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NCT06637631PHASE2Recruiting

A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Crohn's Disease.

Sanofi

Start Date

12/10/2024

Completion Date

5/23/2029

Summary

This is a phase 2, multinational, multicenter, randomized, double-blind, placebo-controlled, dose ranging study to evaluate the efficacy and safety of SAR441566 in adults with moderate to severe Crohn's Disease (CD). The primary objective of this study is to assess the efficacy of different doses of SAR441566 compared with placebo in participants with moderate to severe CD. This study will have an anticipated duration of up to 59 weeks which will include a screening period of 4 weeks (+7 calendar days if needed), followed by the Main Study (MS) treatment period, lasting 52 weeks, and a 2-week follow-up period after end of treatment for participants not enrolling in the Long Term Safety (LTS) study. The MS period includes a Double-Blind (DB) treatment period with 12 weeks of induction followed by 40 weeks of maintenance. Additionally, an Open Label (OL) period of up to 40 weeks will be offered to eligible participants. The combined duration of the DB maintenance and OL periods cannot exceed 40 weeks, depending on when participants switch.

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: 1. Male or female participants aged 18 to 75 years at the time of signing the ICF 2. Confirmed diagnosis of CD for at least 3 months prior to Baseline 3. Confirmed diagnosis of moderate to severe CD as assessed by: * Crohn's Disease Activity Index (CDAI) score and the Simple Endoscopic Score for Crohn's disease (SES-CD) on an endoscopy confirmed by a central reader * stool frequency (SF), abdominal pain (AP) score 4. History of prior exposure to standard treatment (5-ASA, steroids, immunomodulators or antibiotics) or advanced therapies (biologics or small molecules), but having inadequate response to, loss or response to or intolerance to at least one of these therapies 5. On stable doses of standard treatments prior to screening (oral 5-ASA compounds, oral corticosteroids, thiopurines (eg. AZA, 6-MP), or MTX) 6. Contraceptive use by men and women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Women participants should not be pregnant or breastfeeding. Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: 1. Participants with active UC, indeterminate colitis or short bowel syndrome 2. Participants with CD isolated to the stomach, duodenum, jejunum, or peri anal region, without colonic or ileal involvement 3. Participants with following ongoing known complications of CD: fistula, abscess, symptomatic stricture/stenosis, fulminant colitis, toxic megacolon, recent bowel resection within 3 months of screening or history of \> 3 bowel resections 4. Participants with stool sample positive for infectious pathogens 5. Participants with active tuberculosis (TB) or a history of incompletely treated active or latent TB per local guidelines 6. Participants with Positive Hepatitis B surface antigen (HBsAg) or positive Hepatitis B core antibody (HBcAb); and/or positive Hepatitis C antibody (HCV) at the Screening Visit 7. Participants with any other active, chronic or recurrent infection, including recurrent or disseminated herpes zoster or disseminated herpes simplex 8. Participants with a known history of Human Immunodeficiency Virus (HIV) infection or positive HIV-1 or HIV-2 serology at screening 9. Participants presenting with active malignancies, lymphoproliferative disease, or recurrence of either, within the 5 years before screening 10. History of colonic mucosal dysplasia or presence of colonic mucosal dysplasia or adenomatous colonic polyps not removed during colonoscopy at screening visit 11. Infection(s) requiring treatment with IV anti infectives within 30 days or oral/intramuscular anti-infectives within 14 days prior to the screening visit 12. Participants requiring or receiving any parental nutrition and/or exclusive enteral nutrition 13. Participants who received cyclosporine, tacrolimus, mycophenolate mofetil, or thalidomide within 30 days prior to screening 14. Participants who received fecal microbial transplantation within 30 days prior to screening 15. Participants who have ever been exposed to natalizumab (Tysabri®) or oral carotegrast methyl (Carogra®) 16. Participants who received IV corticosteroids within 14 days prior to screening or during screening period 17. Participants who received therapeutic enema or suppository, other than required for colonoscopy within 14 days prior to screening or during screening 18. Screening laboratory and other analyses show abnormal results The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Interventions

