2026-525922-39-00RecruitingPhase 3
A Phase 3, Randomized, Double-blind, and Active‑controlled Multicenter Study to Evaluate the Efficacy and Safety of JNJ‑78934804 in Participants With Moderately to Severely Active Crohn’s Disease
Janssen Cilag International126 sites in 5 countries194 target enrollmentStarted: August 3, 2026Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Janssen Cilag International
- Enrollment
- 194
- Locations
- 126
- Primary Endpoint
- Clinical remission at Week 48 Endoscopic remission at Week 48
Study Overview
Brief Summary
To evaluate the efficacy of JNJ-4804 at Week 48 compared with guselkumab
Eligibility Criteria
- Ages
- 18 years to 65+ years (65+ Years, 18-64 Years)
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •At the time of informed consent, must be ≥18 years of age
- •Have a diagnosis of CD established ≥12 weeks by both endoscopic evidence and a histopathology report.
- •Have moderately to severely active CD defined as a baseline CDAI score ≥220 but ≤450 in addition to a mean daily stool frequency count ≥4.0 or a mean daily abdominal pain score ≥2.0
- •Have a screening Simple Endoscopic Score for Crohn's Disease (SES-CD) ≥6 (or ≥4 for participants with isolated ileal disease).
- •Have an inadequate initial response, loss of response, or intolerance to previously approved systemic therapies
Exclusion Criteria
- •Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, UC or clinical findings highly suggestive of UC.
- •Has a history of short bowel syndrome, is missing >2 of the 5 ileocolonic segments, or has any other medical condition that could preclude or confound the ability to assess efficacy.
- •Has previously demonstrated inadequate initial response, loss of response, allergy, hypersensitivity or intolerance to guselkumab or to golimumab.
- •Is a participant who is pregnant, or breastfeeding, or planning to become pregnant, or plans to father a child, while enrolled in this study or within 6 months after the last dose of study intervention.
Arms & Interventions
Guselkumab
Comparator
Intervention: Guselkumab (Drug)
JNJ-78934804
Test
Intervention: JNJ-78934804 (Drug)
Outcomes
Primary Outcomes
Clinical remission at Week 48 Endoscopic remission at Week 48
Clinical remission at Week 48 Endoscopic remission at Week 48
Secondary Outcomes
No secondary outcomes reported
Investigators
CTIS Point of Contact
Scientific
Janssen Cilag International
Study Sites (126)
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