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NCT05242471 · ClinicalTrials.gov registry record · Phase 2
A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease
A Phase 2 study of Crohn's Disease, sponsored by Janssen Research & Development.
- Active
- Registry status
- Phase 2
- Development phase
- 703
- Enrollment target
- 20
- Study locations
NCT05242471: Active Phase 2 study of Crohn's Disease, sponsored by Janssen Research & Development.
NCT05242471 is a Phase 2 study of Crohn's Disease that is active but no longer recruiting, run by Janssen Research & Development. The registered enrollment target is 703 participants, below the 2,388-participant average among 105 other Crohn's Disease trials with a reported enrollment target (71% lower). The trial reports 20 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05242471, a Phase 2 study of Crohn's Disease, is active but no longer recruiting, sponsored by Janssen Research & Development.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 2
- Development phase
- 703 participants
- Enrollment target
- 20
- Study locations
Study Summary
The purpose of this study is to evaluate the efficacy of JNJ-78934804 at Week 48 compared to guselkumab and golimumab.
Primary Outcome
Percentage of participants with clinical remission at Week 48 will be reported. Clinical remission is based on the Crohn's Disease Activity Index (CDAI).
Conditions Studied
Interventions
- DRUG Placebo
- BIOLOGICAL Guselkumab
- BIOLOGICAL Golimumab
- BIOLOGICAL JNJ-78934804
Study Locations (20)
California
- Om Research LLC - Apple Valley
- Valley Gastroenterology Medical Group - Arcadia
- Southern California Research Center - Coronado
- Desert Gastroenterology Associates - Lancaster
- Cedars Sinai Medical Center - Los Angeles
- UCLA - Los Angeles
- Hoag Memorial Hospital - Newport Beach
- UCI Irvine Medical Center - Orange
- Medical Associates Research Group, Inc. - San Diego
- University of California San Francisco - San Francisco
Florida
- Pioneer Research Solutions Inc. - Coconut Creek
- Homestead Associates in Research Inc - Homestead
- Osceola Mental Health D/B/A Park Place Behavioral Health Care - Kissimmee
Connecticut
- Medical Research Center of Connecticut - Hamden
- Yale University School Of Medicine - New Haven
Alabama
- University of Alabama Liver Center - Birmingham
Arizona
- Del Sol Research Management, LLC - Tucson
Arkansas
- Moore Clinical Trials, LLC - Little Rock
Colorado
- University of Colorado - Aurora
District of Columbia
- MedStar Georgetown University Hospital - Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 703 participants |
| Start Date | 2022-07-22 |
| Est. Completion | 2029-11-05 |
| Phase | Phase 2 |
What the registry record for NCT05242471 still lists
NCT05242471 is an interventional study that assigns participants to a tested intervention. The registered 703 participants enrollment target is mid-sized for trials with a published cap, below the 2,388-participant average among 105 other Crohn's Disease trials with a reported enrollment target (71% lower).
The record links to 1 condition, with Crohn's Disease appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT05242471 names 20 study sites across 8 states, led by California, Florida, Connecticut.
Frequently Asked Questions
What is clinical trial NCT05242471 about?
NCT05242471 is a clinical study titled "A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Crohn's Disease". The purpose of this study is to evaluate the efficacy of JNJ-78934804 at Week 48 compared to guselkumab and golimumab.
What is the current status of trial NCT05242471?
This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 703 participants. The study started on 2022-07-22. Estimated completion is 2029-11-05.
What conditions does trial NCT05242471 study?
This clinical trial studies the following conditions: Crohn's Disease.
What interventions are being tested in trial NCT05242471?
The interventions under investigation include: Placebo (DRUG), Guselkumab (BIOLOGICAL), Golimumab (BIOLOGICAL), JNJ-78934804 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05242471?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05242471 being conducted?
This trial has 20 study locations across Alabama, Arizona, Arkansas, California, Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT05242471's enrollment target sits among peer trials
703 18th of 105 higher than 88 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.
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