Um estudo para investigar a eficácia e segurança do SAR441566 em pacientes com doença de Crohn. (SPECIFI-CD)
Um estudo de fase 2, multinacional, multicêntrico, randomizado, duplo-cego, controlado por placebo e de variação de dose para avaliar a eficácia e segurança de SAR441566 em adultos com doença de Crohn moderada a grave.
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 2
Contactos e Locais
Locais de estudo
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Berlin, Alemanha, 10318
- Investigational Site Number : 2760004
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Berlin, Alemanha, 12203
- Investigational Site Number : 2760002
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Fulda, Alemanha, 36043
- Investigational Site Number : 2760001
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Halle, Alemanha, 06108
- Investigational Site Number : 2760005
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Ludwigshafen, Alemanha, 67067
- Investigational Site Number : 2760006
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Magdeburg, Alemanha, 39104
- Investigational Site Number : 2760008
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Nordhausen, Alemanha, 99734
- Investigational Site Number : 2760007
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Buenos Aires, Argentina, 1061
- Investigational Site Number : 0320003
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Buenos Aires, Argentina, 1119
- Investigational Site Number : 0320005
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Buenos Aires, Argentina, 1125
- Investigational Site Number : 0320001
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Buenos Aires, Argentina, 1221
- Investigational Site Number : 0320004
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Buenos Aires, Argentina, 1280
- Investigational Site Number : 0320006
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Tucumán Province
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San Miguel de Tucumán, Tucumán Province, Argentina, 4000
- Investigational Site Number : 0320002
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New South Wales
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Sydney, New South Wales, Austrália, 2139
- Investigational Site Number : 0360002
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Queensland
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South Brisbane, Queensland, Austrália, 4101
- Investigational Site Number : 0360001
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Victoria
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Parkville, Victoria, Austrália, 3050
- Investigational Site Number : 0360003
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Estado de Bahia
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Salvador, Estado de Bahia, Brasil, 41820-020
- Centro de Pesquisas da Clínica IBIS- Site Number : 0760001
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brasil, 90035-902
- Hospital Moinhos de Vento- Site Number : 0760006
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Porto Alegre, Rio Grande do Sul, Brasil, 90035903
- Hospital de Clinicas de Porto Alegre- Site Number : 0760007
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Porto Alegre, Rio Grande do Sul, Brasil, 90160-093
- Hospital Ernesto Dornelles- Site Number : 0760002
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São Paulo
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Santo André, São Paulo, Brasil, 09080-110
- Pesquisare Saude- Site Number : 0760004
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Gorna Oryahovitsa, Bulgária, 5100
- Investigational Site Number : 1000001
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Sofia, Bulgária, 1680
- Investigational Site Number : 1000005
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Sofia, Bulgária, 1431
- Investigational Site Number : 1000004
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Alberta
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Calgary, Alberta, Canadá, T2N 4Z6
- Investigational Site Number : 1240001
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Quebec
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Montreal, Quebec, Canadá, H3H 1E8
- Investigational Site Number : 1240003
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Québec, Quebec, Canadá, G1N 4V3
- Investigational Site Number : 1240005
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Biobio
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Concepción, Biobio, Chile, 4070038
- Investigational Site Number : 1520006
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Reg Metropolitana de Santiago
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Santiago, Reg Metropolitana de Santiago, Chile, 8331143
- Investigational Site Number : 1520001
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Santiago, Reg Metropolitana de Santiago, Chile, 8380456
- Investigational Site Number : 1520003
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Valparaiso
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Viña del Mar, Valparaiso, Chile, 2540364
- Investigational Site Number : 1520002
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Changzhou, China, 213003
- Investigational Site Number : 1560008
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Chongqing, China, 400013
- Investigational Site Number : 1560009
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Fuzhou, China, 350005
- Investigational Site Number : 1560012
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Guangzhou, China, 510080
- Investigational Site Number : 1560001
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Guangzhou, China, 510655
- Investigational Site Number : 1560002
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Hangzhou, China, 310009
- Investigational Site Number : 1560004
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Hangzhou, China, 310016
- Investigational Site Number : 1560003
