En studie for å undersøke effekt og sikkerhet for SAR441566 hos pasienter med ulcerøs kolitt (SPECIFI-UC)
En fase 2, multinasjonal, multisenter, randomisert, dobbeltblind, placebokontrollert, doseringsundersøkelse for å evaluere effektiviteten og sikkerheten til SAR441566 hos voksne med moderat til alvorlig ulcerøs kolitt
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Fase 2
Kontakter og plasseringer
Studiesteder
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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, Australia, 5037
- Investigational Site Number : 0360003
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Victoria
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Richmond, Victoria, Australia, 3121
- Investigational Site Number : 0360005
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Ghent, Belgia, 9000
- Investigational Site Number : 0560002
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Leuven, Belgia, 3000
- Investigational Site Number : 0560001
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brasil, 90035903
- Hospital de Clinicas de Porto Alegre- Site Number : 0760002
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Porto Alegre, Rio Grande do Sul, Brasil, 90160-093
- Hospital Ernesto Dornelles- Site Number : 0760003
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Burgas, Bulgaria, 8000
- Investigational Site Number : 1000001
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Rousse, Bulgaria, 7002
- Investigational Site Number : 1000003
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Sofia, Bulgaria, 1612
- Investigational Site Number : 1000002
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Nova Scotia
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Kentville, Nova Scotia, Canada, B4N 0A3
- Investigational Site Number : 1240004
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Ontario
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Ajax, Ontario, Canada, L1S 7K7
- Investigational Site Number : 1240006
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Richmond Hill, Ontario, Canada, L4C 9M7
- Investigational Site Number : 1240005
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Quebec
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Québec, Quebec, Canada, G1N 4V3
- Investigational Site Number : 1240001
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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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Arizona
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Sun City, Arizona, Forente stater, 85351
- GI Alliance - Arizona Digestive Health - Sun City- Site Number : 8400003
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Connecticut
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Bristol, Connecticut, Forente stater, 06010
- Bristol Hospital- Site Number : 8400017
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Florida
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Clermont, Florida, Forente stater, 34711
- Novum Research- Site Number : 8400018
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Kissimmee, Florida, Forente stater, 34741
- Clinical Research of Osceola- Site Number : 8400012
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Miami Lakes, Florida, Forente stater, 33016
- Wellness Clinical Research - Miami Lakes - 8181 Northwest 154th Street- Site Number : 8400002
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Tampa, Florida, Forente stater, 33609
- GCP Clinical Research- Site Number : 8400016
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Illinois
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Glenview, Illinois, Forente stater, 60026
- GI Alliance - Glenview- Site Number : 8400005
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Gurnee, Illinois, Forente stater, 60031
- Illinois Gastroenterology Group- Site Number : 8400004
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Michigan
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Ann Arbor, Michigan, Forente stater, 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, Forente stater, 10029
- Icahn School of Medicine at Mount Sinai- Site Number : 8400001
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Queens Village, New York, Forente stater, 11428
- Queens Village Primary Medical Center- Site Number : 8400011
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Ohio
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Lima, Ohio, Forente stater, 45805
- NexGen Research- Site Number : 8400020
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Pennsylvania
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Uniontown, Pennsylvania, Forente stater, 15401
- Frontier Clinical Research - Uniontown- Site Number : 8400006
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South Carolina
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Charleston, South Carolina, Forente stater, 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, Forente stater, 77494
- Gastro Health & Nutrition- Site Number : 8400007
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Lubbock, Texas, Forente stater, 79424
- SI Research Associates- Site Number : 8400019
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Southlake, Texas, Forente stater, 76092
- Texas Digestive Disease Consultants - Southlake- Site Number : 8400015
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Washington
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Seattle, Washington, Forente stater, 98195
- University of Washington Medical Center- Site Number : 8400014
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Tacoma, Washington, Forente stater, 98405
- Washington Gastroenterology - Tacoma- Site Number : 8400009
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Nice, Frankrike, 06202
- Investigational Site Number : 2500003
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Toulouse, Frankrike, 31059
- Investigational Site Number : 2500001
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Vandœuvre-lès-Nancy, Frankrike, 54511
- Investigational Site Number : 2500002
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Tbilisi, Georgia, 0160
- Investigational Site Number : 2680003
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Tbilisi, Georgia, 0144
- Investigational Site Number : 2680002
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Tbilisi, Georgia, 0180
- Investigational Site Number : 2680001
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Athens, Hellas, 124 62
- Investigational Site Number : 3000003
