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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 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.
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).
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05528510
The ClinicalTrials.gov registry entry for NCT05528510 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 418 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 391-participant average among 28 other Colitis, Ulcerative trials with a reported enrollment target. The listed sponsor is Janssen Research & Development, which has 593 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 9 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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