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SAR442970 for adults with moderate to severe ulcerative colitis

A Phase 2b, Multi-national, Multi-center, Randomized, Double-blind, Placebo-controlled, Dose-ranging Study Followed by a Long-term Extension to Evaluate the Efficacy and Safety of SAR442970 in Adult Participants With Moderate to Severe Ulcerative Colitis

Phase 2 Interventional Sanofi · NCT06975722

This tests whether different doses of the experimental drug SAR442970 can help adults with moderate to severe ulcerative colitis compared with a placebo.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment99 (estimated)
Ages18 Years to 75 Years
SexAll
SponsorSanofi Industry-sponsored
Drugs / interventionsmethotrexate
Locations67 sites (Escondido, California and 66 other locations)
Trial IDNCT06975722 on ClinicalTrials.gov

What this trial studies

This is a randomized, double-blind, three-arm Phase 2b trial comparing different doses of SAR442970 to placebo in adults with moderate to severe ulcerative colitis. Eligible participants must have active disease confirmed by endoscopy and meet specific modified Mayo Score criteria. The treatment period can last up to 158 weeks with an optional open-label long-term extension of up to 104 weeks for those who qualify, and total participation may be up to 168 weeks. The study is sponsored by Sanofi and is being conducted at investigational sites in Southern California.

Who should consider this trial

Good fit: Adults aged 18–75 with active moderate-to-severe ulcerative colitis (mMS 5–9 with required subscores, mMES ≥2, disease extent ≥15 cm) who have had inadequate response, loss of response, or intolerance to prior standard therapies are the intended participants.

Not a fit: Patients in remission, with only mild disease, outside the 18–75 age range, without endoscopically confirmed active disease, or with contraindications to the study drug are unlikely to benefit or may be ineligible.

Why it matters

Potential benefit: If successful, SAR442970 could reduce symptoms and help maintain remission in adults with moderate to severe ulcerative colitis.

How similar studies have performed: Other targeted biologic and small-molecule therapies have shown benefit in moderate-to-severe ulcerative colitis, but SAR442970 is a newer agent and this phase 2b trial will build early efficacy and safety evidence.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

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):

  1. 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
  2. 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 Criteria:

* 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.

Where this trial is running

Escondido, California and 66 other locations

+17 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Ulcerative Colitis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.