Tutkimus SAR441566:n tehon ja turvallisuuden tutkimiseksi Crohnin tautia sairastavilla potilailla. (SPECIFI-CD)
Vaihe 2, monikansallinen, monikeskus, satunnaistettu, kaksoissokkoutettu, lumekontrolloitu, annosvälitteinen tutkimus SAR441566:n tehon ja turvallisuuden arvioimiseksi aikuisilla, joilla on keskivaikea tai vaikea Crohnin tauti.
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.
Tutkimuksen yleiskatsaus
Tila
Ehdot
Interventio / Hoito
Opintotyyppi
Ilmoittautuminen (Todellinen)
Vaihe
- Vaihe 2
Yhteystiedot ja paikat
Opiskelupaikat
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Breda, Alankomaat, 4818 CK
- Investigational Site Number : 5280004
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Nijmegen, Alankomaat, 6525 GA
- Investigational Site Number : 5280002
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Tilburg, Alankomaat, 5022 GC
- Investigational Site Number : 5280001
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Utrecht, Alankomaat, 3584 CX
- Investigational Site Number : 5280003
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Buenos Aires, Argentiina, 1061
- Investigational Site Number : 0320003
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Buenos Aires, Argentiina, 1119
- Investigational Site Number : 0320005
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Buenos Aires, Argentiina, 1125
- Investigational Site Number : 0320001
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Buenos Aires, Argentiina, 1221
- Investigational Site Number : 0320004
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Buenos Aires, Argentiina, 1280
- Investigational Site Number : 0320006
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Tucumán Province
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San Miguel de Tucumán, Tucumán Province, Argentiina, 4000
- Investigational Site Number : 0320002
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New South Wales
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Sydney, New South Wales, Australia, 2139
- Investigational Site Number : 0360002
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Queensland
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South Brisbane, Queensland, Australia, 4101
- Investigational Site Number : 0360001
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Victoria
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Parkville, Victoria, Australia, 3050
- Investigational Site Number : 0360003
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Estado de Bahia
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Salvador, Estado de Bahia, Brasilia, 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, Brasilia, 90035-902
- Hospital Moinhos de Vento- Site Number : 0760006
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Porto Alegre, Rio Grande do Sul, Brasilia, 90035903
- Hospital de Clinicas de Porto Alegre- Site Number : 0760007
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Porto Alegre, Rio Grande do Sul, Brasilia, 90160-093
- Hospital Ernesto Dornelles- Site Number : 0760002
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São Paulo
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Santo André, São Paulo, Brasilia, 09080-110
- Pesquisare Saude- Site Number : 0760004
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Gorna Oryahovitsa, Bulgaria, 5100
- Investigational Site Number : 1000001
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Sofia, Bulgaria, 1680
- Investigational Site Number : 1000005
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Sofia, Bulgaria, 1431
- Investigational Site Number : 1000004
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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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Madrid, Comunidad de
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Madrid, Madrid, Comunidad de, Espanja, 28046
- Investigational Site Number : 7240001
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Sevilla
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Seville, Sevilla, Espanja, 41009
- Investigational Site Number : 7240002
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Busan
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Haeundae-Gu, Busan, Etelä -Korea, 48108
- Investigational Site Number : 4100002
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Daegu
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Daegu, Daegu, Etelä -Korea, 41944
- Investigational Site Number : 4100001
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Daejeon
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Daejeon, Daejeon, Etelä -Korea, 34943
- Investigational Site Number : 4100003
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Gangwon-do
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Wŏnju, Gangwon-do, Etelä -Korea, 26426
- Investigational Site Number : 4100004
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Kutaisi, Georgia, 4600
- Investigational Site Number : 2680006
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Tbilisi, Georgia, 0160
- Investigational Site Number : 2680002
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Tbilisi, Georgia, 0102
- Investigational Site Number : 2680007
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Tbilisi, Georgia, 0144
- Investigational Site Number : 2680001
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Tbilisi, Georgia, 0159
- Investigational Site Number : 2680005
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Tbilisi, Georgia, 0172
- Investigational Site Number : 2680003
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Tbilisi, Georgia, 0180
- Investigational Site Number : 2680004
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Hyderabad, Intia, 500032
- Investigational Site Number : 3560007
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Hyderabad, Intia, 500048
- Investigational Site Number : 3560003
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Jaipur, Intia, 302001
- Investigational Site Number : 3560009
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Jaipur, Intia, 302007
- Investigational Site Number : 3560001
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Kolkata, Intia, 700020
- Investigational Site Number : 3560005
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Pune, Intia, 412201
- Investigational Site Number : 3560006
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Secunderabad, Intia, 500003
- Investigational Site Number : 3560002
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Surat, Intia, 395002
- Investigational Site Number : 3560013
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Surat, Intia, 395010
- Investigational Site Number : 3560010
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Pisa, Italia, 56124
- Investigational Site Number : 3800005
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Milano
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Milan, Milano, Italia, 20132
- Investigational Site Number : 3800002
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Milan, Milano, Italia, 20097
- Investigational Site Number : 3800009
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Rozzano, Milano, Italia, 20089
- Investigational Site Number : 3800004
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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, 00168
- Investigational Site Number : 3800006
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Rome, Roma, Italia, 00128
- Investigational Site Number : 3800008
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Hiroshima, Japani, 734-8530
- Investigational Site Number : 3920013
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Tokyo, Japani, 169-0073
- Investigational Site Number : 3920011
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Wakayama, Japani, 640-8558
- Investigational Site Number : 3920012
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Ōita, Japani, 870-0033
- Investigational Site Number : 3920018
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Chiba
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Kashiwa, Chiba, Japani, 277-0871
- Investigational Site Number : 3920004
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Sakura, Chiba, Japani, 285-0841
- Investigational Site Number : 3920001
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Fukuoka
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Kitakyushu, Fukuoka, Japani, 802-0077
- Investigational Site Number : 3920005
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Hokkaido
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Sapporo, Hokkaido, Japani, 065-0033
- Investigational Site Number : 3920007
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Sapporo, Hokkaido, Japani, 004-0041
- Investigational Site Number : 3920006
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Sapporo, Hokkaido, Japani, 064-0919
- Investigational Site Number : 3920010
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Iwate
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Yahaba, Iwate, Japani, 028-3695
- Investigational Site Number : 3920008
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Kagawa-ken
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Takamatsu, Kagawa-ken, Japani, 760-0017
- Investigational Site Number : 3920019
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Niigata
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Nagaoka, Niigata, Japani, 940-2108
- Investigational Site Number : 3920020
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Tokyo
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Bunkyo-Ku, Tokyo, Japani, 113-8510
- Investigational Site Number : 3920003
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Alberta
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Calgary, Alberta, Kanada, T2N 4Z6
- Investigational Site Number : 1240001
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Quebec
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Montreal, Quebec, Kanada, H3H 1E8
- Investigational Site Number : 1240003
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Québec, Quebec, Kanada, G1N 4V3
- Investigational Site Number : 1240005
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Changzhou, Kiina, 213003
- Investigational Site Number : 1560008
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Chongqing, Kiina, 400013
- Investigational Site Number : 1560009
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Fuzhou, Kiina, 350005
- Investigational Site Number : 1560012
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Guangzhou, Kiina, 510080
- Investigational Site Number : 1560001
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Guangzhou, Kiina, 510655
- Investigational Site Number : 1560002
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Hangzhou, Kiina, 310009
- Investigational Site Number : 1560004
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Hangzhou, Kiina, 310016
- Investigational Site Number : 1560003
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Hefei, Kiina, 230022
- Investigational Site Number : 1560007
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Nanchang, Kiina, 330006
- Investigational Site Number : 1560011
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Shanghai, Kiina, 200025
- Investigational Site Number : 1560006
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Shanghai, Kiina, 200127
- Investigational Site Number : 1560005
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Suzhou, Kiina, 215004
- Investigational Site Number : 1560010
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Osijek, Kroatia, 31000
- Investigational Site Number : 1910004
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Zagreb, Kroatia, 10000
- Investigational Site Number : 1910003
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Vacoas, Mauritius
- Investigational Site Number : 4800001
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Kuyavian-Pomeranian Voivodeship
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Torun, Kuyavian-Pomeranian Voivodeship, Puola, 87-100
- Investigational Site Number : 6160005
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Lublin Voivodeship
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Lublin, Lublin Voivodeship, Puola, 20-582
- Investigational Site Number : 6160006
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Masovian Voivodeship
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Warsaw, Masovian Voivodeship, Puola, 02-507
- Investigational Site Number : 6160001
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Warsaw, Masovian Voivodeship, Puola, 00-332
- Investigational Site Number : 6160004
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Pomeranian Voivodeship
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Sopot, Pomeranian Voivodeship, Puola, 81-756
- Investigational Site Number : 6160002
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Montpellier, Ranska, 34090
- Investigational Site Number : 2500005
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Nice, Ranska, 06202
- Investigational Site Number : 2500002
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Saint-Priest-en-Jarez, Ranska, 42270
- Investigational Site Number : 2500004
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Toulouse, Ranska, 31059
- Investigational Site Number : 2500003
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Vandœuvre-lès-Nancy, Ranska, 54511
- Investigational Site Number : 2500001
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Bucharest, Romania, 011461
- Investigational Site Number : 6420004
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Cluj-Napoca, Romania, 400162
- Investigational Site Number : 6420005
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Constanța, Romania, 900673
- Investigational Site Number : 6420003
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Timișoara, Romania, 300002
- Investigational Site Number : 6420001
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Berlin, Saksa, 10318
- Investigational Site Number : 2760004
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Berlin, Saksa, 12203
- Investigational Site Number : 2760002
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Fulda, Saksa, 36043
- Investigational Site Number : 2760001
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Halle, Saksa, 06108
- Investigational Site Number : 2760005
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Ludwigshafen, Saksa, 67067
- Investigational Site Number : 2760006
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Magdeburg, Saksa, 39104
- Investigational Site Number : 2760008
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Nordhausen, Saksa, 99734
- Investigational Site Number : 2760007
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Mersin, Turkki (Türkiye), 33070
- Investigational Site Number : 7920001
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Sanliurfa, Turkki (Türkiye), 63290
- Investigational Site Number : 7920006
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Brno, Tšekki, 602 00
- Investigational Site Number : 2030003
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Brno, Tšekki, 636 00
- Investigational Site Number : 2030002
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Olomouc, Tšekki, 779 00
- Investigational Site Number : 2030001
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Prague, Tšekki, 100 34
- Investigational Site Number : 2030006
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Budapest, Unkari, 1085
- Investigational Site Number : 3480002
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Budapest, Unkari, 1085
- Investigational Site Number : 3480008
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Békéscsaba, Unkari, 5600
- Investigational Site Number : 3480003
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Eger, Unkari, 3300
- Investigational Site Number : 3480010
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Gyöngyös, Unkari, 3200
- Investigational Site Number : 3480001
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Gyöngyös, Unkari, 3200
- Investigational Site Number : 3480009
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Szeged, Unkari, 6720
- Investigational Site Number : 3480005
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Szekszárd, Unkari, 7100
- Investigational Site Number : 3480006
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Tatabánya, Unkari, 2800
- Investigational Site Number : 3480004
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Arizona
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Sun City, Arizona, Yhdysvallat, 85351
- GI Alliance - Arizona Digestive Health - Sun City- Site Number : 8400020
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Connecticut
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Bristol, Connecticut, Yhdysvallat, 06010
- Bristol Hospital- Site Number : 8400007
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Florida
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Clermont, Florida, Yhdysvallat, 34711
- Novum Research- Site Number : 8400021
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Homestead, Florida, Yhdysvallat, 33033
- Homestead Associates in Research- Site Number : 8400012
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Kissimmee, Florida, Yhdysvallat, 34741
- Clinical Research of Osceola- Site Number : 8400013
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Miami Lakes, Florida, Yhdysvallat, 33016
- Wellness Clinical Research - Miami Lakes - 8181 Northwest 154th Street- Site Number : 8400010
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Tampa, Florida, Yhdysvallat, 33609
- GCP Clinical Research- Site Number : 8400004
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Illinois
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Glenview, Illinois, Yhdysvallat, 60026
- GI Alliance - Glenview- Site Number : 8400015
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Gurnee, Illinois, Yhdysvallat, 60031
- Illinois Gastroenterology Group- Site Number : 8400011
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Michigan
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Ann Arbor, Michigan, Yhdysvallat, 48109
- University of Michigan Health System - Ann Arbor- Site Number : 8400017
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Mississippi
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Flowood, Mississippi, Yhdysvallat, 39232
- Gi Alliance - Flowood- Site Number : 8400019
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Nevada
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Las Vegas, Nevada, Yhdysvallat, 89128
- Vector Clinical Trials- Site Number : 8400001
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New York
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Queens Village, New York, Yhdysvallat, 11428
- Queens Village Primary Medical Center- Site Number : 8400005
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North Carolina
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Greenville, North Carolina, Yhdysvallat, 27834
- Carolina Digestive Diseases and Endoscopy Center- Site Number : 8400014
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Pennsylvania
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Uniontown, Pennsylvania, Yhdysvallat, 15401
- Frontier Clinical Research - Uniontown- Site Number : 8400009
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South Carolina
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Charleston, South Carolina, Yhdysvallat, 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, Yhdysvallat, 77494
- Gastro Health & Nutrition- Site Number : 8400003
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Southlake, Texas, Yhdysvallat, 76092
- Texas Digestive Disease Consultants - Southlake- Site Number : 8400002
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Washington
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Tacoma, Washington, Yhdysvallat, 98405
- Washington Gastroenterology - Tacoma- Site Number : 8400008
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
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.
