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

What this study is about

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).

Who can join (things the study team will check)

✅ You may be able to join 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 be able to join 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 this trial is running

• Clinnova Research, Anaheim, California, United States
• Gastro SB Clinic, Chula Vista, California, United States
• Peak Gastroenterology Associates, Colorado Springs, Colorado, United States
• Sanchez Clinical Research, Inc, Miami, Florida, United States
• GCP Clinical Research, Tampa, Florida, United States
• New York Gastroenterology Associates, New York, New York, United States
• IBD SA, Kurralta Park, Australia
• GI Research Institute (G.I.R.I.), Vancouver, British Columbia, Canada
• London Digestive Disease Institute, London, Ontario, Canada
• Bnai Zion Medical Center, Haifa, Israel
• Rambam Medical Center, Haifa, Israel
• Meir Medical Center, Kfar Saba, Israel

+ 10 more sites.

Who to contact

Study Contact · 844-434-4210 · Participate-In-This-Study1@its.jnj.com

It's completely normal to call and ask questions before deciding anything. Mention the study ID: NCT07577843.