Cure8 trial brief
This registered Phase 2 trial tests guselkumab, golimumab, and a new investigational agent (JNJ-78934804) in adults with moderate–severe ulcerative colitis who previously failed advanced therapies. Results could affect future treatment options for patients who have lost response or are intolerant to current biologics.
Adults with moderately to severely active ulcerative colitis (particularly those with prior biologic or advanced therapy failure), gastroenterologists, and IBD researchers.
This ClinicalTrials.gov record describes a Phase 2 interventional study testing combination and comparative regimens in moderately to severely active ulcerative colitis.
The trial compares subcutaneous guselkumab and golimumab, an investigational agent (JNJ-78934804) at two doses, and placebo, with planned escalation for inadequate responders and an option to enter a long-term extension after Week 44. The primary registered outcome is percentage of participants achieving clinical remission at Week 48 per modified Mayo score.
Planned enrollment is about 577 adults (ages 18–65) who have had an inadequate response, loss of response, or intolerance to at least one prior biologic or novel advanced therapy. The study is listed as Phase 2 and ACTIVE_NOT_RECRUITING. This record is a trial registry entry (not a result report).
It describes study design, interventions, eligibility, and outcomes as registered by the sponsor; it does not present trial results or efficacy/safety findings.
Registry entries describe planned design and endpoints but do not provide outcome data. Wait for published results or sponsor reports before drawing conclusions about effectiveness or safety.
Review the original publication for the complete reporting, methods, and context.
This Cure8 brief is based on source text from the linked article. Cure8 is informational only and is not a substitute for professional medical advice, diagnosis, or treatment.
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