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NCT06958536PHASE2Recruiting

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

Sanofi

Start Date

6/3/2025

Completion Date

10/17/2029

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

Age Range: 18 years to 75 years

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 or small molecules), but having inadequate response to, loss or response to or intolerance 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 regulations regarding the methods of contraception for those participating in clinical studies Exclusion Criteria: * Participants with active Ulcerative Colitis (UC), indeterminate colitis, adenomatous colonic 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 absorption including but not limited to short bowel syndrome * Participant with surgical bowel resection within the past three months prior to screening, or a history of \>3 bowel resections * History of any other condition which, in the opinion of the Investigator, would put the 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.

Interventions

DRUG

SAR442970

DRUG

Placebo

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Conditions

Crohn's Disease

Locations

Investigational Site Number: 8400024

Tucson, Arizona 85724

United States

Investigational Site Number: 8400005

Escondido, California 92025

United States

Investigational Site Number: 8400001

Lancaster, California 93534

United States

Investigational Site Number: 8400017

Kissimmee, Florida 34741

United States

Investigational Site Number: 8400015

Lighthouse PT, Florida 33064

United States

Investigational Site Number 8400028

Miami, Florida 33134

United States

Investigational Site Number: 8400012

Miami, Florida 33136

United States

Investigational Site Number: 8400007

Orlando, Florida 32804

United States

Investigational Site Number: 8400011

Palmetto Bay, Florida 33176

United States

Investigational Site Number: 8400019

Marietta, Georgia 30060

United States

Investigational Site Number: 8400025

Iowa City, Iowa 52242

United States

Investigational Site Number: 8400006

Kansas City, Kansas 66160

United States

Investigational Site Number: 8400022

Boston, Massachusetts 02115

United States

Investigational Site Number: 8400008

Wyoming, Michigan 49519

United States

Investigational Site Number: 8400013

St Louis, Missouri 63110

United States

Investigational Site Number: 8400003

Chapel Hill, North Carolina 27599

United States

Investigational Site Number: 8400009

Harrisburg, Pennsylvania 17110

United States

Investigational Site Number: 8400002

Fredericksburg, Texas 78229

United States

Investigational Site Number: 8400016

Ogden, Utah 84405

United States

Investigational Site Number: 8400027

Richmond, Virginia 23249

United States

Investigational Site Number: 0360002

Brisbane, Queensland 4101

Australia

Investigational Site Number: 0360004

Kurralta Park, South Australia 5037

Australia

Investigational Site Number: 0360001

Footscray, 3011

Australia

Investigational Site Number: 0560001

Leuven, B-3000

Belgium

Investigative Site: 1560003

Changsha, 410011

China

Investigational Site Number: 1560008

Changsha, 410013

China

Investigative Site: 1560005

Changzhou, 213003

China

Investigational Site Number: 1560001

Guangzhou, 510655

China

Investigational Site Number: 1560006

Hangzhou, 310009

China

Investigative Site: 1560004

Nanchang, 330006

China

Investigative Site: 1560002

Shanghai, 200092

China

Investigational Site Number: 1560007

Shenyang, 110004

China

Investigational Site Number: 2030002

Brno, JM 61500

Czechia

Investigational Site Number: 2030003

Hradec Králové, 50012

Czechia

Investigational Site Number: 2030005

Slaný, 274 01

Czechia

Investigational Site Number: 2500001

Montpellier, 34090

France

Investigational Site Number: 2500003

Nice, 6000

France

Investigational Site Number: 2500002

Toulouse, 31059

France

Investigational Site Number: 2760002

Minden, Northwest 32423

Germany

Investigational Site Number: 2760003

Jena, 07747

Germany

Investigational Site Number: 2760004

Kiel, 24105

Germany

Investigational Site Number: 2760001

Ulm, 89081

Germany

Investigational Site Number: 3920007

Kashiwa, Chiba 277-0871

Japan

Investigational Site Number: 3920005

Ōita, Oita Prefecture 870-0033

Japan

Investigational Site Number: 3920006

Hamamatsu, Shizuoka 432-8061

Japan

Investigational Site Number: 3920004

Bunkyō City, 113-8519

Japan

Investigational Site Number: 3920003

Hamamatsu, 431-3192

Japan

Investigational Site Number: 3920009

Hirosaki, 036-8545

Japan

Investigational Site Number: 3920001

Morioka, 020-8505

Japan

Investigational Site Number: 3920002

Nishinomiya, 663-8501

Japan

Investigational Site Number: 6160002

Wroclaw, Lower Silesian Voivodeship 53-149

Poland

Investigational Site Number: 6160001

Krakow, 31-501

Poland

Investigational Site Number: 6160005

Lublin, 20-582

Poland

Investigational Site Number: 6160006

Sopot, 81-756

Poland

Investigational Site Number: 6160008

Warsaw, 00-189

Poland

Investigational Site Number: 6160003

Warsaw, 01-783

Poland

Investigational Site Number: 6160004

Wroclaw, 54-206

Poland

Investigational Site Number: 7100003

Johannesburg, 1619

South Africa

Investigational Site Number: 7240002

Madrid, 28003

Spain

Investigational Site Number: 7240001

Madrid, 28046

Spain

Investigational Site Number: 7240003

Seville, 41009

Spain

Investigational Site Number: 8260007

Bury, BL9 7TD

United Kingdom

Investigational Site Number: 8260004

Cambridge, CB2 0QQ

United Kingdom

Investigational Site Number: 8260005

London, E11 1NR

United Kingdom

Investigational Site Number: 8260002

London, HA8 0AD

United Kingdom

Investigational Site Number: 8260001

London, SE1 7EH

United Kingdom