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NCT07577856 · ClinicalTrials.gov registry record · Phase 3
A Study of JNJ-78934804 in Participants With Moderately to Severely Active Ulcerative Colitis
A Phase 3 study, sponsored by Janssen Research & Development.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 644
- Enrollment target
NCT07577856: Recruiting Phase 3 study, sponsored by Janssen Research & Development.
NCT07577856 is a Phase 3 study that is actively recruiting participants, run by Janssen Research & Development. The registered enrollment target is 644 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07577856, a Phase 3 study, is actively recruiting participants, sponsored by Janssen Research & Development.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 644 participants
- Enrollment target
Study Summary
The purpose of this study is to assess how well JNJ-78934804 works (efficacy) and how safe it is (safety) as compared to guselkumab at Week 48 in participants with moderately to severely active ulcerative colitis (UC, a chronic disease of the large intestine in which the lining of the colon becomes inflamed and develops ulcers).
Primary Outcome
Clinical remission is defined as an stool frequency (SF) subscore of 0 or 1, rectal bleeding (RB) subscore of 0, and an endoscopy subscore of 0 or 1.
Interventions
- DRUG Guselkumab
- DRUG JNJ-78934804
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 644 participants |
| Start Date | 2026-05-23 |
| Est. Completion | 2030-10-30 |
| Phase | Phase 3 |
What NCT07577856 shows while recruiting
NCT07577856 is an interventional study that assigns participants to a tested intervention. The registered 644 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (17% lower).
The record links to 0 conditions, and to 2 interventions - of which Guselkumab is the first listed.
NCT07577856 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT07577856 about?
NCT07577856 is a clinical study titled "A Study of JNJ-78934804 in Participants With Moderately to Severely Active Ulcerative Colitis". The purpose of this study is to assess how well JNJ-78934804 works (efficacy) and how safe it is (safety) as compared to guselkumab at Week 48 in participants with moderately to severely active ulcerative colitis (UC, a chronic disease of the large intestine in which the lining of the colon becomes ...
What is the current status of trial NCT07577856?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 644 participants. The study started on 2026-05-23. Estimated completion is 2030-10-30.
What interventions are being tested in trial NCT07577856?
The interventions under investigation include: Guselkumab (DRUG), JNJ-78934804 (DRUG).
Who is sponsoring clinical trial NCT07577856?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT07577856's enrollment target sits among peer trials
644 572nd of 2000 higher than 1,428 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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