A Study to Investigate the Efficacy and Safety of SAR444336 in Adults With Microscopic Colitis in Clinical Remission
Condition(s) studied
Investigational drug(s) / intervention(s)
SAR444336: Pharmaceutical form:Solution for injection -Route of administration:Subcutaneous
Placebo: Pharmaceutical form:Solution for injection -Route of administration:Subcutaneous
Study 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.
Eligibility
Primary outcome measure(s)
- Proportion of participants with sustained steroid-free clinical remission — up to week 24
Clinical remission defined as no relapse during the 24-week period.
Trial sites (24)
| Facility | City | Region | Status |
|---|---|---|---|
| Investigational Site Number : 0560001 | Leuven | Belgium | Recruiting |
| Investigational Site Number : 2080003 | Aarhus | Denmark | Recruiting |
| Investigational Site Number : 2080002 | Hvidovre | Denmark | Recruiting |
| Investigational Site Number : 2500001 | Créteil | France | Recruiting |
| Investigational Site Number : 2500002 | Montfermeil | France | Recruiting |
| Investigational Site Number : 2500003 | Pessac | France | Recruiting |
| Investigational Site Number : 2760001 | Frankfurt | Germany | Recruiting |
| Investigational Site Number : 2760005 | Ludwigshafen | Germany | Recruiting |
| Investigational Site Number : 2760003 | Tübingen | Germany | Recruiting |
| Investigational Site Number : 2760004 | Ulm | Germany | Recruiting |
| Investigational Site Number : 3480002 | Budapest | Hungary | Recruiting |
| Investigational Site Number : 3480003 | Székesfehérvár | Hungary | Recruiting |
| Investigational Site Number : 3800004 | Milan | Milano | Recruiting |
| Investigational Site Number : 3800001 | Padua | Padova | Recruiting |
| Investigational Site Number : 3800003 | Rome | Roma | Recruiting |
| Investigational Site Number : 3800002 | Turin | Torino | Recruiting |
| Investigational Site Number : 6160004 | Bydgoszcz | Kuyavian-Pomeranian Voivodeship | Recruiting |
| Investigational Site Number : 6160003 | Warsaw | Masovian Voivodeship | Recruiting |
| Investigational Site Number : 6160002 | Warsaw | Masovian Voivodeship | Recruiting |
| Investigational Site Number : 7520001 | Linköping | Sweden | Recruiting |
| Investigational Site Number : 7520002 | Stockholm | Sweden | Recruiting |
| Investigational Site Number : 7520003 | Stockholm | Sweden | Recruiting |
| Investigational Site Number : 8260002 | Cambridge | Cambridgeshire | Recruiting |
| Investigational Site Number : 8260001 | Oxford | Oxfordshire | Recruiting |
More Sanofi trials in Italy
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07156175 on ClinicalTrials.gov ↗ ← All trials in Italy