SAR442970 for Ulcerative Colitis
This study is testing a drug called SAR442970 to see if it's safe and effective for adults with moderate to severe ulcerative colitis (a chronic inflammatory bowel disease). You would receive either SAR442970 or a placebo (an inactive substance) through injections under the skin. Researchers want to see if SAR442970 helps people achieve clinical remission (a period where symptoms are reduced or absent) by Week 16, using a measure called the modified Mayo Score. The study aims to enroll about 99 participants aged 18 to 75 who have had active ulcerative colitis for at least 3 months. The current recruitment status is unclear.
- Study design
- This is a Phase 2b, randomized, double-blind study with three groups, comparing different doses of SAR442970 to a placebo. Around 99 participants are planned to be included.
- What's involved
- The total study duration is up to 168 weeks, with a treatment period of up to 158 weeks, including a possible long-term extension.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants may be followed for up to 168 weeks, with a treatment period of up to 158 weeks including a long-term extension of up to 104 weeks.
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NCT06975722
A Study to Investigate the Efficacy and Safety of SAR442970 in Adult Participants With Ulcerative Colitis
Recruiting
PHASE2Ages 18–75InterventionalTreatmentSanofi
~99 participants
Updated 2026-04-23 on ClinicalTrials.gov
What's tested:SAR442970Placebo
At a glance
Recruiting sites
66 of 67 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Proportion of participants who achieve clinical remission at the end of Week 16 by modified Mayo Score (mMS)
Measured over At Week 16
Conditions
Where it's being run
67 sites across 35 statesPoland8
Florida7
France6
Japan4
California3
Jiangsu3
Hungary3
United Kingdom3
Who to contact
Trial Transparency email recommended (Toll free for US & Canada)
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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):
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
What this trial measures
- Proportion of participants who achieve clinical remission at the end of Week 16 by modified Mayo Score (mMS)At Week 16
Clinical remission is based on modified Mayo subscores. The mMS ranges from 0 to 9 with higher scores indicating greater disease severity.