[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100658133":3},{"organization":4,"outcomesModule":7,"designInfo":62,"detailedDescription":11,"studyPopulation":11,"armGroups":73,"interventions":86,"overallOfficials":98,"centralContacts":102,"locations":11,"responsibleParty":110,"collaborators":112,"id":117,"slug":118,"hasResults":119,"nctId":120,"briefTitle":121,"officialTitle":122,"acronym":123,"eligibilityCriteria":124,"healthyVolunteers":119,"sex":125,"minAge":126,"maxAge":127,"enrollmentInfo":128,"targetDuration":11,"studyType":131,"phases":132,"briefSummary":134,"conditions":135,"keywords":11,"overallStatus":137,"whyStopped":11,"lastUpdateSubmitDate":138,"lastUpdatePostDateStruct":139,"startDateStruct":142,"completionDateStruct":144,"leadSponsor":146,"locationsCount":11},{"fullName":5,"class":6},"Hoffmann-La Roche","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Percentage of Participants With Clinical Remission",null,"At Week 12",[14,18,21,24,27,29,31,33,35,37,39,43,46,49,52,56,59],{"measure":15,"description":16,"timeFrame":17},"Change From Baseline in Stool Frequency Subscore (SFS)","The Stool Frequency Subscore (SFS) is measured on a scale from 0 (normal number of stools) to 3 (5 or more stools than normal)","From Baseline up to Week 12",{"measure":19,"description":20,"timeFrame":17},"Change From Baseline in Rectal Bleeding Subscore (RBS)","The Rectal Bleeding Subscore (RBS) is measured on a scale from 0 (no blood seen) to 3 (blood alone passed)",{"measure":22,"description":11,"timeFrame":23},"Percentage of Participants With Symptomatic Response","At Week 4",{"measure":25,"description":11,"timeFrame":26},"Percentage of Participants With Endoscopic Improvement","At Week 12 and Week 24",{"measure":28,"description":11,"timeFrame":26},"Percentage of Participants With Endoscopic Remission",{"measure":30,"description":11,"timeFrame":12},"Percentage of Participants With Clinical Response",{"measure":32,"description":11,"timeFrame":26},"Percentage of Participants With Histologic-Endoscopic Mucosal Improvement",{"measure":10,"description":11,"timeFrame":34},"At Week 24",{"measure":36,"description":11,"timeFrame":26},"Percentage of Participants With Maintenance of Remission",{"measure":38,"description":11,"timeFrame":34},"Percentage of Participants With Histologic Improvement",{"measure":40,"description":41,"timeFrame":42},"Change From Baseline in Bowel Urgency","Bowel urgency will be assessed using two self-reported items over the past 24 hours: presence of bowel urgency (Yes\u002FNo) and severity on an 11-point numerical rating scale from 0 (no urgency) to 10 (worst possible urgency)","From Baseline through Week 12 and Week 24",{"measure":44,"description":45,"timeFrame":42},"Change From Baseline in Abdominal Pain","Abdominal pain will be assessed using two self-reported items over the past 24 hours: presence of abdominal pain (Yes\u002FNo) and severity on an 11-point numerical rating scale from 0 (no pain) to 10 (worst possible pain)",{"measure":47,"description":48,"timeFrame":42},"Change From Baseline in Fatigue","Change in fatigue will be assessed by Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue scale. FACIT-Fatigue is a 13-item self-reported assessment of the level and impact of fatigue. The overall FACIT-Fatigue score ranges between 0 and 52, with higher scores associated with better quality of life concerns related to fatigue",{"measure":50,"description":51,"timeFrame":42},"Change From Baseline in Health-Related Quality of Life","Change in health-related quality of life will be assessed by Inflammatory Bowel Disease Questionnaire (IBDQ) score. IBDQ is a 32-item self-reported assessment of health-related quality of life in participants with inflammatory bowel disease. The overall IBDQ score ranges from 32 to 224, with higher scores associated with better health-related quality of life",{"measure":53,"description":54,"timeFrame":55},"Change From Baseline in Overall UC Symptoms","Change in overall UC symptoms will be assessed by Patient Global Impression of Change (PGIC). PGIC measures overall change in ulcerative colitis symptoms from \"Much better\" to \"Much worse\"","Baseline, Week 2, Week 12 and Week 24",{"measure":57,"description":58,"timeFrame":55},"Change From Baseline in Overall Severity in UC Symptoms","Change in overall severity of UC symptoms will be assessed by Patient Global Impression of Severity (PGIS). PGIS measures severity of ulcerative colitis symptoms from \"None\" to \"Very severe\"",{"measure":60,"description":11,"timeFrame":61},"Incidence and Severity of