced pneumonitis, or idiopathic pneumonitis.\n* Prior bone marrow transplant, solid organ transplant, or previous clinical diagnosis of tuberculosis.",{"count":475,"type":20},900,[24,55],"Cancer is a condition where cells in a specific part of the body grow and reproduce uncontrollably. The pancreas is a gland behind the stomach that produces a digestive fluid that is emptied into the intestines through tube shaped ducts. Pancreatic cancer often starts in these ducts. The purpose of this study is to assess adverse events and change in disease activity of telisotuzumab adizutecan when given in combination with fluorouracil, folinic acid, and oxaliplatin (FOLFOX) to treat adult participants with pancreatic ductal cancer.\n\nTelisotuzumab adizutecan is an investigational drug being developed for the treatment of pancreatic ductal adenocarcinoma (PDAC). This study will be divided into two phases, with the first phase (Phase 2) treating participants with increasing doses of telisotuzumab adizutecan with FOLFOX. Participants will then be randomized into 3 groups called treatment arms. Two groups will receive telisotuzumab adizutecan with FOLFOX with different optimized doses. One group will receive standard of care (SOC) - fluorouracil, leucovorin, oxaliplatin, and irinotecan. In the second phase (Phase 3), participants will be randomized into 2 arms to receive either the optimal dose of telisotuzumab adizutecan (from the previous phase) with FOLFOLX, or SOC. Approximately 900 participants with PDAC will be enrolled in this study in approximately 200 sites worldwide.\n\nPhase 2 includes a dose escalation stage and a dose optimization stage. In the dose escalation stage, participants will receive escalating doses of Intravenous (IV) telisotuzumab adizutecan + FOLFOX. In the dose optimization stage, participants will receive 1 of 2 doses of IV telisotuzumab adizutecan with FOLFOX or SOC. At the start of Phase 3, participants will receive the optimal dose of IV telisotuzumab adizutecan with FOLFOX or SOC. The study will run for a duration of approximately 6 years.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at an approved institution (hospital or clinic). The effect of the treatment will be frequently checked by medical assessments, blood tests, questionnaires and side effects.",[479,480],"Metastatic Pancreatic Ductal Adenocarcinoma","PDAC",[479,480,482],"Telisotuzumab adizutecan",{"date":297,"type":35},{"date":485,"type":35},"2026-04-30",{"date":487,"type":20},"2031-06",{"name":41,"class":42},17,{"id":491,"slug":4,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":4,"enrollmentInfo":492,"targetDuration":4,"studyType":21,"phases":493,"briefSummary":56,"conditions":494,"keywords":495,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":462,"lastUpdatePostDateStruct":496,"startDateStruct":497,"completionDateStruct":498,"leadSponsor":499,"locationsCount":500},"100633324",{"count":53,"type":20},[55],[58],[58,60,61,62,63],{"date":297,"type":35},{"date":66,"type":35},{"date":68,"type":20},{"name":41,"class":42},9,{"id":502,"slug":4,"hasResults":11,"nctId":152,"briefTitle":153,"officialTitle":154,"acronym":49,"eligibilityCriteria":155,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":4,"enrollmentInfo":503,"targetDuration":4,"studyType":21,"phases":504,"briefSummary":159,"conditions":505,"keywords":506,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":462,"lastUpdatePostDateStruct":507,"startDateStruct":508,"completionDateStruct":509,"leadSponsor":510,"locationsCount":511},"100579143",{"count":157,"type":20},[24],[161],[161,163,60],{"date":297,"type":35},{"date":166,"type":35},{"date":168,"type":20},{"name":41,"class":42},53,{"id":513,"slug":4,"hasResults":11,"nctId":200,"briefTitle":201,"officialTitle":202,"acronym":4,"eligibilityCriteria":203,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":4,"enrollmentInfo":514,"targetDuration":4,"studyType":21,"phases":515,"briefSummary":207,"conditions":516,"keywords":517,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":462,"lastUpdatePostDateStruct":518,"startDateStruct":519,"completionDateStruct":520,"leadSponsor":521,"locationsCount":522},"100575464",{"count":205,"type":20},[23,24],[209],[209,211,212,116,213,60,214,215,216,217],{"date":297,"type":35},{"date":220,"type":35},{"date":222,"type":20},{"name":41,"class":42},103,{"id":524,"slug":4,"hasResults":11,"nctId":525,"briefTitle":526,"officialTitle":527,"acronym":528,"eligibilityCriteria":529,"healthyVolunteers":11,"sex":107,"minAge":51,"maxAge":4,"enrollmentInfo":530,"targetDuration":4,"studyType":21,"phases":532,"briefSummary":533,"conditions":534,"keywords":536,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":462,"lastUpdatePostDateStruct":539,"startDateStruct":540,"completionDateStruct":542,"leadSponsor":544,"locationsCount":224},"100548190","NCT06417775","Study of Oral Ubrogepant to Assess Adverse Events and Change in Disease Activity in Adult Participants With Menstrual Migraine","A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, and Tolerability of Ubrogepant for the Preventive Treatment of Menstrual Migraine With an Open-Label Extension","UBRO MM","Inclusion Criteria:\n\n* At least a 1-year history of migraine with or without aura.