Trial intelligence / Profile preview

Rosnilimab in moderate to severe ulcerative colitis

NL-OMON58751Phase 2

Key facts

Status
Completed
Start
Sep 2024
Countries
1
Modality
Monoclonal Antibodies → Antibody-Based Therapeutics, Recombinant Proteins and Enzymes
Conditions
autoimmune colitis
01

Overview

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.

02

Design

2 arms
Study design
RandomizedDouble-blind
  • Rosnilimab

    Participants received rosnilimab.

  • Placebo

    Participants received placebo comparator.

03

Who it enrols

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.

04

Endpoints

Primary

  • Mean change from baseline in modified Mayo score

Secondary

  • Clinical remission rate

  • Endoscopic improvement rate

  • Clinical response rate

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