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A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis
NCT06260163 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 112 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Janssen Research & Development, which has 442 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06260163 reports 20 study locations spanning 4 distinct geographic areas — top geographies include Other, California, Indiana. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06260163?
The interventions under investigation include: Guselkumab Subcutaneous (DRUG), Guselkumab Intravenous (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06260163?
This trial is sponsored by Janssen Research & Development, which has 442 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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