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RECRUITING

NCT06867094

PHASE2

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

Sponsor: Sanofi

View on ClinicalTrials.gov

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.

Official title: 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 Ulcerative Colitis

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

204

Start Date

2025-03-28

Completion Date

2028-05-11

Last Updated

2026-04-06

Healthy Volunteers

Conditions

Colitis Ulcerative

Interventions

DRUG

SAR441566

Pharmaceutical form: Tablet Route of administration: Oral

DRUG

SAR441566 matching Placebo

Pharmaceutical form: Tablet Route of administration: Oral

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.

Locations (112)

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

Sun City, Arizona, United States

Bristol Hospital- Site Number : 8400017

Bristol, Connecticut, United States

Novum Research- Site Number : 8400018

Clermont, Florida, United States

Clinical Research of Osceola- Site Number : 8400012

Kissimmee, Florida, United States

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

Miami Lakes, Florida, United States

GCP Clinical Research- Site Number : 8400016

Tampa, Florida, United States

GI Alliance - Glenview- Site Number : 8400005

Glenview, Illinois, United States

Illinois Gastroenterology Group- Site Number : 8400004

Gurnee, Illinois, United States

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

Ann Arbor, Michigan, United States

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

New York, New York, United States

Queens Village Primary Medical Center- Site Number : 8400011

Queens Village, New York, United States

NexGen Research- Site Number : 8400020

Lima, Ohio, United States

Frontier Clinical Research - Uniontown- Site Number : 8400006

Uniontown, Pennsylvania, United States

Gastro Health & Nutrition- Site Number : 8400007

Katy, Texas, United States

SI Research Associates- Site Number : 8400019

Lubbock, Texas, United States

Texas Digestive Disease Consultants - Southlake- Site Number : 8400015

Southlake, Texas, United States

University of Washington Medical Center- Site Number : 8400014

Seattle, Washington, United States

Washington Gastroenterology - Tacoma- Site Number : 8400009

Tacoma, Washington, United States

Investigational Site Number : 0320004

San Miguel de Tucumán, Tucumán Province, Argentina

Investigational Site Number : 0320003

Buenos Aires, Argentina

Investigational Site Number : 0320002

Buenos Aires, Argentina

Investigational Site Number : 0320001

Buenos Aires, Argentina

Investigational Site Number : 0320005

Buenos Aires, Argentina

Investigational Site Number : 0360003

Kurralta Park, South Australia, Australia

Investigational Site Number : 0400003

Graz, Austria

Investigational Site Number : 0400002

Salzburg, Austria

Investigational Site Number : 0400001

Vienna, Austria

Investigational Site Number : 0560002

Ghent, Belgium

Investigational Site Number : 0560001

Leuven, Belgium

Hospital de Clinicas de Porto Alegre- Site Number : 0760002

Porto Alegre, Rio Grande do Sul, Brazil

Hospital Ernesto Dornelles- Site Number : 0760003

Porto Alegre, Rio Grande do Sul, Brazil

Investigational Site Number : 1000001

Burgas, Bulgaria

Investigational Site Number : 1000003

Rousse, Bulgaria

Investigational Site Number : 1000002

Sofia, Bulgaria

Investigational Site Number : 1240004

Kentville, Nova Scotia, Canada

Investigational Site Number : 1240005

Richmond Hill, Ontario, Canada

Investigational Site Number : 1240001

Québec, Quebec, Canada

Investigational Site Number : 1520002

Santiago, Reg Metropolitana de Santiago, Chile

Investigational Site Number : 1520003

Santiago, Reg Metropolitana de Santiago, Chile

Investigational Site Number : 1520001

Santiago, Reg Metropolitana de Santiago, Chile

Investigational Site Number : 1560002

Guangzhou, China

Investigational Site Number : 1560001

Hangzhou, China

Investigational Site Number : 1560003

Huizhou, China

Investigational Site Number : 1560004

Jiazhuang, China

Investigational Site Number : 1560014

