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

Last updated: March 25, 2026
Sponsor: Sanofi
Overall Status: Active - Recruiting

Phase

2

Condition

Inflammatory Bowel Disease

Colic

Ulcerative Colitis

Treatment

Placebo

SAR442970

Clinical Study ID

NCT06975722
ACT18134
ACT18134
U1111-1305-7281
2024-515241-41-00
  • Ages 18-75
  • All Genders

Study 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

Inclusion

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 signingthe informed consent

  • Participants who have had clinical evidence of active UC for ≥3 months beforescreening and confirmed by endoscopy during the screening period

  • Must have active moderate-to-severe UC at screening as defined by a modified MayoScore (mMS) of 5 to 9 (without the Physician Global Assessment (PGA), with a minimumRectal 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 minimumdisease extent of 15 cm from the anal verge

  • Must have received prior treatment for UC (either "a" or "b" below or combination ofboth):

  1. History of inadequate response to, loss of response to or intolerance tostandard treatment with any of the following compounds: amino-salicylates,corticosteroids, methotrexate, azathioprine, or 6-mercaptopurine, or history ofcorticosteroid dependence (defined as an inability to successfully tapercorticosteroids without recurrence of UC) AND history of no prior exposure toAdvanced Therapies (ATs), such as a biologic agent used to treat UC or advancedsmall molecules used to treat UC

  2. History of inadequate response to, loss of response to or intolerance totreatment with ≥1 approved AT such as a biologic agent used to treat UC oradvanced small molecules used to treat UC

  • Contraceptive use by men and women should be consistent with local regulationsregarding the methods of contraception for those participating in clinical studies

Exclusion

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 microscopiccolitis

  • Participants with fecal sample positive for culture/ova for aerobic pathogens orpositive for Clostridium difficile B toxin in stools

  • Participant with ostomy or ileoanal pouch, prior colectomy or anticipated colectomyduring their participation in the study

  • Participants with the following ongoing known complications of UC: fulminantdisease, toxic megacolon or colonic dysplasia except for adenoma

  • Participants with intestinal failure or short bowel syndrome requiring TotalParenteral Nutrition

  • History of recurrent or recent serious infection within 4 weeks of screening, orinfection(s) requiring hospitalization or treatment with IV anti-infectives within 30 days prior to baseline, or infections(s) requiring oral anti-infectives within 14days 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 AssociationClass III or IV), or recent cerebrovascular accident.

  • History of demyelinating disease (including myelitis) or neurologic symptomssuggestive of demyelinating disease

  • Participants with a history of malignancy or lymphoproliferative disease other thanadequately treated localized carcinoma in situ of the cervix or nonmetastaticsquamous cell carcinoma, or nonmetastatic basal cell carcinoma of the skin

  • Participants with a diagnosis of inflammatory conditions other than UC (includingbut not limited to systemic lupus erythematosus, systemic sclerosis, myositis,rheumatoid arthritis, primary biliary cirrhosis, multiple sclerosis, Behcet'sdisease, sarcoidosis, etc.)

  • History of Human Immunodeficiency Virus (HIV) infection or positive HIV serology atScreening

  • 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 positiveHepatitis 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 putthe 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

Total Participants: 99
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 2
Study Start date:
July 07, 2025
Estimated Completion Date:
October 17, 2029

