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NCT05528510 · ClinicalTrials.gov registry record · Phase 3
A Study of Guselkumab Therapy in 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
- 418
- Enrollment target
- 20
- Study locations
NCT05528510: Active Phase 3 study of Colitis, Ulcerative, sponsored by Janssen Research & Development.
NCT05528510 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 418 participants, roughly in line with the 391-participant average among 28 other Colitis, Ulcerative trials with a reported enrollment target. The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05528510, 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
- 418 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the efficacy, including clinical remission of guselkumab subcutaneous (SC) induction compared to placebo in participants with moderately to severely active ulcerative colitis (UC).
Primary Outcome
Percentage of participants in clinical remission at Week 12 was reported. Clinical remission is defined as a Mayo stool frequency subscore of 0 or 1 and not increased from baseline, a Mayo rectal bleeding subscore of 0, and a Mayo endoscopy subscore of 0, or 1 with no friability present on the endoscopy. Mayo stool frequency subscore was determined on the average number of stools more than normal in 24 hours, score ranged from 0 (normal number of stools) to 3 (5 or more stools more than normal),
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Guselkumab Dose 1
- DRUG Guselkumab Dose 2
- DRUG Guselkumab Dose 3
Study Locations (20)
Florida
- Gastro Florida - Clearwater
- I.H.S. Health. LLC - Kissimmee
- Columbus Clinical Services LLC - Miami
- Vista Health Research, LLC - Miami
- Orlando Health - Orlando
- Theia Clincial Research, LLC - Temple Terrace
California
- Om Research LLC - Apple Valley
- Om Research LLC - Lancaster
- Medical Associates Research Group, Inc. - San Diego
Georgia
- Digestive Healthcare of Georgia, P.C - Atlanta
- Atlanta Gastroenterology Associates - Atlanta
- Gastroenterology Associates of Central GA - Macon
Michigan
- Clinical Research Institute of Michigan, LLC - Chesterfield
- Detroit Clinical Research Center - Farmington Hills
North Carolina
- University of North Carolina - Chapel Hill
- Peters Medical Research - High Point
Arizona
- Research Solutions of Arizona - Litchfield Park
Colorado
- Peak Gastroenterology Associates - Colorado Springs
Kansas
- Cotton O'Neil Digestive Health Center - Topeka
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 418 participants |
| Start Date | 2022-09-13 |
| Est. Completion | 2028-10-06 |
| Phase | Phase 3 |
What the registry record for NCT05528510 still lists
NCT05528510 is an interventional study that assigns participants to a tested intervention. The registered 418 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 391-participant average among 28 other Colitis, Ulcerative trials with a reported enrollment target.
The record links to 1 condition, with Colitis, Ulcerative appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT05528510 names 20 study sites across 9 states, led by Florida, California, Georgia.
Frequently Asked Questions
What is clinical trial NCT05528510 about?
NCT05528510 is a clinical study titled "A Study of Guselkumab Therapy in Participants With Moderately to Severely Active Ulcerative Colitis". The purpose of this study is to evaluate the efficacy, including clinical remission of guselkumab subcutaneous (SC) induction compared to placebo in participants with moderately to severely active ulcerative colitis (UC).
What is the current status of trial NCT05528510?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 418 participants. The study started on 2022-09-13. Estimated completion is 2028-10-06.
What conditions does trial NCT05528510 study?
This clinical trial studies the following conditions: Colitis, Ulcerative.
What interventions are being tested in trial NCT05528510?
The interventions under investigation include: Placebo (OTHER), Guselkumab Dose 1 (DRUG), Guselkumab Dose 2 (DRUG), Guselkumab Dose 3 (DRUG).
Who is sponsoring clinical trial NCT05528510?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05528510 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Colitis, Ulcerative
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 NCT05528510's enrollment target sits among peer trials
418 10th of 28 higher than 19 of 28 other Colitis, Ulcerative trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Colitis, Ulcerative 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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