Studie pro zkoumání účinnosti a bezpečnosti SAR441566 u pacientů s ulcerativní kolitidou (SPECIFI-UC)
Fáze 2, nadnárodní, multicentrická, randomizovaná, dvojitě zaslepená, placebem kontrolovaná, dávka v rozpětí pro vyhodnocení účinnosti a bezpečnosti SAR441566 u dospělých s mírnou až těžkou ulcerativní kolitidou
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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Typ studie
Zápis (Aktuální)
Fáze
- Fáze 2
Kontakty a umístění
Studijní místa
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Buenos Aires, Argentina, 1061
- Investigational Site Number : 0320001
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Buenos Aires, Argentina, 1006
- Investigational Site Number : 0320003
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Buenos Aires, Argentina, 1023
- Investigational Site Number : 0320002
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Buenos Aires, Argentina, 1125
- Investigational Site Number : 0320005
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Tucumán Province
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San Miguel de Tucumán, Tucumán Province, Argentina, 4000
- Investigational Site Number : 0320004
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South Australia
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Kurralta Park, South Australia, Austrálie, 5037
- Investigational Site Number : 0360003
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Victoria
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Richmond, Victoria, Austrálie, 3121
- Investigational Site Number : 0360005
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Ghent, Belgie, 9000
- Investigational Site Number : 0560002
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Leuven, Belgie, 3000
- Investigational Site Number : 0560001
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brazílie, 90035903
- Hospital de Clinicas de Porto Alegre- Site Number : 0760002
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Porto Alegre, Rio Grande do Sul, Brazílie, 90160-093
- Hospital Ernesto Dornelles- Site Number : 0760003
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Burgas, Bulharsko, 8000
- Investigational Site Number : 1000001
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Rousse, Bulharsko, 7002
- Investigational Site Number : 1000003
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Sofia, Bulharsko, 1612
- Investigational Site Number : 1000002
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Reg Metropolitana de Santiago
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Santiago, Reg Metropolitana de Santiago, Chile, 8330034
- Investigational Site Number : 1520003
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Santiago, Reg Metropolitana de Santiago, Chile, 7500010
- Investigational Site Number : 1520002
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Santiago, Reg Metropolitana de Santiago, Chile, 8331143
- Investigational Site Number : 1520001
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Osijek, Chorvatsko, 31000
- Investigational Site Number : 1910001
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Nice, Francie, 06202
- Investigational Site Number : 2500003
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Toulouse, Francie, 31059
- Investigational Site Number : 2500001
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Vandœuvre-lès-Nancy, Francie, 54511
- Investigational Site Number : 2500002
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Tbilisi, Gruzie, 0160
- Investigational Site Number : 2680003
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Tbilisi, Gruzie, 0144
- Investigational Site Number : 2680002
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Tbilisi, Gruzie, 0180
- Investigational Site Number : 2680001
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Hyderabad, Indie, 500082
- Investigational Site Number : 3560005
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Jaipur, Indie, 302001
- Investigational Site Number : 3560003
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Jaipur, Indie, 302004
- Investigational Site Number : 3560009
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Kolkata, Indie, 700020
- Investigational Site Number : 3560002
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Ludhiana, Indie, 141002
- Investigational Site Number : 3560004
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Secunderabad, Indie, 500003
- Investigational Site Number : 3560007
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Surat, Indie, 395002
- Investigational Site Number : 3560001
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Visakhapatnam, Indie, 530040
- Investigational Site Number : 3560010
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Alessandria, Itálie, 15100
- Investigational Site Number : 3800007
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Palermo, Itálie, 90127
- Investigational Site Number : 3800009
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Pisa, Itálie, 56124
- Investigational Site Number : 3800004
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Genova
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Genoa, Genova, Itálie, 16132
- Investigational Site Number : 3800006
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Milano
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Milan, Milano, Itálie, 20132
- Investigational Site Number : 3800002
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Rozzano, Milano, Itálie, 20089
- Investigational Site Number : 3800003
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Napoli
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Naples, Napoli, Itálie, 80131
- Investigational Site Number : 3800008
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Padova
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Padua, Padova, Itálie, 35128
- Investigational Site Number : 3800001
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Roma
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Rome, Roma, Itálie, 00161
- Investigational Site Number : 3800011
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Torino
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Turin, Torino, Itálie, 10126
- Investigational Site Number : 3800010
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Hiroshima, Japonsko, 734-8530
- Investigational Site Number : 3920012
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Kagoshima, Japonsko, 892-0843
