A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis

Running, not enrolling · Phase 3

Conditions studied: Colitis, Ulcerative

In brief

The purpose of this study is to evaluate the efficacy of guselkumab in pediatric participants with moderately to severely active ulcerative colitis at the end of maintenance therapy among participants who were induction responders.

Key facts

Study ID

NCT06260163

Run by

Janssen Research & Development, LLC

People needed

112

Starts

2024-01-19

Expected to finish

2027-04-28

Last updated by the study team

2026-07-31

Who can join

Age: 2 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Weight greater than or equal to (>=) 10 kilogram (kg) at the time of consent for screening
• A pathology report to support a documented diagnosis of Ulcerative Colitis (UC) must be available in the source documents. There is no maximum duration for which a participant needs to be diagnosed with UC. If the pathology report to support a documented diagnosis of UC is not available in the source documents, the screening endoscopy with biopsies (obtained within 3 weeks before first study intervention administration) needs to support the diagnosis of UC.
• Moderately to severely active UC, defined by a baseline modified Mayo (without physician's global assessment) score of 5 through 9 inclusive, with a screening Mayo endoscopy subscore >= 2 as determined by a central review of the video of the endoscopy
• Medically stable based on physical examination, medical history, and vital signs, performed at screening. Any abnormalities must be consistent with the underlying illness in the study population and this determination must be recorded in the participant's source documents and acknowledged by the investigator
• Participants must have had an inadequate response and/or intolerance to biologic therapy and/or conventional therapies or be dependent upon corticosteroids

You may not qualify if…

• Have UC limited to the rectum only or to less than (<) 20 centimeter of the colon
• Presence of a stoma
• Has had any kind of bowel resection within 6 months or any other intra-abdominal surgery within 3 months of baseline
• Have severe colitis or have evidence of Crohn's Disease (CD)

Where it is running

• Riley Hospital for Children — Indianapolis, Indiana, United States
• NYU Langone Health — Lake Success, New York, United States
• The Kids Research Institute Australia on behalf of the Centre for Child Health Research — Nedlands, Australia
• Mater Hospital Brisbane Inflammatory Bowel Diseases — South Brisbane, Australia
• The Children's Hospital at Westmead — Westmead, Australia
• CHU Charleroi Chimay — Charleroi, Belgium
• UZ Gent — Ghent, Belgium
• UZ Brussel — Jette, Belgium
• UZ Leuven — Leuven, Belgium
• Capital Center For Children's health Capital Medical University — Beijing, China
• Peking University Third Hospital — Beijing, China
• Changzhou No 2 Peoples Hospital — Changzhou, China
• The Childrens Hospital Zhejiang University School Of Medicine — Hangzhou, China
• Sir Run Run Shaw Hospital Zhejiang University School of Medicine — Hangzhou, China
• Ruijin Hospital Shanghai Jiao Tong University — Shanghai, China
• Shengjing Hospital Of China Medical University — Shenyang, China
• Henan Children's Hospital, Zhengzhou Children's Hospital — Zhengzhou, China
• Aarhus Universitetshospital — Aarhus N, Denmark
• Hvidovre Hospital — Hvidovre, Denmark
• Hospices Civils de Lyon - Groupement Hospitalier Est - Hopital Femme Mere Enfant — Bron, France
• Hopital Francois Mitterand — Dijon, France
• CHRU Lille — Lille, France
• APHP Hopital Robert Debre — Paris, France
• CHU Toulouse — Toulouse, France
• Children's Hospital Oakland — Oakland, California, United States

Full record on ClinicalTrials.gov

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