A Study of JNJ-78934804 in Participants With Moderately to Severely Active Crohn's Disease

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: Crohn Disease.

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:

• Have a diagnosis of Crohn's disease (CD) or fistulizing CD established greater than or equal to (>=) 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of CD
• Have moderately to severely active CD based on crohn's disease activity index (CDAI) criteria defined as a baseline CDAI score >= 220 but less than or equal to (<=) 450 and either: a. Mean daily stool frequency (SF) count >= 4.0, based on…
• Have moderately to severely active ileal and/or colonic CD as assessed by central review of the screening video ileocolonoscopy based on simple endoscopic score for crohn's disease (SES-CD) criteria
• Have had an inadequate initial response, loss of response, or intolerance to previously 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 460 participants are expected to take part.
• The study has 2 groups.
• Start date: 2026-05-22.
• Main results expected around 2028-06-12 (estimate from the record).
• 252 study sites listed (252 marked recruiting) in Argentina, Australia, Austria, Belgium and Brazil and 25 more countries.

Groups in this study

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

Main thing being measured

• Co-Primary: Percentage of Participants with Clinical Remission at Week 48 (At Week 48)
• Co-Primary: Percentage of Participants with Endoscopic 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 Crohn's disease (a long-term, progressive \[worsens with time\] and life-threatening disease of the intestine).

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.