[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100607164":3},{"organization":4,"outcomesModule":7,"designInfo":61,"detailedDescription":35,"studyPopulation":35,"armGroups":72,"interventions":88,"overallOfficials":35,"centralContacts":99,"locations":106,"responsibleParty":2000,"collaborators":2002,"id":2005,"slug":2006,"hasResults":2007,"nctId":2008,"briefTitle":2009,"officialTitle":2010,"acronym":2011,"eligibilityCriteria":2012,"healthyVolunteers":2007,"sex":2013,"minAge":2014,"maxAge":2015,"enrollmentInfo":2016,"targetDuration":35,"studyType":2019,"phases":2020,"briefSummary":2022,"conditions":2023,"keywords":35,"overallStatus":109,"whyStopped":35,"lastUpdateSubmitDate":2025,"lastUpdatePostDateStruct":2026,"startDateStruct":2029,"completionDateStruct":2031,"leadSponsor":2033,"locationsCount":2034},{"fullName":5,"class":6},"Sanofi","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":35},[9],{"measure":10,"description":11,"timeFrame":12},"Proportion of participants achieving clinical remission.","Clinical remission is defined as modified Mayo Score (mMS) score of 0 to 2, including SFS of 0 or 1, RBS of 0, and modified Mayo Endoscopic Score (MES) of 0 or 1 (score of 1 modified to exclude friability). mMS is a composite index designed to measure UC disease activity. The score ranges from 0 to 9 with higher scores indicating greater disease severity.","Week 12",[14,17,20,23,27,30,33,36,40,43,46,49,52,54,57,59],{"measure":15,"description":16,"timeFrame":12},"Proportion of participants who achieve endoscopic improvement.","Endoscopic improvement is defined as MES of 0 or 1 (score of 1 excludes friability). Endoscopies were assessed by a blinded central reader and scored according to the following scale: 0 = Normal or inactive disease; 1 = Mild disease (erythema, decreased vascular pattern); 2 = Moderate disease (marked erythema, lack of vascular pattern, any friability, erosions); 3 = Severe disease (spontaneous bleeding, ulceration).",{"measure":18,"description":19,"timeFrame":12},"Proportion of participants achieving clinical response by modified Mayo Score (mMS).","Clinical response is defined as a decrease from baseline in the mMS of ≥2 points and at least a 30% reduction from baseline, and a decrease in RB subscore of ≥1 or an absolute RB subscore of 0 or 1. mMS is a composite index designed to measure UC disease activity. The score ranges from 0 to 9 with higher scores indicating greater disease severity.",{"measure":21,"description":22,"timeFrame":12},"Proportion of participants achieving histological endoscopic mucosal improvement.","Histological endoscopic mucosal improvement is defined as MES of 0 or 1 without the evidence of friability and Geboes Score ≤3.1. The Geboes score has 6 grades: Grade 0, structural change only; Grade 1, chronic inflammation; Grade 2, lamina propria neutrophils and eosinophils; Grade 3, neutrophils in epithelium; Grade 4, crypt destruction; and Grade 5, erosions or ulceration.",{"measure":24,"description":25,"timeFrame":26},"Change from baseline in PROMIS-Fatigue Short Form 7a T-score.","The PROMIS-Fatigue Short Form 7 is a tool that assessesfatigue severity and its impact on daily functioning over the past week.","Baseline, Week 12",{"measure":28,"description":29,"timeFrame":12},"Proportion of participants with symptomatic (SFS and RBS) remission","Symptomatic remission (SF and RB): stool-frequency sub score (SFS ) of 0 or 1, and rectal bleeding sub score (RBS) of 0.",{"measure":31,"description":32,"timeFrame":12},"Proportion of participants with no bowel urgency.","The NRS for bowel urgency is a patient-reported tool designed to measure the severity of bowel urgency-the sudden or immediate need to have a bowel movement-experienced in the past 24 hours. This tool utilizes an 11-point