Trials / Recruiting
RecruitingNCT07156175
A Study to Investigate the Efficacy and Safety of SAR444336 in Adults With Microscopic Colitis in Clinical Remission
A Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Assess the Efficacy, Safety, and Tolerability of SAR444336 in Participants With Microscopic Colitis in Clinical Remission With Budesonide
- Status
- Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 54 (estimated)
- Sponsor
- Sanofi · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a parallel, placebo-controlled, multicenter, randomized, double-blind, Phase 2, proof of concept study. The study aims to evaluate the efficacy and safety of SAR444336 in adult participants with microscopic colitis. Participants are required to have a histologically confirmed diagnosis of microscopic colitis, be in clinical remission and be receiving budesonide therapy. The overall study duration is approximately 32 weeks.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | SAR444336 | Pharmaceutical form:Solution for injection -Route of administration:Subcutaneous |
| DRUG | Placebo | Pharmaceutical form:Solution for injection -Route of administration:Subcutaneous |
Timeline
- Start date
- 2025-10-14
- Primary completion
- 2027-04-08
- Completion
- 2027-05-06
- First posted
- 2025-09-05
- Last updated
- 2026-02-24
Locations
26 sites across 9 countries: Belgium, Denmark, France, Germany, Hungary, Italy, Poland, Sweden, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07156175. Inclusion in this directory is not an endorsement.