Study of OSE-127 vs Placebo in Patients With Moderate to Severe Active Ulcerative Colitis
NCT04882007 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 136
Last updated 2025-06-22
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
Interventions
- DRUG
-
OSE-127
mAb antagonist to CD127 receptor (or IL-7Rα)
- DRUG
-
Normal saline
Sponsors & Collaborators
-
OSE Immunotherapeutics
lead INDUSTRY
Principal Investigators
-
Silvia Comis, MD · OSE Immunotherapeutics
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2020-10-02
- Primary Completion
- 2024-04-30
- Completion
- 2025-01-28
Countries
- Belarus
- Belgium
- Bulgaria
- Croatia
- Georgia
- Hungary
- Latvia
- Poland
- Russia
- South Africa
- Ukraine
Study Locations
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