\n* Have experienced migraine attacks in at least 2 of 3 perimenstrual periods (PMPs) during the screening period.\n* Collection of daily eDiary data for 3 perimenstrual periods during the up to 16-week screening period to confirm a menstrual migraine (MM) diagnosis.\n* Have regular menstrual cycles of between 21-35 days in length.\n* Less than 15 headache days per month.\n* At least 70% compliance completing screening period and at least 3 out of 5 days of ediary data in each of 3 screening PMP.\n\nExclusion Criteria:\n\n* History of migraine with brainstem aura, hemiplegic migraine, or retinal migraine.\n* Clinically significant history of cardiovascular or cerebrovascular disease per the investigator's opinion.\n* Clinically significant abnormalities in the physical examination as determined by the investigator.\n* Clinically significant hematologic, endocrine, pulmonary, renal, hepatic, gastrointestinal, gynecological, or neurologic disease per the investigator's opinion.\n* Acute headache medication overuse.",{"count":531,"type":20},496,[55],"A migraine is a moderate to severe headache typically on one side of the head. A migraine attack is a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. Menstrual migraine (MM) is defined as migraine attacks that occur within the perimenstrual period (PMP) in at least 2 out of 3 menstrual cycles. The PMP is from 2 days before the onset of menstrual bleeding to 2 days after. This study will assess how safe and effective ubrogepant is in treating menstrual migraine. Adverse Events and change in disease activity will be assessed.\n\nUbrogepant is an investigational drug being developed for short-term prevention of menstrual migraine. Participants will be randomly assigned to one of the 2 groups to receive either ubrogepant or placebo. Around 496 adult female participants with menstrual migraine will be enrolled in approximately 100 sites in the United States and Puerto Rico.\n\nParticipants will receive oral ubrogepant tablets once daily for 7 consecutive days starting 3 days prior to estimated onset of menses per cycle for 3 PMPs during double-blind period (16 weeks). Eligible participants may continue to receive oral ubrogepant tablets once daily for 7 consecutive days per cycle starting 3 days prior to estimated onset of menses during open-label extension period (52 weeks).\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will collect data daily in electronic diaries and attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.",[535],"Migraine",[535,537,461,538],"Menstrual Migraine","UBRELVY",{"date":297,"type":35},{"date":541,"type":35},"2024-09-10",{"date":543,"type":20},"2027-09",{"name":41,"class":42},{"id":546,"slug":4,"hasResults":11,"nctId":547,"briefTitle":548,"officialTitle":549,"acronym":550,"eligibilityCriteria":551,"healthyVolunteers":11,"sex":16,"minAge":51,"maxAge":4,"enrollmentInfo":552,"targetDuration":4,"studyType":80,"phases":4,"briefSummary":553,"conditions":554,"keywords":556,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":558,"lastUpdatePostDateStruct":559,"startDateStruct":560,"completionDateStruct":562,"leadSponsor":564,"locationsCount":565},"100595950","NCT07039110","Study to Assess Change in Quality of Life of Risankizumab Treatment in Adult Participants With Moderate-to-Severe Plaque Psoriasis","The Real-World Impact of Risankizumab on the Quality of Life and Cumulative Life Course Impairment (CLCI) in Patients With Moderate-to-Severe Plaque Psoriasis (DREAM)","DREAM","Inclusion Criteria:\n\n* Participants with a Confirmed diagnosis of moderate-to-severe plaque psoriasis with or without joint involvement according to the treating physician's clinical judgment, prior to time of enrollment.\n* Treatment with risankizumab is indicated per summary of product characteristics (SmPC) or local label and local prescribing\u002Ftreatment guidelines.\n* Decision to treat with risankizumab is made prior to and independently of study participation.\n\nExclusion Criteria:\n\n* History of a sleep disorder diagnosis which the patient is currently being treated for.\n* Current or recent (within the last 30 days) participation in an interventional clinical trial or an observational study.\n* Currently receiving other biologic treatments and\u002For small molecules including Janus kinase (JAK) inhibitors, tyrosine kinase 2 (TYK2) inhibitors, and phosphodiesterase 4 (PDE4) inhibitors for any reason.",{"count":53,"type":20},"Psoriasis is a chronic, systemic, inflammatory disease in which skin cells build up and develop thick, red and white scaly patches on the skin. This study will assess the change in quality of life of risankizumab treatment in adult participants with moderate to severe plaque psoriasis real-world clinical practice.