A Study of JNJ-78934804 in Participants With Moderately to Severely Active Ulcerative Colitis

In plain English

What this trial is testing

This study is testing JNJ-78934804 (a drug) and Guselkumab (a drug) as a possible treatment. Condition(s) listed: Colitis, Ulcerative.

Participants are assigned to groups by chance (randomized).

It is blinded: participants and the study team do not know who receives what.

Phase 3 studies are large studies comparing a treatment with placebo or standard care. They are often the last step before a company asks regulators for approval.

Who can join

• Ages 18 and older
• Any sex

Some of the main requirements, copied from the record:

• Diagnosis of ulcerative colitis (UC) established at least 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of UC.
• Moderately to severely active UC defined as baseline (Week 0) modified Mayo score of 5 to 9, inclusive, using the Mayo endoscopy subscore obtained during central review of the screening video endoscopy
• An endoscopy subscore >=2 as obtained during central review of the screening video endoscopy
• Have had an inadequate initial response, loss of response, or intolerance to previous approved systemic therapies

There are also 5 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.

What's involved

• About 644 participants are expected to take part.
• The study has 2 groups.
• Start date: 2026-05-23.
• Main results expected around 2028-08-11 (estimate from the record).
• 279 study sites listed (279 marked recruiting) in Argentina, Australia, Austria, Belgium and Brazil and 27 more countries.

Groups in this study

• JNJ-78934804 (listed as: experimental group)
• Guselkumab (listed as: active comparator group)

Main thing being measured

• Percentage of Participants in Clinical Remission at Week 48 (At Week 48)

In the researchers’ words

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).

This summary was written automatically from the official record using fixed templates (no AI), so it only says what the record says, and may leave things out.