Um estudo de manutenção de Mirikizumab em participantes com colite ulcerativa ativa moderada a grave (LUCENT 2)
12 de maio de 2026 atualizado por: Eli Lilly and Company
Um estudo de manutenção fase 3, multicêntrico, randomizado, duplo-cego, de braço paralelo, controlado por placebo de Mirikizumab em pacientes com colite ulcerativa ativa moderada a grave (LUCENT 2)
O objetivo deste estudo é avaliar a eficácia e a segurança de mirikizumabe como terapia de manutenção em participantes que completaram como respondedores clínicos no estudo de indução anterior de 12 semanas LUCENT-1 (NCT03518086).
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Real)
1328
Estágio
- Fase 3
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Berlin, Alemanha, 14163
- Krankenhaus Waldfriede
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Berlin, Alemanha, 12203
- Charité Campus Virchow-Klinikum
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Brandenburg, Alemanha, 14770
- Städtisches Klinikum Brandenburg
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Hamburg, Alemanha, 20251
- HaFCED - Hamburgisches Forschungsinstitut für chronisch entzündliche Darmerkrankungen
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Weyhe, Alemanha, 28844
- Internistische Praxisgemeinschaft
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Lower Saxony
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Hanover, Lower Saxony, Alemanha, 30625
- Medizinische Hochschule Hanover
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Rhineland-Palatinate
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Ludwigshafen am Rhein, Rhineland-Palatinate, Alemanha, 67067
- Gemeinschaftspraxis Dr. Peter Uebel
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Saxony-Anhalt
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Halle, Saxony-Anhalt, Alemanha, 06108
- Studiengesellschaft BSF Unternehmergesellschaft
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Halle, Saxony-Anhalt, Alemanha, 06120
- Universitätsklinikum Halle
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Córdoba, Argentina, X5016KEH
- Hospital Privado Centro Medico de Cordoba SA
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Buenos Aires
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CABA, Buenos Aires, Argentina, C1027AAP
- Centro de Investigaciones Metabolicas (CINME)
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Ciudad Autonoma de Buenos Air, Buenos Aires, Argentina, C1128AAF
- Mautalen Salud e Investigacion-Centro de Osteopatías Médicas
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Quilmes, Buenos Aires, Argentina, B1878DVC
- Cer Instituto Medico
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Santa Fe Province
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Rosario, Santa Fe Province, Argentina, S2000DEJ
- Fundacion de Estudios Clinicos
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Tucumán Province
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SAN M. de Tucuman, Tucumán Province, Argentina, T4000AXL
- Centro de Investigaciones Médicas Tucuman
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San Miguel de Tucumán, Tucumán Province, Argentina, 4000
- C.I.C.E. 9 de Julio
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Essex
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Harlow, Essex, Austrália, CM20 1QX
- Princess Alexandra Hospital
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Queensland
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Maroochydore, Queensland, Austrália, 4558
- Coastal Digestive Health
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South Brisbane, Queensland, Austrália, 4101
- Mater University Hospital
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South Australia
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Adelaide, South Australia, Austrália, 5000
- Royal Adelaide Hospital
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Victoria
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Box Hill, Victoria, Austrália, 3128
- Box Hill Hospital Outpatients
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Malvern, Victoria, Austrália, 3144
- Melbourne Gastrointestinal Investigation Unit (MGIU)
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Melbourne, Victoria, Austrália, 3004
- The Alfred Hospital
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Parkville, Victoria, Austrália, 3050
- The Royal Melbourne Hospital
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Brasschaat, Bélgica, 2930
- AZ Klina
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Leuven, Bélgica, 3000
- Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
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Oost-Vlaanderen
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Ghent, Oost-Vlaanderen, Bélgica, 9000
- Universitair Ziekenhuis Gent
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Wallonne, Région
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Tournai, Wallonne, Région, Bélgica, 7500
- Centre Hospitalier de Wallonie Picarde - Site Notre Dame
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Alberta
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Edmonton, Alberta, Canadá, T5R 1W2
- West Edmonton Diabetes Center
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British Columbia
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Vancouver, British Columbia, Canadá, V6Z 2K5
- GI Research Institute
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Vancouver, British Columbia, Canadá, V5Z 1M9
- The Gordon and Leslie Diamond Health Care Centre