Connect with a study center

  • Investigational Site Number: 0360003

    Brisbane, Queensland 4101
    Australia

    Active - Recruiting

  • Investigational Site Number: 0360003

    Brisbane 2174003, Queensland 2152274 4101
    Australia

    Site Not Available

  • Mater Misericordiae Limited - Site Number: 0360003

    Brisbane 2174003, Queensland 2152274 4101
    Australia

    Active - Recruiting

  • Investigational Site Number: 0360001

    Clayton, Victoria 3168
    Australia

    Active - Recruiting

  • Investigational Site Number: 1560004

    Huizhou, Ghangdong 516001
    China

    Active - Recruiting

  • Investigational Site Number: 1560005

    Guangzhou, Guangdong 510655
    China

    Active - Recruiting

  • Investigative Site: 1560005

    Guangzhou 1809858, Guangdong 1809935 510655
    China

    Site Not Available

  • Investigational Site Number: 1560002

    Nanjing, Jiangsu 210029
    China

    Active - Recruiting

  • Investigational Site Number: 1560008

    Suzhou, Jiangsu 215006
    China

    Active - Recruiting

  • Investigational Site Number: 1560003

    Wuxi, Jiangsu 214023
    China

    Active - Recruiting

  • Investigative Site: 1560002

    Nanjing 1799962, Jiangsu 1806260 210029
    China

    Site Not Available

  • Investigative Site: 1560008

    Suzhou 1886760, Jiangsu 1806260 215006
    China

    Site Not Available

  • Investigative Site: 1560003

    Wuxi 1790923, Jiangsu 1806260 214023
    China

    Site Not Available

  • Investigational Site Number: 1560001

    Hangzhou, 310016
    China

    Active - Recruiting

  • Investigational Site Number: 1560001

    Hangzhou 1808926, 310016
    China

    Site Not Available

  • Investigational Site Number: 1560007

    Ningbo, 315010
    China

    Active - Recruiting

  • Investigational Site Number: 1560007

    Ningbo 1799397, 315010
    China

    Site Not Available

  • Investigational Site Number: 2030001

    Brno, JM 61500
    Czechia

    Active - Recruiting

  • Investigational Site Number: 2030001

    Brno 3078610, JM 61500
    Czechia

    Site Not Available

  • Vojenska Nemocnice Brno - Site Number: 2030001

    Brno 3078610, JM 61500
    Czechia

    Active - Recruiting

  • Investigational Site Number: 2030002

    Slaný, 27401
    Czechia

    Active - Recruiting

  • Investigational Site Number: 2500002

    Lille, 59037
    France

    Active - Recruiting

  • Investigational Site Number: 2500002

    Lille 2998324, 59037
    France

    Site Not Available

  • Investigative Site: 2500006

    Nice, 6200
    France

    Active - Recruiting

  • Investigative Site: 2500006

    Nice 2990440, 6200
    France

    Site Not Available

  • Investigational Site Number: 2500005

    Pierre-Bénite, 69495
    France

    Active - Recruiting

  • Centre Hospitalier Lyon-Sud - Site Number: 2500005

    Pierre-Bénite 2987314, 69495
    France

    Active - Recruiting

  • Investigational Site Number: 2500005

    Pierre-Bénite 2987314, 69495
    France

    Site Not Available

  • Investigational Site Number: 2500001

    Saint-Priest-en-Jarez, 42270
    France

    Active - Recruiting

  • Investigational Site Number: 2500001

    Saint-Priest-en-Jarez 2977350, 42270
    France

    Site Not Available

  • Investigational Site Number: 2500003

    Toulouse, 31400
    France

    Active - Recruiting

  • Investigational Site Number: 2500003

    Toulouse 2972315, 31400
    France

    Site Not Available

  • Investigational Site Number: 2500004

    Vandœuvre-lès-Nancy, 54500
    France

    Site Not Available

  • Investigational Site Number: 2500004

    Vandœuvre-lès-Nancy 2970797, 54500
    France

    Site Not Available

  • Investigational Site Number: 2760001

    Minden, Northwest 32423
    Germany

    Active - Recruiting

  • Gastroenterologische Gemeinschaftspraxis Minden - Site Number: 2760001