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Hefei, China, 230022
- Investigational Site Number : 1560007
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Nanchang, China, 330006
- Investigational Site Number : 1560011
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Shanghai, China, 200025
- Investigational Site Number : 1560006
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Shanghai, China, 200127
- Investigational Site Number : 1560005
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Suzhou, China, 215004
- Investigational Site Number : 1560010
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Busan
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Haeundae-Gu, Busan, Coréia do Sul, 48108
- Investigational Site Number : 4100002
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Daegu
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Daegu, Daegu, Coréia do Sul, 41944
- Investigational Site Number : 4100001
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Daejeon
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Daejeon, Daejeon, Coréia do Sul, 34943
- Investigational Site Number : 4100003
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Gangwon-do
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Wŏnju, Gangwon-do, Coréia do Sul, 26426
- Investigational Site Number : 4100004
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Osijek, Croácia, 31000
- Investigational Site Number : 1910004
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Zagreb, Croácia, 10000
- Investigational Site Number : 1910003
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Madrid, Comunidad de
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Madrid, Madrid, Comunidad de, Espanha, 28046
- Investigational Site Number : 7240001
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Sevilla
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Seville, Sevilla, Espanha, 41009
- Investigational Site Number : 7240002
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Arizona
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Sun City, Arizona, Estados Unidos, 85351
- GI Alliance - Arizona Digestive Health - Sun City- Site Number : 8400020
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Connecticut
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Bristol, Connecticut, Estados Unidos, 06010
- Bristol Hospital- Site Number : 8400007
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Florida
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Clermont, Florida, Estados Unidos, 34711
- Novum Research- Site Number : 8400021
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Homestead, Florida, Estados Unidos, 33033
- Homestead Associates in Research- Site Number : 8400012
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Kissimmee, Florida, Estados Unidos, 34741
- Clinical Research of Osceola- Site Number : 8400013
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Miami Lakes, Florida, Estados Unidos, 33016
- Wellness Clinical Research - Miami Lakes - 8181 Northwest 154th Street- Site Number : 8400010
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Tampa, Florida, Estados Unidos, 33609
- GCP Clinical Research- Site Number : 8400004
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Illinois
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Glenview, Illinois, Estados Unidos, 60026
- GI Alliance - Glenview- Site Number : 8400015
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Gurnee, Illinois, Estados Unidos, 60031
- Illinois Gastroenterology Group- Site Number : 8400011
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48109
- University of Michigan Health System - Ann Arbor- Site Number : 8400017
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Mississippi
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Flowood, Mississippi, Estados Unidos, 39232
- Gi Alliance - Flowood- Site Number : 8400019
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Nevada
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Las Vegas, Nevada, Estados Unidos, 89128
- Vector Clinical Trials- Site Number : 8400001
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New York
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Queens Village, New York, Estados Unidos, 11428
- Queens Village Primary Medical Center- Site Number : 8400005
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North Carolina
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Greenville, North Carolina, Estados Unidos, 27834
- Carolina Digestive Diseases and Endoscopy Center- Site Number : 8400014
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Pennsylvania
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Uniontown, Pennsylvania, Estados Unidos, 15401
- Frontier Clinical Research - Uniontown- Site Number : 8400009
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South Carolina
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Charleston, South Carolina, Estados Unidos, 29401
- Medical University Of South Carolina - MUSC Health Ashley River Tower - ART- Site Number : 8400016
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Texas
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Katy, Texas, Estados Unidos, 77494
- Gastro Health & Nutrition- Site Number : 8400003
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Southlake, Texas, Estados Unidos, 76092
- Texas Digestive Disease Consultants - Southlake- Site Number : 8400002
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Washington
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Tacoma, Washington, Estados Unidos, 98405
- Washington Gastroenterology - Tacoma- Site Number : 8400008
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Montpellier, França, 34090
- Investigational Site Number : 2500005
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Nice, França, 06202
- Investigational Site Number : 2500002
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Saint-Priest-en-Jarez, França, 42270