- Investigational Site Number : 3920016
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Niigata, Japonsko, 950-1104
- Investigational Site Number : 3920001
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Osaka, Japonsko, 530-0011
- Investigational Site Number : 3920010
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Tokyo, Japonsko, 108-8642
- Investigational Site Number : 3920015
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Chiba
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Kashiwa, Chiba, Japonsko, 277-0871
- Investigational Site Number : 3920005
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Hiroshima
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Kure, Hiroshima, Japonsko, 737-0811
- Investigational Site Number : 3920014
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Hokkaido
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Sapporo, Hokkaido, Japonsko, 004-0041
- Investigational Site Number : 3920003
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Sapporo, Hokkaido, Japonsko, 065-0033
- Investigational Site Number : 3920007
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Iwate
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Yahaba, Iwate, Japonsko, 028-3695
- Investigational Site Number : 3920009
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Kanagawa
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Yokohama, Kanagawa, Japonsko, 220-0041
- Investigational Site Number : 3920013
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Tokyo
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Bunkyo-Ku, Tokyo, Japonsko, 113-8510
- Investigational Site Number : 3920002
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Kodaira, Tokyo, Japonsko, 187-8510
- Investigational Site Number : 3920011
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Yamanashi
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Kofu, Yamanashi, Japonsko, 400-0027
- Investigational Site Number : 3920006
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Cape Town, Jižní Afrika, 7405
- Investigational Site Number : 7100002
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Cape Town, Jižní Afrika, 7708
- Investigational Site Number : 7100001
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KwaDukuza, Jižní Afrika, 4449
- Investigational Site Number : 7100004
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Pretoria, Jižní Afrika, 0157
- Investigational Site Number : 7100005
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Pretoria, Jižní Afrika, 0002
- Investigational Site Number : 7100003
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Nova Scotia
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Kentville, Nova Scotia, Kanada, B4N 0A3
- Investigational Site Number : 1240004
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Ontario
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Ajax, Ontario, Kanada, L1S 7K7
- Investigational Site Number : 1240006
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Richmond Hill, Ontario, Kanada, L4C 9M7
- Investigational Site Number : 1240005
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Quebec
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Québec, Quebec, Kanada, G1N 4V3
- Investigational Site Number : 1240001
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Budapest, Maďarsko
- Investigational Site Number : 3480001
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Berlin, Německo, 10117
- Investigational Site Number : 2760005
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Berlin, Německo, 14050
- Investigational Site Number : 2760008
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Duisburg, Německo, 47055
- Investigational Site Number : 2760010
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Frankfurt, Německo, 60590
- Investigational Site Number : 2760009
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Hanover, Německo, 30625
- Investigational Site Number : 2760003
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Tübingen, Německo, 72076
- Investigational Site Number : 2760011
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Ulm, Německo, 89081
- Investigational Site Number : 2760006
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Lesser Poland Voivodeship
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Oświęcim, Lesser Poland Voivodeship, Polsko, 32-600
- Investigational Site Number : 6160008
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Lower Silesian Voivodeship
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Wroclaw, Lower Silesian Voivodeship, Polsko, 53-034
- Investigational Site Number : 6160005
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Masovian Voivodeship
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Warsaw, Masovian Voivodeship, Polsko, 03-580
- Investigational Site Number : 6160004
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Warsaw, Masovian Voivodeship, Polsko, 04-501
- Investigational Site Number : 6160001
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Podkarpackie Voivodeship
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Rzeszów, Podkarpackie Voivodeship, Polsko, 35-055
- Investigational Site Number : 6160002
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Salzburg, Rakousko, 5020
- Investigational Site Number : 0400002
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Vienna, Rakousko, 1090
- Investigational Site Number : 0400001
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Constanța, Rumunsko, 900673
- Investigational Site Number : 6420001
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Arizona
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Sun City, Arizona, Spojené státy, 85351
- GI Alliance - Arizona Digestive Health - Sun City- Site Number : 8400003
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Connecticut
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Bristol, Connecticut, Spojené státy, 06010
- Bristol Hospital- Site Number : 8400017
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Florida
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Clermont, Florida, Spojené státy, 34711
- Novum Research- Site Number : 8400018
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Kissimmee, Florida, Spojené státy, 34741
- Clinical Research of Osceola- Site Number : 8400012
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Miami Lakes, Florida, Spojené státy, 33016