    Minden 2871039, Northwest 32423
    Germany

    Active - Recruiting

  • Investigational Site Number: 2760001

    Minden 2871039, Northwest 32423
    Germany

    Site Not Available

  • Investigational Site Number: 2760005

    Kiel, Schleswig-Holstein 24105
    Germany

    Active - Recruiting

  • Investigational Site Number: 2760005

    Kiel 2891122, Schleswig-Holstein 2838632 24105
    Germany

    Site Not Available

  • Universitatsklinikum Schleswig-Holstein - Site Number: 2760005

    Kiel 2891122, Schleswig-Holstein 2838632 24105
    Germany

    Active - Recruiting

  • Investigational Site Number: 2760003

    Ulm, 89081
    Germany

    Active - Recruiting

  • Investigational Site Number: 3480002

    Budapest, 1088
    Hungary

    Active - Recruiting

  • Investigational Site Number: 3480003

    Budapest, 1066
    Hungary

    Active - Recruiting

  • Investigational Site Number: 3480003

    Budapest 3054643, 1066
    Hungary

    Active - Recruiting

  • Investigative Site: 3480002

    Budapest 3054643, 1088
    Hungary

    Site Not Available

  • Investigational Site Number: 3480001

    Vác, 2600
    Hungary

    Active - Recruiting

  • Investigational Site Number: 3480001

    Vác 3043293, 2600
    Hungary

    Site Not Available

  • Investigational Site Number: 3920002

    Kashiwa, Chiba 277-0871
    Japan

    Active - Recruiting

  • Investigational Site Number: 3920002

    Kashiwa 1859924, Chiba 2113014 277-0871
    Japan

    Site Not Available

  • Tsujinaka Hospital-Kashiwanoha - Site Number: 3920002

    Kashiwa 1859924, Chiba 2113014 277-0871
    Japan

    Active - Recruiting

  • Investigational Site Number: 3920006

    Ōita, Oita Prefecture 870-0033
    Japan

    Active - Recruiting

  • Investigational Site Number: 3920006

    Ōita 1854487, Oita Prefecture 1854484 870-0033
    Japan

    Site Not Available

  • Oita Red Cross Hospital - Site Number: 3920006

    Ōita 1854487, Oita Prefecture 1854484 870-0033
    Japan

    Active - Recruiting

  • Investigational Site Number: 3920005

    Hamamatsu, 431-3192
    Japan

    Active - Recruiting

  • Investigational Site Number: 3920005

    Hamamatsu 1863289, 431-3192
    Japan

    Site Not Available

  • Investigational Site Number: 3920003

    Hirosaki, 036-8545
    Japan

    Active - Recruiting

  • Investigational Site Number: 3920003

    Hirosaki 2130057, 036-8545
    Japan

    Site Not Available

  • Investigational Site Number: 3920001

    Morioka, 020-8505
    Japan

    Active - Recruiting

  • Investigational Site Number: 3920001

    Morioka 2111834, 020-8505
    Japan

    Site Not Available

  • Investigational Site Number: 3920004

    Nishinomiya, 663-8501
    Japan

    Active - Recruiting

  • Investigational Site Number: 3920004

    Nishinomiya 1855207, 663-8501
    Japan

    Site Not Available

  • Investigational Site Number: 4980001

    Chisinau, 2025
    Moldova

    Active - Recruiting

  • Investigational Site Number: 4980001

    Chisinau 618426, 2025
    Moldova

    Site Not Available

  • Investigational Site Number: 6160006

    Wroclaw, Lower Silesian Voivodeship 53-149
    Poland

    Active - Recruiting

  • Investigational Site Number: 6160006

    Wroclaw 3081368, Lower Silesian Voivodeship 3337492 53-149
    Poland

    Active - Recruiting

  • Vistamed & Vertigo Sp. z o.o. - Site Number: 6160006

    Wroclaw 3081368, Lower Silesian Voivodeship 3337492 53-149
    Poland

    Active - Recruiting

  • Investigational Site Number: 6160002

    Bydgoszcz, 85-229
    Poland

    Active - Recruiting

  • Investigational Site Number: 6160002

    Bydgoszcz 3102014, 85-229
    Poland

    Site Not Available

  • Investigational Site Number: 6160009

    Chojnice, 89-600
    Poland

    Active - Recruiting

  • Investigational Site Number: 6160009

    Chojnice 3101672, 89-600
    Poland

    Site Not Available

