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NCT05242484 · ClinicalTrials.gov registry record · Phase 2
A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis
A Phase 2 study of Colitis, Ulcerative, sponsored by Janssen Research & Development.
- Active
- Registry status
- Phase 2
- Development phase
- 577
- Enrollment target
- 20
- Study locations
NCT05242484: Active Phase 2 study of Colitis, Ulcerative, sponsored by Janssen Research & Development.
NCT05242484 is a Phase 2 study of Colitis, Ulcerative that is active but no longer recruiting, run by Janssen Research & Development. The registered enrollment target is 577 participants, above the 385-participant average among 28 other Colitis, Ulcerative trials with a reported enrollment target (50% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05242484, a Phase 2 study of Colitis, Ulcerative, is active but no longer recruiting, sponsored by Janssen Research & Development.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 577 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the efficacy and safety of JNJ-78934804 as compared to guselkumab and golimumab in participants with moderately to severely active ulcerative colitis who have had an inadequate initial response, loss of response, or intolerance to one or more approved advanced therapy.
Primary Outcome
Percentage of participants with clinical remission at Week 48 will be reported. Clinical remission based on the modified Mayo subscores.
Conditions Studied
Interventions
- DRUG Placebo
- BIOLOGICAL Guselkumab
- BIOLOGICAL Golimumab
- BIOLOGICAL JNJ-78934804
Study Locations (20)
Florida
- Pioneer Research Solutions Inc. - Coconut Creek
- Digestive and Liver Disease Institute - Kissimmee
- Osceola Regional Hospital - Kissimmee
- Florida Research Center Inc. - Lakewood Rch
- University of Miami - Miami
- Gastroenterology Group Of Naples - Naples
- Omega Research Consultants - Orlando
- Synergy Clinical Research - St. Petersburg
- GCP Clinical Research - Tampa
California
- Valley Gastroenterology Medical Group - Arcadia
- Southern California Research Center - Coronado
- Om Research LLC - Lancaster
- Cedars Sinai Medical Center - Los Angeles
- University of California San Francisco - San Francisco
Colorado
- University of Colorado - Aurora
- Peak Gastroenterology Associates - Colorado Springs
Connecticut
- Medical Research Center of Connecticut - Hamden
- Yale University - New Haven
District of Columbia
- MedStar Georgetown University Hospital - Washington D.C.
Georgia
- Atlanta Gastroenterology Associates - Atlanta
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 577 participants |
| Start Date | 2022-09-19 |
| Est. Completion | 2029-03-27 |
| Phase | Phase 2 |
What the registry record for NCT05242484 still lists
NCT05242484 is an interventional study that assigns participants to a tested intervention. The registered 577 participants enrollment target is mid-sized for trials with a published cap, above the 385-participant average among 28 other Colitis, Ulcerative trials with a reported enrollment target (50% higher).
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.
NCT05242484 names 20 study sites across 6 states, led by Florida, California, Colorado.
Frequently Asked Questions
What is clinical trial NCT05242484 about?
NCT05242484 is a clinical study titled "A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis". The purpose of this study is to evaluate the efficacy and safety of JNJ-78934804 as compared to guselkumab and golimumab in participants with moderately to severely active ulcerative colitis who have had an inadequate initial response, loss of response, or intolerance to one or more approved advance...
What is the current status of trial NCT05242484?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 577 participants. The study started on 2022-09-19. Estimated completion is 2029-03-27.
What conditions does trial NCT05242484 study?
This clinical trial studies the following conditions: Colitis, Ulcerative.
What interventions are being tested in trial NCT05242484?
The interventions under investigation include: Placebo (DRUG), Guselkumab (BIOLOGICAL), Golimumab (BIOLOGICAL), JNJ-78934804 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05242484?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05242484 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, District of Columbia, Florida. 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 NCT05242484's enrollment target sits among peer trials
577 9th of 28 higher than 20 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.
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