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

No results posted yet for this study

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

Placebo

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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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04882007 on ClinicalTrials.gov