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Victoria, British Columbia, Canadá, V8V 3M9
- PerCuro Clinical Research
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Ontario
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London, Ontario, Canadá, N6A 4G5
- Victoria Hospital
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London, Ontario, Canadá, N6A 5G1
- University of Western Ontario
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Quebec
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Greenfield Park, Quebec, Canadá, J4V 2H1
- Centre de santé et de services sociaux Champlain-Charles-Le Moyne
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Montreal, Quebec, Canadá, H1T 2M4
- Hopital Maisonneure-Rosemount
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Montreal, Quebec, Canadá, H3G 1A4
- Inflammatory Bowel Disease Centre Montreal General Hospital - MUHC
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Wuhan, China, 430030
- Tongji Hospital of Tongji University
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Anhui
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Hefei, Anhui, China, 230022
- The First Affiliated Hospital of Anhui Medical University
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Hefei, Anhui, China, 230000
- Anhui Provincial Hospital
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Changsha City
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Kaifu District, Changsha City, China, 410008
- Xiangya Hospital Central South University
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Chongqing Municipality
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Chongqing, Chongqing Municipality, China, 400037
- The Affiliated 2nd Hosp. of Third Military Med. Univ. of PLA
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Chongqing, Chongqing Municipality, China, 400038
- The First Hospital Affiliated to AMU (SOUTHWEST HOSPITAL)
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Guangdong
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Guangzhou, Guangdong, China, 510655
- The Sixth Affiliated Hospital, Sun Yat-sen University
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Hubei
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Wuhan, Hubei, China, 430022
- Union Hospital Tongji Medical College Huazhong University Of Science And Technology
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Wuhan, Hubei, China, 430060
- Renmin Hospital of Wuhan University
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Jiangsu
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Nanjing, Jiangsu, China, 210008
- The Affiliated Drum Tower Hospital of Nanjing University
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Nanjing, Jiangsu, China, 210029
- Zhongda Hospital Southeast University
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Nanjing, Jiangsu, China, 211106
- Nanjing Medical University - Nanjing Jiangning Hospital
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Jiangxi
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Pingxiang, Jiangxi, China, 337055
- Jiangxi Pingxiang People's Hospital
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Jilin
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Jilin, Jilin, China, 132011
- Jilin Central General Hospital
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Shandong
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Jinan, Shandong, China, 250021
- Shandong Provincial Hospital
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Jinan, Shandong, China, 250014
- Qilu Hospital of Shandong University
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Liaocheng, Shandong, China, 252000
- Liaocheng People's Hospital
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Qingdao, Shandong, China, 266000
- The Affiliated Hospital of Qingdao University
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Taian, Shandong, China, 271000
- Taian City Central Hospital
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Shanghai Municipality
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Shanghai, Shanghai Municipality, China, 200025
- Shanghai Jiaotong University School of Medicine Ruijin Hospital
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Shanghai, Shanghai Municipality, China, 200127
- Renji Hospital Affliated to Shanghai Jiaotong University
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Sichuan
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Chengdu, Sichuan, China, 610041
- West China Hospital, Sichuan University
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Yunnan
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Kunming, Yunnan, China, 650034
- The First People's Hospital of Yunnan Province
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Kunming, Yunnan, China, 650032
- Kunming Medical College Affiliated First Hospital
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Zhejiang
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Hangzhou, Zhejiang, China, 310016
- Sir Run Run Shaw Hospital
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Hangzhou, Zhejiang, China, 310003
- First Affiliated Hosp of College of Med, Zhejiang University
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Hangzhou, Zhejiang, China, 310000
- The Second Affiliated Hospital of Zhejiang University School of Med
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Wenzhou, Zhejiang, China, 325027
- The Second Affiliated Hospital YuYing Childens Hospital of Wenzhou Medical university
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Busan, Coréia do Sul, 48108
- Inje University Haeundae Paik Hospital
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Daegu, Coréia do Sul, 42415
- Yeungnam Univeristy Medical Center
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Gangwon-do
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Wŏnju, Gangwon-do, Coréia do Sul, 26426
- Severance Hospital, Yonsei University Health System
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Korea
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Seoul, Korea, Coréia do Sul, 02447
- Kyung Hee University Hospital
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Pusan-Kwangyǒkshi
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Busan, Pusan-Kwangyǒkshi, Coréia do Sul, 49201
- Dong-A University Hospital
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Seoul-teukbyeolsi [Seoul]
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Seoul, Seoul-teukbyeolsi [Seoul], Coréia do Sul, 06351
- Samsung Medical Center
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Seoul, Seoul-teukbyeolsi [Seoul], Coréia do Sul, 05505
- Asan Medical Center
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Seoul, Seoul-teukbyeolsi [Seoul], Coréia do Sul, 03181
- Kangbuk Samsung Hospital
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Taejǒn-Kwangyǒkshi
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Daejeon, Taejǒn-Kwangyǒkshi, Coréia do Sul, 34943
- The Catholic University of Korea, Daejeon ST. Mary's Hospital
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Herlev, Dinamarca, 2730
- Herlev and Gentofte Hospital
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Køge, Dinamarca, 4600
- Zealand University Hospital Køge
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Banská Bystrica, Eslováquia, 975 17
- Fakultna nemocnica s poliklinikou Roosevelta Banska Bystrica
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Bratislava, Eslováquia, 82007
- Univerzitna nemocnica Bratislava
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Nitra Region
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Nitra, Nitra Region, Eslováquia, 949 01
- KM Management
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Presov
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Prešov, Presov, Eslováquia, 080 01
- Gastro
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Vranov N. Toplou, Presov, Eslováquia, 093 01
- Endomed, s.r.o.
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A Coruña, Espanha, 15006
- Complexo Hospitalario Universitario A Coruña, CHUAC
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Alicante, Espanha, 3004
- Instituto de Ciencias Médicas
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Girona, Espanha, 17007
- Hospital Universitari de Girona
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Huelva, Espanha, 21005
- Hospital Universitario Juan Ramón Jiménez
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Las Palmas de Gran Canaria, Espanha, 35010
- Hospital de Gran Canaria Dr. Negrín
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Madrid, Espanha, 28046
- Hospital Universitario La Paz
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Oviedo, Espanha, 3306
- Hospital Universitario Central de Asturias
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Andalusia
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Seville, Andalusia, Espanha, 41013
- Hospital Universitario Virgen del Rocío
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Baleares Islands
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Palma de Mallorca, Baleares Islands, Espanha, 07120
- Hospital Universitari Son Espases
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Cantabria
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Santander, Cantabria, Espanha, 39008
- Hospital Universitario Marqués de Valdecilla
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Madrid
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Fuenlabrada, Madrid, Espanha, 28942
- Hospital De Fuenlabrada
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Valencia
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Sagunto, Valencia, Espanha, 46520
- Hospital Gen. Juan Ramon Jimenez - Depto de Digestivo
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Alabama
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Dothan, Alabama, Estados Unidos, 36305
- Digestive Health Specialists Of The Southeast
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Arizona
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Litchfield Park, Arizona, Estados Unidos, 85340
- Dcr-Pi, Pc
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Phoenix, Arizona, Estados Unidos, 85008
- Maricopa Integrated Health System
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Tempe, Arizona, Estados Unidos, 85284
- Physicians Research Group
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California
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Arcadia, California, Estados Unidos, 91006
- Valley Gastroenterology
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Berkeley, California, Estados Unidos, 94705
- Care Access Research
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Lancaster, California, Estados Unidos, 93534
- Om Research, LLC
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Northridge, California, Estados Unidos, 91324
- California Medical Research Associates
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San Diego, California, Estados Unidos, 92103
- Clinical Applications Laboratories, Inc.
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San Francisco, California, Estados Unidos, 94158
- UCSF Medical Center at Mission Bay
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Florida
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Hialeah, Florida, Estados Unidos, 33012
- Direct Helpers Research Center
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Inverness, Florida, Estados Unidos, 34452
- Nature Coast Clinical Research, LLC
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Kissimmee, Florida, Estados Unidos, 34741
- SIH Research, LLC
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Miami, Florida, Estados Unidos, 33134
- Research Associates of South Florida, LLC
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Miami Lakes, Florida, Estados Unidos, 33016
- Wellness Clinical Research
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Orlando, Florida, Estados Unidos, 32818
- Clintheory Healthcare
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Orlando, Florida, Estados Unidos, 32803
- Center for Interventional Endoscopy
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Pensacola, Florida, Estados Unidos, 32503
- Gastroenterology Associates of Pensacola, PA
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Zephyrhills, Florida, Estados Unidos, 33542-7505
- Florida Medical Clinic LLC
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Georgia
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Atlanta, Georgia, Estados Unidos, 30309
- Digestive Healthcare of Georgia
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Idaho
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Idaho Falls, Idaho, Estados Unidos, 83404
- Grand Teton Research Group
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Illinois
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Evanston, Illinois, Estados Unidos, 60201
- Northshore University Healthsystem
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Indiana
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Indianapolis, Indiana, Estados Unidos, 46202
- Indiana University School of Medicine
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Kansas
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Topeka, Kansas, Estados Unidos, 66606
- Cotton-O'Neil Clinical Research Center, Digestive Health
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Louisiana
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Baton Rouge, Louisiana, Estados Unidos, 70809
- Texas Digestive Disease Consultants
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Monroe, Louisiana, Estados Unidos, 71201
- Delta Research Partners LLC
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New Orleans, Louisiana, Estados Unidos, 70125
- Nola Research Works, LLC
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Michigan
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Chesterfield, Michigan, Estados Unidos, 48047
- Clinical Research Institute of Michigan, LLC
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Novi, Michigan, Estados Unidos, 48377
- Henry Ford Health System
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Wyoming, Michigan, Estados Unidos, 49519
- Gastroenterology Associates of Western Michigan, P.L.C.
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Ypsilanti, Michigan, Estados Unidos, 48197
- Huron Gastroenterology Associates
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Minnesota
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Plymouth, Minnesota, Estados Unidos, 55446
- MNGI Digestive Health - Plymouth Endoscopy Center & Clinic
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Mississippi
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Jackson, Mississippi, Estados Unidos, 39206
- Care Access Research LLC
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Tupelo, Mississippi, Estados Unidos, 38801
- Digestive Health Specialists
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New York
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Great Neck, New York, Estados Unidos, 11021
- Northwell Health
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New York, New York, Estados Unidos, 10021
- Weill Cornell Medical College
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North Carolina
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Chapel Hill, North Carolina, Estados Unidos, 27599
- University of North Carolina Center for Inflammatory Bowel Disease
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Greenville, North Carolina, Estados Unidos, 27834
- Carolina Digestive Diseases and Endoscopy Center
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Ohio
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Middleburg Heights, Ohio, Estados Unidos, 44130
- Paramount Medical Research
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Poland, Ohio, Estados Unidos, 44514
- Care Access - Youngstown
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Oklahoma
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Norman, Oklahoma, Estados Unidos, 73071
- Central Sooner Research
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Oklahoma City, Oklahoma, Estados Unidos, 73104
- University of Oklahoma Health Sciences Center
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Pennsylvania
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Wyomissing, Pennsylvania, Estados Unidos, 19610
- Digestive Disease Associates
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South Dakota
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Sioux Falls, South Dakota, Estados Unidos, 57108
- Midwest Medical Care
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Tennessee
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Germantown, Tennessee, Estados Unidos, 38138
- Gastro One
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Hixson, Tennessee, Estados Unidos, 37343
- Galen Medical Group
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Texas
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Garland, Texas, Estados Unidos, 75044
- Digestive Health Associates of Texas
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Houston, Texas, Estados Unidos, 77043
- Biopharma Informatic, LLC
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Houston, Texas, Estados Unidos, 77030
- Houston Methodist Research Ins
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San Antonio, Texas, Estados Unidos, 78229
- Southern Star Research Institute, LLC
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San Antonio, Texas, Estados Unidos, 78229
- Gastroenterology Research of San Antonio
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Southlake, Texas, Estados Unidos, 76092
- Texas Digestive Disease Consultants
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Utah
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Ogden, Utah, Estados Unidos, 84403
- Care Access Research LLC - Salt Lake City
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Virginia
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Leesburg, Virginia, Estados Unidos, 20176
- Emeritas Research Group
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Reston, Virginia, Estados Unidos, 20191
- The Gastroenterology Group, P.C.
