- A Study of JNJ-78934804 in Participants With Moderately to Severely Active Ulcerative Colitis — Recruiting • Phase III • Rheumatology • NCT07577856.
- What is being tested: JNJ-78934804, a novel therapeutic agent, is being evaluated for efficacy and safety in treating moderately to severely active ulcerative colitis, with direct comparison against guselkumab as the active comparator at Week 48.
- Patient eligibility overview: The trial enrolls adults with moderately to severely active ulcerative colitis; specific eligibility criteria (disease duration, prior treatment exposure, comorbidities) would be detailed in the full protocol but typically exclude those with severe complications or contraindications to immunological therapies.
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
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
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.