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NCT06975722PHASE2Recruiting

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

Sanofi

Start Date

7/7/2025

Completion Date

10/17/2029

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 Criteria

Age Range: 18 years to 75 years

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.

Interventions

DRUG

SAR442970

DRUG

Placebo

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Conditions

Ulcerative Colitis

Locations

Investigational Site Number: 8400009

Escondido, California 92025

United States

Investigational Site Number: 8400006

Lancaster, California 93534

United States

Investigational Site Number: 8400025

Thousand Oaks, California 91360

United States

Investigational Site Number: 8400024

Jacksonville, Florida 32258

United States

Investigational Site Number: 8400030

Kissimmee, Florida 347441

United States

Investigational Site Number: 8400003

Lighthouse PT, Florida 33064

United States

Investigational Site Number: 8400001

Miami, Florida 33134

United States

Investigational Site Number: 8400011

Miami, Florida 33136

United States

Investigational Site Number: 8400010

Palmetto Bay, Florida 33176

United States

Investigational Site Number: 8400019

Tampa, Florida 33609

United States

Investigational Site Number: 8400018

Marietta, Georgia 30060

United States

Investigational Site Number: 8400005

Iowa City, Iowa 52242

United States

Investigational Site Number: 8400017

Boston, Massachusetts 02115

United States

Investigational Site Number: 8400012

Wyoming, Michigan 49519

United States

Investigational Site Number: 8400014

St Louis, Missouri 63110

United States

Investigational Site Number: 8400021

New York, New York 10029

United States

Investigational Site Number: 8400029

Queens Village, New York 11428

United States

Investigational Site Number: 8400002

Chapel Hill, North Carolina 27514

United States

Investigational Site Number: 8400013

Harrisburg, Pennsylvania 17110

United States

Investigational Site Number: 8400023

Houston, Texas 77030

United States

Investigational Site Number: 8400007

Ogden, Utah 84405

United States

Investigational Site Number: 0360003

Brisbane, Queensland 4101

Australia

Investigational Site Number: 0360001

Clayton, Victoria 3168

Australia

Investigational Site Number: 1560004

Huizhou, Ghangdong 516001

China

Investigational Site Number: 1560005

Guangzhou, Guangdong 510655

China

Investigational Site Number: 1560002

Nanjing, Jiangsu 210029

China

Investigational Site Number: 1560008

Suzhou, Jiangsu 215006

China

Investigational Site Number: 1560003

Wuxi, Jiangsu 214023

China

Investigational Site Number: 1560009

Shanghai, Shanghai Municipality 200025

China

Investigational Site Number: 1560001

Hangzhou, 310016

China

Investigational Site Number: 1560007

Ningbo, 315010

China

Investigational Site Number: 2030001

Brno, JM 61500

Czechia

Investigational Site Number: 2030002

Slaný, 27401

Czechia

Investigational Site Number: 2500002

Lille, 59037

France

Investigative Site: 2500006

Nice, 6200

France

Investigational Site Number: 2500005

Pierre-Bénite, 69495

France

Investigational Site Number: 2500001

Saint-Priest-en-Jarez, 42270

France

Investigational Site Number: 2500003

Toulouse, 31400

France

Investigational Site Number: 2500004

Vandœuvre-lès-Nancy, 54500

France

Investigational Site Number: 2760001

Minden, Northwest 32423

Germany

Investigational Site Number: 2760005

Kiel, Schleswig-Holstein 24105

Germany

Investigational Site Number: 2760003

Ulm, 89081

Germany

Investigational Site Number: 3480003

Budapest, 1066

Hungary

Investigational Site Number: 3480002

Budapest, 1088

Hungary

Investigational Site Number: 3480001

Vác, 2600

Hungary

Investigational Site Number: 3920002

Kashiwa, Chiba 277-0871

Japan

Investigational Site Number: 3920006

Ōita, Oita Prefecture 870-0033

Japan

Investigational Site Number: 3920005

Hamamatsu, 431-3192

Japan

Investigational Site Number: 3920003

Hirosaki, 036-8545

Japan

Investigational Site Number: 3920001

Morioka, 020-8505

Japan

Investigational Site Number: 3920004

Nishinomiya, 663-8501

Japan

Investigational Site Number: 4980001

Chisinau, 2025

Moldova

Investigational Site Number: 6160006

Wroclaw, Lower Silesian Voivodeship 53-149

Poland

Investigational Site Number: 6160002

Bydgoszcz, 85-229

Poland

Investigational Site Number: 6160009

Chojnice, 89-600

Poland

Investigational Site Number: 6160007

Katowice, 40-748

Poland

Investigational Site Number: 6160005

Sopot, 81-756

Poland

Investigational Site Number: 6160008

Tychy, 43-100

Poland

Investigational Site Number: 6160004

Warsaw, 00-189

Poland

Investigational Site Number: 6160003

Warsaw, 04-501

Poland

Investigational Site Number: 6160001

Wroclaw, 52-210

Poland

Investigational Site Number: 7240001

Las Palmas de Gran Canaria, 35010

Spain

Investigational Site Number: 7240002

Madrid, 28046

Spain

Investigational Site Number: 8260002

Northwich, CHW CW9 7LS

United Kingdom

Investigational Site Number: 8260003

Bury, BL9 7TD

United Kingdom

Investigational Site Number: 8260001

London, E11 1NR

United Kingdom

Investigational Site Number: 8260004

London, SE1 7EH

United Kingdom