scale for evaluation, where 0 represents \"no urgency\" and 10 signifies the \"worst possible urgency\".",{"measure":34,"description":35,"timeFrame":12},"Proportion of participants reporting no nocturnal bowel movements.",null,{"measure":37,"description":38,"timeFrame":39},"Proportion of participants with symptomatic (stool-frequency sub score [SFS] and = rectal bleeding sub score [RBS]) remission.","Symptomatic response is defined as ≥30% decrease from baseline in the composite clinical endpoint of the sum of SFS and RBS.","Week 4",{"measure":41,"description":42,"timeFrame":12},"Proportion of participants who achieve endoscopic remission.","Endoscopic remission is defined as mMES of 0.",{"measure":44,"description":45,"timeFrame":12},"Proportion of participants with no abdominal pain by Numeric Rating Scale (NRS).","The abdominal pain NRS is a tool to rate the severity of abdominal pain over the past 24 hours using a score of 0 (\"no pain\") to 10 (\"worst possible pain\").",{"measure":47,"description":48,"timeFrame":26},"Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) total score.","IBDQ is a tool to the quality of life of individuals suffering from IBD. The total score ranges from 32 to 224, with higher scores correlating to a better quality of life.",{"measure":50,"description":35,"timeFrame":51},"Proportion of participants with UC-related hospitalization.","Baseline through Week 12",{"measure":53,"description":35,"timeFrame":12},"Proportion of participants achieving clinical remission and no steroid use.",{"measure":55,"description":35,"timeFrame":56},"Incidence of Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Adverse Events of Special Interest (TEAESIs), Treatment-Emergent Serious Adverse Events (TESAEs), and TEAEs leading to permanent study intervention discontinuation.","Baseline through 45 days after last dose",{"measure":58,"description":35,"timeFrame":51},"Serum concentration of duvakitug measured over time.",{"measure":60,"description":35,"timeFrame":51},"Incidence of treatment-emergent Anti-Drug Antibodies (ADA) against duvakitug.",{"allocation":62,"interventionModel":63,"interventionModelDescription":35,"primaryPurpose":64,"observationalModel":35,"timePerspective":35,"maskingInfo":65},"RANDOMIZED","PARALLEL","TREATMENT",{"masking":66,"maskingDescription":35,"whoMasked":67},"QUADRUPLE",[68,69,70,71],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR",[73,79,83],{"label":74,"type":75,"description":76,"interventionNames":77},"Duvakitug - 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Site Number: 8400113","Folsom","95630",{"type":116,"coordinates":188},[189,190],-121.17606,38.67796,{"lat":190,"lon":189},{"facility":193,"status":109,"city":194,"state":158,"zip":195,"country":113,"countryCode":114,"cosmosGeoPoint":196,"geoPoint":200,"contacts":35},"Om Research, LLC - Lancaster - Site Number: 8400148","Lancaster","93534",{"type":116,"coordinates":197},[198,199],-118.13674,34.69804,{"lat":199,"lon":198},{"facility":202,"status":109,"city":203,"state":158,"zip":204,"country":113,"countryCode":114,"cosmosGeoPoint":205,"geoPoint":209,"contacts":35},"TLC Clinical Research Inc. - Site Number: 8400030","Los Angeles","90048",{"type":116,"coordinates":206},[207,208],-118.24368,34.05223,{"lat":208,"lon":207},{"facility":211,"status":109,"city":212,"state":158,"zip":213,"country":113,"countryCode":114,"cosmosGeoPoint":214,"geoPoint":218,"contacts":35},"United Medical Doctors CA - Site Number: 8400044","Murrieta","92563",{"type":116,"coordinates":215},[216,217],-117.21392,33.55391,{"lat":217,"lon":216},{"facility":220,"status":109,"city":221,"state":158,"zip":222,"country":113,"countryCode":114,"cosmosGeoPoint":223,"geoPoint":227,"contacts":35},"Om Research, LLC - Oxnard - Site Number: 