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RECRUITING Phase 3 ClinicalTrials.gov

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

Sponsor: AbbVie • ClinicalTrials.gov ID: NCT07071519

Registry updated: 2026-10-20
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Description

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.

Interventions

  • Risankizumab (Drug)
    Risankizumab intravenous (IV) infusion
  • Risankizumab (Drug)
    Risankizumab subcutaneous (SC) injection

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.

Conditions

Ulcerative Colitis

Locations

  • Phoenix Children's Hospital /ID# 273015 — Phoenix, Arizona, United States
  • Rady Children's Hospital /ID# 271873 — San Diego, California, United States
  • University of California San Francisco - Mission Bay /ID# 273022 — San Francisco, California, 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
  • University of Chicago Medical Center /ID# 271588 — Chicago, Illinois, United States
  • Goryeb Children's Hospital /ID# 271801 — Morristown, New Jersey, United States
  • University Hospitals Cleveland Medical Center /ID# 271831 — Cleveland, Ohio, United States
  • The Children's Hospital of Philadelphia /ID# 273222 — Philadelphia, Pennsylvania, United States
  • Upmc Children'S Hospital Of Pittsburgh /ID# 272328 — Pittsburgh, Pennsylvania, United States
  • Patewood Medical Campus /ID# 272477 — Greenville, South Carolina, United States
  • University of Texas - Southwestern Medical Center /ID# 271835 — Dallas, Texas, United States
  • Cliniques Universitaires UCL Saint-Luc /ID# 270123 — Brussels, Brussels Capital, Belgium
  • Hospital Universite Enfants Reine Fabiola /ID# 271860 — Brussels, Belgium
  • Centre Hospitalier Regional de la Citadelle /ID# 270459 — Liège, Belgium
  • Galileo Medical Research /ID# 271817 — Juiz de Fora, Minas Gerais, Brazil
  • Hospital Pequeno Principe /ID# 271814 — Curitiba, Paraná, Brazil
  • Hospital Sirio Libanes - Sao Paulo /ID# 271818 — São Paulo, Brazil
  • Alberta Children's Hospital /ID# 272635 — Calgary, Alberta, Canada
  • University of Alberta Hospital /ID# 271168 — Edmonton, Alberta, Canada
  • London Health Sciences Centre - Verspeeten Family Cancer Centre /ID# 271157 — London, Ontario, Canada
  • Guangzhou Medical University Affiliated Women and Children's Medical Center /ID# 277962 — Guangzhou, Guangdong, China
  • Henan Children's Hospital Zhengzhou Children's Hospital /ID# 278794 — Zhengzhou, Henan, China
  • Hunan Children's Hospital /ID# 278111 — Changsha, Hunan, China
  • The First Hospital of Jilin University - Changchun /ID# 279290 — Changchun, Jilin, China
  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine /ID# 278113 — Shanghai, Shanghai Municipality, China
  • Sir Run Run Shaw Hospital of Zhejiang University School of Medicine /ID# 277994 — Hangzhou, Zhejiang, China
  • The Childrens Hospital of Zhejiang University School of Medicine /ID# 278815 — Hangzhou, Zhejiang, China
  • 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
  • Thoracic General Hospital of Athens I Sotiria /ID# 270143 — Athens, Attica, Greece
  • University General Hospital Attikon /ID# 272361 — Chaïdári, 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 - Naples /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
  • Aichi Children's Health And Medical Center /ID# 280462 — Ōbu, Aichi-ken, Japan
  • Tsujinaka Hospital - Kashiwanoha /ID# 280303 — Kashiwa-shi, Chiba, Japan
  • Kurume University Hospital /ID# 280792 — Kurume-shi, Fukuoka, Japan
  • Gunma University Hospital /ID# 281179 — Maebashi, Gunma, Japan
  • Kobe University Hospital /ID# 281796 — Kobe, Hyōgo, Japan
  • Japanese Red Cross Kumamoto Hospital /ID# 280696 — Kumamoto, Kumamoto, Japan
  • Saga University Hospital /ID# 281232 — Saga, Saga-ken, Japan
  • Saitama Children's Medical Center /ID# 280603 — Saitama-shi, Saitama, Japan
  • Hamamatsu University Hospital /ID# 281614 — Hamamatsu, Shizuoka, Japan
  • Juntendo University Hospital /ID# 280463 — Bunkyo-ku, Tokyo, Japan
  • Institute of Science Tokyo Hospital /ID# 280694 — Bunkyo-ku, Tokyo, Japan
  • Tokyo Metropolitan Children's Medical Center /ID# 280791 — Fuchu-shi, Tokyo, Japan
  • National Center For Child Health And Development /ID# 280460 — Setagaya City, Tokyo, Japan
  • Fukushima Medical University Hospital /ID# 281178 — Fukushima, Japan
  • Centrum Zdrowia Mdm /ID# 276942 — Warsaw, Masovian Voivodeship, Poland
  • 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
  • Karolinska University Hospital Solna /ID# 271679 — Solna, Stockholm County, Sweden
  • 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
  • Addenbrookes Hospital /ID# 271489 — Cambridge, Cambridgeshire, United Kingdom
  • Sheffield Children's Hospital NHS Foundation Trust /ID# 271490 — Sheffield, England, United Kingdom
  • Alder Hey Children's NHS Foundation Trust /ID# 271533 — Liverpool, United Kingdom
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record