- Investigational Site Number : 2500004
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Toulouse, França, 31059
- Investigational Site Number : 2500003
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Vandœuvre-lès-Nancy, França, 54511
- Investigational Site Number : 2500001
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Kutaisi, Geórgia, 4600
- Investigational Site Number : 2680006
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Tbilisi, Geórgia, 0160
- Investigational Site Number : 2680002
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Tbilisi, Geórgia, 0102
- Investigational Site Number : 2680007
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Tbilisi, Geórgia, 0144
- Investigational Site Number : 2680001
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Tbilisi, Geórgia, 0159
- Investigational Site Number : 2680005
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Tbilisi, Geórgia, 0172
- Investigational Site Number : 2680003
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Tbilisi, Geórgia, 0180
- Investigational Site Number : 2680004
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Breda, Holanda, 4818 CK
- Investigational Site Number : 5280004
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Nijmegen, Holanda, 6525 GA
- Investigational Site Number : 5280002
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Tilburg, Holanda, 5022 GC
- Investigational Site Number : 5280001
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Utrecht, Holanda, 3584 CX
- Investigational Site Number : 5280003
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Budapest, Hungria, 1085
- Investigational Site Number : 3480002
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Budapest, Hungria, 1085
- Investigational Site Number : 3480008
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Békéscsaba, Hungria, 5600
- Investigational Site Number : 3480003
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Eger, Hungria, 3300
- Investigational Site Number : 3480010
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Gyöngyös, Hungria, 3200
- Investigational Site Number : 3480001
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Gyöngyös, Hungria, 3200
- Investigational Site Number : 3480009
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Szeged, Hungria, 6720
- Investigational Site Number : 3480005
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Szekszárd, Hungria, 7100
- Investigational Site Number : 3480006
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Tatabánya, Hungria, 2800
- Investigational Site Number : 3480004
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Pisa, Itália, 56124
- Investigational Site Number : 3800005
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Milano
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Milan, Milano, Itália, 20132
- Investigational Site Number : 3800002
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Milan, Milano, Itália, 20097
- Investigational Site Number : 3800009
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Rozzano, Milano, Itália, 20089
- Investigational Site Number : 3800004
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Padova
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Padua, Padova, Itália, 35128
- Investigational Site Number : 3800001
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Roma
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Rome, Roma, Itália, 00168
- Investigational Site Number : 3800006
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Rome, Roma, Itália, 00128
- Investigational Site Number : 3800008
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Hiroshima, Japão, 734-8530
- Investigational Site Number : 3920013
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Tokyo, Japão, 169-0073
- Investigational Site Number : 3920011
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Wakayama, Japão, 640-8558
- Investigational Site Number : 3920012
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Ōita, Japão, 870-0033
- Investigational Site Number : 3920018
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Chiba
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Kashiwa, Chiba, Japão, 277-0871
- Investigational Site Number : 3920004
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Sakura, Chiba, Japão, 285-0841
- Investigational Site Number : 3920001
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Fukuoka
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Kitakyushu, Fukuoka, Japão, 802-0077
- Investigational Site Number : 3920005
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Hokkaido
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Sapporo, Hokkaido, Japão, 065-0033
- Investigational Site Number : 3920007
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Sapporo, Hokkaido, Japão, 004-0041
- Investigational Site Number : 3920006
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Sapporo, Hokkaido, Japão, 064-0919
- Investigational Site Number : 3920010
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Iwate
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Yahaba, Iwate, Japão, 028-3695
- Investigational Site Number : 3920008
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Kagawa-ken
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Takamatsu, Kagawa-ken, Japão, 760-0017
- Investigational Site Number : 3920019
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Niigata
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Nagaoka, Niigata, Japão, 940-2108
- Investigational Site Number : 3920020
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Tokyo
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Bunkyo-Ku, Tokyo, Japão, 113-8510
- Investigational Site Number : 3920003
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Vacoas, Maurício
- Investigational Site Number : 4800001
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Kuyavian-Pomeranian Voivodeship
