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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 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.
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.
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05242484
The ClinicalTrials.gov registry entry for NCT05242484 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 577 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 385-participant average among 28 other Colitis, Ulcerative trials with a reported enrollment target (50% higher). 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.
NCT05242484 reports 20 study locations spanning 6 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.