- Wellness Clinical Research - Miami Lakes - 8181 Northwest 154th Street- Site Number : 8400002
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Tampa, Florida, Spojené státy, 33609
- GCP Clinical Research- Site Number : 8400016
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Illinois
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Glenview, Illinois, Spojené státy, 60026
- GI Alliance - Glenview- Site Number : 8400005
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Gurnee, Illinois, Spojené státy, 60031
- Illinois Gastroenterology Group- Site Number : 8400004
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Michigan
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Ann Arbor, Michigan, Spojené státy, 48109
- University of Michigan Health System - Ann Arbor- Site Number : 8400010
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New York
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New York, New York, Spojené státy, 10029
- Icahn School of Medicine at Mount Sinai- Site Number : 8400001
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Queens Village, New York, Spojené státy, 11428
- Queens Village Primary Medical Center- Site Number : 8400011
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Ohio
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Lima, Ohio, Spojené státy, 45805
- NexGen Research- Site Number : 8400020
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Pennsylvania
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Uniontown, Pennsylvania, Spojené státy, 15401
- Frontier Clinical Research - Uniontown- Site Number : 8400006
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South Carolina
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Charleston, South Carolina, Spojené státy, 29401
- Medical University Of South Carolina - MUSC Health Ashley River Tower - ART- Site Number : 8400008
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Texas
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Katy, Texas, Spojené státy, 77494
- Gastro Health & Nutrition- Site Number : 8400007
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Lubbock, Texas, Spojené státy, 79424
- SI Research Associates- Site Number : 8400019
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Southlake, Texas, Spojené státy, 76092
- Texas Digestive Disease Consultants - Southlake- Site Number : 8400015
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Washington
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Seattle, Washington, Spojené státy, 98195
- University of Washington Medical Center- Site Number : 8400014
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Tacoma, Washington, Spojené státy, 98405
- Washington Gastroenterology - Tacoma- Site Number : 8400009
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Istanbul, Turecko (Türkiye), 34899
- Investigational Site Number : 7920002
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Izmir, Turecko (Türkiye), 35100
- Investigational Site Number : 7920003
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Mersin, Turecko (Türkiye), 33070
- Investigational Site Number : 7920001
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Olomouc, Česko, 779 00
- Investigational Site Number : 2030001
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Ostrava, Česko, 710 00
- Investigational Site Number : 2030002
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Guangzhou, Čína, 510655
- Investigational Site Number : 1560002
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Hangzhou, Čína, 310016
- Investigational Site Number : 1560001
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Huizhou, Čína, 516001
- Investigational Site Number : 1560003
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Huizhou, Čína, 516001
- Investigational Site Number : 1560017
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Jiazhuang, Čína, 050000
- Investigational Site Number : 1560004
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Linhai, Čína, 317000
- Investigational Site Number : 1560014
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Luoyang, Čína, 471003
- Investigational Site Number : 1560008
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Shanghai, Čína, 200120
- Investigational Site Number : 1560005
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Wuhan, Čína, 430014
- Investigational Site Number : 1560011
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Athens, Řecko, 124 62
- Investigational Site Number : 3000003
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Athens, Řecko, 106 76
- Investigational Site Number : 3000001
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Heraklion, Řecko, 711 10
- Investigational Site Number : 3000002
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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 inclusive, at the time of signing the informed consent
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Participants who have clinical evidence of active UC for ≥3 months before screening and confirmed by endoscopy during the screening period
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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
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Must have received prior treatment for UC (either "a" or "b" below or a combination of both "a" and "b"):
- 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
- 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
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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.
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Čtyřnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: SAR441566 dose regimen 1
Participants will receive SAR441566 dose regimen 1 |
Pharmaceutical form: Tablet Route of administration: Oral |
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Experimentální: SAR441566 dose regimen 2
Participants will receive SAR441566 dose regimen 2 |
Pharmaceutical form: Tablet Route of administration: Oral |
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Experimentální: SAR441566 dose regimen 3
Participants will receive SAR441566 dose regimen 3 |
Pharmaceutical form: Tablet Route of administration: Oral |
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Komparátor placeba: Placebo
Participants will receive SAR441566-matching placebo |
Pharmaceutical form: Tablet Route of administration: Oral |
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Proportion of participants achieving clinical remission at Week 12 by modified Mayo Score (mMS)