8400150","Oxnard","93030",{"type":116,"coordinates":224},[225,226],-119.17705,34.1975,{"lat":226,"lon":225},{"facility":229,"status":109,"city":230,"state":158,"zip":231,"country":113,"countryCode":114,"cosmosGeoPoint":232,"geoPoint":236,"contacts":35},"UC Davis Health System - Site Number: 8400071","Sacramento","95817",{"type":116,"coordinates":233},[234,235],-121.4944,38.58157,{"lat":235,"lon":234},{"facility":238,"status":109,"city":239,"state":158,"zip":240,"country":113,"countryCode":114,"cosmosGeoPoint":241,"geoPoint":245,"contacts":35},"Clinical Applications Laboratories Inc - Site Number: 8400056","San Diego","92103",{"type":116,"coordinates":242},[243,244],-117.16472,32.71571,{"lat":244,"lon":243},{"facility":247,"status":109,"city":239,"state":158,"zip":248,"country":113,"countryCode":114,"cosmosGeoPoint":249,"geoPoint":251,"contacts":35},"Medical Associates Research Group - Site Number: 8400063","92123",{"type":116,"coordinates":250},[243,244],{"lat":244,"lon":243},{"facility":253,"status":109,"city":254,"state":158,"zip":255,"country":113,"countryCode":114,"cosmosGeoPoint":256,"geoPoint":260,"contacts":35},"Santa Maria Gastroenterology - FOMAT Medical Research HyperCORE - Site Number: 8400025","Santa Maria","93458",{"type":116,"coordinates":257},[258,259],-120.43572,34.95303,{"lat":259,"lon":258},{"facility":262,"status":109,"city":263,"state":158,"zip":264,"country":113,"countryCode":114,"cosmosGeoPoint":265,"geoPoint":269,"contacts":35},"Valiance Clinical Research - Tarzana - Site Number: 8400023","Tarzana","91356",{"type":116,"coordinates":266},[267,268],-118.55397,34.17334,{"lat":268,"lon":267},{"facility":271,"status":109,"city":272,"state":158,"zip":273,"country":113,"countryCode":114,"cosmosGeoPoint":274,"geoPoint":278,"contacts":35},"Clinical Trials Management Services - Site Number: 8400047","Thousand Oaks","91360",{"type":116,"coordinates":275},[276,277],-118.83759,34.17056,{"lat":277,"lon":276},{"facility":280,"status":109,"city":281,"state":158,"zip":282,"country":113,"countryCode":114,"cosmosGeoPoint":283,"geoPoint":287,"contacts":35},"Amicis Research Center-Valencia -Site Number: 8400064","Valencia","91355",{"type":116,"coordinates":284},[285,286],-118.60953,34.44361,{"lat":286,"lon":285},{"facility":289,"status":109,"city":290,"state":158,"zip":291,"country":113,"countryCode":114,"cosmosGeoPoint":292,"geoPoint":296,"contacts":35},"Om Research, LLC - 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Where permitted locally, participants 16 to \\\u003C18 years of age who meet the definition of Tanner Stage 5 for development\n* Confirmed diagnosis of moderately to severely active UC for at least 3 months prior to Baseline\n* Demonstrated inadequate response, have shown loss of response or intolerance to conventional therapies or advanced therapies\n\nExclusion Criteria:\n\n* Participants with Crohn's Disease (CD), indeterminate colitis\n* Current diagnosis of Ulcerative Proctitis\n* Participants with surgical bowel resection within the past 3 months prior to Baseline, or a history of \\>3 bowel resections\n* Prior or current high-grade gastrointestinal (GI) dysplasia\n* Participants on treatment with but not on stable doses of conventional therapies prior to baseline\n* Participants with prohibited medications or therapies prior to baseline\n* Participants with previous exposure to anti-TL1A investigational therapy The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.","ALL","16 Years","80 Years",{"count":2017,"type":2018},980,"ESTIMATED","INTERVENTIONAL",[2021],"PHASE3","This is a multinational, multicenter, randomized, double-blind, placebo-controlled, Phase 3 induction study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Ulcerative Colitis (UC). 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