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A Study to Learn More About How Risankizumab Works in Young Participants With Ulcerative Colitis
Sponsor: AbbVie
Summary
Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine). This study will assess how Risankizumab moves through the body as well as how safe and effective it is in treating pediatric participants with moderate to severely active UC. Adverse events and change in disease activity will be assessed. Risankizumab is an approved medication for moderate to severe UC in multiple countries and is being developed for the treatment of UC in pediatrics. This study is comprised of 3 cohorts that may participate in 3 substudies (SS). Cohort 1 will enroll participants with ages from 6 to less than 18 years. Cohort 2 will enroll participants with ages from 2 to less than 6 years. Cohort 3 will enroll participants with ages from 2 to less than 18 years. SS1 is an open-label induction period where participants will receive a weight-based induction regimen of risankizumab. SS2 is a double-blind maintenance period where participants will be randomized to receive 1 of 2 doses of weight-based maintenance regimen of risankizumab. SS3 is an open-label extension period where participants will receive risankizumab based off of their response in SS2. Around 120 pediatric participants with UC will be enrolled at around 80 sites worldwide. Participants in SS1 will receive risankizumab intravenously during the 12-week induction period. Participants in SS2 will receive risankizumab subcutaneously during the 52-week randomized maintenance period. Participants in SS3 will receive risankizumab subcutaneously during the 208-week open label period. Participants will be followed-up for approximately 140 days. There 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.
Official title: 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
Key Details
Gender
All
Age Range
2 Years - 17 Years
Study Type
INTERVENTIONAL
Enrollment
120
Start Date
2025-07-28
Completion Date
2034-07
Last Updated
2026-02-11
Healthy Volunteers
No
Conditions
Interventions
Risankizumab
Risankizumab intravenous (IV) infusion
Risankizumab
Risankizumab subcutaneous (SC) injection
Locations (33)
Phoenix Children's Hospital /ID# 273015
Phoenix, Arizona, United States
Nicklaus Children'S Hospital - Miami - Southwest 62nd Avenue /ID# 271585
Miami, Florida, United States
Childrens Center For Digestive Health Care /ID# 273228
Atlanta, Georgia, United States
Goryeb Children's Hospital /ID# 271801
Morristown, New Jersey, United States
Upmc Children'S Hospital Of Pittsburgh /ID# 272328
Pittsburgh, Pennsylvania, United States
Patewood Medical Campus /ID# 272477
Greenville, South Carolina, United States
Cliniques Universitaires UCL Saint-Luc /ID# 270123
Brussels, Brussels Capital, Belgium
Centre Hospitalier Régional de la Citadelle /ID# 270459
Liège, Liege, Belgium
Hospital Universite Enfants Reine Fabiola /ID# 271860
Brussels, Belgium
Medizinische Universitaet Lausitz - Carl Thiem /ID# 272023
Cottbus, Brandenburg, Germany
Klinikum Kassel /ID# 271546
Kassel, Hesse, Germany
Universitaetsklinikum Muenster /ID# 271898
Münster, North Rhine-Westphalia, Germany
General Hospital of Chest Diseases of Athens SOTIRIA /ID# 270143
Athens, Attica, Greece
University General Hospital Attikon /ID# 272361
Athens, Attica, Greece
General Hospital of Thessaloniki Hippokrateio /ID# 271939
Thessaloniki, Greece
Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 271889
San Giovanni Rotondo, Foggia, Italy
Azienda Ospedaliera Universitaria Federico II /ID# 271895
Naples, Napoli, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 272967
Rome, Roma, Italy
Ospedale Infantile Burlo Garofolo /ID# 274442
Trieste, Italy
University Children's Hospital /ID# 269960
Belgrade, Beograd, Serbia
Institut za zdravstvenu zastitu majke i deteta Srbije Dr Vukan Cupic /ID# 270696
Belgrade-Vračar, Beograd, Serbia
Institute for Child and Youth Health Care of Vojvodina /ID# 269961
Novi Sad, Serbia
Pusan National University Yangsan Hospital /ID# 272769
Yangsan, Gyeongsangnam-do, South Korea
Seoul National University Hospital /ID# 272852
Seoul, Seoul Teugbyeolsi, South Korea
Kangbuk Samsung Hospital /ID# 273333
Seoul, Seoul Teugbyeolsi, South Korea
Yonsei University Health System Severance Hospital /ID# 272894
Seoul, Seoul Teugbyeolsi, South Korea
Samsung Medical Center /ID# 272862
Seoul, Seoul Teugbyeolsi, South Korea
Hospital Teresa Herrera - CHUAC /ID# 271459
A Coruña, A Coruna, Spain
Hospital Universitario Puerta de Hierro - Majadahonda /ID# 271466
Majadahonda, Madrid, Spain
Sodersjukhuset /ID# 271678
Stockholm, Stockholm County, Sweden
Sahlgrenska Universitetssjukhuset /ID# 271675
Gothenburg, Västra Götaland County, Sweden
Taichung Veterans General Hospital /ID# 269242
Taichung, Taiwan
National Taiwan University Hospital /ID# 269244
Taipei, Taiwan