NCT07577843 A Study of JNJ-78934804 in Participants With Moderately to Severely Active Crohn's Disease
| NCT ID | NCT07577843 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Janssen Research & Development, LLC |
| Condition | Crohn Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 460 participants |
| Start Date | 2026-05-22 |
| Primary Completion | 2028-06-12 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 460 participants in total. It began in 2026-05-22 with a primary completion date of 2028-06-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Crohn's disease (a long-term, progressive \[worsens with time\] and life-threatening disease of the intestine).
Eligibility Criteria
Inclusion criteria: * 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 the unweighted CDAI component of the number of liquid or very soft stools or b. Mean daily AP score \>= 2.0, based on the unweighted CDAI component of abdominal pain (AP) * 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 Exclusion criteria: * Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, ulcerative colitis (UC) or clinical findings highly suggestive of UC * Complications of CD such as symptomatic bowel strictures or stenoses, or any other manifestation that may require intestinal surgery while enrolled in the study * Presence of draining (that is, functioning) stoma or ostomy * Has a history of short bowel syndrome, is missing greater than (\>) 2 of the 5 ileocolonic segments, or has any other medical condition that could preclude or confound the ability to use efficacy assessment tools (such as CDAI) to assess response to study intervention * Currently has or is suspected of having an abscess
Contact & Investigator
Janssen Research & Development, LLC Clinical Trial
STUDY DIRECTOR
Janssen Research & Development, LLC
Frequently Asked Questions
Who can join the NCT07577843 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Crohn Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07577843 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 460 participants.
Is NCT07577843 currently recruiting?
Yes, NCT07577843 is actively recruiting participants. Contact the research team at Participate-In-This-Study1@its.jnj.com for enrollment information.
Where is the NCT07577843 trial being conducted?
This trial is being conducted at Scottsdale, United States, Sun City, United States, Anaheim, United States, Chula Vista, United States and 11 additional locations.
Who is sponsoring the NCT07577843 clinical trial?
NCT07577843 is sponsored by Janssen Research & Development, LLC. The principal investigator is Janssen Research & Development, LLC Clinical Trial at Janssen Research & Development, LLC. The trial plans to enroll 460 participants.