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NCT06867094PHASE2Recruiting

A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Ulcerative Colitis

Sanofi

Start Date

3/28/2025

Completion Date

5/11/2028

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 UC. The primary objective of this study is to assess efficacy of different doses of SAR441566 on clinical remission in participants with moderate-to-severe ulcerative colitis. This study will include a screening period of up to 28 days (+ 7 calendar days if needed) followed by the main study treatment period of 52 weeks which will be comprised of a double blind (DB) treatment period with 12 weeks of induction period followed by a maintenance period of 40 weeks and 2-week follow-up after end of treatment. Additionally, an Open Label (OL) period of up to 40 weeks will be offered to eligible participants (for participants not enrolling in the LTS study). * The study duration will be up to 59 weeks. * The treatment duration will be up to 52 weeks in the DB arm and up to 40 weeks in the OL arm. * The number of visits will be 12 for the main study treatment period and 8 for the OL treatment period.

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 clinical evidence of active UC for ≥3 months before screening and confirmed by endoscopy during the screening period * 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, a mMES ≥2 confirmed by central reader, a minimum sum of all subscores of 5, and a disease extent \>15 cm from the anal verge * Must have received prior treatment for UC (either "a" or "b" below or a combination of both "a" and "b"): 1. History of no prior exposure to approved Advanced Therapy (AT), but having inadequate response to, loss of response to or intolerance to standard treatment with any of the following : 5-ASA, thiopurines (eg.6-MP, AZA), MTX, oral or intravenous (IV) corticosteroids or history of corticosteroid dependence (defined an inability to successfully taper corticosteroids without recurrence of UC) OR 2. History of inadequate response to, loss of response to or intolerance to treatment with ≥1 approved AT such as a biologic agent (eg. TNF antagonists, anti-integrin other than natalizumab, anti-IL-12/23, anti-IL-23, or a small molecule (such as a JAKi or S1PRm) for 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 CD, indeterminate colitis, ischemic colitis, microscopic colitis * Participants with the following ongoing known complications of UC: fulminant colitis, toxic megacolon, or any other manifestation that might require bowel surgery while enrolled in the study * Participant with prior colectomy, ostomy or ileoanal pouch, or anticipated colectomy during their participation in the study * Participants with fecal sample positive for ova or parasites, bacterial pathogens, or positive for Clostridium difficile B toxin in stools * Participants with active tuberculosis (TB) or a history of incompletely treated active TB or latent TB infection per local guidelines * Participants with Positive Hepatitis B surface antigen (HBsAg), or hepatitis B core antibody (HBcAb) and/or hepatitis C virus antibody (HCVAb) at the screening visit * Participants with any other active, chronic or recurrent infection, including recurrent or disseminated herpes zoster or disseminated herpes simplex * Participants with a known history of human immunodeficiency virus (HIV) infection or positive HIV-1 or HIV-2 serology at screening * Participants presenting with active malignancies, lymphoproliferative disease, or recurrence of either, within the 5 years before screening * History of gastro-intestinal dysplasia other than completely removed low grade dysplasia OR presence of colonic mucosal dysplasia or adenomatous colonic polyps not removed during endoscopy by the time of the screening visit. * If the participant has extensive colitis for ≥8 years or disease limited to left side of colon (ie, distal to splenic flexure) for \>10 years, regardless of age, a colonoscopy within 1 year of the screening visit is required to survey for dysplasia. Participants with dysplasia or cancer identified on biopsies will be excluded. * Female participants who is pregnant, breastfeeding, or is considering becoming pregnant during the study or within 3 months after the last dose of study drug * Infection(s) requiring treatment with IV anti-infectives within 30 days prior to the screening visit or oral/intramuscular anti-infectives within 14 days prior to the screening visit * Participants requiring or receiving any parental nutrition and/or exclusive enteral nutrition * Participants who received cyclosporine, tacrolimus, mycophenolate mofetil, or thalidomide within 30 days prior to screening * Participants who received fecal microbial transplantation within 30 days prior to screening * Participants who have ever been exposed to natalizumab (Tysabri®) or oral carotegrast methyl (Carogra®) * Participants who received IV corticosteroids within 14 days prior to screening or during screening period * Screening laboratory and other analyses show abnormal results. The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Interventions

DRUG

SAR441566

DRUG

SAR441566 matching Placebo

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Conditions

Colitis Ulcerative

Locations

GI Alliance - Arizona Digestive Health - Sun City- Site Number : 8400003

Sun City, Arizona 85351

United States

Bristol Hospital- Site Number : 8400017

Bristol, Connecticut 06010

United States

Novum Research- Site Number : 8400018

Clermont, Florida 34711

United States

Clinical Research of Osceola- Site Number : 8400012

Kissimmee, Florida 34741

United States

Wellness Clinical Research - Miami Lakes - 8181 Northwest 154th Street- Site Number : 8400002

Miami Lakes, Florida 33016

United States

GCP Clinical Research- Site Number : 8400016

Tampa, Florida 33609

United States

GI Alliance - Glenview- Site Number : 8400005

Glenview, Illinois 60026

United States

Illinois Gastroenterology Group- Site Number : 8400004

Gurnee, Illinois 60031

United States

University of Michigan Health System - Ann Arbor- Site Number : 8400010

Ann Arbor, Michigan 48109

United States

Icahn School of Medicine at Mount Sinai- Site Number : 8400001

New York, New York 10029

United States

Queens Village Primary Medical Center- Site Number : 8400011

Queens Village, New York 11428

United States

NexGen Research- Site Number : 8400020

Lima, Ohio 45805

United States

Frontier Clinical Research - Uniontown- Site Number : 8400006

Uniontown, Pennsylvania 15401

United States

Medical University Of South Carolina - MUSC Health Ashley River Tower - ART- Site Number : 8400008

Charleston, South Carolina 29401

United States

Gastro Health & Nutrition- Site Number : 8400007

Katy, Texas 77494

United States

SI Research Associates- Site Number : 8400019

Lubbock, Texas 79424

United States

Texas Digestive Disease Consultants - Southlake- Site Number : 8400015

Southlake, Texas 76092

United States

University of Washington Medical Center- Site Number : 8400014

Seattle, Washington 98195

United States

Washington Gastroenterology - Tacoma- Site Number : 8400009

Tacoma, Washington 98405

United States

Investigational Site Number : 0320004

San Miguel de Tucumán, Tucumán Province 4000

Argentina

Investigational Site Number : 0320003

Buenos Aires, 1006

Argentina

Investigational Site Number : 0320002

Buenos Aires, 1023

Argentina

Investigational Site Number : 0320001

Buenos Aires, 1061

Argentina

Investigational Site Number : 0320005

Buenos Aires, 1125

Argentina

Investigational Site Number : 0360003

Kurralta Park, South Australia 5037

Australia

Investigational Site Number : 0360005

Richmond, Victoria 3121

Australia

Investigational Site Number : 0400003

Graz, 8036

Austria

Investigational Site Number : 0400002

Salzburg, 5020

Austria

Investigational Site Number : 0400001

Vienna, 1090

Austria

Investigational Site Number : 0560002

Ghent, 9000

Belgium

Investigational Site Number : 0560001

Leuven, 3000

Belgium

Hospital de Clinicas de Porto Alegre- Site Number : 0760002

Porto Alegre, Rio Grande do Sul 90035903

Brazil

Hospital Ernesto Dornelles- Site Number : 0760003

Porto Alegre, Rio Grande do Sul 90160-093

Brazil

Investigational Site Number : 1000001

Burgas, 8000

Bulgaria

Investigational Site Number : 1000003

Rousse, 7002

Bulgaria

Investigational Site Number : 1000002

Sofia, 1612

Bulgaria

Investigational Site Number : 1240004

Kentville, Nova Scotia B4N 0A3

Canada

Investigational Site Number : 1240005

Richmond Hill, Ontario L4C 9M7

Canada

Investigational Site Number : 1240001

Québec, Quebec G1N 4V3

Canada

Investigational Site Number : 1520002

Santiago, Reg Metropolitana de Santiago 7500010

Chile

Investigational Site Number : 1520003

Santiago, Reg Metropolitana de Santiago 8330034

Chile

Investigational Site Number : 1520001

Santiago, Reg Metropolitana de Santiago 8331143

Chile

Investigational Site Number : 1560002

Guangzhou, 510655

China

Investigational Site Number : 1560001

Hangzhou, 310016

China

Investigational Site Number : 1560003

Huizhou, 516001

China

Investigational Site Number : 1560017

Huizhou, 516001

China

Investigational Site Number : 1560004

Jiazhuang, 050000

China

Investigational Site Number : 1560014

Linhai, 317000

China

Investigational Site Number : 1560008

Luoyang, 471003

China

Investigational Site Number : 1560005

Shanghai, 200120

China

Investigational Site Number : 1560011

Wuhan, 430014

China

Investigational Site Number : 2030001

Olomouc, 779 00

Czechia

Investigational Site Number : 2030002

Ostrava, 710 00

Czechia

Investigational Site Number : 2500003

Nice, 06202

France

Investigational Site Number : 2500001

Toulouse, 31059

France

Investigational Site Number : 2500002

