A Study to Investigate Efficacy and Safety of SAR442970 in Patients With Crohn's Disease

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

Phase

2

Condition

Ulcerative Colitis

Bowel Dysfunction

Inflammatory Bowel Disease

Treatment

SAR442970

Placebo

Clinical Study ID

NCT06958536
DRI18450
U1111-1306-7510
DRI18450
2024-517016-30-00
  • Ages 18-75
  • All Genders

Study Summary

This is a phase 2b, randomized, double-blind, 3-arm study for the treatment of Crohn's disease. 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 Crohn's disease. 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:

  • Diagnosis of Crohn's Disease (CD) for at least 3 months prior to screening

  • Confirmed diagnosis of moderate-to-severe CD

  • History of prior exposure to standard treatment (5-Amino Salicylates (5-ASAs),steroids, immunomodulators or antibiotics) or advanced therapies (ATs) (biologics orsmall molecules), but having inadequate response to, loss or response to orintolerance to at least one of these therapies

  • On stable doses of standard treatments prior to screening (Oral 5-ASA compounds,Oral corticosteroids, Azathioprine (AZA), 6-Mercaptopurine (6-MP), or Methotrexate (MTX), or Antibiotics, etc.)

  • 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 with active Ulcerative Colitis (UC), indeterminate colitis, adenomatouscolonic polyps not excised, colonic mucosal dysplasia (low- or high-grade dysplasia)or short bowel syndrome

  • Participants with CD isolated to the stomach, duodenum, jejunum, or perianal region,without colonic or ileal involvement

  • Participants with following ongoing known complications of CD:

  • Any manifestation that might require bowel surgery while enrolled in the study

  • Participant with ostomy or ileoanal pouch

  • Participant diagnosed with conditions that could interfere with drug absorptionincluding but not limited to short bowel syndrome

  • Participant with surgical bowel resection within the past three months prior toscreening, or a history of >3 bowel resections

  • History of any other condition which, in the opinion of the Investigator, would putthe participant at risk by participation in the study

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Study Design

Total Participants: 99
Treatment Group(s): 2
Primary Treatment: SAR442970
Phase: 2
Study Start date:
June 03, 2025
Estimated Completion Date:
October 17, 2029