DRUG

SAR441566

DRUG

SAR441566 matching Placebo

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Conditions

Crohn's Disease

Locations

GI Alliance - Arizona Digestive Health - Sun City- Site Number : 8400020

Sun City, Arizona 85351

United States

Bristol Hospital- Site Number : 8400007

Bristol, Connecticut 06010

United States

Novum Research- Site Number : 8400021

Clermont, Florida 34711

United States

Homestead Associates in Research- Site Number : 8400012

Homestead, Florida 33033

United States

Clinical Research of Osceola- Site Number : 8400013

Kissimmee, Florida 34741

United States

Wellness Clinical Research - Miami Lakes - 8181 Northwest 154th Street- Site Number : 8400010

Miami Lakes, Florida 33016

United States

GCP Clinical Research- Site Number : 8400004

Tampa, Florida 33609

United States

GI Alliance - Glenview- Site Number : 8400015

Glenview, Illinois 60026

United States

Illinois Gastroenterology Group- Site Number : 8400011

Gurnee, Illinois 60031

United States

University of Michigan Health System - Ann Arbor- Site Number : 8400017

Ann Arbor, Michigan 48109

United States

Gi Alliance - Flowood- Site Number : 8400019

Flowood, Mississippi 39232

United States

Vector Clinical Trials- Site Number : 8400001

Las Vegas, Nevada 89128

United States

Queens Village Primary Medical Center- Site Number : 8400005

Queens Village, New York 11428

United States

Carolina Digestive Diseases and Endoscopy Center- Site Number : 8400014

Greenville, North Carolina 27834

United States

Frontier Clinical Research - Uniontown- Site Number : 8400009

Uniontown, Pennsylvania 15401

United States

Medical University Of South Carolina - MUSC Health Ashley River Tower - ART- Site Number : 8400016

Charleston, South Carolina 29401

United States

Gastro Health & Nutrition- Site Number : 8400003

Katy, Texas 77494

United States

Texas Digestive Disease Consultants - Southlake- Site Number : 8400002

Southlake, Texas 76092

United States

Washington Gastroenterology - Tacoma- Site Number : 8400008

Tacoma, Washington 98405

United States

Investigational Site Number : 0320002

San Miguel de Tucumán, Tucumán Province 4000

Argentina

Investigational Site Number : 0320003

Buenos Aires, 1061

Argentina

Investigational Site Number : 0320005

Buenos Aires, 1119

Argentina

Investigational Site Number : 0320001

Buenos Aires, 1125

Argentina

Investigational Site Number : 0320004

Buenos Aires, 1221

Argentina

Investigational Site Number : 0320006

Buenos Aires, 1280

Argentina

Investigational Site Number : 0360002

Sydney, New South Wales 2139

Australia

Investigational Site Number : 0360001

South Brisbane, Queensland 4101

Australia

Investigational Site Number : 0360003

Parkville, Victoria 3050

Australia

Centro de Pesquisas da Clínica IBIS- Site Number : 0760001

Salvador, Estado de Bahia 41820-020

Brazil

Hospital Moinhos de Vento- Site Number : 0760006

Porto Alegre, Rio Grande do Sul 90035-902

Brazil

Hospital de Clinicas de Porto Alegre- Site Number : 0760007

Porto Alegre, Rio Grande do Sul 90035903

Brazil

Hospital Ernesto Dornelles- Site Number : 0760002

Porto Alegre, Rio Grande do Sul 90160-093

Brazil

Pesquisare Saude- Site Number : 0760004

Santo André, São Paulo 09080-110

Brazil

Investigational Site Number : 1000001

Gorna Oryahovitsa, 5100

Bulgaria

Investigational Site Number : 1000004

Sofia, 1431

Bulgaria

Investigational Site Number : 1000005

Sofia, 1680

Bulgaria

Investigational Site Number : 1240001

Calgary, Alberta T2N 4Z6

Canada

Investigational Site Number : 1240003

Montreal, Quebec H3H 1E8

Canada

Investigational Site Number : 1240005

Québec, Quebec G1N 4V3

Canada

Investigational Site Number : 1520006

Concepción, Biobio 4070038

Chile

Investigational Site Number : 1520004

Talcahuano, Biobio 2687000

Chile

Investigational Site Number : 1520007

Temuco, La Araucanía 4781156

Chile

Investigational Site Number : 1520001

Santiago, Reg Metropolitana de Santiago 8331143

Chile

Investigational Site Number : 1520003

Santiago, Reg Metropolitana de Santiago 8380456

Chile

Investigational Site Number : 1520002

Viña del Mar, Valparaiso 2540364

Chile

Investigational Site Number : 1560008

Changzhou, 213003

China

Investigational Site Number : 1560009

Chongqing, 400013

China

Investigational Site Number : 1560012

Fuzhou, 350005

China

Investigational Site Number : 1560001

Guangzhou, 510080

China

Investigational Site Number : 1560002

Guangzhou, 510655

China

Investigational Site Number : 1560004

Hangzhou, 310009

China

Investigational Site Number : 1560003

Hangzhou, 310016

China

Investigational Site Number : 1560007

Hefei, 230022

China

Investigational Site Number : 1560011

Nanchang, 330006

China

Investigational Site Number : 1560006

Shanghai, 200025

China

Investigational Site Number : 1560005

Shanghai, 200127

China

Investigational Site Number : 1560010

Suzhou, 215004

China

Investigational Site Number : 1910004

Osijek, 31000

Croatia

Investigational Site Number : 1910003

Zagreb, 10000

Croatia

Investigational Site Number : 2030003

Brno, 602 00

Czechia

Investigational Site Number : 2030002

Brno, 636 00

Czechia

Investigational Site Number : 2030004

Hradec Králové, 500 12

Czechia

Investigational Site Number : 2030006

Prague, 100 34

Czechia

Investigational Site Number : 2500005

Montpellier, 34295

France

Investigational Site Number : 2500002

Nice, 06202

France

Investigational Site Number : 2500004

Saint-Priest-en-Jarez, 42270

France

Investigational Site Number : 2500003

Toulouse, 31059

France

Investigational Site Number : 2500001

Vandœuvre-lès-Nancy, 54511

France

Investigational Site Number : 2680006

Kutaisi, 4600

Georgia

Investigational Site Number : 2680007

Tbilisi, 0102

Georgia

Investigational Site Number : 2680001

Tbilisi, 0144

Georgia

Investigational Site Number : 2680005

Tbilisi, 0159

Georgia

Investigational Site Number : 2680002

Tbilisi, 0160

Georgia

Investigational Site Number : 2680003

Tbilisi, 0172

Georgia

Investigational Site Number : 2680004

Tbilisi, 0180

Georgia

