Status:
RECRUITING
A Study to Investigate the Efficacy and Safety of SAR442970 in Adult Participants With Ulcerative Colitis
Lead Sponsor:
Sanofi
Conditions:
Ulcerative Colitis
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 Ulcerative Colitis. The primary objective of this study is to assess the efficacy of different doses of SAR442970 compare...
Eligibility Criteria
Inclusion
- Participants are eligible to be included in the study only if all of the following criteria apply:
- Male or female participants aged 18 to 75 years inclusive, at the time of signing the informed consent
- Participants who have had clinical evidence of active UC for ≥3 months before screening and confirmed by endoscopy during the screening period
- Must have active moderate-to-severe UC at screening as defined by a modified Mayo Score (mMS) of 5 to 9 (without the Physician Global Assessment (PGA), with a minimum Rectal Bleeding (RB) subscore ≥1, a minimum Stool Frequency (SF) subscore ≥1, mMES ≥2 confirmed by central reader, a minimum sum of all subscores of 5, and a minimum disease extent of 15 cm from the anal verge
- Must have received prior treatment for UC (either "a" or "b" below or combination of both):
- History of inadequate response to, loss of response to or intolerance to standard treatment with any of the following compounds: amino-salicylates, corticosteroids, methotrexate, azathioprine, or 6-mercaptopurine, or history of corticosteroid dependence (defined as an inability to successfully taper corticosteroids without recurrence of UC) AND history of no prior exposure to Advanced Therapies (ATs), such as a biologic agent used to treat UC or advanced small molecules used to treat UC
- History of inadequate response to, loss of response to or intolerance to treatment with ≥1 approved AT such as a biologic agent used to treat UC or advanced small molecules used to treat UC
- 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 are excluded from the study if any of the following criteria apply:
- Participants with active Crohn's Disease (CD), indeterminate colitis or microscopic colitis
- Participants with fecal sample positive for culture/ova for aerobic pathogens or positive for Clostridium difficile B toxin in stools
- Participant with ostomy or ileoanal pouch, prior colectomy or anticipated colectomy during their participation in the study
- Participants with the following ongoing known complications of UC: fulminant disease, toxic megacolon or colonic dysplasia except for adenoma
- Participants with intestinal failure or short bowel syndrome requiring Total Parenteral Nutrition
- History of recurrent or recent serious infection within 4 weeks of screening, or infection(s) requiring hospitalization or treatment with IV anti-infectives within 30 days prior to baseline, or infections(s) requiring oral anti-infectives within 14 days prior to baseline, except as required as part of an anti-Tuberculosis (TB) regimen
- Known history of or suspected significant current immunosuppression.
- History or solid organ transplant or splenectomy
- History of moderate to severe congestive heart failure (New York Health Association Class III or IV), or recent cerebrovascular accident.
- History of demyelinating disease (including myelitis) or neurologic symptoms suggestive of demyelinating disease
- Participants with a history of malignancy or lymphoproliferative disease other than adequately treated localized carcinoma in situ of the cervix or nonmetastatic squamous cell carcinoma, or nonmetastatic basal cell carcinoma of the skin
- Participants with a diagnosis of inflammatory conditions other than UC (including but not limited to systemic lupus erythematosus, systemic sclerosis, myositis, rheumatoid arthritis, primary biliary cirrhosis, multiple sclerosis, Behcet's disease, sarcoidosis, etc.)
- History of Human Immunodeficiency Virus (HIV) infection or positive HIV serology at Screening
- History of Interstitial Lung Disease
- Participants with any of the following results at Screening:
- Positive (or indeterminate) Hepatitis B surface antigen (HBs Ag) or,
- Positive total Hepatitis B core antibody (anti-HBc) confirmed by positive Hepatitis B Virus (HBV) Deoxyribonucleic acid (DNA) or,
- Positive Hepatitis C Virus (HCV) antibody
- Screening laboratory and other analyses showing abnormal results
- History of any other condition which, in the opinion of the Investigator, would put the participant at risk by participation in the protocol
- The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial
- NOTE - Additional criteria apply, please contact the investigator for more information
Key Trial Info
Start Date :
July 7 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 17 2029
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT06975722
Start Date
July 7 2025
End Date
October 17 2029
Last Update
December 17 2025
Active Locations (52)
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1
Investigational Site Number: 8400009
Escondido, California, United States, 92025
2
Investigational Site Number: 8400006
Lancaster, California, United States, 93534
3
Investigational Site Number: 8400025
Thousand Oaks, California, United States, 91360
4
Investigational Site Number: 8400024
Jacksonville, Florida, United States, 32258