A phase 3 randomized, double-blind, and active controlled, multi-center study to evaluate the efficacy and safety of JNJ-78934804 in participants with moderately to severely active ulcerative colitis
Moderately to Severely Active Ulcerative Colitis
Experimental: JNJ-78934804 Drug: JNJ-78934804 (guselkumab and golimumab) will be administered subcutaneously. Participants will receive JNJ-78934804 induction dose at Weeks 0, 4, and 8 followed by JNJ-78934804 maintenance dose, once every 4 weeks (q4w) starting at Week 12. All participants who meet the rescue criteria will receive JNJ-78934804 induction dose at Weeks 16, 20, and 24 followed by JNJ-78934804 maintenance dose q4w starting at Week 28. Participants who complete double-blind (DB) treatment phase (Week 48) and benefit from continued study intervention in the opinion of the investigator will have the opportunity to enter the long term extension (LTE) phase. Active Comparator: Guselkumab Drug: Guselkumab will be administered subcutaneously. Participants with moderately to severely active UC will receive guselkumab induction dose at Weeks 0, 4, and 8 followed by guselkumab maintenance dose q4w starting at Week 12. All participants who meet the rescue criteria will receive JNJ-78934804 induction dose at Weeks 16, 20, and 24 followed by JNJ-78934804 maintenance dose q4w starting at Week 28. Participants who complete DB treatment phase (Week 48) and benefit from continued study intervention in the opinion of the investigator will have the opportunity to enter the LTE phase.
1. 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. 2. 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 3. An endoscopy subscore >=2 as obtained during central review of the screening video endoscopy 4. Have had an inadequate initial response, loss of response, or intolerance to previous approved systemic therapies
1. 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 2. Diagnosis of indeterminate colitis, microscopic colitis, ischemic colitis, Crohn’s colitis or any findings suggestive of CD 3. Has a history of or ongoing chronic or recurrent infectious disease 4. Has previously demonstrated inadequate initial response, loss of response, allergy, hypersensitivity or intolerance to guselkumab or to golimumab 5. 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