\n\nRisankizumab is an approved drug for treating participants with Psoriasis. Approximately 700 participants who are prescribed risankizumab by their physician in accordance with local label will be enrolled in approximately 70 sites worldwide.\n\nParticipants will receive risankizumab as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 2.5 years.\n\nThere is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.",[555],"Plaque Psoriasis",[555,557,264],"Moderate to Severe Plaque Psoriasis","2026-06-25",{"date":322,"type":35},{"date":561,"type":35},"2025-09-09",{"date":563,"type":20},"2028-03",{"name":41,"class":42},78,{"id":567,"slug":4,"hasResults":11,"nctId":568,"briefTitle":569,"officialTitle":570,"acronym":4,"eligibilityCriteria":571,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":572,"targetDuration":4,"studyType":21,"phases":574,"briefSummary":575,"conditions":576,"keywords":578,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":558,"lastUpdatePostDateStruct":581,"startDateStruct":582,"completionDateStruct":584,"leadSponsor":586,"locationsCount":587},"100593486","NCT07007065","Study to Assess the Injection Burden, Adverse Events, Change in Disease Activity, and Long-Term Preservation of Visual Acuity of Surabgene Lomparvovec in Adult Participants With Neovascular Age-Related Macular Degeneration (nAMD)","A Randomized, Controlled, Partially Masked, Phase 3b Study to Assess the Injection Burden, Efficacy, Safety, and Long-Term Preservation of Visual Acuity of Surabgene Lomparvovec (ABBV-RGX-314) in a Real-World Context in Subjects With Neovascular Age-Related Macular Degeneration (nAMD)","Inclusion Criteria:\n\n* Pseudophakic (at least 12 weeks post cataract surgery at Screening Visit 1 \\[Week -6\\]) in the study eye.\n* Must have a diagnosis of choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) in the study eye\n\n  --CNV lesion characteristics as assessed by the central reading center: lesion size needs to be less than 10-disc areas (typical disc area = 2.54 mm\\^2)\n* Must have received at least 2 intravitreal anti-vascular endothelial growth factor (VEGF) injections in the past 6 months in the study eye prior to Screening Visit 1 (Week -6) and have been responsive (determined by investigator)\n\nExclusion Criteria:\n\n* CNV or macular edema in the study eye that is secondary to any causes other than AMD\n* Study eye with nAMD diagnosed \\> 4 years from Screening Visit 1\n* Any retinal pigment epithelial detachment \\> 400 μm or any pigment epithelial detachment \\> 350 μm within the central subfield (central 1 mm) in the study eye at Screening Visit 1 (Week -6), as assessed by the central reading center.\n* Any subretinal hemorrhage in the study eye \\> 50% of the total lesion area or within the parafovea (3 mm center of the macula), as determined by the central reading center\n* Retinal pigment epithelial tear involving the central subfield (central 1 mm) in the study eye as determined by the central reading center.",{"count":573,"type":20},561,[55],"Neovascular age-related macular degeneration (nAMD), also known as \"wet\" AMD, is the abnormal growth of new blood vessels in the light-sensitive tissue at the back of the eye called the retina. The purpose of this study is to assess how safe and effective Surabgene Lomparvovec is in treating participants with Neovascular age-related macular degeneration (nAMD).\n\nSurabgene Lomparvovec (ABBV-RGX-314) is an investigational gene therapy being developed for the treatment of neovascular age-related macular degeneration (nAMD). Participants will be placed into 1 of 3 groups, called treatment arms. Each group receives different treatment. Adult participants aged 50 and older years with a diagnosis of previously treated nAMD will be enrolled. Around 561 participants will be enrolled in the study at approximately 150 sites worldwide.\n\nParticipants in groups 1 and 2 will receive a single subretinal dose of ABBV-RGX-314. Participants in group 3 will receive Ranibizumab as needed throughout the study. Ranibizumab will be given as an intravitreal injection (injection into the jelly-like tissue that fills the eyeball injection), and ABBV-RGX-314 will be given as a subretinal (between the retina and the back of the eye) injection. The Assessment Period begins after randomization (1:1:1) to one of the ABBV-RGX-314 treatment groups or control at Week -2 and lasts up to 5 years.\n\nThere may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular monthly visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.",[577],"Neovascular Age-related Macular Degeneration",[579,580,321],"Neovascular age-related macular degeneration","Surabgene Lomparvovec",{"date":322,"type":35},{"date":583,"type":35},"2025-11-05",{"date":585,"type":20},"2033-03",{"name":41,"class":42},127,""]