Adverse Events (AEs)","From Baseline up to approximately 42 Weeks",{"allocation":63,"interventionModel":64,"interventionModelDescription":11,"primaryPurpose":65,"observationalModel":11,"timePerspective":11,"maskingInfo":66},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":67,"maskingDescription":11,"whoMasked":68},"QUADRUPLE",[69,70,71,72],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[74,80],{"label":75,"type":76,"description":77,"interventionNames":78},"Afimkibart","EXPERIMENTAL","Participants will receive afimkibart administered as subcutaneous (SC) injection.",[79],"Drug: Afimkibart",{"label":81,"type":82,"description":83,"interventionNames":84},"Placebo","PLACEBO_COMPARATOR","Participants will receive placebo adminsitered as SC injection.",[85],"Drug: Placebo",[87,95],{"type":88,"name":75,"description":89,"armGroupLabels":90,"otherNames":91},"DRUG","Afimkibart will be administered as SC injection.",[75],[92,93,94],"PF-06480605","RVT-3101","RO7790121",{"type":88,"name":81,"description":96,"armGroupLabels":97,"otherNames":11},"Placebo will be administered as SC injection.",[81],[99],{"name":100,"affiliation":5,"role":101},"Clinical Trials","STUDY_DIRECTOR",[103,108],{"name":104,"role":105,"phone":106,"phoneExt":11,"email":107},"Reference Study ID Number: CA46523 https:\u002F\u002Fforpatients.roche.com\u002F No attachments to email below.","CONTACT","888-662-6728 (U.S. and Canada)","global-roche-genentech-trials@gene.com",{"name":109,"role":105,"phone":11,"phoneExt":11,"email":11},"Fastest response: use the inquiry form. https:\u002F\u002Fwww.gene.com\u002Fcontact-us\u002Fsubmit-medical-inquiry",{"type":111,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[113,115],{"name":114,"class":6},"Chugai Pharmaceutical",{"name":116,"class":6},"Pfizer","100658133","phase-3-a-study-to-assess-the-efficacy-and-safety-of-afimkibart-for-induction-therapy-in-participants-with-moderately-to-severely-active-ulcerative-colitis-100658133",false,"NCT07846683","A Study to Assess the Efficacy and Safety of Afimkibart for Induction Therapy in Participants With Moderately to Severely Active Ulcerative Colitis","A Phase III, Multicenter, Double-Blind Placebo-Controlled Study to Assess the Efficacy and Safety of Subcutaneous Induction Therapy With Afimkibart in Patients With Moderately to Severely Active Ulcerative Colitis","AMETRINE-SC","Inclusion Criteria:\n\n* Confirmed diagnosis of UC.\n* Moderately to severely active UC assessed by modified Mayo Score (mMS).\n* Bodyweight \\>= 40 kilogram (kg).\n* Up to date with colorectal cancer (CRC) screening performed according to local standards.\n* Demonstrated inadequate response, loss of response and\u002For intolerance to at least one protocol-specified conventional or advanced UC therapy.\n* Females of childbearing potential must meet protocol criteria for contraception requirements.\n\nExclusion Criteria:\n\n* Currently known complications of UC (e.g. fulminant colitis, toxic megacolon).\n* Current diagnosis of Crohn's disease (CD) or indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis.\n* Presence of an ostomy or ileoanal pouch.\n* Current diagnosis or suspicion of primary sclerosing cholangitis.\n* Pregnancy or breastfeeding, or intention of becoming pregnant during the study.\n* Past or current evidence of definite low-grade or high-grade colonic dysplasia or adenomas or neoplasia not completely removed.\n* History of malignancy within 5 years, with the exception of malignancies adequately treated with resection for non-metastatic basal cell or squamous cell cancer or in situ cervical cancer.\n* Evidence of infection with Clostridioides difficile (C. difficile; formerly known as Clostridium difficile), cytomegalovirus (CMV), human immunodeficiency virus (HIV), Hepatitis B (HBV), Hepatitis C (HCV).\n* Has evidence of active tuberculosis (TB), latent TB not successfully treated (per local guidance) or inadequately treated TB.\n* Has received protocol-specified prohibited medicines, including known exposure to any type of anti-TL1A therapy.","ALL","16 Years","80 Years",{"count":129,"type":130},350,"ESTIMATED","INTERVENTIONAL",[133],"PHASE3","The purpose of this study is to assess the efficacy and safety of subcutaneous induction with afimkibart in participants with moderately to severely active ulcerative colitis (UC).",[136],"Moderately to Severely Active Ulcerative Colitis","NOT_YET_RECRUITING","2026-09-22",{"date":140,"type":141},"2026-09-29","ACTUAL",{"date":143,"type":130},"2026-11-15",{"date":145,"type":130},"2030-12-31",{"name":5,"class":6}]