A Study to Investigate Efficacy and Safety of SAR442970 in Patients With Crohn's Disease
Recruiting · NCT06958536 · Interventional (participants receive a specific treatment) · Lead sponsor: Sanofi
View the official record on ClinicalTrials.gov →Interventions studied
PlaceboSAR442970
What this trial is about
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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
60 locations listed across 14 US states.
- 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: 3920004 - Bunkyō City, Japan
- Investigational Site Number: 8260007 - Bury, United Kingdom
- Investigational Site Number: 8260004 - Cambridge, United Kingdom
- Investigative Site: 1560003 - Changsha, China
- Investigational Site Number: 1560008 - Changsha, China
- Investigative Site: 1560005 - Changzhou, China
- Investigational Site Number: 0360001 - Footscray, Australia
- Investigational Site Number: 1560001 - Guangzhou, China
- Investigational Site Number: 3920003 - Hamamatsu, Japan
- Investigational Site Number: 1560006 - Hangzhou, China
- Investigational Site Number: 3920009 - Hirosaki, Japan
- Investigational Site Number: 2030003 - Hradec Králové, Czechia
- Investigational Site Number: 2760003 - Jena, Germany
- Investigational Site Number: 7100003 - Johannesburg, South Africa
- Investigational Site Number: 2760004 - Kiel, Germany
- Investigational Site Number: 6160001 - Krakow, Poland
- Investigational Site Number: 0560001 - Leuven, Belgium
- Investigational Site Number: 8260005 - London, United Kingdom
- Investigational Site Number: 8260002 - London, United Kingdom
- Investigational Site Number: 8260001 - London, United Kingdom
- Investigational Site Number: 6160005 - Lublin, Poland
- Investigational Site Number: 7240002 - Madrid, Spain
- Investigational Site Number: 7240001 - Madrid, Spain
- Investigational Site Number: 2500001 - Montpellier, France
- Investigational Site Number: 3920001 - Morioka, Japan
- Investigative Site: 1560004 - Nanchang, China
- Investigational Site Number: 2500003 - Nice, France
- Investigational Site Number: 3920002 - Nishinomiya, Japan
- Investigational Site Number: 7240003 - Seville, Spain
- Investigative Site: 1560002 - Shanghai, China
- Investigational Site Number: 1560007 - Shenyang, China
- Investigational Site Number: 2030005 - Slaný, Czechia
- Investigational Site Number: 6160006 - Sopot, Poland
- Investigational Site Number: 2500002 - Toulouse, France
- Investigational Site Number: 2760001 - Ulm, Germany
- Investigational Site Number: 6160008 - Warsaw, Poland
- Investigational Site Number: 6160003 - Warsaw, Poland
- Investigational Site Number: 6160004 - Wroclaw, Poland
- Investigational Site Number: 3920007 - Kashiwa, Chiba, Japan
- Investigational Site Number: 2030002 - Brno, JM, Czechia
Showing 60 of 66 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →