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A Study to Investigate the Efficacy and Safety of SAR442970 in Adult Participants With Ulcerative Colitis | Clinical Trials | Clareo Health

RECRUITINGPHASE2

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

NCT06975722•Sanofi

View on ClinicalTrials.gov

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 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.

Eligibility

Age

18 - 75 years

Sex

ALL

Healthy Volunteers

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.
+12 more criteria

Locations (65)

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

Key Dates

Start Date

July 7, 2025

Primary Completion Date

December 17, 2026

Completion Date

October 17, 2029

Last Updated

March 9, 2026

Enrollment

ESTIMATED participants

Conditions

Ulcerative Colitis

Interventions

SAR442970

DRUG

Placebo

DRUG

Contacts

Trial Transparency email recommended (Toll free for US & Canada)

CONTACT

800-633-1610 contact-us@sanofi.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 9, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis

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An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis

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