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NCT06260163 · ClinicalTrials.gov registry record · Phase 3
A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis
A Phase 3 study of Colitis, Ulcerative, sponsored by Janssen Research & Development.
- Active
- Registry status
- Phase 3
- Development phase
- 112
- Enrollment target
- 20
- Study locations
NCT06260163: Active Phase 3 study of Colitis, Ulcerative, sponsored by Janssen Research & Development.
NCT06260163 is a Phase 3 study of Colitis, Ulcerative that is active but no longer recruiting, run by Janssen Research & Development. The registered enrollment target is 112 participants, below the 402-participant average among 28 other Colitis, Ulcerative trials with a reported enrollment target (72% lower). The trial reports 20 study locations across 4 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06260163, a Phase 3 study of Colitis, Ulcerative, is active but no longer recruiting, sponsored by Janssen Research & Development.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 112 participants
- Enrollment target
- 20
- Study locations
Study Summary
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.
Primary Outcome
Percentage of participants with clinical remission as assessed by modified Mayo score at Week 56 among participants who were induction responders will be reported. Clinical remission per modified Mayo score is defined as a stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1 with no friability present on the endoscopy, where the stool frequency subscore has not increased from induction baseline.
Conditions Studied
Interventions
- DRUG Guselkumab Subcutaneous
- DRUG Guselkumab Intravenous
Study Locations (20)
Other
- The Kids Research Institute Australia on behalf of the Centre for Child Health Research - Nedlands
- Mater Hospital Brisbane Inflammatory Bowel Diseases - South Brisbane
- The Children's Hospital at Westmead - Westmead
- CHU Charleroi Chimay - Charleroi
- UZ Gent - Ghent
- UZ Brussel - Jette
- UZ Leuven - Leuven
- Capital Center For Children's health Capital Medical University - Beijing
- Peking University Third Hospital - Beijing
- Changzhou No 2 Peoples Hospital - Changzhou
- The Childrens Hospital Zhejiang University School Of Medicine - Hangzhou
- Sir Run Run Shaw Hospital Zhejiang University School of Medicine - Hangzhou
- Ruijin Hospital Shanghai Jiao Tong University - Shanghai
- Shengjing Hospital Of China Medical University - Shenyang
- Henan Children's Hospital, Zhengzhou Children's Hospital - Zhengzhou
- Aarhus Universitetshospital - Aarhus N
- Hvidovre Hospital - Hvidovre
California
- Children's Hospital Oakland - Oakland
Indiana
- Riley Hospital for Children - Indianapolis
New York
- NYU Langone Health - Lake Success
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 112 participants |
| Start Date | 2024-01-19 |
| Est. Completion | 2028-08-14 |
| Phase | Phase 3 |
What the registry record for NCT06260163 still lists
NCT06260163 is an interventional study that assigns participants to a tested intervention. The registered 112 participants enrollment target is mid-sized for trials with a published cap, below the 402-participant average among 28 other Colitis, Ulcerative trials with a reported enrollment target (72% lower).
The record links to 1 condition, with Colitis, Ulcerative appearing as the primary indexed condition, and to 2 interventions - of which Guselkumab Subcutaneous is the first listed.
NCT06260163 names 20 study sites across 4 states, led by Other, California, Indiana.
Frequently Asked Questions
What is clinical trial NCT06260163 about?
NCT06260163 is a clinical study titled "A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis". 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.
What is the current status of trial NCT06260163?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 112 participants. The study started on 2024-01-19. Estimated completion is 2028-08-14.
What conditions does trial NCT06260163 study?
This clinical trial studies the following conditions: Colitis, Ulcerative.
What interventions are being tested in trial NCT06260163?
The interventions under investigation include: Guselkumab Subcutaneous (DRUG), Guselkumab Intravenous (DRUG).
Who is sponsoring clinical trial NCT06260163?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06260163 being conducted?
This trial has 20 study locations across California, Indiana, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Colitis, Ulcerative
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06260163's enrollment target sits among peer trials
112 22nd of 28 higher than 7 of 28 other Colitis, Ulcerative trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colitis, Ulcerative trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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A Study of Guselkumab Therapy in Participants With Moderately to Severely Active Ulcerative Colitis
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