A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Ulcerative Colitis
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
Interventions
SAR441566
SAR441566 matching Placebo
Conditions
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)