A Study of JNJ-78934804 in Participants With Moderately to Severely Active Ulcerative Colitis

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 ulcerative colitis (UC, a chronic disease of the large intestine in which the lining of the colon becomes inflamed and develops ulcers).

Who can join (things the study team will check)

✅ You may be able to join if…

• Diagnosis of ulcerative colitis (UC) established at least 12 weeks before screening including both endoscopic evidence and a histopathology report consistent with a diagnosis of UC.
• Moderately to severely active UC defined as baseline (Week 0) modified Mayo score of 5 to 9, inclusive, using the Mayo endoscopy subscore obtained during central review of the screening video endoscopy
• An endoscopy subscore >=2 as obtained during central review of the screening video endoscopy
• Have had an inadequate initial response, loss of response, or intolerance to previous approved systemic therapies

🚫 You may not be able to join if…

• Isolated proctitis (UC limited to the rectum only or to less than [<] 20 centimeter [cm] from the anal verge) as determined during central review of the screening video endoscopy OR Has a diagnosis of isolated proctitis
• Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, Crohn's colitis or any findings suggestive of CD
• Has a history of or ongoing chronic or recurrent infectious disease
• Has previously demonstrated inadequate initial response, loss of response, allergy, hypersensitivity or intolerance to guselkumab or to golimumab
• Is a participant who is pregnant, 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

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
• Southern Star Research Institute, LLC, San Antonio, Texas, United States
• SA Gastrointestinal Services, Kurralta Park, Australia
• GI Research Institute (G.I.R.I.), Vancouver, British Columbia, Canada
• London Digestive Disease Institute, London, Ontario, Canada
• Rambam Medical Center, Haifa, Israel
• Bnai Zion Medical Center, Haifa, Israel

+ 14 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: NCT07577856.