Vandœuvre-lès-Nancy, 54511

France

Investigational Site Number : 2680002

Tbilisi, 0144

Georgia

Investigational Site Number : 2680003

Tbilisi, 0160

Georgia

Investigational Site Number : 2680001

Tbilisi, 0180

Georgia

Investigational Site Number : 2760005

Berlin, 10117

Germany

Investigational Site Number : 2760008

Berlin, 14050

Germany

Investigational Site Number : 2760010

Duisburg, 47055

Germany

Investigational Site Number : 2760009

Frankfurt, 60590

Germany

Investigational Site Number : 2760003

Hanover, 30625

Germany

Investigational Site Number : 2760011

Tübingen, 72076

Germany

Investigational Site Number : 2760006

Ulm, 89081

Germany

Investigational Site Number : 3000001

Athens, 106 76

Greece

Investigational Site Number : 3000003

Athens, 124 62

Greece

Investigational Site Number : 3000002

Heraklion, 711 10

Greece

Investigational Site Number : 3480001

Budapest, 1085

Hungary

Investigational Site Number : 3560005

Hyderabad, 500082

India

Investigational Site Number : 3560003

Jaipur, 302001

India

Investigational Site Number : 3560009

Jaipur, 302004

India

Investigational Site Number : 3560002

Kolkata, 700020

India

Investigational Site Number : 3560004

Ludhiana, 141002

India

Investigational Site Number : 3560007

Secunderabad, 500003

India

Investigational Site Number : 3560001

Surat, 395002

India

Investigational Site Number : 3560010

Visakhapatnam, 530040

India

Investigational Site Number : 3800006

Genoa, Genova 16132

Italy

Investigational Site Number : 3800002

Milan, Milano 20132

Italy

Investigational Site Number : 3800003

Rozzano, Milano 20089

Italy

Investigational Site Number : 3800008

Naples, Napoli 80131

Italy

Investigational Site Number : 3800001

Padua, Padova 35128

Italy

Investigational Site Number : 3800011

Rome, Roma 00161

Italy

Investigational Site Number : 3800010

Turin, Torino 10126

Italy

Investigational Site Number : 3800007

Alessandria, 15100

Italy

Investigational Site Number : 3800009

Palermo, 90127

Italy

Investigational Site Number : 3800004

Pisa, 56124

Italy

Investigational Site Number : 3920005

Kashiwa, Chiba 277-0871

Japan

Investigational Site Number : 3920014

Kure, Hiroshima 737-0811

Japan

Investigational Site Number : 3920003

Sapporo, Hokkaido 004-0041

Japan

Investigational Site Number : 3920007

Sapporo, Hokkaido 065-0033

Japan

Investigational Site Number : 3920009

Yahaba, Iwate 028-3695

Japan

Investigational Site Number : 3920013

Yokohama, Kanagawa 220-0041

Japan

Investigational Site Number : 3920002

Bunkyo-Ku, Tokyo 113-8510

Japan

Investigational Site Number : 3920011

Kodaira, Tokyo 187-8510

Japan

Investigational Site Number : 3920006

Kofu, Yamanashi 400-0027

Japan

Investigational Site Number : 3920012

Hiroshima, 734-8530

Japan

Investigational Site Number : 3920016

Kagoshima, 892-0843

Japan

Investigational Site Number : 3920001

Niigata, 950-1104

Japan

Investigational Site Number : 3920010

Osaka, 530-0011

Japan

Investigational Site Number : 3920015

Tokyo, 108-8642

Japan

Investigational Site Number : 6160008

Oświęcim, Lesser Poland Voivodeship 32-600

Poland

Investigational Site Number : 6160005

Wroclaw, Lower Silesian Voivodeship 50-750

Poland

Investigational Site Number : 6160004

Warsaw, Masovian Voivodeship 03-580

Poland

Investigational Site Number : 6160001

Warsaw, Masovian Voivodeship 04-501

Poland

Investigational Site Number : 6160002

Rzeszów, Podkarpackie Voivodeship 35-055

Poland

Investigational Site Number : 7100002

Cape Town, 7405

South Africa

Investigational Site Number : 7100001

Cape Town, 7708

South Africa

Investigational Site Number : 7100004

KwaDukuza, 4449

South Africa

Investigational Site Number : 7100003

Pretoria, 0002

South Africa

Investigational Site Number : 7100005

Pretoria, 0157

South Africa

Investigational Site Number : 7920002

Istanbul, 34899

Turkey (Türkiye)

Investigational Site Number : 7920003

Izmir, 35100

Turkey (Türkiye)

Investigational Site Number : 7920001

Mersin, 33070

Turkey (Türkiye)