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Nelinkertaistaa
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: SAR441566 dose 1
Participants will receive SAR441566 dose 1. |
Pharmaceutical form: Tablet Route of administration: Oral |
|
Kokeellinen: SAR441566 dose 2
Participants will receive SAR441566 dose 2. |
Pharmaceutical form: Tablet Route of administration: Oral |
|
Kokeellinen: SAR441566 dose 3
Participants will receive SAR441566 dose 3. |
Pharmaceutical form: Tablet Route of administration: Oral |
|
Placebo Comparator: Placebo
Participants will receive SAR441566 matching placebo. |
Pharmaceutical form: Tablet Route of administration: Oral |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Proportion of participants achieving endoscopic response
Aikaikkuna: Week 12
|
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
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
SAR441566:n pitoisuudet plasmassa ennen annostusta valituilla käynneillä
Aikaikkuna: Viikolle 52 asti
|
Viikolle 52 asti
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|
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SAR441566:n annoksen jälkeiset plasmapitoisuudet valituilla käynneillä
Aikaikkuna: Viikolle 52 asti
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Viikolle 52 asti
|
|
|
Proportion of participants achieving clinical remission based on Crohn's Disease Activity Index (CDAI)
Aikaikkuna: Week 12
|
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
|
|
Proportion of participants achieving Patient-Reported Outcome (PRO-2) remission
Aikaikkuna: Week 12
|
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
|
|
Proportion of participants achieving both clinical remission and endoscopic response
Aikaikkuna: Week 12
|
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
|
|
Proportion of participants achieving endoscopic remission based on centrally read SES-CD
Aikaikkuna: From Baseline to Week 12
|
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
|
|
Proportion of participants achieving CDAI clinical response
Aikaikkuna: From Baseline to Week 12
|
CDAI clinical response is defined as a CDAI reduction from baseline ≥100 points. |
From Baseline to Week 12
|
|
Proportion of participants achieving Inflammatory Bowel Disease Questionnaire (IBDQ) remission
Aikaikkuna: Week 12
|
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
|
|
Proportion of participants achieving IBDQ response
Aikaikkuna: From baseline to Week 12
|
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
Aikaikkuna: From Baseline to week 12
|
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
|
|
Number of participants experiencing any TEAEs
Aikaikkuna: Up to week 52
|
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
|
|
Number of participants experiencing any TEAEs
Aikaikkuna: From week 12 to week 52
|
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
|
Yhteistyökumppanit ja tutkijat
Sponsori
Julkaisuja ja hyödyllisiä linkkejä
Hyödyllisiä linkkejä
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- DRI18212
- 2024-512633-32-00 (Rekisterin tunniste: CTIS)
- U1111-1301-3830 (Muu tunniste: WHO ICTRP)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
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
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
Nämä tiedot haettiin suoraan verkkosivustolta clinicaltrials.gov ilman muutoksia. Jos sinulla on pyyntöjä muuttaa, poistaa tai päivittää tutkimustietojasi, ota yhteyttä register@clinicaltrials.gov. Heti kun muutos on otettu käyttöön osoitteessa clinicaltrials.gov, se päivitetään automaattisesti myös verkkosivustollemme .