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Study identifier: NCT06637631 Synced from ClinicalTrials.gov · August 06, 2026
● Study status: Recruiting

A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Crohn's Disease.

Condition: Crohn's Disease  ·  Sponsor: Sanofi

PhasePhase 2
Planned participants260
Who can joinAll sexes, 18 Years to 75 Years
Healthy volunteersNo

About this study

This is a phase 2, multinational, multicenter, randomized, double-blind, placebo-controlled, dose ranging study to evaluate the efficacy and safety of SAR441566 in adults with moderate to severe Crohn's Disease (CD). The primary objective of this study is to assess the efficacy of different doses of SAR441566 compared with placebo in participants with moderate to severe CD. This study will have an anticipated duration of up to 59 weeks which will include a screening period of 4 weeks (+7 calendar days if needed), followed by the Main Study (MS) treatment period, lasting 52 weeks, and a 2-week follow-up period after end of treatment for participants not enrolling in the Long Term Safety (LTS) study. The MS period includes a Double-Blind (DB) treatment period with 12 weeks of induction followed by 40 weeks of maintenance. Additionally, an Open Label (OL) period of up to 40 weeks will be offered to eligible participants. The combined duration of the DB maintenance and OL periods cannot exceed 40 weeks, depending on when participants switch.

This description comes directly from the study's public registry record.

Talk to the study team

Trial Transparency email recommended (Toll free for US & Canada)  ·  800-633-1610  ·  contact-us@sanofi.com

Always discuss trial participation with your own doctor first.

Locations (139)

GI Alliance - Arizona Digestive Health - Sun City- Site Number : 8400020Sun City, Arizona, United StatesRecruiting
Bristol Hospital- Site Number : 8400007Bristol, Connecticut, United StatesRecruiting
Novum Research- Site Number : 8400021Clermont, Florida, United StatesRecruiting
Homestead Associates in Research- Site Number : 8400012Homestead, Florida, United StatesRecruiting
Clinical Research of Osceola- Site Number : 8400013Kissimmee, Florida, United StatesRecruiting
Wellness Clinical Research - Miami Lakes - 8181 Northwest 154th Street- Site Number : 8400010Miami Lakes, Florida, United StatesRecruiting
GCP Clinical Research- Site Number : 8400004Tampa, Florida, United StatesRecruiting
GI Alliance - Glenview- Site Number : 8400015Glenview, Illinois, United StatesRecruiting
Illinois Gastroenterology Group- Site Number : 8400011Gurnee, Illinois, United StatesRecruiting
University of Michigan Health System - Ann Arbor- Site Number : 8400017Ann Arbor, Michigan, United StatesRecruiting
Gi Alliance - Flowood- Site Number : 8400019Flowood, Mississippi, United StatesRecruiting
Vector Clinical Trials- Site Number : 8400001Las Vegas, Nevada, United StatesRecruiting

+ 127 more locations — full list on the registry record.

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