Connect with a study center

  • Investigational Site Number: 0360002

    Brisbane, Queensland 4101
    Australia

    Active - Recruiting

  • Investigational Site Number: 0360002

    Brisbane 2174003, Queensland 2152274 4101
    Australia

    Site Not Available

  • Mater Misericordiae Limited - Site Number: 0360002

    Brisbane 2174003, Queensland 2152274 4101
    Australia

    Active - Recruiting

  • Investigational Site Number: 0360004

    Kurralta Park, South Australia 5037
    Australia

    Active - Recruiting

  • Investigational Site Number: 0360004

    Kurralta Park 8348005, South Australia 2061327 5037
    Australia

    Site Not Available

  • SA Group of Specialists - IBDSA - Site Number: 0360004

    Kurralta Park 8348005, South Australia 2061327 5037
    Australia

    Active - Recruiting

  • Investigational Site Number: 0360001

    Footscray, 3011
    Australia

    Active - Recruiting

  • Investigational Site Number: 0360001

    Footscray 2166370, 3011
    Australia

    Site Not Available

  • Investigational Site Number: 0560001

    Leuven, B-3000
    Belgium

    Active - Recruiting

  • Investigational Site Number: 0560001

    Leuven 2792482, B-3000
    Belgium

    Site Not Available

  • Investigational Site Number: 1560008

    Changsha, 410013
    China

    Active - Recruiting

  • Investigative Site: 1560003

    Changsha, 410011
    China

    Active - Recruiting

  • Investigative Site: 1560003

    Changsha 1815577, 410011
    China

    Site Not Available

  • Investigative Site: 1560005

    Changzhou, 213003
    China

    Active - Recruiting

  • Investigative Site: 1560005

    Changzhou 1815456, 213003
    China

    Site Not Available

  • Investigational Site Number: 1560001

    Guangzhou, 510655
    China

    Active - Recruiting

  • Investigational Site Number: 1560001

    Guangzhou 1809858, 510655
    China

    Site Not Available

  • Investigational Site Number: 1560006

    Hangzhou, 310009
    China

    Active - Recruiting

  • Investigational Site Number: 1560006

    Hangzhou 1808926, 310009
    China

    Site Not Available

  • Investigative Site: 1560004

    Nanchang, 330006
    China

    Active - Recruiting

  • Investigative Site: 1560004

    Nanchang 1800163, 330006
    China

    Site Not Available

  • Investigative Site: 1560002

    Shanghai, 200092
    China

    Active - Recruiting

  • Investigative Site: 1560002

    Shanghai 1796236, 200092
    China

    Site Not Available

  • Investigational Site Number: 1560007

    Shenyang, 110004
    China

    Active - Recruiting

  • Investigational Site Number: 2030002

    Brno, JM 61500
    Czechia

    Active - Recruiting

  • Investigational Site Number: 2030002

    Brno 3078610, JM 61500
    Czechia

    Site Not Available

  • Vojenska Nemocnice Brno - Site Number: 2030002

    Brno 3078610, JM 61500
    Czechia

    Active - Recruiting

  • Investigational Site Number: 2030003

    Hradec Králové, 50012
    Czechia

    Active - Recruiting

  • Hepato-Gastroenterologie HK, s.r.o. - Site Number: 2030003

    Hradec Králové 3074967, 50012
    Czechia

    Active - Recruiting

  • Investigational Site Number: 2030003

    Hradec Králové 3074967, 50012
    Czechia

    Site Not Available

  • Investigational Site Number: 2030005

    Slaný, 274 01
    Czechia

    Active - Recruiting

  • Investigational Site Number: 2500001

    Montpellier, 34090
    France

    Active - Recruiting

  • Investigational Site Number: 2500001

    Montpellier 2992166, 34090
    France

    Site Not Available

  • Investigational Site Number: 2500003

    Nice, 6000
    France

    Active - Recruiting

  • Investigative Site: 2500003

    Nice, 6000
    France

    Active - Recruiting

  • Investigative Site: 2500003

    Nice 2990440, 6000
    France

    Site Not Available

  • Investigational Site Number: 2500002

    Toulouse, 31059
    France

    Active - Recruiting

  • Investigational Site Number: 2500002

    Toulouse 2972315, 31059
    France

    Site Not Available

  • Investigational Site Number: 2760002

    Minden, Northwest 32423
    Germany

    Active - Recruiting

  • Gastroenterologische Gemeinschaftspraxis Minden - Site Number: 2760002

    Minden 2871039, Northwest 32423
    Germany

    Active - Recruiting

  • Investigational Site Number: 2760002

    Minden 2871039, Northwest 32423
    Germany

    Site Not Available

  • Investigational Site Number: 2760003

    Jena, 07747
    Germany

    Active - Recruiting

  • Investigational Site Number: 2760004

    Kiel, 24105
    Germany

    Active - Recruiting

  • Investigational Site Number: 2760004

    Kiel 2891122, 24105
