NCT04882007

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

Randomized, Double-blind, Phase 2 Study to Evaluate the Efficacy and the Safety of OSE-127 Versus Placebo in Subjects With Moderate to Severe Active Ulcerative Colitis Who Have Failed or Are Intolerant to Previous Treatment(s)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 136 (actual)
• Sponsor: OSE Immunotherapeutics · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

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

Conditions

• Ulcerative Colitis

Interventions

Type	Name	Description
DRUG	OSE-127	mAb antagonist to CD127 receptor (or IL-7Rα)
DRUG	Placebo	Normal saline

Timeline

• Start date: 2020-10-02
• Primary completion: 2024-04-30
• Completion: 2025-01-28
• First posted: 2021-05-11
• Last updated: 2025-06-22

Locations

55 sites across 11 countries: Belarus, Belgium, Bulgaria, Croatia, Georgia, Hungary, Latvia, Poland, Russia, South Africa, Ukraine