Status:
RECRUITING
A Study to Investigate Efficacy and Safety of SAR442970 in Patients With Crohn's Disease
Lead Sponsor:
Sanofi
Conditions:
Crohn's Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief 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 w...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 3 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 17 2029
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT06958536
Start Date
June 3 2025
End Date
October 17 2029
Last Update
December 17 2025
Active Locations (50)
Enter a location and click search to find clinical trials sorted by distance.
1
Investigational Site Number: 8400005
Escondido, California, United States, 92025
2
Investigational Site Number: 8400001
Lancaster, California, United States, 93534
3
Investigational Site Number: 8400017
Kissimmee, Florida, United States, 34741
4
Investigational Site Number: 8400015
Lighthouse PT, Florida, United States, 33064