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).
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
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
Parallel
JNJ-78934804
DrugJNJ-78934804 will be administered subcutaneously.
Guselkumab
DrugGuselkumab will be administered subcutaneously.
Percentage of Participants in Clinical Remission at Week 48
Clinical remission is defined as an stool frequency (SF) subscore of 0 or 1, rectal bleeding (RB) subscore of 0, and an endoscopy subscore of 0 or 1.
Percentage of Participants with Endoscopic Improvement at Week 48
Endoscopic improvement is defined as an endoscopy subscore of 0 or 1.
Percentage of Participants with Corticosteroid-free (90 day) Clinical Remission at Week 48
Corticosteroid-free (90 day) clinical remission is defined as clinical remission at the visit and not receiving corticosteroids for 90 days prior to the visit.
Percentage of Participants Achieving a Combination of Histologic Remission and Endoscopic Improvement at Week 48
Endoscopic improvement is defined as an endoscopy subscore of 0 or 1. Histologic remission is defined as an absence of neutrophils from the mucosa (both lamina propria and epithelium), no crypt destruction, and no erosions, ulcerations or granulation tissue according to the Geboes grading system.
Percentage of Participants with Fatigue Response (PROMIS Fatigue Short Form 7a) at Week 48
Fatigue response is defined as a greater than or equal to (\>=) 7- point reduction in the patient-reported outcomes measurement information system (PROMIS) fatigue short form 7a total score from baseline. The PROMIS fatigue SF-7a contains 7 items evaluating fatigue-related symptoms (that is, tiredness, exhaustion, mental tiredness, and lack of energy) and associated impacts on daily activities (that is, activity limitations related to work, self-care, and exercise).
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