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A Study to Investigate Efficacy and Safety of SAR442970 in Patients With Crohn's Disease

NCT06958536 · Sanofi
In plain English

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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
About this study
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.
Eligibility criteria
Inclusion Criteria: * Diagnosis of Crohn's Disease (CD) for at least 3 months prior to screening * Confirmed diagnosis of moderate-to-severe CD * History of prior exposure to standard treatment (5-Amino Salicylates (5-ASAs), steroids, immunomodulators or antibiotics) or advanced therapies (ATs) (biologics or small molecules), but having inadequate response to, loss or response to or intolerance to at least one of these therapies * On stable doses of standard treatments prior to screening (Oral 5-ASA compounds, Oral corticosteroids, Azathioprine (AZA), 6-Mercaptopurine (6-MP), or Methotrexate (MTX), or Antibiotics, etc.) * Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies Exclusion Criteria: * Participants with active Ulcerative Colitis (UC), indeterminate colitis, adenomatous colonic polyps not excised, colonic mucosal dysplasia (low- or high-grade dysplasia) or short bowel syndrome * Participants with CD isolated to the stomach, duodenum, jejunum, or perianal region, without colonic or ileal involvement * Participants with following ongoing known complications of CD: * Any manifestation that might require bowel surgery while enrolled in the study * Participant with ostomy or ileoanal pouch * Participant diagnosed with conditions that could interfere with drug absorption including but not limited to short bowel syndrome * Participant with surgical bowel resection within the past three months prior to screening, or a history of \>3 bowel resections * History of any other condition which, in the opinion of the Investigator, would put the participant at risk by participation in the study The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Study design
Enrollment target: 99 participants
Allocation: randomized
Masking: quadruple
Age groups: adult, older_adult
Timeline
Starts: 2025-06-03
Estimated completion: 2029-10-17
Last updated: 2026-03-27
Interventions
Drug: SAR442970Drug: Placebo
Primary outcomes
  • Percentage of participants who achieve endoscopic response at Week 16 (From Baseline to Week 16)
Sponsor
Sanofi · industry
Contacts & investigators
ContactTrial Transparency email recommended (Toll free for US & Canada) · contact · contact-us@sanofi.com · 800-633-1610
All locations (66)
Investigational Site Number: 8400024Recruiting
Tucson, Arizona, United States
Investigational Site Number: 8400005Recruiting
Escondido, California, United States
Investigational Site Number: 8400001Recruiting
Lancaster, California, United States
Investigational Site Number: 8400017Recruiting
Kissimmee, Florida, United States
Investigational Site Number: 8400015Recruiting
Lighthouse PT, Florida, United States
Investigational Site Number 8400028Recruiting
Miami, Florida, United States
Investigational Site Number: 8400012Recruiting
Miami, Florida, United States
Investigational Site Number: 8400007Recruiting
Orlando, Florida, United States
Investigational Site Number: 8400011Recruiting
Palmetto Bay, Florida, United States
Investigational Site Number: 8400019Recruiting
Marietta, Georgia, United States
Investigational Site Number: 8400025Recruiting
Iowa City, Iowa, United States
Investigational Site Number: 8400006Recruiting
Kansas City, Kansas, United States
Investigational Site Number: 8400022Recruiting
Boston, Massachusetts, United States
Investigational Site Number: 8400008Recruiting
Wyoming, Michigan, United States
Investigational Site Number: 8400013Recruiting
St Louis, Missouri, United States
Investigational Site Number: 8400003Recruiting
Chapel Hill, North Carolina, United States
Investigational Site Number: 8400009Recruiting
Harrisburg, Pennsylvania, United States
Investigational Site Number: 8400002Recruiting
Fredericksburg, Texas, United States
Investigational Site Number: 8400016Recruiting
Ogden, Utah, United States
Investigational Site Number: 8400027Recruiting
Richmond, Virginia, United States
Investigational Site Number: 0360002Recruiting
Brisbane, Queensland, Australia
Investigational Site Number: 0360004Recruiting
Kurralta Park, South Australia, Australia
Investigational Site Number: 0360001Recruiting
Footscray, Australia
Investigational Site Number: 0560001Recruiting
Leuven, Belgium
Investigative Site: 1560003Recruiting
Changsha, China
Investigational Site Number: 1560008Recruiting
Changsha, China
Investigative Site: 1560005Recruiting
Changzhou, China
Investigational Site Number: 1560001Recruiting
Guangzhou, China
Investigational Site Number: 1560006Recruiting
Hangzhou, China
Investigative Site: 1560004Recruiting
Nanchang, China
Investigative Site: 1560002Recruiting
Shanghai, China
Investigational Site Number: 1560007Recruiting
Shenyang, China
Investigational Site Number: 2030002Recruiting
Brno, JM, Czechia
Investigational Site Number: 2030003Recruiting
Hradec Králové, Czechia
Investigational Site Number: 2030005Recruiting
Slaný, Czechia
Investigational Site Number: 2500001Recruiting
Montpellier, France
Investigational Site Number: 2500003Recruiting
Nice, France
Investigational Site Number: 2500002Recruiting
Toulouse, France
Investigational Site Number: 2760002Recruiting
Minden, Northwest, Germany
Investigational Site Number: 2760003Recruiting
Jena, Germany
Investigational Site Number: 2760004Recruiting
Kiel, Germany
Investigational Site Number: 2760001Recruiting
Ulm, Germany
Investigational Site Number: 3920007Recruiting
Kashiwa, Chiba, Japan
Investigational Site Number: 3920005Recruiting
Ōita, Oita Prefecture, Japan
Investigational Site Number: 3920006Recruiting
Hamamatsu, Shizuoka, Japan
Investigational Site Number: 3920004Recruiting
Bunkyō City, Japan
Investigational Site Number: 3920003Recruiting
Hamamatsu, Japan
Investigational Site Number: 3920009Recruiting
Hirosaki, Japan
Investigational Site Number: 3920001Recruiting
Morioka, Japan
Investigational Site Number: 3920002Recruiting
Nishinomiya, Japan
Investigational Site Number: 6160002Recruiting
Wroclaw, Lower Silesian Voivodeship, Poland
Investigational Site Number: 6160001Recruiting
Krakow, Poland
Investigational Site Number: 6160005Recruiting
Lublin, Poland
Investigational Site Number: 6160006Recruiting
Sopot, Poland
Investigational Site Number: 6160008Recruiting
Warsaw, Poland
Investigational Site Number: 6160003Recruiting
Warsaw, Poland
Investigational Site Number: 6160004Recruiting
Wroclaw, Poland
Investigational Site Number: 7100003Recruiting
Johannesburg, South Africa
Investigational Site Number: 7240002Recruiting
Madrid, Spain
Investigational Site Number: 7240001Recruiting
Madrid, Spain
Investigational Site Number: 7240003Recruiting
Seville, Spain
Investigational Site Number: 8260007Recruiting
Bury, United Kingdom
Investigational Site Number: 8260004Recruiting
Cambridge, United Kingdom
Investigational Site Number: 8260005Recruiting
London, United Kingdom
Investigational Site Number: 8260002Recruiting
London, United Kingdom
Investigational Site Number: 8260001Recruiting
London, United Kingdom
A Study to Investigate Efficacy and Safety of SAR442970 in Patients With Crohn's Disease · TrialPath