    Germany

    Site Not Available

  • Universitatsklinikum Schleswig-Holstein - Site Number: 2760004

    Kiel 2891122, 24105
    Germany

    Active - Recruiting

  • Investigational Site Number: 2760001

    Ulm, 89081
    Germany

    Active - Recruiting

  • Investigational Site Number: 3920007

    Kashiwa, Chiba 277-0871
    Japan

    Active - Recruiting

  • Investigational Site Number: 3920007

    Kashiwa 1859924, Chiba 2113014 277-0871
    Japan

    Site Not Available

  • Tsujinaka Hospital-Kashiwanoha - Site Number: 3920007

    Kashiwa 1859924, Chiba 2113014 277-0871
    Japan

    Active - Recruiting

  • Investigational Site Number: 3920005

    Ōita, Oita Prefecture 870-0033
    Japan

    Active - Recruiting

  • Investigational Site Number: 3920005

    Ōita 1854487, Oita Prefecture 1854484 870-0033
    Japan

    Site Not Available

  • Oita Red Cross Hospital - Site Number: 3920005

    Ōita 1854487, Oita Prefecture 1854484 870-0033
    Japan

    Active - Recruiting

  • Investigational Site Number: 3920006

    Hamamatsu, Shizuoka 432-8061
    Japan

    Active - Recruiting

  • Investigational Site Number: 3920006

    Hamamatsu 1863289, Shizuoka 1851715 432-8061
    Japan

    Active - Recruiting

  • Matsuda Hospital - Site Number: 3920006

    Hamamatsu 1863289, Shizuoka 1851715 432-8061
    Japan

    Active - Recruiting

  • Investigational Site Number: 3920004

    Bunkyō City, 113-8519
    Japan

    Active - Recruiting

  • Investigational Site Number: 3920004

    Bunkyō City 11790632, 113-8519
    Japan

    Site Not Available

  • Investigational Site Number: 3920003

    Hamamatsu, 431-3192
    Japan

    Active - Recruiting

  • Investigational Site Number: 3920003

    Hamamatsu 1863289, 431-3192
    Japan

    Site Not Available

  • Investigational Site Number: 3920009

    Hirosaki, 036-8545
    Japan

    Active - Recruiting

  • Investigational Site Number: 3920009

    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: 3920002

    Nishinomiya, 663-8501
    Japan

    Active - Recruiting

  • Investigational Site Number: 3920002

    Nishinomiya 1855207, 663-8501
    Japan

    Site Not Available

  • Investigational Site Number: 6160002

    Wroclaw, Lower Silesian Voivodeship 53-149
    Poland

    Active - Recruiting

  • Investigational Site Number: 6160002

    Wroclaw 3081368, Lower Silesian Voivodeship 3337492 53-149
    Poland

    Active - Recruiting

  • Vistamed & Vertigo Sp. z o.o. - Site Number: 6160002

    Wroclaw 3081368, Lower Silesian Voivodeship 3337492 53-149
    Poland

    Active - Recruiting

  • Investigational Site Number: 6160001

    Krakow, 31-501
    Poland

    Active - Recruiting

  • Investigational Site Number: 6160001

    Krakow 3094802, 31-501
    Poland

    Site Not Available

  • Investigational Site Number: 6160005

    Lublin, 20-582
    Poland

    Active - Recruiting

  • Investigational Site Number: 6160005

    Lublin 765876, 20-582
    Poland

    Site Not Available

  • Investigational Site Number: 6160006

    Sopot, 81-756
    Poland

    Active - Recruiting

  • Investigational Site Number: 6160006

    Sopot 3085151, 81-756
    Poland

    Site Not Available

  • Investigational Site Number: 6160003

    Warsaw, 01-783
    Poland

    Active - Recruiting

  • Investigational Site Number: 6160008

    Warsaw, 00-189
    Poland

    Active - Recruiting

  • Investigational Site Number: 6160003

    Warsaw 756135, 01-783
    Poland

    Active - Recruiting

  • Investigational Site Number: 6160008

    Warsaw 756135, 00-189
    Poland

    Site Not Available

  • Investigational Site Number: 6160004

    Wroclaw, 54-206
    Poland

    Active - Recruiting

  • Investigational Site Number: 6160004

    Wroclaw 3081368, 54-206
    Poland

    Site Not Available

  • Investigational Site Number: 7100003

    Johannesburg, 1619
    South Africa

    Active - Recruiting

  • Investigational Site Number: 7240001

    Madrid, 28046
    Spain

    Active - Recruiting

  • Investigational Site Number: 7240002

    Madrid, 28003
    Spain

    Active - Recruiting

  • Investigative Site: 7240001

    Madrid, 28046
    Spain

    Active - Recruiting

  • FutureMeds - Madrid Santa Elena - Site Number: 7240002

    Madrid 3117735, 28003
    Spain

    Active - Recruiting

  • Investigational Site Number: 7240002

    Madrid 3117735, 28003
    Spain

    Active - Recruiting

  • Investigative Site: 7240001

    Madrid 3117735, 28046
    Spain

    Site Not Available

  • Investigational Site Number: 7240003

    Seville, 41009
    Spain

    Active - Recruiting

  • Investigational Site Number: 7240003