Investigational Site Number : 2760004

Berlin, 10318

Germany

Investigational Site Number : 2760002

Berlin, 12203

Germany

Investigational Site Number : 2760001

Fulda, 36043

Germany

Investigational Site Number : 2760005

Halle, 06108

Germany

Investigational Site Number : 2760006

Ludwigshafen, 67067

Germany

Investigational Site Number : 3480003

Békéscsaba, 5600

Hungary

Investigational Site Number : 3480008

Budapest, 1085

Hungary

Investigational Site Number : 3480010

Eger, 3300

Hungary

Investigational Site Number : 3480001

Gyöngyös, 3200

Hungary

Investigational Site Number : 3480009

Gyöngyös, 3200

Hungary

Investigational Site Number : 3480005

Szeged, 6720

Hungary

Investigational Site Number : 3480006

Szekszárd, 7100

Hungary

Investigational Site Number : 3480004

Tatabánya, 2800

Hungary

Investigational Site Number : 3560007

Hyderabad, 500032

India

Investigational Site Number : 3560003

Hyderabad, 500048

India

Investigational Site Number : 3560009

Jaipur, 302001

India

Investigational Site Number : 3560001

Jaipur, 302007

India

Investigational Site Number : 3560005

Kolkata, 700020

India

Investigational Site Number : 3560006

Pune, 412201

India

Investigational Site Number : 3560002

Secunderabad, 500003

India

Investigational Site Number : 3560013

Surat, 395002

India

Investigational Site Number : 3560010

Surat, 395010

India

Investigational Site Number : 3800009

Milan, Milano 20097

Italy

Investigational Site Number : 3800002

Milan, Milano 20132

Italy

Investigational Site Number : 3800004

Rozzano, Milano 20089

Italy

Investigational Site Number : 3800001

Padua, Padova 35128

Italy

Investigational Site Number : 3800008

Rome, Roma 00128

Italy

Investigational Site Number : 3800006

Rome, Roma 00168

Italy

Investigational Site Number : 3800005

Pisa, 56124

Italy

Investigational Site Number : 3920004

Kashiwa, Chiba 277-0871

Japan

Investigational Site Number : 3920001

Sakura, Chiba 285-0841

Japan

Investigational Site Number : 3920005

Kitakyushu, Fukuoka 802-0077

Japan

Investigational Site Number : 3920006

Sapporo, Hokkaido 004-0041

Japan

Investigational Site Number : 3920010

Sapporo, Hokkaido 064-0919

Japan

Investigational Site Number : 3920007

Sapporo, Hokkaido 065-0033

Japan

Investigational Site Number : 3920008

Yahaba, Iwate 028-3695

Japan

Investigational Site Number : 3920019

Takamatsu, Kagawa-ken 760-0017

Japan

Investigational Site Number : 3920020

Nagaoka, Niigata 940-2108

Japan

Investigational Site Number : 3920003

Bunkyo-Ku, Tokyo 113-8510

Japan

Investigational Site Number : 3920013

Hiroshima, 734-8530

Japan

Investigational Site Number : 3920018

Ōita, 870-0033

Japan

Investigational Site Number : 3920011

Tokyo, 169-0073

Japan

Investigational Site Number : 3920012

Wakayama, 640-8558

Japan

Investigational Site Number : 4800001

Vacoas, 72218

Mauritius

Investigational Site Number : 5280004

Breda, 4818 CK

Netherlands

Investigational Site Number : 5280002

Nijmegen, 6525 GA

Netherlands

Investigational Site Number : 5280001

Tilburg, 5022 GC

Netherlands

Investigational Site Number : 5280003

Utrecht, 3584 CX

Netherlands

Investigational Site Number : 6160005

Torun, Kuyavian-Pomeranian Voivodeship 87-100

Poland

Investigational Site Number : 6160006

Lublin, Lublin Voivodeship 20-582

Poland

Investigational Site Number : 6160004

Warsaw, Masovian Voivodeship 00-332

Poland

Investigational Site Number : 6160001

Warsaw, Masovian Voivodeship 02-507

Poland

Investigational Site Number : 6160002

Sopot, Pomeranian Voivodeship 81-756

Poland

Investigational Site Number : 6420004

Bucharest, 011461

Romania

Investigational Site Number : 6420003

Constanța, 900673

Romania

Investigational Site Number : 6420001

Timișoara, 300002

Romania

Investigational Site Number : 4100002

Haeundae-Gu, Busan 48108

South Korea

Investigational Site Number : 4100001

Daegu, Daegu 41944

South Korea

Investigational Site Number : 4100003

Daejeon, Daejeon 34943

South Korea

Investigational Site Number : 7240002

Seville, Sevilla 41009

Spain

Investigational Site Number : 7240001

Madrid, 28046

Spain

Investigational Site Number : 7920003

Istanbul, 34899

Turkey (Türkiye)

Investigational Site Number : 7920001

Mersin, 33070

Turkey (Türkiye)

Investigational Site Number : 7920006

Sanliurfa, 63290

Turkey (Türkiye)