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Roanoke, Virginia, Estados Unidos, 24016
- Carilion Clinic
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Wisconsin
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Milwaukee, Wisconsin, Estados Unidos, 53215
- Wisconsin Center for Advanced Research
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Chambray-lès-Tours, França, 37170
- CHU Tours - Hôpital Trousseau
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Marseille, França, 13915
- Assistance Publique Hôpitaux de Marseille - Hôpital Nord
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Montpellier, França, 34295
- CHRU de Montpellier-Hopital St Eloi
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Nice, França, 06200
- Hopital l'Archet 2
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Pessac, França, 33604
- CHU Bordeaux - Hôpital Haut-Lévêque
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Reims, França, 51092
- Robert Debre Hospital
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Saint-Priest-en-Jarez, França, 42270
- CHU de Saint Etienne Hopital Nord
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Vandœuvre-lès-Nancy, França, 54500
- CHRU Nancy Brabois - Hôpital d'Enfants
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Bas Rhin
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Strasbourg, Bas Rhin, França, 67098
- Hopital de Hautepierre - Service d'Hépatogastroentérolgie
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Cedex 10
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Paris, Cedex 10, França, 75475
- Hôpital Saint-Louis
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Nord
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Lille, Nord, França, 59037
- CHU Lille - Hôpital Claude Huriez
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Paris
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Clichy, Paris, França, 92110
- Hopital Beaujon
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Pyrénées-Atlantiques
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Pau, Pyrénées-Atlantiques, França, 64046
- Centre Hospitalier de Pau
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Rhone
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Pierre-Bénite, Rhone, França, 69495
- Hospices Civils de Lyon - Centre Hospitalier Lyon Sud -
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Somme
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Amiens, Somme, França, 80480
- CHU Amiens Picardie-Site Sud - RDC Service Hépato gastro
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Uden, Holanda, 5406 PT
- Bernhoven Ziekenhuis
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Utrecht, Holanda, 3584 CX
- UMC Utrecht, Dept. of Internal Medicine, MDL
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North Brabant
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Tilburg, North Brabant, Holanda, 5022 GC
- St Elisabeth Ziekenhuis
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North Holland
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Amsterdam, North Holland, Holanda, 1105 AZ
- Amsterdam UMC, Locatie AMC
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Budapest, Hungria, 1088
- Semmelweis Egyetem
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Budapest, Hungria, 1036
- Óbudai Egészségügyi Centrum
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Debrecen, Hungria, 4032
- Debreceni Egyetem Klinikai Központ
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Miskolc, Hungria, 3526
- Endomedix Diagnosztikai Központ - Miskolc
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Mosonmagyaróvár, Hungria, 9200
- Karolina Korhaz-Rendelointezet
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Szeged, Hungria, 6720
- Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont I. Belgyogyaszati Klinika
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Szekszárd, Hungria, 7100
- CLINFAN Szolgáltató Kft
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EU
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Balatonfüred, EU, Hungria, 8230
- DRC Gyogyszervizsgalo Kozpont Kft.