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Torun, Kuyavian-Pomeranian Voivodeship, Polônia, 87-100
- Investigational Site Number : 6160005
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Lublin Voivodeship
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Lublin, Lublin Voivodeship, Polônia, 20-582
- Investigational Site Number : 6160006
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Masovian Voivodeship
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Warsaw, Masovian Voivodeship, Polônia, 02-507
- Investigational Site Number : 6160001
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Warsaw, Masovian Voivodeship, Polônia, 00-332
- Investigational Site Number : 6160004
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Pomeranian Voivodeship
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Sopot, Pomeranian Voivodeship, Polônia, 81-756
- Investigational Site Number : 6160002
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Bucharest, Romênia, 011461
- Investigational Site Number : 6420004
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Cluj-Napoca, Romênia, 400162
- Investigational Site Number : 6420005
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Constanța, Romênia, 900673
- Investigational Site Number : 6420003
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Timișoara, Romênia, 300002
- Investigational Site Number : 6420001
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Brno, Tcheca, 602 00
- Investigational Site Number : 2030003
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Brno, Tcheca, 636 00
- Investigational Site Number : 2030002
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Olomouc, Tcheca, 779 00
- Investigational Site Number : 2030001
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Prague, Tcheca, 100 34
- Investigational Site Number : 2030006
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Mersin, Turquia (Türkiye), 33070
- Investigational Site Number : 7920001
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Sanliurfa, Turquia (Türkiye), 63290
- Investigational Site Number : 7920006
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Hyderabad, Índia, 500032
- Investigational Site Number : 3560007
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Hyderabad, Índia, 500048
- Investigational Site Number : 3560003
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Jaipur, Índia, 302001
- Investigational Site Number : 3560009
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Jaipur, Índia, 302007
- Investigational Site Number : 3560001
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Kolkata, Índia, 700020
- Investigational Site Number : 3560005
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Pune, Índia, 412201
- Investigational Site Number : 3560006
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Secunderabad, Índia, 500003
- Investigational Site Number : 3560002
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Surat, Índia, 395002
- Investigational Site Number : 3560013
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Surat, Índia, 395010
- Investigational Site Number : 3560010
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
Inclusion Criteria:
Participants are eligible to be included in the study only if all of the following criteria apply:
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Male or female participants aged 18 to 75 years at the time of signing the ICF
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Confirmed diagnosis of CD for at least 3 months prior to Baseline
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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
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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
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On stable doses of standard treatments prior to screening (oral 5-ASA compounds, oral corticosteroids, thiopurines (eg. AZA, 6-MP), or MTX)
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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:
- Participants with active UC, indeterminate colitis or short bowel syndrome
- Participants with CD isolated to the stomach, duodenum, jejunum, or peri anal region, without colonic or ileal involvement
- 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
- Participants with stool sample positive for infectious pathogens
- Participants with active tuberculosis (TB) or a history of incompletely treated active or latent TB per local guidelines
- 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
- 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 colonic mucosal dysplasia or presence of colonic mucosal dysplasia or adenomatous colonic polyps not removed during colonoscopy at screening visit
- Infection(s) requiring treatment with IV anti infectives within 30 days 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
- Participants who received therapeutic enema or suppository, other than required for colonoscopy within 14 days prior to screening or during screening
- 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.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: SAR441566 dose 1
Participants will receive SAR441566 dose 1. |
Pharmaceutical form: Tablet Route of administration: Oral |
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Experimental: SAR441566 dose 2
Participants will receive SAR441566 dose 2. |
Pharmaceutical form: Tablet Route of administration: Oral |
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Experimental: SAR441566 dose 3
Participants will receive SAR441566 dose 3. |
Pharmaceutical form: Tablet Route of administration: Oral |
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Comparador de Placebo: Placebo
Participants will receive SAR441566 matching placebo. |
Pharmaceutical form: Tablet Route of administration: Oral |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Proportion of participants achieving endoscopic response
Prazo: Week 12
