CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 136 enrolled / 136 target
Drug / intervention
OSE-127 +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04882007
NCT04882007Phase 2CompletedMonitor (2.0/mo)Completion was 26mo ago
CompareCT.gov

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)

OSE Immunotherapeutics·interventional·Posted May 11, 2021·Updated Jun 23, 2026

In Brief

A Phase 2 clinical trial evaluating OSE-127 and Placebo for Ulcerative Colitis. Completed, enrolled 136 participants across 55 sites in 11 countries.

Signals

Enrolling slower than its timeline implies

Detailed Summary

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

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUlcerative Colitis
CountriesBelarus, Belgium, Bulgaria, Croatia, Georgia, Hungary, Latvia, Poland, Russia, South Africa, Ukraine
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedMay 11, 2021
Enrollment StartOct 2, 2020
Primary CompletionApr 30, 2024
Study CompletionJan 28, 2025
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 5.1 years ago

Arms & Interventions

OSE-127 High dose induction phaseexperimental

OSE-127 mAb antagonist to CD127 receptor (or IL-7Rα) intravenous infusion 3 total infusions, weeks 0, 2, and 6

Drug: OSE-127
OSE-127 Low dose induction phaseexperimental

OSE-127 mAb antagonist to CD127 receptor (or IL-7Rα) intravenous infusion 3 total infusions, weeks 0, 2, and 6

Drug: OSE-127
Placebo induction phaseplacebo_comparator

Normal saline intravenous infusion 3 total infusions, weeks 0, 2, and 6

Drug: Placebo
OSE-127 High dose optional extension phaseexperimental

OSE-127 mAb antagonist to CD127 receptor (or IL-7Rα) intravenous infusion 7 total infusions, weeks 10, 14, 18, 22, 26, 30, and 34

Drug: OSE-127

Interventions

OSE-127drug

mAb antagonist to CD127 receptor (or IL-7Rα)

Placebodrug

Normal saline