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A Study to Investigate Efficacy and Safety of SAR442970 in Patients With Crohn's Disease
Sponsor: Sanofi
Summary
This is a phase 2b, randomized, double-blind, 3-arm study for the treatment of Crohn's disease. The primary objective of this study is to assess the efficacy of different doses of SAR442970 compared with placebo in participants with moderate to severe Crohn's disease. The total study duration is up to 168 weeks, with a treatment period of up to 158 weeks including an open-label (OL) long-term extension (LTE) period of up to 104 weeks for eligible participants.
Official title: A Phase 2, Multicenter, Randomized, Double-blind, Placebo Controlled, Dose-ranging Study to Evaluate the Efficacy and Safety of SAR442970 in Adults With Moderate to Severe Crohn's Disease
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
99
Start Date
2025-06-03
Completion Date
2029-10-17
Last Updated
2026-03-27
Healthy Volunteers
No
Conditions
Interventions
SAR442970
Route of Administration: Subcutaneous
Placebo
Route of Administration: Subcutaneous
Locations (66)
Investigational Site Number: 8400024
Tucson, Arizona, United States
Investigational Site Number: 8400005
Escondido, California, United States
Investigational Site Number: 8400001
Lancaster, California, United States
Investigational Site Number: 8400017
Kissimmee, Florida, United States
Investigational Site Number: 8400015
Lighthouse PT, Florida, United States
Investigational Site Number 8400028
Miami, Florida, United States
Investigational Site Number: 8400012
Miami, Florida, United States
Investigational Site Number: 8400007
Orlando, Florida, United States
Investigational Site Number: 8400011
Palmetto Bay, Florida, United States
Investigational Site Number: 8400019
Marietta, Georgia, United States
Investigational Site Number: 8400025
Iowa City, Iowa, United States
Investigational Site Number: 8400006
Kansas City, Kansas, United States
Investigational Site Number: 8400022
Boston, Massachusetts, United States
Investigational Site Number: 8400008
Wyoming, Michigan, United States
Investigational Site Number: 8400013
St Louis, Missouri, United States
Investigational Site Number: 8400003
Chapel Hill, North Carolina, United States
Investigational Site Number: 8400009
Harrisburg, Pennsylvania, United States
Investigational Site Number: 8400002
Fredericksburg, Texas, United States
Investigational Site Number: 8400016
Ogden, Utah, United States
Investigational Site Number: 8400027
Richmond, Virginia, United States
Investigational Site Number: 0360002
Brisbane, Queensland, Australia
Investigational Site Number: 0360004
Kurralta Park, South Australia, Australia
Investigational Site Number: 0360001
Footscray, Australia
Investigational Site Number: 0560001
Leuven, Belgium
Investigative Site: 1560003
Changsha, China
Investigational Site Number: 1560008
Changsha, China
Investigative Site: 1560005
Changzhou, China
Investigational Site Number: 1560001
Guangzhou, China
Investigational Site Number: 1560006
Hangzhou, China
Investigative Site: 1560004
Nanchang, China
Investigative Site: 1560002
Shanghai, China
Investigational Site Number: 1560007
Shenyang, China
Investigational Site Number: 2030002
Brno, JM, Czechia
Investigational Site Number: 2030003
Hradec Králové, Czechia
Investigational Site Number: 2030005
Slaný, Czechia
Investigational Site Number: 2500001
Montpellier, France
Investigational Site Number: 2500003
Nice, France
Investigational Site Number: 2500002
Toulouse, France
Investigational Site Number: 2760002
Minden, Northwest, Germany
Investigational Site Number: 2760003
Jena, Germany
Investigational Site Number: 2760004
Kiel, Germany
Investigational Site Number: 2760001
Ulm, Germany
Investigational Site Number: 3920007
Kashiwa, Chiba, Japan
Investigational Site Number: 3920005
Ōita, Oita Prefecture, Japan
Investigational Site Number: 3920006
Hamamatsu, Shizuoka, Japan
Investigational Site Number: 3920004
Bunkyō City, Japan
Investigational Site Number: 3920003
Hamamatsu, Japan
Investigational Site Number: 3920009
Hirosaki, Japan
Investigational Site Number: 3920001
Morioka, Japan
Investigational Site Number: 3920002
Nishinomiya, Japan
Investigational Site Number: 6160002
Wroclaw, Lower Silesian Voivodeship, Poland
Investigational Site Number: 6160001
Krakow, Poland
Investigational Site Number: 6160005
Lublin, Poland
Investigational Site Number: 6160006
Sopot, Poland
Investigational Site Number: 6160008
Warsaw, Poland
Investigational Site Number: 6160003
Warsaw, Poland
Investigational Site Number: 6160004
Wroclaw, Poland
Investigational Site Number: 7100003
Johannesburg, South Africa
Investigational Site Number: 7240002
Madrid, Spain
Investigational Site Number: 7240001
Madrid, Spain
Investigational Site Number: 7240003
Seville, Spain
Investigational Site Number: 8260007
Bury, United Kingdom
Investigational Site Number: 8260004
Cambridge, United Kingdom
Investigational Site Number: 8260005
London, United Kingdom
Investigational Site Number: 8260002
London, United Kingdom
Investigational Site Number: 8260001
London, United Kingdom