Časové okno: Week 12
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Clinical remission by modified Mayo score (mMS) is defined as a mMS ≤2 with no subscore >1 (stool frequency [SF] of 0 or 1 with at least a 1-point decrease from baseline, rectal bleeding [RB] of 0 and modified Mayo Endoscopic Subscore [mMES] of 0 or 1 where 1 does not include friability). Each component of the mMS (SF, RB, and mMES) is scored from 0 to 3. The total mMS ranges from 0 to 9 with higher scores indicating greater disease severity. |
Week 12
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Plazma předložila koncentrace SAR441566 při vybraných návštěvách
Časové okno: Až do týdne 52
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Až do týdne 52
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Koncentrace podoby SAR441566 v plazmě při vybraných návštěvách
Časové okno: Až do týdne 52
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Až do týdne 52
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Počet účastníků s jakýmikoli nežádoucími účinky (TEAE) během období indukce a údržby
Časové okno: Až do týdne 52
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Až do týdne 52
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Počet účastníků s jakýmikoli nežádoucími účinky (TEAES) s ošetřením během otevřeného období ošetření
Časové okno: Od 12. do 52. týdne
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Od 12. do 52. týdne
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Proportion of participants achieving clinical response at Week 12 by modified Mayo Score (mMS)
Časové okno: Week 12
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Clinical response by modified Mayo score (mMS) is defined as a decrease from baseline in the mMS of ≥2 points and an improvement of ≥30% from baseline plus a decrease in rectal bleeding (RB) subscore ≥1 or an absolute RB subscore ≤1. Each component of the mMS (SF, RB, and mMES) is scored from 0 to 3. The total mMS ranges from 0 to 9 with higher scores indicating greater disease severity. |
Week 12
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Proportion of participants achieving clinical response at Week 12 by full Mayo score (MS)
Časové okno: Week 12
|
Clinical response by full Mayo score (MS) is defined as a decrease from baseline in the MS of ≥3 points and an improvement of ≥30% from baseline plus a decrease in rectal bleeding (RB) subscore ≥1 or an absolute RB subscore ≤1. The MS (also referred to as the full Mayo Score) is a composite index designed to measure ulcerative colitis (UC) disease activity and consists of 4 subscores: RB and SF, which are patient-reported subscores, Physician's global assessment (PGA), and endoscopic findings. Individual items are rated 0 to 3, giving the composite score a maximum of 12, with higher scores indicating greater disease severity. |
Week 12
|
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Proportion of participants achieving clinical remission at Week 12 by full Mayo score (MS)
Časové okno: Week 12
|
Clinical remission by full Mayo score (MS) is defined as a MS ≤2 with no score >1. |
Week 12
|
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Proportion of participants achieving the combination of patient-reported outcome 2 (PRO2) remission and endoscopic remission at Week 12
Časové okno: Week 12
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Patient-reported outcome 2 (PRO2) remission is defined as PRO2 score ≤1 with rectal bleeding (RB) of 0, and endoscopic remission is defined as mMES of 0. PRO2 score is defined as the sum of Mayo SF and RB subscores. |
Week 12
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Proportion of participants achieving endoscopic remission at Week 12
Časové okno: Week 12
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Endoscopic remission is defined as mMES of 0. |
Week 12
|
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Change from baseline in PRO2 from randomization to Week 12
Časové okno: From Baseline to Week 12
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PRO2 score is defined as the sum of the Mayo SF and RB subscores. |
From Baseline to Week 12
|
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Proportion of participants achieving endoscopic response at Week 12
Časové okno: Week 12
|
Endoscopic response is defined as mMES decrease of at least 1 point. |
Week 12
|
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Proportion of participants achieving endoscopic improvement at Week 12
Časové okno: Week 12
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Endoscopic improvement is defined as mMES of 0 or 1 where 1 does not include friability. |
Week 12
|
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Proportion of participants achieving HEMI at Week 12
Časové okno: Week 12
|
Histologic endoscopic mucosal improvement (HEMI) is defined by achievement of modified Mayo endoscopic improvement (mMES of 0 or 1 where 1 does not include friability) and histological improvement (original Geboes Score [OGS] ≤3.1). |
Week 12
|
|
Proportion achieving Inflammatory Bowel Disease Questionnaire (IBDQ) remission at Week 12
Časové okno: Week 12
|
Inflammatory Bowel Disease Questionnaire (IBDQ) remission is considered as an IBDQ-32 total score ≥170 points. IBDQ is designed to capture the patient's experience of IBD on 4 domains of functioning and well-being: bowel and systemic symptoms and emotional and social function. The total IBDQ score ranges from 32 to 224 which indicates better quality of life. |
Week 12
|
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Proportion of participants achieving Inflammatory Bowel Disease Questionnaire (IBDQ) response at Week 12
Časové okno: Week 12
|
Inflammatory Bowel Disease Questionnaire (IBDQ) response is defined as an increase from baseline in the total IBDQ score in the range of 16 to 32 points. |
Week 12
|
Spolupracovníci a vyšetřovatelé
Sponzor
Publikace a užitečné odkazy
Užitečné odkazy
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
Další identifikační čísla studie
- DRI17822
- U1111-1308-9729 (Jiný identifikátor: WHO)
- 2025-520705-12 (Identifikátor registru: CTIS)
- 2025 (Grant/smlouva NIH USA)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu 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
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Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
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