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Pest County
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Vác, Pest County, Hungria, 2600
- Jávorszky Ödön Kórház
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Dublin, Irlanda, D9
- Beaumont Hospital, Dublin
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Beersheba, Israel, 8410101
- Soroka Medical Center - Pediatric Outpatient Clinic
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Nahariya, Israel, 2210001
- Galilee Medical Center Department of Internal Medicine A
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Rehovot, Israel, 7610001
- Kaplan Medical Center
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Tel Aviv, Israel, 6423906
- Tel Aviv Sourasky Medical Center
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Ẕerifin, Israel, 70300
- King Fahad Medical City
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Jerusalem
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Bait Vagan, Jerusalem, Israel, 91031
- Shaare Zedek Medical Center
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-
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Brescia, Itália, 25123
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
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Catanzaro, Itália, 88100
- Azienda ospedaliero-universitaria Mater Domini
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Genova, Itália, 16132
- Azienda Ospedaliero Universitaria San Martino
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Milan, Itália, 20122
- Gastroenterology and Endoscopy Unit IRCCS Ca' Granda Ospedale Maggiore Policlinico Foundation
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Modena, Itália, 41124
- Azienda Ospedaliera Universitaria Policlinico de Modena
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Pisa, Itália, 56124
- Azienda Ospedaliera Universitaria Pisana
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Roma, Itália, 00168
- Policlinico Gemelli - Università Cattolica del Sacro Cuore
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Torino, Itália, 10128
- Ospedale Mauriziano Umberto I
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Udine, Itália, 33100
- Azienda Ospedaliero-Universitaria Santa Maria della Misericordia Gastroenterologia
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Milano
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Rho, Milano, Itália, 20017
- Presidio di Rho
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Rozzano, Milano, Itália, 20089
- Istituto Clinico Humanitas
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San Donato Milanese, Milano, Itália, 20097
- Istituti di Ricovero e Cura a Carattere Scientifico Policlinico San Donato Gastroenterologia
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Roma
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Rome, Roma, Itália, 00157
- Ospedale Sandro Pertini
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Torre, Roma, Itália, 00133
- Azienda Ospedaliera Universitaria Policlinico Tor Vergata
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-
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Fukuoka, Japão, 814-0180
- Fukuoka University Hospital
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Hiroshima, Japão, 734-8551
- Hiroshima University Hospital
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Kagoshima, Japão, 892-0846
- Sameshima Hospital
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Kyoto, Japão, 612-8555
- National Hospital Organization Kyoto Medical Center
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Okayama, Japão, 700-8558
- Okayama University Hospital
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Saitama, Japão, 336-0963
- Tokitokai Tokito Clinic
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Toyama, Japão, 930-0975
- Toyama Prefectural Central Hospital
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Aichi-ken
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Nagakute-shi, Aichi-ken, Japão, 480-1195
- Aichi Medical University Hospital
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Toyoake, Aichi-ken, Japão, 470-1192
- Fujita Health University
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Aomori
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Hirosaki, Aomori, Japão, 036-8545
- National Hospital Organization Hirosaki National Hospital
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Chiba
