Recruiting
Phase 2

SAR442970

Sponsor:

Sanofi

Code:

NCT06975722

Conditions

Ulcerative Colitis

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

SAR442970

Placebo

Study Details

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 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.

Conditions

Ulcerative Colitis

Study ID

NCT06975722

Start date

Jul 7, 2025

Status verified date

Apr, 2026

Completion date

Oct 17, 2029

Anticipated

Primary completion date

Dec 17, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

99 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: SAR442970 Dose Regimen A

Participants will receive SAR442970 dose regimen A

experimental: SAR442970 Dose Regimen B

Participants will receive SAR442970 dose regimen B

placebo comparator: Placebo

Participants will receive SAR442970-matching placebo

Interventions

SAR442970

Route of administration: Subcutaneous

Placebo

Route of administration: Subcutaneous

Primary outcome measure

  • Proportion of participants who achieve clinical remission at the end of Week 16 by modified Mayo Score (mMS) [ Time Frame: At Week 16 ]

Central Contacts and Locations

Central contacts

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

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

Locations

Investigational Site Number: 8400009

Recruiting

Escondido, California, United States, 92025

Investigational Site Number: 8400006

Recruiting

Lancaster, California, United States, 93534

Investigational Site Number: 8400025

Recruiting

Thousand Oaks, California, United States, 91360

Investigational Site Number: 8400024

Recruiting

Jacksonville, Florida, United States, 32258

Investigational Site Number: 8400030

Recruiting

Kissimmee, Florida, United States, 347441

Investigational Site Number: 8400003

Recruiting

Lighthouse PT, Florida, United States, 33064

Investigational Site Number: 8400001

Recruiting

Miami, Florida, United States, 33134

Investigational Site Number: 8400011

Recruiting

Miami, Florida, United States, 33136

Investigational Site Number: 8400010

Recruiting

Palmetto Bay, Florida, United States, 33176

Investigational Site Number: 8400019

Recruiting

Tampa, Florida, United States, 33609

Investigational Site Number: 8400018

Recruiting

Marietta, Georgia, United States, 30060

Investigational Site Number: 8400005

Recruiting

Iowa City, Iowa, United States, 52242

Investigational Site Number: 8400017

Recruiting

Boston, Massachusetts, United States, 02115

Investigational Site Number: 8400012

Recruiting

Wyoming, Michigan, United States, 49519

Investigational Site Number: 8400014

Recruiting

St Louis, Missouri, United States, 63110

Investigational Site Number: 8400021

Recruiting

New York, New York, United States, 10029

Investigational Site Number: 8400029

Recruiting

Queens Village, New York, United States, 11428

Investigational Site Number: 8400002

Recruiting

Chapel Hill, North Carolina, United States, 27514

Investigational Site Number: 8400013

Recruiting

Harrisburg, Pennsylvania, United States, 17110

Investigational Site Number: 8400023

Recruiting

Houston, Texas, United States, 77030

Investigational Site Number: 8400007

Recruiting

Ogden, Utah, United States, 84405

More Information

Sponsor

Sanofi

Last update posted

Apr 23, 2026

Last verified

Apr, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Sanofi on 2026-04-23.