{ "data": { "asOf": "2026-10-30T22:27:23.540Z", "dedupMethod": "exact cross-registry identifier matching; probabilistic = review only", "byRegistry": { "clinicaltrials_gov": 1 }, "canonicalTrial": { "canonicalId": "NCT07071519", "title": "A Study to Learn More About How Risankizumab Works in Young Participants With Ulcerative Colitis", "scientificTitle": "A Phase 3, Multi-Center Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Risankizumab With Open-Label Induction, Randomized Double-Blind Maintenance, and Open-Label Long-Term Extension Periods in Pediatric Subjects (2 to < 18 Years of Age) With Moderately to Severely Active Ulcerative Colitis", "status": "recruiting", "studyType": "interventional", "phase": [ "PHASE3" ], "conditions": [ "Ulcerative Colitis" ], "interventions": [ { "name": "Risankizumab", "type": "DRUG", "description": "Risankizumab intravenous (IV) infusion" }, { "name": "Risankizumab", "type": "DRUG", "description": "Risankizumab subcutaneous (SC) injection" } ], "sponsor": { "name": "AbbVie", "type": "INDUSTRY" }, "locations": [ { "city": "Phoenix", "country": "United States", "facility": "Phoenix Children's Hospital /ID# 273015" }, { "city": "San Diego", "country": "United States", "facility": "Rady Children's Hospital /ID# 271873" }, { "city": "San Francisco", "country": "United States", "facility": "University of California San Francisco - 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Southwestern Medical Center /ID# 271835" }, { "city": "Brussels", "country": "Belgium", "facility": "Cliniques Universitaires UCL Saint-Luc /ID# 270123" }, { "city": "Brussels", "country": "Belgium", "facility": "Hospital Universite Enfants Reine Fabiola /ID# 271860" }, { "city": "Liège", "country": "Belgium", "facility": "Centre Hospitalier Regional de la Citadelle /ID# 270459" }, { "city": "Juiz de Fora", "country": "Brazil", "facility": "Galileo Medical Research /ID# 271817" }, { "city": "Curitiba", "country": "Brazil", "facility": "Hospital Pequeno Principe /ID# 271814" }, { "city": "São Paulo", "country": "Brazil", "facility": "Hospital Sirio Libanes - Sao Paulo /ID# 271818" }, { "city": "Calgary", "country": "Canada", "facility": "Alberta Children's Hospital /ID# 272635" }, { "city": "Edmonton", "country": "Canada", "facility": "University of Alberta Hospital /ID# 271168" }, { "city": "London", "country": "Canada", "facility": "London Health Sciences Centre - Verspeeten Family Cancer Centre /ID# 271157" }, { "city": "Guangzhou", "country": "China", "facility": "Guangzhou Medical University Affiliated Women and Children's Medical Center /ID# 277962" }, { "city": "Zhengzhou", "country": "China", "facility": "Henan Children's Hospital Zhengzhou Children's Hospital /ID# 278794" }, { "city": "Changsha", "country": "China", "facility": "Hunan Children's Hospital /ID# 278111" }, { "city": "Changchun", "country": "China", "facility": "The First Hospital of Jilin University - Changchun /ID# 279290" }, { "city": "Shanghai", "country": "China", "facility": "Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 278113" }, { "city": "Hangzhou", "country": "China", "facility": "Sir Run Run Shaw Hospital of Zhejiang University School of Medicine /ID# 277994" }, { "city": "Hangzhou", "country": "China", "facility": "The Childrens Hospital of Zhejiang University School of Medicine /ID# 278815" }, { "city": "Cottbus", "country": "Germany", "facility": "Medizinische Universitaet Lausitz - Carl Thiem /ID# 272023" }, { "city": "Kassel", "country": "Germany", "facility": "Klinikum Kassel /ID# 271546" }, { "city": "Münster", "country": "Germany", "facility": "Universitaetsklinikum Muenster /ID# 271898" }, { "city": "Athens", "country": "Greece", "facility": "Thoracic General Hospital of Athens I Sotiria /ID# 270143" }, { "city": "Chaïdári", "country": "Greece", "facility": "University General Hospital Attikon /ID# 272361" }, { "city": "Thessaloniki", "country": "Greece", "facility": "General Hospital of