    Seville 2510911, 41009
    Spain

    Site Not Available

  • Investigational Site Number: 8260007

    Bury, BL9 7TD
    United Kingdom

    Active - Recruiting

  • Investigational Site Number: 8260007

    Bury 2654187, BL9 7TD
    United Kingdom

    Site Not Available

  • Investigational Site Number: 8260004

    Cambridge, CB2 0QQ
    United Kingdom

    Active - Recruiting

  • Investigational Site Number: 8260004

    Cambridge 2653941, CB2 0QQ
    United Kingdom

    Site Not Available

  • Investigational Site Number: 8260001

    London, SE1 7EH
    United Kingdom

    Active - Recruiting

  • Investigational Site Number: 8260002

    London, HA8 0AD
    United Kingdom

    Active - Recruiting

  • Investigational Site Number: 8260005

    London, E11 1NR
    United Kingdom

    Active - Recruiting

  • Elpida Sciences Clinical Trials - Site Number: 8260002

    London 2643743, HA8 0AD
    United Kingdom

    Active - Recruiting

  • Investigational Site Number: 8260001

    London 2643743, SE1 7EH
    United Kingdom

    Active - Recruiting

  • Investigational Site Number: 8260002

    London 2643743, HA8 0AD
    United Kingdom

    Active - Recruiting

  • Investigational Site Number: 8260005

    London 2643743, E11 1NR
    United Kingdom

    Site Not Available

  • Investigational Site Number: 84000024

    Tucson, Arizona 85724
    United States

    Active - Recruiting

  • Investigational Site Number: 8400024

    Tucson, Arizona 85724
    United States

    Active - Recruiting

  • Investigational Site Number: 8400005

    Escondido, California 92025
    United States

    Active - Recruiting

  • Gastro Care Institute - Site Number: 8400001

    Lancaster, California 93534
    United States

    Site Not Available

  • Investigational Site Number: 8400001

    Lancaster, California 93534
    United States

    Active - Recruiting

  • Gastroenterology & Liver Institute - Site Number: 8400005

    Escondido 5346827, California 5332921 92025
    United States

    Active - Recruiting

  • Investigational Site Number: 8400005

    Escondido 5346827, California 5332921 92025
    United States

    Site Not Available

  • Gastro Care Institute - Site Number: 8400001

    Lancaster 5364940, California 5332921 93534
    United States

    Active - Recruiting

  • Investigational Site Number: 8400001

    Lancaster 5364940, California 5332921 93534
    United States

    Site Not Available

  • Central Florida Gastro Research - Site Number: 8400017

    Kissimmee, Florida 34741
    United States

    Site Not Available

  • Investigational Site Number: 8400017

    Kissimmee, Florida 34741
    United States

    Active - Recruiting

  • Investigational Site Number: 8400015

    Lighthouse PT, Florida 33064
    United States

    Active - Recruiting

  • Alliance Medical Research LLC - Site Number: 8400015

    Lighthouse Point, Florida 33064
    United States

    Site Not Available

  • Investigational Site Number 84000028

    Miami, Florida 33134
    United States

    Active - Recruiting

  • Investigational Site Number 8400028

    Miami, Florida 33134
    United States

    Active - Recruiting

  • Investigational Site Number: 8400012

    Miami, Florida 33136
    United States

    Active - Recruiting

  • Investigational Site Number: 8400007

    Orlando, Florida 32804
    United States

    Active - Recruiting

  • Investigational Site Number: 8400011

    Palmetto Bay, Florida 33176
    United States

    Active - Recruiting

  • Tropical Clinical Trials - Site Number: 8400011

    Palmetto Bay, Florida 33176
    United States

    Site Not Available

  • Central Florida Gastro Research - Site Number: 8400017

    Kissimmee 4160983, Florida 4155751 34741
    United States

    Active - Recruiting

  • Investigational Site Number: 8400017

    Kissimmee 4160983, Florida 4155751 34741
    United States

    Site Not Available

  • Alliance Medical Research LLC - Site Number: 8400015

    Lighthouse PT 4161957, Florida 4155751 33064
    United States

    Active - Recruiting

  • Investigational Site Number: 8400015

    Lighthouse PT 4161957, Florida 4155751 33064
    United States

    Site Not Available

  • Investigational Site Number: 8400012

    Miami 4164138, Florida 4155751 33136
    United States

    Site Not Available

  • Investigational Site Number: 8400011

    Palmetto Bay 4167634, Florida 4155751 33176
    United States

    Site Not Available

  • Tropical Clinical Trials - Site Number: 8400011

    Palmetto Bay 4167634, Florida 4155751 33176
    United States

    Active - Recruiting

  • Gastrointestinal Specialists of Georgia, PC - Site Number: 8400019