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Endoscopic response is defined as ≥50% reduction from baseline in centrally read Simple Endoscopic Score for Crohn's Disease (SES-CD). The SES-CD evaluates 4 endoscopic variables (ulcer size, ulcerated surface, affected surface, and narrowing, each on a scale from 0 (none) to 3 in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, sigmoid and left colon, and rectum). The total score is the sum of the 4 endoscopic variable scores and ranges from 0 to 56, where higher scores indicate more severe disease. |
Week 12
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Concentrações plasmáticas pré-dose de SAR441566 em visitas selecionadas
Prazo: Até a semana 52
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Até a semana 52
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Concentrações plasmáticas pós-dose de SAR441566 em visitas selecionadas
Prazo: Até a semana 52
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Até a semana 52
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Proportion of participants achieving clinical remission based on Crohn's Disease Activity Index (CDAI)
Prazo: Week 12
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CDAI clinical remission is defined as CDAI score <150. CDAI is a composite instrument that includes participant symptoms evaluated over 7 days (abdominal pain, stool frequency and general well-being), as well as presence of complications (arthritis/arthralgia, iritis/uveitis, erythema nodosum/pyoderma gangrenosum/aphthous stomatitis, anal fissure/fistula/abscess, other fistula, and fever), the use of antidiarrheal medicines, presence of an abdominal mass, hematocrit, and body weight. These items are scored individually, weighted, and do not contribute equally to the overall score. The CDAI is derived from summing up the weighted individual scores of eight items. CDAI approximately ranges from 0 to 600 with higher scores indicating more severe disease. |
Week 12
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Proportion of participants achieving Patient-Reported Outcome (PRO-2) remission
Prazo: Week 12
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PRO 2 remission is defined as the unweighted CDAI component of daily abdominal pain (AP) score ≤1, and the unweighted CDAI component of daily average stool frequency (SF) score ≤3 (ie, AP ≤1 and SF ≤3 and no worsening from baseline). |
Week 12
|
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Proportion of participants achieving both clinical remission and endoscopic response
Prazo: Week 12
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Clinical remission and endoscopic response based on CDAI <150 and ≥50% reduction from baseline in centrally read Simple Endoscopic Score for Crohn's Disease (SES-CD) |
Week 12
|
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Proportion of participants achieving endoscopic remission based on centrally read SES-CD
Prazo: From Baseline to Week 12
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Endoscopic remission is defined as a centrally read SES-CD ≤4 points (SES-CD ≤2 points for isolated ileal disease) and a SES-CD decrease from baseline ≥2 points with no SES-CD sub score >1 point |
From Baseline to Week 12
|
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Proportion of participants achieving CDAI clinical response
Prazo: From Baseline to Week 12
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CDAI clinical response is defined as a CDAI reduction from baseline ≥100 points. |
From Baseline to Week 12
|
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Proportion of participants achieving Inflammatory Bowel Disease Questionnaire (IBDQ) remission
Prazo: Week 12
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IBDQ remission is defined as IBDQ total score ≥170 points. The Inflammatory Bowel Disease Questionnaire (IBDQ) is used to assess health-related quality of life (HRQoL) in patients with inflammatory bowel disease. It consists of 32 questions evaluating bowel and systemic symptoms, as well as emotional and social functions. Each question is answered on a scale from 1 (worst) to 7 (best). The total score ranges from 32 to 224 with higher scores indicating better health-related quality of life. |
Week 12
|
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Proportion of participants achieving IBDQ response
Prazo: From baseline to Week 12
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IBDQ response defined as an improvement of IBDQ scores by 27 points or more at Week 12 compared with baseline |
From baseline to Week 12
|
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Change from baseline in the IBDQ scores
Prazo: From Baseline to week 12
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The total IBDQ score ranges from 32 to 224 which indicates better quality of life. A positive change from Baseline indicates improvement. |
From Baseline to week 12
|
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Number of participants experiencing any TEAEs
Prazo: Up to week 52
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Any TEAEs, including any serious opportunistic infections, psoriasiform skin lesions or other immune mediated phenomena during double-blind (DB) induction and maintenance treatment period |
Up to week 52
|
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Number of participants experiencing any TEAEs
Prazo: From week 12 to week 52
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Any TEAEs, including any serious opportunistic infections, psoriasiform skin lesions or other immune mediated phenomena during open-label treatment period |
From week 12 to week 52
|
Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- DRI18212
- 2024-512633-32-00 (Identificador de registro: CTIS)
- U1111-1301-3830 (Outro identificador: WHO ICTRP)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
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