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NCT06663332 · ClinicalTrials.gov registry record · Phase 3
A Long-term Extension (LTE) Study of Guselkumab in Pediatric Participants
A Phase 3 study of Crohn's Disease and Colitis, Ulcerative, sponsored by Janssen Research & Development.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 196
- Enrollment target
- 20
- Study locations
NCT06663332: Recruiting Phase 3 study of Crohn's Disease and Colitis, Ulcerative, sponsored by Janssen Research & Development.
NCT06663332 is a Phase 3 study of Crohn's Disease and Colitis, Ulcerative that is actively recruiting participants, run by Janssen Research & Development. The registered enrollment target is 196 participants, below the 2,393-participant average among 105 other Crohn's Disease trials with a reported enrollment target (92% lower). The trial reports 20 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06663332, a Phase 3 study of Crohn's Disease and Colitis, Ulcerative, is actively recruiting participants, sponsored by Janssen Research & Development.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 196 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate long-term safety of subcutaneous guselkumab in pediatric participants with moderately to severely active ulcerative colitis, or moderately to severely active Crohn's disease, or juvenile psoriatic arthritis (jPsA).
Primary Outcome
Treatment-emergent adverse events will be reported to analyze the long-term safety of guselkumab in pediatric participants.
Conditions Studied
Interventions
- DRUG Guselkumab
Study Locations (20)
Other
- Instituto Caici - Rosario
- Capital Center For Children's health Capital Medical University - 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
- Hospital Center University De Lille - Lille
- Schon Klinik Hamburg Eilbek - Hamburg
- ASST Papa Giovanni XXIII Bergamo - Bergamo
- Azienda USL di Bologna - Ospedale Maggiore - Bologna
- Kanazawa University Hospital - Kanazawa
- Kobe University Hospital - Kobe
- Japanese Red Cross Kumamoto Hospital - Kumamoto
- Shinshu University Hospital - Matsumoto
- Saga University Hospital - Saga
Georgia
- Emory University - Atlanta
Indiana
- Riley Hospital for Children - Indianapolis
Ohio
- Cincinnati Children's Hospital Medical Center - Cincinnati
Utah
- University of Utah - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 196 participants |
| Start Date | 2024-10-29 |
| Est. Completion | 2031-12-12 |
| Phase | Phase 3 |
What NCT06663332 shows while recruiting
NCT06663332 is an interventional study that assigns participants to a tested intervention. The registered 196 participants enrollment target is mid-sized for trials with a published cap, below the 2,393-participant average among 105 other Crohn's Disease trials with a reported enrollment target (92% lower).
The record links to 4 conditions, with Crohn's Disease appearing as the primary indexed condition, and to 1 intervention - of which Guselkumab is the first listed.
NCT06663332 names 20 study sites across 5 states, led by Other, Georgia, Indiana.
Frequently Asked Questions
What is clinical trial NCT06663332 about?
NCT06663332 is a clinical study titled "A Long-term Extension (LTE) Study of Guselkumab in Pediatric Participants". The purpose of this study is to evaluate long-term safety of subcutaneous guselkumab in pediatric participants with moderately to severely active ulcerative colitis, or moderately to severely active Crohn's disease, or juvenile psoriatic arthritis (jPsA).
What is the current status of trial NCT06663332?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 196 participants. The study started on 2024-10-29. Estimated completion is 2031-12-12.
What conditions does trial NCT06663332 study?
This clinical trial studies the following conditions: Crohn's Disease, Colitis, Ulcerative, Arthritis, Psoriatic, Arthritis, Juvenile.
What interventions are being tested in trial NCT06663332?
The interventions under investigation include: Guselkumab (DRUG).
Who is sponsoring clinical trial NCT06663332?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06663332 being conducted?
This trial has 20 study locations across Georgia, Indiana, Ohio, Utah. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Crohn's Disease
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 NCT06663332's enrollment target sits among peer trials
196 53rd of 105 higher than 53 of 105 other Crohn's Disease trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Crohn's Disease 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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