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Athens, Hellas, 106 76
- Investigational Site Number : 3000001
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Heraklion, Hellas, 711 10
- Investigational Site Number : 3000002
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Hyderabad, India, 500082
- Investigational Site Number : 3560005
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Jaipur, India, 302001
- Investigational Site Number : 3560003
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Jaipur, India, 302004
- Investigational Site Number : 3560009
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Kolkata, India, 700020
- Investigational Site Number : 3560002
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Ludhiana, India, 141002
- Investigational Site Number : 3560004
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Secunderabad, India, 500003
- Investigational Site Number : 3560007
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Surat, India, 395002
- Investigational Site Number : 3560001
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Visakhapatnam, India, 530040
- Investigational Site Number : 3560010
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Alessandria, Italia, 15100
- Investigational Site Number : 3800007
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Palermo, Italia, 90127
- Investigational Site Number : 3800009
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Pisa, Italia, 56124
- Investigational Site Number : 3800004
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Genova
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Genoa, Genova, Italia, 16132
- Investigational Site Number : 3800006
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Milano
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Milan, Milano, Italia, 20132
- Investigational Site Number : 3800002
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Rozzano, Milano, Italia, 20089
- Investigational Site Number : 3800003
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Napoli
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Naples, Napoli, Italia, 80131
- Investigational Site Number : 3800008
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Padova
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Padua, Padova, Italia, 35128
- Investigational Site Number : 3800001
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Roma
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Rome, Roma, Italia, 00161
- Investigational Site Number : 3800011
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Torino
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Turin, Torino, Italia, 10126
- Investigational Site Number : 3800010
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Hiroshima, Japan, 734-8530
- Investigational Site Number : 3920012
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Kagoshima, Japan, 892-0843
- Investigational Site Number : 3920016
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Niigata, Japan, 950-1104
- Investigational Site Number : 3920001
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Osaka, Japan, 530-0011
- Investigational Site Number : 3920010
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Tokyo, Japan, 108-8642
- Investigational Site Number : 3920015
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Chiba
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Kashiwa, Chiba, Japan, 277-0871
- Investigational Site Number : 3920005
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Hiroshima
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Kure, Hiroshima, Japan, 737-0811
- Investigational Site Number : 3920014
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Hokkaido
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Sapporo, Hokkaido, Japan, 004-0041
- Investigational Site Number : 3920003
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Sapporo, Hokkaido, Japan, 065-0033
- Investigational Site Number : 3920007
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Iwate
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Yahaba, Iwate, Japan, 028-3695
- Investigational Site Number : 3920009
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Kanagawa
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Yokohama, Kanagawa, Japan, 220-0041
- Investigational Site Number : 3920013
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Tokyo
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Bunkyo-Ku, Tokyo, Japan, 113-8510
- Investigational Site Number : 3920002
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Kodaira, Tokyo, Japan, 187-8510
- Investigational Site Number : 3920011
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Yamanashi
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Kofu, Yamanashi, Japan, 400-0027
- Investigational Site Number : 3920006
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Guangzhou, Kina, 510655
- Investigational Site Number : 1560002
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Hangzhou, Kina, 310016
- Investigational Site Number : 1560001
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Huizhou, Kina, 516001
- Investigational Site Number : 1560003
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Huizhou, Kina, 516001
- Investigational Site Number : 1560017
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Jiazhuang, Kina, 050000
- Investigational Site Number : 1560004
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Linhai, Kina, 317000
- Investigational Site Number : 1560014
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Luoyang, Kina, 471003
- Investigational Site Number : 1560008
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Shanghai, Kina, 200120
- Investigational Site Number : 1560005
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Wuhan, Kina, 430014
- Investigational Site Number : 1560011
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Osijek, Kroatia, 31000
- Investigational Site Number : 1910001
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Lesser Poland Voivodeship
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Oświęcim, Lesser Poland Voivodeship, Polen, 32-600
- Investigational Site Number : 6160008
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Lower Silesian Voivodeship
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Wroclaw, Lower Silesian Voivodeship, Polen, 53-034
- Investigational Site Number : 6160005
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Masovian Voivodeship
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Warsaw, Masovian Voivodeship, Polen, 03-580
