Study of OSE-127 vs Placebo in Patients With Moderate to Severe Active Ulcerative Colitis

Summary

This is a phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group study in patients with moderate to severe active ulcerative colitis.

Timeline

Start

2020-10-02

Primary completion

2024-04-30

Completion

2025-01-28

Outcome

Met primary endpoint

registry analysis (superiority test); Lusvertikimab 850 mg vs Placebo; p = 0.036; Least Square Mean Difference -0.90 (95% CI -1.73 to -0.06); ANCOVA NCT04882007 ↗

registry analysis (superiority test); Lusvertikimab 450 mg vs Placebo; p = 0.019; Least Square Mean Difference -1.16 (95% CI -2.12 to -0.19); ANCOVA NCT04882007 ↗

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	LUSVERTIKIMAB	Monoclonal antibody	—	Intravenous

Indications