Overview
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).
Eligibility
Inclusion criteria:
- 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
Exclusion criteria:
- 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
