Clinical Trial

A Real-World Study of Guselkumab in Chinese Participants With Ulcerative Colitis

Study acronym: GENIUS
Recruiting
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Summary
The purpose of this study is to assess the measurable changes in health, function, or quality of life (clinical outcomes) after receiving guselkumab in real-world clinical practice amongst Chinese participants with ulcerative colitis (UC; a long-term disease of the large intestine in which the lining of the colon \[part of large intestine\] becomes inflamed and develops tiny open ulcers), who have not received biologic therapy (a medicine made from living organisms or their components) previously.
Protocol Amendment History 1 change
notable Trial sites expanded: 1 -> 9 locations 2026-05-09
Trial Details
NCT Number NCT07302360
Lead Sponsor Xian-Janssen Pharmaceutical Ltd.
Conditions Colitis, Ulcerative
Enrollment 200 participants
Start Date 2025-12-11
Primary Completion 2028-06-30 (estimated)
Study Completion 2028-06-30 (estimated)
Updated on ClinicalTrials.gov 2026-07-31