๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-08-27

A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis (NCT06260163)

A Phase 3 Randomized, Open-label Induction, Double-blind Maintenance, Parallel-group, Multicenter Protocol to Evaluate the Efficacy, Safety, and Pharmacokinetics of Guselkumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis

๐Ÿ”ต Active, Not Recruiting Phase3 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Janssen Research & Development, LLC

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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.

Who can join: Review the eligibility criteria below.

Location: Children's Hospital Oakland โ€” Oakland, California

Age range: 2 Years to 17 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (61 Sites)

Showing the first 25 of 61 sites.

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

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—