A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis
Public ClinicalTrials.gov record NCT06260163. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
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
Study identification
- NCT ID
- NCT06260163
- Recruitment status
- Active, not recruiting
- Study type
- Interventional
- Phase
- Phase 3
- Lead sponsor
- Janssen Research & Development, LLC
- Industry
- Enrollment
- 112 participants
Conditions and interventions
Conditions
Interventions
- Guselkumab Intravenous Drug
- Guselkumab Subcutaneous Drug
Drug
Eligibility (public fields only)
- Age range
- 2 Years to 17 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 18, 2024
- Primary completion
- May 21, 2028
- Completion
- Aug 13, 2028
- Last update posted
- Apr 12, 2026
2024 – 2028
United States locations
- U.S. sites
- 3
- U.S. states
- 3
- U.S. cities
- 3
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Children's Hospital Oakland | Oakland | California | 94609 | — |
| Riley Hospital for Children | Indianapolis | Indiana | 46202 | — |
| NYU Langone Health | Lake Success | New York | 11042 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 58 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT06260163, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 12, 2026 · Synced Apr 23, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT06260163 live on ClinicalTrials.gov.