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

Recruiting now · Phase 3

Conditions studied: Colitis, Ulcerative

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

Key facts

Study ID

NCT07577856

Run by

Janssen Research & Development, LLC

People needed

644

Starts

2026-05-23

Expected to finish

2030-10-30

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…

• 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 qualify 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 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)
• 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)
• Southern Star Research Institute, LLC — San Antonio, Texas, United States (enrolling)
• Banksia Trials SA — Adelaide, Australia (enrolling)
• SA Gastrointestinal Services — Kurralta Park, Australia (enrolling)
• Mater Misericordiae Hospital — South Brisbane, Australia (enrolling)
• Pesquisare Saude — Santo André, Brazil (enrolling)
• BR Trials — São Paulo, Brazil (enrolling)
• South Edmonton Gastroenterology Research Clinic — Edmonton, Alberta, Canada (enrolling)
• GI Research Institute (G.I.R.I.) — Vancouver, British Columbia, Canada (enrolling)
• Viable Clinical Research — Kentville, Nova Scotia, Canada (enrolling)
• Barrie GI Associates — Barrie, Ontario, Canada (enrolling)
• Charlton Digestive Disease Centre — Hamilton, Ontario, Canada (enrolling)
• London Digestive Disease Institute — London, Ontario, Canada (enrolling)
• Toronto Immune and Digestive Health Institute Inc — Toronto, Ontario, Canada (enrolling)
• CHUM - Centre hospitalier universitaire de Montreal — Montreal, Quebec, Canada (enrolling)
• Clinnova Research — Anaheim, California, United States (enrolling)

Full record on ClinicalTrials.gov

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