Thessaloniki Hippokrateio /ID# 271939" }, { "city": "San Giovanni Rotondo", "country": "Italy", "facility": "Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 271889" }, { "city": "Naples", "country": "Italy", "facility": "Azienda Ospedaliera Universitaria Federico II - Naples /ID# 271895" }, { "city": "Rome", "country": "Italy", "facility": "Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 272967" }, { "city": "Trieste", "country": "Italy", "facility": "Ospedale Infantile Burlo Garofolo /ID# 274442" }, { "city": "Ōbu", "country": "Japan", "facility": "Aichi Children's Health And Medical Center /ID# 280462" }, { "city": "Kashiwa-shi", "country": "Japan", "facility": "Tsujinaka Hospital - Kashiwanoha /ID# 280303" }, { "city": "Kurume-shi", "country": "Japan", "facility": "Kurume University Hospital /ID# 280792" }, { "city": "Maebashi", "country": "Japan", "facility": "Gunma University Hospital /ID# 281179" }, { "city": "Kobe", "country": "Japan", "facility": "Kobe University Hospital /ID# 281796" }, { "city": "Kumamoto", "country": "Japan", "facility": "Japanese Red Cross Kumamoto Hospital /ID# 280696" }, { "city": "Saga", "country": "Japan", "facility": "Saga University Hospital /ID# 281232" }, { "city": "Saitama-shi", "country": "Japan", "facility": "Saitama Children's Medical Center /ID# 280603" }, { "city": "Hamamatsu", "country": "Japan", "facility": "Hamamatsu University Hospital /ID# 281614" }, { "city": "Bunkyo-ku", "country": "Japan", "facility": "Juntendo University Hospital /ID# 280463" }, { "city": "Bunkyo-ku", "country": "Japan", "facility": "Institute of Science Tokyo Hospital /ID# 280694" }, { "city": "Fuchu-shi", "country": "Japan", "facility": "Tokyo Metropolitan Children's Medical Center /ID# 280791" }, { "city": "Setagaya City", "country": "Japan", "facility": "National Center For Child Health And Development /ID# 280460" }, { "city": "Fukushima", "country": "Japan", "facility": "Fukushima Medical University Hospital /ID# 281178" }, { "city": "Warsaw", "country": "Poland", "facility": "Centrum Zdrowia Mdm /ID# 276942" }, { "city": "Warsaw", "country": "Poland", "facility": "Medical Network Sp. z o.o. /ID# 276903" }, { "city": "Bialystok", "country": "Poland", "facility": "Uniwersytecki Dzieciecy Szpital Kliniczny im. L. Zamenhofa w Bialymstoku /ID# 276771" }, { "city": "Belgrade", "country": "Serbia", "facility": "University Children's Hospital /ID# 269960" }, { "city": "Belgrade-Vračar", "country": "Serbia", "facility": "Institut za zdravstvenu zastitu majke i deteta Srbije Dr Vukan Cupic /ID# 270696" }, { "city": "Novi Sad", "country": "Serbia", "facility": "Institute for Child and Youth Health Care of Vojvodina /ID# 269961" }, { "city": "Yangsan", "country": "South Korea", "facility": "Pusan National University Yangsan Hospital /ID# 272769" }, { "city": "Seoul", "country": "South Korea", "facility": "Seoul National University Hospital /ID# 272852" }, { "city": "Seoul", "country": "South Korea", "facility": "Kangbuk Samsung Hospital /ID# 273333" }, { "city": "Seoul", "country": "South Korea", "facility": "Yonsei University Health System - Severance Hospital /ID# 272894" }, { "city": "Seoul", "country": "South Korea", "facility": "Samsung Medical Center /ID# 272862" }, { "city": "A Coruña", "country": "Spain", "facility": "Hospital Teresa Herrera - CHUAC /ID# 271459" }, { "city": "Majadahonda", "country": "Spain", "facility": "Hospital Universitario Puerta de Hierro - Majadahonda /ID# 271466" }, { "city": "Solna", "country": "Sweden", "facility": "Karolinska University Hospital Solna /ID# 271679" }, { "city": "Stockholm", "country": "Sweden", "facility": "Sodersjukhuset /ID# 271678" }, { "city": "Gothenburg", "country": "Sweden", "facility": "Sahlgrenska Universitetssjukhuset /ID# 271675" }, { "city": "Taichung", "country": "Taiwan", "facility": "Taichung Veterans General Hospital /ID# 269242" }, { "city": "Taipei", "country": "Taiwan", "facility": "National Taiwan University Hospital /ID# 269244" }, { "city": "Cambridge", "country": "United Kingdom", "facility": "Addenbrookes Hospital /ID# 271489" }, { "city": "Sheffield", "country": "United Kingdom", "facility": "Sheffield Children's Hospital NHS Foundation Trust /ID# 271490" }, { "city": "Liverpool", "country": "United Kingdom", "facility": "Alder Hey Children's NHS Foundation Trust /ID# 271533" } ], "outcomes": { "other": [], "primary": [ "PK Lead-In Cohort 1: Maximum Observed Serum Concentration (Cmax)", "PK Lead-In Cohort 2: Maximum Observed Serum Concentration (Cmax)", "PK Lead-In Cohort 1: Time to Maximum Serum Concentration (Tmax)", "PK Lead-In Cohort 2: Time to Maximum Serum Concentration (Tmax)", "PK Lead-In Cohort 1: Area Under the Serum Concentration-Time Curve Over the Dosing Interval (AUCtau)", "PK Lead-In Cohort 2: Area Under the Serum Concentration-Time Curve Over the Dosing Interval (AUCtau)", "Expansion Cohort 3: Achievement of Clinical Remission per Modified Mayo Score (mMS) Among Week 12 Clinical Responders per mMS", "Number of Participants With Adverse Events" ], "secondary": [ "PK Lead-In Cohort 1: Achievement of clinical remission per mMS among Week 12 responders per mMS", "PK Lead-In Cohort 2: Achievement of clinical remission per mMS among Week 12 responders per mMS", "PK Lead-In Cohort 1: Achievement of clinical remission per mMS", "PK Lead-In Cohort 2: Achievement of clinical remission per mMS", "PK Lead-In Cohort 1: Achievement of clinical response per mMS", "PK Lead-In Cohort 2: Achievement of clinical response per mMS", "PK Lead-In Cohort 1: Achievement of endoscopic improvement", "PK Lead-In Cohort 2: Achievement of endoscopic improvement", "PK Lead-In Cohort 1: Symptomatic response per partial mMS", "PK Lead-In Cohort 2: Symptomatic response per partial mMS", "PK Lead-In Cohort 1: Achievement of clinical response per mMS among Week 12 responders per mMS", "PK Lead-In Cohort 2: Achievement of clinical response per mMS among Week 12 responders per mMS", "PK Lead-In Cohort 1: Achievement of endoscopic improvement among Week 12 responders per mMS", "PK Lead-In Cohort 2: Achievement of endoscopic improvement among Week 12 responders per mMS", "PK Lead-In Cohort 1: Achievement of corticosteroid-free (at least 90 days without corticosteroid exposure) clinical remission per mMS at Week 64 among Week 12 responders per mMS", "PK Lead-In Cohort 2: Achievement of corticosteroid-free (at least 90 days without corticosteroid exposure) clinical remission per mMS at Week 64 among Week 12 responders per mMS", "Expansion Cohort 3: Achievement of clinical remission per mMS", "Expansion Cohort 3: Achievement of clinical response per mMS", "Expansion Cohort 3: Achievement of endoscopic improvement", "Expansion Cohort 3: Symptomatic response per partial mMS", "Expansion Cohort 3: Achievement of clinical response per mMS among Week 12 responders per mMS", "Expansion Cohort 3: Achievement of endoscopic improvement among Week 12 responders per mMS", "Expansion Cohort 3: Achievement of corticosteroid-free clinical remission per mMS among Week 12 responders per mMS" ] }, "eligibility": { "sex": "ALL", "criteria": "Inclusion Criteria:\n\n* Active ulcerative colitis (UC) with an modified Mayo Score (mMS) of 5 to 9 points and endoscopic subscore of 2 to 3 (confirmed by central reader).\n* Demonstrated intolerance or inadequate response (IR) to one or more of the following categories of drugs:\n\naminosalicylates (except in countries where failure of this drug class is not sufficient for eligibility), oral locally acting corticosteroids, systemic steroids (prednisone or equivalent), immunomodulators (IMMs), and/or biologic therapies, as outlined in the protocol.\n\n\\- Subjects must have a documented history of UC for at least 3 months prior to Baseline, confirmed by colonoscopy during the screening period, with exclusion of current infection, colonic dysplasia and/or malignancy. 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