  • Investigational Site Number: 6160007

    Katowice, 40-748
    Poland

    Active - Recruiting

  • Investigational Site Number: 6160007

    Katowice 3096472, 40-748
    Poland

    Site Not Available

  • Investigational Site Number: 6160005

    Sopot, 81-756
    Poland

    Active - Recruiting

  • Investigational Site Number: 6160005

    Sopot 3085151, 81-756
    Poland

    Site Not Available

  • Investigational Site Number: 6160008

    Tychy, 43-100
    Poland

    Active - Recruiting

  • Investigative Site: 6160008

    Tychy 3082914, 43-100
    Poland

    Site Not Available

  • Investigational Site Number: 6160003

    Warsaw, 04-501
    Poland

    Active - Recruiting

  • Investigational Site Number: 6160004

    Warsaw, 00-189
    Poland

    Active - Recruiting

  • Investigational Site Number: 6160003

    Warsaw 756135, 04-501
    Poland

    Active - Recruiting

  • Investigational Site Number: 6160004

    Warsaw 756135, 00-189
    Poland

    Site Not Available

  • Investigational Site Number: 6160001

    Wroclaw, 52-210
    Poland

    Active - Recruiting

  • Investigational Site Number: 6160001

    Wroclaw 3081368, 52-210
    Poland

    Site Not Available

  • Investigational Site Number: 7240001

    Las Palmas de Gran Canaria, 35010
    Spain

    Active - Recruiting

  • Investigational Site Number: 7240001

    Las Palmas de Gran Canaria 2515270, 35010
    Spain

    Site Not Available

  • Investigational Site Number: 7240002

    Madrid, 28046
    Spain

    Active - Recruiting

  • Investigational Site Number: 7240002

    Madrid 3117735, 28046
    Spain

    Site Not Available

  • Investigational Site Number: 8260002

    Northwich, CHW CW9 7LS
    United Kingdom

    Active - Recruiting

  • Elpida Sciences Clinical Trials - Site Number: 8260002

    Northwich 2641224, CHW CW9 7LS
    United Kingdom

    Active - Recruiting

  • Investigational Site Number: 8260002

    Northwich 2641224, CHW CW9 7LS
    United Kingdom

    Site Not Available

  • Investigational Site Number: 8260003

    Bury, BL9 7TD
    United Kingdom

    Active - Recruiting

  • Investigational Site Number: 8260003

    Bury 2654187, BL9 7TD
    United Kingdom

    Site Not Available

  • Investigational Site Number: 8260001

    London, E11 1NR
    United Kingdom

    Active - Recruiting

  • Investigational Site Number: 8260004

    London, SE1 7EH
    United Kingdom

    Active - Recruiting

  • Investigational Site Number: 8260001

    London 2643743, E11 1NR
    United Kingdom

    Active - Recruiting

  • Investigational Site Number: 8260004

    London 2643743, SE1 7EH
    United Kingdom

    Site Not Available

  • Investigational Site Number: 8400009

    Escondido, California 92025
    United States

    Active - Recruiting

  • Gastro Care Institute - Site Number: 8400006

    Lancaster, California 93534
    United States

    Site Not Available

  • Investigational Site Number: 8400006

    Lancaster, California 93534
    United States

    Active - Recruiting

  • Investigational Site Number: 8400025

    Thousand Oaks, California 91360
    United States

    Active - Recruiting

  • Gastroenterology & Liver Institute - Site Number: 8400009

    Escondido 5346827, California 5332921 92025
    United States

    Active - Recruiting

  • Investigational Site Number: 8400009

    Escondido 5346827, California 5332921 92025
    United States

    Site Not Available

  • Gastro Care Institute - Site Number: 8400006

    Lancaster 5364940, California 5332921 93534
    United States

    Active - Recruiting

  • Investigational Site Number: 8400006

    Lancaster 5364940, California 5332921 93534
    United States

    Site Not Available

  • Clinical Trials Management Services, LLC

    Thousand Oaks 5402405, California 5332921 91360
    United States

    Active - Recruiting

  • Investigational Site Number: 8400025

