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

Recruiting now · Phase 3

Conditions studied: Crohn Disease

In brief

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).

Key facts

Study ID

NCT07577843

Run by

Janssen Research & Development, LLC

People needed

460

Starts

2026-05-22

Expected to finish

2030-07-12

Last updated by the study team

2026-07-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Gastro SB Clinic — Chula Vista, California, United States (enrolling)
• Medical Associates Research Group, Inc. — San Diego, California, United States (enrolling)
• Peak Gastroenterology Associates — Colorado Springs, Colorado, United States (enrolling)
• Sanchez Clinical Research, Inc — Miami, Florida, United States (enrolling)
• GCP Clinical Research — Tampa, Florida, United States (enrolling)
• Atlanta Gastroenterology Specialists — Suwanee, Georgia, United States (enrolling)
• Tri-State Gastroenterology Assoc — Crestview Hills, Kentucky, United States (enrolling)
• Michigan Center of Medical Research — Farmington Hills, Michigan, United States (enrolling)
• New York Gastroenterology Associates — New York, New York, United States (enrolling)
• Great Lakes Gastroenterology Research, LLC — Mentor, Ohio, United States (enrolling)
• Digestive Disease Specialists Inc — Oklahoma City, Oklahoma, United States (enrolling)
• Banksia Trials SA — Adelaide, Australia (enrolling)
• IBD SA — Kurralta Park, Australia (enrolling)
• Mater Misericordiae Hospital — South Brisbane, Australia (enrolling)
• BR Trials — São Paulo, Brazil (enrolling)
• GI Research Institute (G.I.R.I.) — Vancouver, British Columbia, Canada (enrolling)
• Viable Clinical Research — Kentville, Nova Scotia, Canada (enrolling)
• London Digestive Disease Institute — London, Ontario, Canada (enrolling)
• West GTA Research Inc — Mississauga, Ontario, Canada (enrolling)
• Toronto Immune and Digestive Health Institute Inc — Toronto, Ontario, Canada (enrolling)
• CHUM - Centre hospitalier universitaire de Montreal — Montreal, Quebec, Canada (enrolling)
• Assuta Medical center — Ashdod, Israel (enrolling)
• Bnai Zion Medical Center — Haifa, Israel (enrolling)
• Rambam Medical Center — Haifa, Israel (enrolling)
• Clinnova Research — Anaheim, California, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.