- Investigational Site Number : 6160004
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Warsaw, Masovian Voivodeship, Polen, 04-501
- Investigational Site Number : 6160001
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Podkarpackie Voivodeship
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Rzeszów, Podkarpackie Voivodeship, Polen, 35-055
- Investigational Site Number : 6160002
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Constanța, Romania, 900673
- Investigational Site Number : 6420001
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Cape Town, Sør-Afrika, 7405
- Investigational Site Number : 7100002
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Cape Town, Sør-Afrika, 7708
- Investigational Site Number : 7100001
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KwaDukuza, Sør-Afrika, 4449
- Investigational Site Number : 7100004
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Pretoria, Sør-Afrika, 0157
- Investigational Site Number : 7100005
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Pretoria, Sør-Afrika, 0002
- Investigational Site Number : 7100003
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Olomouc, Tsjekkia, 779 00
- Investigational Site Number : 2030001
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Ostrava, Tsjekkia, 710 00
- Investigational Site Number : 2030002
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Istanbul, Tyrkia (Türkiye), 34899
- Investigational Site Number : 7920002
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Izmir, Tyrkia (Türkiye), 35100
- Investigational Site Number : 7920003
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Mersin, Tyrkia (Türkiye), 33070
- Investigational Site Number : 7920001
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Berlin, Tyskland, 10117
- Investigational Site Number : 2760005
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Berlin, Tyskland, 14050
- Investigational Site Number : 2760008
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Duisburg, Tyskland, 47055
- Investigational Site Number : 2760010
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Frankfurt, Tyskland, 60590
- Investigational Site Number : 2760009
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Hanover, Tyskland, 30625
- Investigational Site Number : 2760003
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Tübingen, Tyskland, 72076
- Investigational Site Number : 2760011
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Ulm, Tyskland, 89081
- Investigational Site Number : 2760006
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Budapest, Ungarn
- Investigational Site Number : 3480001
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Salzburg, Østerrike, 5020
- Investigational Site Number : 0400002
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Vienna, Østerrike, 1090
- Investigational Site Number : 0400001
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: SAR441566 dose regimen 1
Participants will receive SAR441566 dose regimen 1 |
Pharmaceutical form: Tablet Route of administration: Oral |
|
Eksperimentell: SAR441566 dose regimen 2
Participants will receive SAR441566 dose regimen 2 |
Pharmaceutical form: Tablet Route of administration: Oral |
|
Eksperimentell: SAR441566 dose regimen 3
Participants will receive SAR441566 dose regimen 3 |
Pharmaceutical form: Tablet Route of administration: Oral |
|
Placebo komparator: Placebo
Participants will receive SAR441566-matching placebo |
Pharmaceutical form: Tablet Route of administration: Oral |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Proportion of participants achieving clinical remission at Week 12 by modified Mayo Score (mMS)
Tidsramme: Week 12
|
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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Plasma predosekonsentrasjoner av SAR441566 ved utvalgte besøk
Tidsramme: Opp til uke 52
|
Opp til uke 52
|
|
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Plasma -postdosekonsentrasjoner av SAR441566 ved utvalgte besøk
Tidsramme: Opp til uke 52
|
Opp til uke 52
|
|
|
Antall deltakere med eventuelle behandlingsoppførende bivirkninger (TEAE) i løpet av induksjon og vedlikeholdsbehandlingsperiode
Tidsramme: Opp til uke 52
|
Opp til uke 52
|
|
|
Antall deltakere med eventuelle behandlingsoppførende bivirkninger (TEAE) i løpet av åpen label behandlingsperiode
Tidsramme: Fra uke 12 til uke 52
|
Fra uke 12 til uke 52
|
|
|
Proportion of participants achieving clinical response at Week 12 by modified Mayo Score (mMS)
Tidsramme: Week 12
|
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
|
|
Proportion of participants achieving clinical response at Week 12 by full Mayo score (MS)
Tidsramme: 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
|
|
Proportion of participants achieving clinical remission at Week 12 by full Mayo score (MS)
Tidsramme: Week 12
|
Clinical remission by full Mayo score (MS) is defined as a MS ≤2 with no score >1. |
Week 12
|
|
Proportion of participants achieving the combination of patient-reported outcome 2 (PRO2) remission and endoscopic remission at Week 12
Tidsramme: Week 12
|
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
|
|
Proportion of participants achieving endoscopic remission at Week 12
Tidsramme: Week 12
|
Endoscopic remission is defined as mMES of 0. |
Week 12
|
|
Change from baseline in PRO2 from randomization to Week 12
Tidsramme: From Baseline to Week 12
|
PRO2 score is defined as the sum of the Mayo SF and RB subscores. |
From Baseline to Week 12
|
|
Proportion of participants achieving endoscopic response at Week 12
Tidsramme: Week 12
|
Endoscopic response is defined as mMES decrease of at least 1 point. |
Week 12
|
|
Proportion of participants achieving endoscopic improvement at Week 12
Tidsramme: Week 12
|
Endoscopic improvement is defined as mMES of 0 or 1 where 1 does not include friability. |
Week 12
|
|
Proportion of participants achieving HEMI at Week 12
Tidsramme: 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
Tidsramme: 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
|
|
Proportion of participants achieving Inflammatory Bowel Disease Questionnaire (IBDQ) response at Week 12
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- DRI17822
- U1111-1308-9729 (Annen identifikator: WHO)
- 2025-520705-12 (Registeridentifikator: CTIS)
- 2025 (U.S. NIH-stipend/kontrakt)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
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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