A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Crohn's Disease.
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
Interventions
SAR441566
SAR441566 matching Placebo
Conditions
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)