Linhai, China

Investigational Site Number : 1560008

Luoyang, China

Investigational Site Number : 1560005

Shanghai, China

Investigational Site Number : 1560007

Shanghai, China

Investigational Site Number : 1560011

Wuhan, China

Investigational Site Number : 2030001

Olomouc, Czechia

Investigational Site Number : 2030002

Ostrava, Czechia

Investigational Site Number : 2500003

Nice, France

Investigational Site Number : 2500001

Toulouse, France

Investigational Site Number : 2500002

Vandœuvre-lès-Nancy, France

Investigational Site Number : 2680002

Tbilisi, Georgia

Investigational Site Number : 2680003

Tbilisi, Georgia

Investigational Site Number : 2680001

Tbilisi, Georgia

Investigational Site Number : 2760005

Berlin, Germany

Investigational Site Number : 2760008

Berlin, Germany

Investigational Site Number : 2760010

Duisburg, Germany

Investigational Site Number : 2760009

Frankfurt, Germany

Investigational Site Number : 2760003

Hanover, Germany

Investigational Site Number : 2760011

Tübingen, Germany

Investigational Site Number : 2760006

Ulm, Germany

Investigational Site Number : 3000001

Athens, Greece

Investigational Site Number : 3000003

Athens, Greece

Investigational Site Number : 3000002

Heraklion, Greece

Investigational Site Number : 3480001

Budapest, Hungary

Investigational Site Number : 3560005

Hyderabad, India

Investigational Site Number : 3560003

Jaipur, India

Investigational Site Number : 3560009

Jaipur, India

Investigational Site Number : 3560002

Kolkata, India

Investigational Site Number : 3560007

Secunderabad, India

Investigational Site Number : 3560001

Surat, India

Investigational Site Number : 3560010

Visakhapatnam, India

Investigational Site Number : 3800006

Genoa, Genova, Italy

Investigational Site Number : 3800002

Milan, Milano, Italy

Investigational Site Number : 3800003

Rozzano, Milano, Italy

Investigational Site Number : 3800008

Naples, Napoli, Italy

Investigational Site Number : 3800001

Padua, Padova, Italy

Investigational Site Number : 3800011

Rome, Roma, Italy

Investigational Site Number : 3800010

Turin, Torino, Italy

Investigational Site Number : 3800007

Alessandria, Italy

Investigational Site Number : 3800009

Palermo, Italy

Investigational Site Number : 3800004

Pisa, Italy

Investigational Site Number : 3920005

Kashiwa, Chiba, Japan

Investigational Site Number : 3920014

Kure, Hiroshima, Japan

Investigational Site Number : 3920003

Sapporo, Hokkaido, Japan

Investigational Site Number : 3920007

Sapporo, Hokkaido, Japan

Investigational Site Number : 3920009

Yahaba, Iwate, Japan

Investigational Site Number : 3920013

Yokohama, Kanagawa, Japan

Investigational Site Number : 3920002

Bunkyo, Tokyo, Japan

Investigational Site Number : 3920011

Kodaira, Tokyo, Japan

Investigational Site Number : 3920006

Kofu, Yamanashi, Japan

Investigational Site Number : 3920012

Hiroshima, Japan

Investigational Site Number : 3920016

Kagoshima, Japan

Investigational Site Number : 3920001

Niigata, Japan

Investigational Site Number : 3920010

Osaka, Japan

Investigational Site Number : 3920015

Tokyo, Japan

Investigational Site Number : 6160008

Oświęcim, Lesser Poland Voivodeship, Poland

Investigational Site Number : 6160005

Wroclaw, Lower Silesian Voivodeship, Poland

Investigational Site Number : 6160004

Warsaw, Masovian Voivodeship, Poland

Investigational Site Number : 6160001

Warsaw, Masovian Voivodeship, Poland

Investigational Site Number : 6160002

Rzeszów, Podkarpackie Voivodeship, Poland

Investigational Site Number : 7100002

Cape Town, South Africa

Investigational Site Number : 7100001

Cape Town, South Africa

Investigational Site Number : 7100004

KwaDukuza, South Africa

Investigational Site Number : 7100003

Pretoria, South Africa

Investigational Site Number : 7100005

Pretoria, South Africa

Investigational Site Number : 7920002

Istanbul, Turkey (Türkiye)

Investigational Site Number : 7920003

Izmir, Turkey (Türkiye)

Investigational Site Number : 7920001

Mersin, Turkey (Türkiye)

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (112)