    Thousand Oaks 5402405, California 5332921 91360
    United States

    Site Not Available

  • Green Leaf Clinical Trials - Site Number: 8400024

    Jacksonville, Florida 32258
    United States

    Site Not Available

  • Investigational Site Number: 8400024

    Jacksonville, Florida 32258
    United States

    Active - Recruiting

  • Investigational Site Number: 8400030

    Kissimmee, Florida 347441
    United States

    Active - Recruiting

  • Investigational Site Number: 8400003

    Lighthouse PT, Florida 33064
    United States

    Active - Recruiting

  • Alliance Medical Research LLC - Site Number: 8400003

    Lighthouse Point, Florida 33064
    United States

    Site Not Available

  • Investigational Site Number: 8400001

    Miami, Florida 33134
    United States

    Active - Recruiting

  • Investigational Site Number: 8400011

    Miami, Florida 33136
    United States

    Active - Recruiting

  • Research Associates of South Florida, LLC - Site Number: 8400001

    Miami, Florida 33134
    United States

    Site Not Available

  • Investigational Site Number: 8400010

    Palmetto Bay, Florida 33176
    United States

    Active - Recruiting

  • Tropical Clinical Trials - Site Number: 8400010

    Palmetto Bay, Florida 33176
    United States

    Site Not Available

  • Investigational Site Number: 8400019

    Tampa, Florida 33609
    United States

    Active - Recruiting

  • Green Leaf Clinical Trials - Site Number: 8400024

    Jacksonville 4160021, Florida 4155751 32258
    United States

    Active - Recruiting

  • Investigational Site Number: 8400024

    Jacksonville 4160021, Florida 4155751 32258
    United States

    Site Not Available

  • Investigational Site Number: 8400030

    Kissimmee 4160983, Florida 4155751 347441
    United States

    Site Not Available

  • Alliance Medical Research LLC - Site Number: 8400003

    Lighthouse PT 4161957, Florida 4155751 33064
    United States

    Active - Recruiting

  • Investigational Site Number: 8400003

    Lighthouse PT 4161957, Florida 4155751 33064
    United States

    Site Not Available

  • Investigational Site Number: 8400001

    Miami 4164138, Florida 4155751 33134
    United States

    Site Not Available

  • Investigational Site Number: 8400011

    Miami 4164138, Florida 4155751 33136
    United States

    Active - Recruiting

  • Research Associates of South Florida, LLC - Site Number: 8400001

    Miami 4164138, Florida 4155751 33134
    United States

    Active - Recruiting

  • Sylvester Comprehensive Cancer Center - Site Number: 8400011

    Miami 4164138, Florida 4155751 33136
    United States

    Active - Recruiting

  • Investigational Site Number: 8400010

    Palmetto Bay 4167634, Florida 4155751 33176
    United States

    Site Not Available

  • Tropical Clinical Trials - Site Number: 8400010

    Palmetto Bay 4167634, Florida 4155751 33176
    United States

    Active - Recruiting

  • Investigational Site Number: 8400019

    Tampa 4174757, Florida 4155751 33609
    United States

    Site Not Available

  • Gastrointestinal Specialists of Georgia, PC - Site Number: 8400018

    Marietta, Georgia 30060
    United States

    Site Not Available

  • Investigational Site Number: 8400018

    Marietta, Georgia 30060
    United States

    Active - Recruiting

  • Gastrointestinal Specialists of Georgia, PC - Site Number: 8400018

    Marietta 4207783, Georgia 4197000 30060
    United States

    Active - Recruiting

  • Investigational Site Number: 8400018

    Marietta 4207783, Georgia 4197000 30060
    United States

    Site Not Available

  • Investigational Site Number: 8400005

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

  • University of Iowa Hospitals and Clinics - Site Number: 8400005

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • Investigational Site Number: 8400005

