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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

A Study to Investigate the Efficacy and Safety of SAR442970 in Adult Participants With 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

A Study to Investigate the Efficacy and Safety of SAR442970 in Adult Participants With Ulcerative Colitis (NCT06975722) is a Phase 2 interventional studying Ulcerative Colitis, sponsored by Sanofi. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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 compared with placebo in participants with moderate to severe Ulcerative Colitis. 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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against Ulcerative Colitis and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 99 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused Ulcerative Colitis subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: 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 willing to sign a consent form - 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 Who Should NOT Join This Trial: - 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

DRUG

SAR442970

Route of administration: Subcutaneous

DRUG

Placebo

Route of administration: Subcutaneous

Locations (20)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Investigational Site Number: 8400009
Escondido, California, United States
Investigational Site Number: 8400006
Lancaster, California, United States
Investigational Site Number: 8400025
Thousand Oaks, California, United States
Investigational Site Number: 8400024
Jacksonville, Florida, United States
Investigational Site Number: 8400030
Kissimmee, Florida, United States
Investigational Site Number: 8400003
Lighthouse PT, Florida, United States
Investigational Site Number: 8400001
Miami, Florida, United States
Investigational Site Number: 8400011
Miami, Florida, United States
Investigational Site Number: 8400010
Palmetto Bay, Florida, United States
Investigational Site Number: 8400019
Tampa, Florida, United States
Investigational Site Number: 8400018
Marietta, Georgia, United States
Investigational Site Number: 8400005
Iowa City, Iowa, United States
Investigational Site Number: 8400017
Boston, Massachusetts, United States
Investigational Site Number: 8400012
Wyoming, Michigan, United States
Investigational Site Number: 8400014
St Louis, Missouri, United States
Investigational Site Number: 8400021
New York, New York, United States
Investigational Site Number: 8400029
Queens Village, New York, United States
Investigational Site Number: 8400002
Chapel Hill, North Carolina, United States
Investigational Site Number: 8400013
Harrisburg, Pennsylvania, United States
Investigational Site Number: 8400023
Houston, Texas, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06975722), the sponsor (Sanofi), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06975722 clinical trial studying?

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 compared with placebo in participants with moderate to severe Ulcerative Colitis. 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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06975722?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06975722?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06975722. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06975722. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.