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
Location: See all (26) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Participants with histologically confirmed diagnosis of microscopic colitis (including all histological sub-types).
• Receiving budesonide therapy.
• Documented clinical remission from 2 weeks before screening.
• At least 1 microscopic colitis relapse in the last 8 months prior to screening that required treatment with budesonide.
• Body mass index within the range 18 to 35 kg/m2 (inclusive) at screening visit.
• All contraceptive methods used by participants should be consistent with local regulations regarding the methods of contraception.
Locations
Other Locations
Belgium
Investigational Site Number : 0560002
RECRUITING
Ghent
Investigational Site Number : 0560001
RECRUITING
Leuven
Denmark
Investigational Site Number : 2080003
RECRUITING
Aarhus
Investigational Site Number : 2080002
RECRUITING
Hvidovre
France
Investigational Site Number : 2500001
RECRUITING
Créteil
Investigational Site Number : 2500002
RECRUITING
Montfermeil
Investigational Site Number : 2500003
RECRUITING
Pessac
Germany
Investigational Site Number : 2760001
RECRUITING
Frankfurt
Investigational Site Number : 2760005
RECRUITING
Ludwigshafen
Investigational Site Number : 2760002
RECRUITING
Potsdam
Investigational Site Number : 2760003
RECRUITING
Tübingen
Investigational Site Number : 2760004
RECRUITING
Ulm
Hungary
Investigational Site Number : 3480002
RECRUITING
Budapest
Investigational Site Number : 3480003
RECRUITING
Székesfehérvár
Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico, Investigational Site Number : 380004
RECRUITING
Milan
Azienda Ospedale Università Padova, Investigational Site Number : 380001
RECRUITING
Padua
Fondazione Policlinico Gemelli IRCCS Roma, Investigational Site Number : 380003
RECRUITING
Rome
A.O.U. Città della Salute e della Scienza di Torino, Presidio Molinette, S.C. Gastroenterologia U., Investigational Site Number : 380002
RECRUITING
Turin
Poland
Investigational Site Number : 6160004
RECRUITING
Bydgoszcz
Investigational Site Number : 6160002
RECRUITING
Warsaw
Investigational Site Number : 6160003
RECRUITING
Warsaw
Sweden
Investigational Site Number : 7520001
RECRUITING
Linköping
Investigational Site Number : 7520002
RECRUITING
Stockholm
Investigational Site Number : 7520003
RECRUITING
Stockholm
United Kingdom
Investigational Site Number : 8260002
RECRUITING
Cambridge
Investigational Site Number : 8260001
RECRUITING
Oxford
Contact Information
Primary
Trial Transparency email recommended (Toll free for US & Canada)
contact-us@sanofi.com
800-633-1610
Time Frame
Start Date:2025-10-14
Estimated Completion Date:2027-05-06
Participants
Target number of participants:54
Treatments
Experimental: SAR444336
Each participant will receive several injections of SAR444336. Budesonide will be taken at the dose administered by the physician.
Placebo_comparator: Placebo
Each participant will receive several injections of placebo. Budesonide will be taken at the dose administered by the physician.