    Marietta, Georgia 30060
    United States

    Site Not Available

  • Investigational Site Number: 8400019

    Marietta, Georgia 30060
    United States

    Active - Recruiting

  • Gastrointestinal Specialists of Georgia, PC - Site Number: 8400019

    Marietta 4207783, Georgia 4197000 30060
    United States

    Active - Recruiting

  • Investigational Site Number: 8400019

    Marietta 4207783, Georgia 4197000 30060
    United States

    Site Not Available

  • Investigational Site Number: 8400025

    Iowa City, Iowa 52242
    United States

    Active - Recruiting

  • University of Iowa Hospitals and Clinics - Site Number: 8400025

    Iowa City, Iowa 52242
    United States

    Site Not Available

  • Investigational Site Number: 8400025

    Iowa City 4862034, Iowa 4862182 52242
    United States

    Site Not Available

  • University of Iowa Hospitals and Clinics - Site Number: 8400025

    Iowa City 4862034, Iowa 4862182 52242
    United States

    Active - Recruiting

  • Investigational Site Number: 8400006

    Kansas City, Kansas 66160
    United States

    Active - Recruiting

  • Investigational Site Number: 8400022

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • Brigham and Women's Hospital - Site Number: 8400022

    Boston 4930956, Massachusetts 6254926 02115
    United States

    Active - Recruiting

  • Investigational Site Number: 8400022

    Boston 4930956, Massachusetts 6254926 02115
    United States

    Site Not Available

  • Gastroenterology Associates of Western Michigan - Site Number: 8400008

    Wyoming, Michigan 49519
    United States

    Site Not Available

  • Investigational Site Number: 8400008

    Wyoming, Michigan 49519
    United States

    Active - Recruiting

  • Gastroenterology Associates of Western Michigan - Site Number: 8400008

    Wyoming 5015618, Michigan 5001836 49519
    United States

    Active - Recruiting

  • Investigational Site Number: 8400008

    Wyoming 5015618, Michigan 5001836 49519
    United States

    Site Not Available

  • Investigational Site Number: 8400013

    St Louis, Missouri 63110
    United States

    Active - Recruiting

  • Investigational Site Number: 8400013

    St Louis 4407066, Missouri 4398678 63110
    United States

    Site Not Available

  • Investigational Site Number: 8400003

    Chapel Hill, North Carolina 27599
    United States

    Active - Recruiting

  • Investigational Site Number: 8400002

    Chapel Hill 4460162, North Carolina 4482348 27599
    United States

    Site Not Available

  • University of North Carolina (UNC) - Site Number: 8400002

    Chapel Hill 4460162, North Carolina 4482348 27599
    United States

    Active - Recruiting

  • Investigational Site Number: 8400009

    Harrisburg, Pennsylvania 17110
    United States

    Active - Recruiting

  • Jackson Siegelbaum Gastroenterology - East Shore - Site Number: 8400009

    Harrisburg, Pennsylvania 17110
    United States

    Site Not Available

  • Investigational Site Number: 8400009

    Harrisburg 5192726, Pennsylvania 6254927 17110
    United States

    Site Not Available

  • Jackson Siegelbaum Gastroenterology - East Shore - Site Number: 8400009

    Harrisburg 5192726, Pennsylvania 6254927 17110
    United States

    Active - Recruiting

  • Gastroenterology Research of America, LLC. - Site Number: 8400002

    Fredericksburg, Texas 78229
    United States

    Site Not Available

  • Investigational Site Number: 8400002

    Fredericksburg, Texas 78229
    United States

    Active - Recruiting

  • Gastroenterology Research of America, LLC. - Site Number: 8400002

    Fredericksburg 4692279, Texas 4736286 78229
    United States

    Active - Recruiting

  • Investigational Site Number: 8400002

    Fredericksburg 4692279, Texas 4736286 78229
    United States

    Site Not Available

  • Investigational Site Number: 8400016

    Ogden, Utah 84405
    United States

    Active - Recruiting

  • Advanced Research Institute - Site Number: 8400016

    Ogden 5779206, Utah 5549030 84405
    United States

    Active - Recruiting

  • Investigational Site Number: 8400016

    Ogden 5779206, Utah 5549030 84405
    United States

    Site Not Available

  • Investigational Site Number: 8400027

    Richmond, Virginia 23249
    United States

    Active - Recruiting

  • Investigational Site Number: 8400027

    Richmond 4781708, Virginia 6254928 23249
    United States

    Site Not Available

  • Richmond VA Medical Center - Site Number: 8400027

    Richmond 4781708, Virginia 6254928 23249
    United States

    Active - Recruiting

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