    Iowa City 4862034, Iowa 4862182 52242
    United States

    Site Not Available

  • University of Iowa Hospitals and Clinics - Site Number: 8400005

    Iowa City 4862034, Iowa 4862182 52242
    United States

    Active - Recruiting

  • Investigational Site Number: 8400017

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • Investigational Site: 8400017

    Boston 4930956, Massachusetts 6254926 02115
    United States

    Site Not Available

  • Gastroenterology Associates of Western Michigan - Site Number: 8400012

    Wyoming, Michigan 49519
    United States

    Site Not Available

  • Investigational Site Number: 8400012

    Wyoming, Michigan 49519
    United States

    Active - Recruiting

  • Gastroenterology Associates of Western Michigan - Site Number: 8400012

    Wyoming 5015618, Michigan 5001836 49519
    United States

    Active - Recruiting

  • Investigational Site Number: 8400012

    Wyoming 5015618, Michigan 5001836 49519
    United States

    Site Not Available

  • Investigational Site Number: 8400014

    St Louis, Missouri 63110
    United States

    Active - Recruiting

  • Investigational Site Number: 8400014

    St Louis 4407066, Missouri 4398678 63110
    United States

    Site Not Available

  • Washington University School of Medicine - Site Number: 8400014

    St Louis 4407066, Missouri 4398678 63110
    United States

    Active - Recruiting

  • Investigational Site Number: 8400021

    New York, New York 10029
    United States

    Active - Recruiting

  • Investigational Site Number: 8400029

    Queens Village, New York 11428
    United States

    Active - Recruiting

  • Investigational Site Number: 8400021

    New York 5128581, New York 5128638 10029
    United States

    Site Not Available

  • Investigational Site Number: 8400029

    Queens Village 5133271, New York 5128638 11428
    United States

    Site Not Available

  • Investigational Site Number: 8400002

    Chapel Hill, North Carolina 27514
    United States

    Active - Recruiting

  • Investigational Site Number: 8400002

    Chapel Hill 4460162, North Carolina 4482348 27514
    United States

    Site Not Available

  • University of North Carolina Medical Center - Site Number: 8400002

    Chapel Hill 4460162, North Carolina 4482348 27514
    United States

    Active - Recruiting

  • Investigational Site Number: 8400013

    Harrisburg, Pennsylvania 17110
    United States

    Active - Recruiting

  • Jackson Siegelbaum Gastroenterology - East Shore - Site Number: 8400013

    Harrisburg, Pennsylvania 17110
    United States

    Site Not Available

  • Investigational Site Number: 8400013

    Harrisburg 5192726, Pennsylvania 6254927 17110
    United States

    Site Not Available

  • Jackson Siegelbaum Gastroenterology - East Shore - Site Number: 8400013

    Harrisburg 5192726, Pennsylvania 6254927 17110
    United States

    Active - Recruiting

  • Investigational Site Number: 8400023

    Houston, Texas 77030
    United States

    Active - Recruiting

  • Investigational Site Number: 8400023

    Houston 4699066, Texas 4736286 77030
    United States

    Site Not Available

  • Investigational Site Number: 8400007

    Ogden, Utah 84405
    United States

    Active - Recruiting

  • Advanced Research Institute - Site Number: 8400007

    Ogden 5779206, Utah 5549030 84405
    United States

    Active - Recruiting

  • Investigational Site Number: 8400007

    Ogden 5779206, Utah 5549030 84405
    United States

    Site Not Available

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