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Trial intelligence / Profile preview
NL-OMON58751Phase 2
Key facts
Phase 2, randomised, double-blind trial in autoimmune colitis comparing Rosnilimab with Placebo (2 arms). Primary endpoint: Mean change from baseline in modified Mayo score. Started Sep 2024; status: completed.
Rosnilimab
Participants received rosnilimab.
Placebo
Participants received placebo comparator.
Adults with ulcerative colitis diagnosed for more than 90 days and moderate to severe active disease were eligible if they had prior inadequate response, loss of response, or intolerance to at least 2 ulcerative colitis therapy classes. Patients with Crohn's disease or other excluded colitides, rectum-limited disease, prior major bowel surgery, recent intestinal infection, GI dysplasia, prior PD-1/PD-L1 pathway therapy, or excessive prior advanced therapy exposure were excluded.
Mean change from baseline in modified Mayo score
Clinical remission rate
Endoscopic improvement rate
Clinical response rate
Beyond the preview
Full results, competitive context and analysis are in the Gosset platform.
Available in the Gosset platform where reported.
Available in the Gosset platform where reported.
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