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A Study to Learn More About How Risankizumab Works in Young Participants With Ulcerative Colitis

NCT07071519 · AbbVie
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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
About this study
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.
Eligibility criteria
Inclusion Criteria: * 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). * Demonstrated intolerance or inadequate response (IR) to one or more of the following categories of drugs: aminosalicylates (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. \- 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. Documentation of pathology results consistent with the diagnosis of UC must be available. Exclusion Criteria: * Participants who have had a major surgery performed within 12 weeks prior to Baseline or planned during the conduct of the study (e.g., inguinal hernia repair, cholecystectomy, intestinal resection). * Participants who have concurrent clinically significant medical conditions other than the indication being studied or any other reason that the investigator determines would interfere with the subject's participation in this study, would make the subject an unsuitable candidate to receive study treatment, or would put the subject at risk by participating in the study.
Study design
Enrollment target: 120 participants
Allocation: randomized
Masking: double
Age groups: child
Timeline
Starts: 2025-07-28
Estimated completion: 2034-07
Last updated: 2026-02-11
Interventions
Drug: RisankizumabDrug: Risankizumab
Primary outcomes
  • PK Lead-In Cohort 1: Maximum Observed Serum Concentration (Cmax) (At Week 64)
  • PK Lead-In Cohort 2: Maximum Observed Serum Concentration (Cmax) (At Week 64)
  • PK Lead-In Cohort 1: Time to Maximum Serum Concentration (Tmax) (At Week 64)
Sponsor
AbbVie · industry
Contacts & investigators
ContactABBVIE CALL CENTER · contact · abbvieclinicaltrials@abbvie.com · 844-663-3742
InvestigatorABBVIE INC. · study_director, AbbVie
All locations (33)
Phoenix Children's Hospital /ID# 273015Recruiting
Phoenix, Arizona, United States
Nicklaus Children'S Hospital - Miami - Southwest 62nd Avenue /ID# 271585Recruiting
Miami, Florida, United States
Childrens Center For Digestive Health Care /ID# 273228Recruiting
Atlanta, Georgia, United States
Goryeb Children's Hospital /ID# 271801Recruiting
Morristown, New Jersey, United States
Upmc Children'S Hospital Of Pittsburgh /ID# 272328Recruiting
Pittsburgh, Pennsylvania, United States
Patewood Medical Campus /ID# 272477Recruiting
Greenville, South Carolina, United States
Cliniques Universitaires UCL Saint-Luc /ID# 270123Recruiting
Brussels, Brussels Capital, Belgium
Centre Hospitalier Régional de la Citadelle /ID# 270459Recruiting
Liège, Liege, Belgium
Hospital Universite Enfants Reine Fabiola /ID# 271860Recruiting
Brussels, Belgium
Medizinische Universitaet Lausitz - Carl Thiem /ID# 272023Recruiting
Cottbus, Brandenburg, Germany
Klinikum Kassel /ID# 271546Recruiting
Kassel, Hesse, Germany
Universitaetsklinikum Muenster /ID# 271898Recruiting
Münster, North Rhine-Westphalia, Germany
General Hospital of Chest Diseases of Athens SOTIRIA /ID# 270143Recruiting
Athens, Attica, Greece
University General Hospital Attikon /ID# 272361Recruiting
Athens, Attica, Greece
General Hospital of Thessaloniki Hippokrateio /ID# 271939Recruiting
Thessaloniki, Greece
Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 271889Recruiting
San Giovanni Rotondo, Foggia, Italy
Azienda Ospedaliera Universitaria Federico II /ID# 271895Recruiting
Naples, Napoli, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 272967Recruiting
Rome, Roma, Italy
Ospedale Infantile Burlo Garofolo /ID# 274442Recruiting
Trieste, Italy
University Children's Hospital /ID# 269960Recruiting
Belgrade, Beograd, Serbia
Institut za zdravstvenu zastitu majke i deteta Srbije Dr Vukan Cupic /ID# 270696Recruiting
Belgrade-Vračar, Beograd, Serbia
Institute for Child and Youth Health Care of Vojvodina /ID# 269961Recruiting
Novi Sad, Serbia
Pusan National University Yangsan Hospital /ID# 272769Recruiting
Yangsan, Gyeongsangnam-do, South Korea
Seoul National University Hospital /ID# 272852Recruiting
Seoul, Seoul Teugbyeolsi, South Korea
Kangbuk Samsung Hospital /ID# 273333Recruiting
Seoul, Seoul Teugbyeolsi, South Korea
Yonsei University Health System Severance Hospital /ID# 272894Recruiting
Seoul, Seoul Teugbyeolsi, South Korea
Samsung Medical Center /ID# 272862Recruiting
Seoul, Seoul Teugbyeolsi, South Korea
Hospital Teresa Herrera - CHUAC /ID# 271459Recruiting
A Coruña, A Coruna, Spain
Hospital Universitario Puerta de Hierro - Majadahonda /ID# 271466Recruiting
Majadahonda, Madrid, Spain
Sodersjukhuset /ID# 271678Recruiting
Stockholm, Stockholm County, Sweden
Sahlgrenska Universitetssjukhuset /ID# 271675Recruiting
Gothenburg, Västra Götaland County, Sweden
Taichung Veterans General Hospital /ID# 269242Recruiting
Taichung, Taiwan
National Taiwan University Hospital /ID# 269244Recruiting
Taipei, Taiwan