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NCT05923073 · ClinicalTrials.gov registry record · Phase 3
A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease
A Phase 3 study of Crohn's Disease, sponsored by Janssen Research & Development.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 120
- Enrollment target
- 20
- Study locations
NCT05923073: Recruiting Phase 3 study of Crohn's Disease, sponsored by Janssen Research & Development.
NCT05923073 is a Phase 3 study of Crohn's Disease that is actively recruiting participants, run by Janssen Research & Development. The registered enrollment target is 120 participants, below the 2,393-participant average among 105 other Crohn's Disease trials with a reported enrollment target (95% lower). The trial reports 20 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05923073, a Phase 3 study of Crohn's Disease, is actively recruiting participants, sponsored by Janssen Research & Development.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 120 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the clinical and endoscopic efficacy of guselkumab in pediatric participants with Crohn's Disease (CD) at the end of maintenance therapy (Week 52) among participants who were in clinical response to guselkumab at Week 12.
Primary Outcome
Percentage of participants with clinical remission at Week 52 will be assessed. Clinical remission is defined as pediatric Crohn's Disease activity index (PCDAI) less than or equal to (\<=) 10.
Conditions Studied
Interventions
- DRUG Guselkumab
Study Locations (20)
Other
- Mater Hospital Brisbane - South Brisbane
- The Children's Hospital at Westmead - Westmead
- AKH - Medizinische Universitat Wien - Vienna
- Universitair Ziekenhuis Brussel - Brussels
- Cliniques Universitaires Saint Luc - Brussels
- Universitair Ziekenhuis Gent - Ghent
- UZ Leuven - Leuven
New York
- Weill Cornell Medical College - Judith Jaffe Multiple Sclerosis Center - New York
- Icahn School of Medicine at Mount Sinai - New York
- Columbia University Medical Center - New York
Georgia
- Emory University - Atlanta
- Children's Center for Digestive Health Care - Atlanta
California
- Cedars Sinai Medical Center - Los Angeles
Connecticut
- Connecticut Children's Medical Center - Hartford
Indiana
- Riley Hospital for Children - Indianapolis
Massachusetts
- Boston Childrens Hospital - Boston
Ohio
- The Children's Medical Center of Dayton - Dayton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2024-03-13 |
| Est. Completion | 2028-07-12 |
| Phase | Phase 3 |
What NCT05923073 shows while recruiting
NCT05923073 is an interventional study that assigns participants to a tested intervention. The registered 120 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 (95% lower).
The record links to 1 condition, with Crohn's Disease appearing as the primary indexed condition, and to 1 intervention - of which Guselkumab is the first listed.
NCT05923073 names 20 study sites across 11 states, led by Other, New York, Georgia.
Frequently Asked Questions
What is clinical trial NCT05923073 about?
NCT05923073 is a clinical study titled "A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Crohn's Disease". The purpose of this study is to evaluate the clinical and endoscopic efficacy of guselkumab in pediatric participants with Crohn's Disease (CD) at the end of maintenance therapy (Week 52) among participants who were in clinical response to guselkumab at Week 12.
What is the current status of trial NCT05923073?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 120 participants. The study started on 2024-03-13. Estimated completion is 2028-07-12.
What conditions does trial NCT05923073 study?
This clinical trial studies the following conditions: Crohn's Disease.
What interventions are being tested in trial NCT05923073?
The interventions under investigation include: Guselkumab (DRUG).
Who is sponsoring clinical trial NCT05923073?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05923073 being conducted?
This trial has 20 study locations across California, Connecticut, Georgia, Indiana, Massachusetts. 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 NCT05923073's enrollment target sits among peer trials
120 63rd of 105 higher than 42 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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