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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06260163
The ClinicalTrials.gov registry entry for NCT06260163 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 112 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 402-participant average among 28 other Colitis, Ulcerative trials with a reported enrollment target (72% lower). The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 4 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.