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Sakura, Chiba, Japão, 285-8741
- Toho University Sakura Medical Center
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Fukoka
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Kitakyusyu-shi, Fukoka, Japão, 802-0077
- Kitakyushu Municipal Medical Center
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Fukuoka
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Chikushino-shi, Fukuoka, Japão, 818-8502
- Fukuoka University Chikushi Hospital
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Kurume-shi, Fukuoka, Japão, 839 0809
- Hidaka Coloproctology Clinic
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Gunma
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Maebashi, Gunma, Japão, 371-8511
- Gunma University Hospital
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Takasaki, Gunma, Japão, 370-0829
- National Hospital Organization Takasaki General Medical Centar
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HigaShiibaraki-Gun
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Ibaraki-machi, HigaShiibaraki-Gun, Japão, 311 3193
- NHO Mito Medical Center
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Hokkaido
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Asahikawa, Hokkaido, Japão, 070-8610
- Asahikawa City Hospital
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Sapporo, Hokkaido, Japão, 065-0033
- Sapporo Higashi Tokushukai Hospital
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Sapporo, Hokkaido, Japão, 004 0041
- Tokushukai Sapporo Tokushukai Hospital
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Sapporo, Hokkaido, Japão, 060 0033
- Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
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Hyōgo
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Kobe, Hyōgo, Japão, 650 0015
- Aoyama Clinic GI Endoscopy & IBD Center
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Kagawa-ken
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Takamatsu, Kagawa-ken, Japão, 760-8557
- Kagawa Prefectural Central Hospital
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Kanagawa
-
Kamakura, Kanagawa, Japão, 247-0056
- Ofuna Central Hospital
-
Kawasaki, Kanagawa, Japão, 210-0013
- Kawasaki Municipal Hospital
-
Yokohama, Kanagawa, Japão, 232-0024
- Yokohama City University Medical Center
-
Yokohama, Kanagawa, Japão, 234-0032
- Showa University Northern Yokohama Hospital
-
Yokohama, Kanagawa, Japão, 226 0025
- Sankikai Yokohama Shin midori General Hospital
-
-
Kumamoto
-
Kumamoto, Kumamoto, Japão, 860-0012
- Kumamoto University Hospital
-
-
Mie-ken
-
Tsu, Mie-ken, Japão, 514-8507
- Mie University Hospital
-
-
Miyagi
-
Sendai, Miyagi, Japão, 981 3213
- Takagi Clinic - Sendai
-
-
Niigata
-
Nagaoka-shi, Niigata, Japão, 940-8653
- Nagaoka Chuo General Hospital
-
-
Oita Prefecture
-
Ōita, Oita Prefecture, Japão, 870 0823
- Ishida Clinic of IBD and Gastroenterology
-
-
Osaka
-
Fujiidera, Osaka, Japão, 583-0027
- Sai Gastroenterologist Proctology
-
Osaka, Osaka, Japão, 530 0011
- Infusion Clinic
-
Osaka, Osaka, Japão, 540 0006
- NHO Osaka National Hospital
-
-
Saga-ken
-
Saga, Saga-ken, Japão, 840-8571
- Saga-Ken Medical Center Koseikan
-
-
Saitama
-
Kumagaya-shi, Saitama, Japão, 360-8567
- Kumagaya General Hospital
-
-
Shizuoka
-
Hamamatsu, Shizuoka, Japão, 4328061
- Matsuda Hospital
-
-
Tochigi
-
Shimotsuke-shi, Tochigi, Japão, 329-0498
- Jichi Medical University Hospital
-
-
Tokyo
-
Bunkyo-ku, Tokyo, Japão, 113-8431
- Juntendo University Hospital
-
Bunkyō, Tokyo, Japão, 113-8519
- Tokyo Medical and Dental University Hospital
-
Koto-ku, Tokyo, Japão, 135 8577
- Showa University Koto Toyosu Hospital
-
Minato-Ku, Tokyo, Japão, 108 8642
- Kitasato University Kitasato Institute Hospital
-
Mitaka, Tokyo, Japão, 181-8611
- Kyorin University Hospital
-
Shinjuku-ku, Tokyo, Japão, 169-0073
- JHCO Tokyo Yamate Medical Center
-
-
Tokyo-To
-
Chiyoda-ku, Tokyo-To, Japão, 101-8643
- Mitsui Memorial Hospital
-
Shinjuku-ku, Tokyo-To, Japão, 162 8655
- Center Hospital of the National Center for Global Health and Medicine
-
-
-
-
-
Riga, Letônia, 1079
- Digestive Diseases Center "Gastro"
-
Riga, Letônia, LV-1038
- Riga Eastern Clinical University Hospital
-
-
Riga
-
Riga, Riga, Letônia, LV-1002
- Pauls Stradins Clinical Univeristy Hospital
-
-
-
-
-
Kaunas, Lituânia, 50009
- Hospital of Lithuanian University of Health Sciences Kaunas
-
Klaipėda, Lituânia, 92288
- Klaipeda Seamen's Hospital
-
Klaipėda, Lituânia, 92231
- Republic Hospital of Klaipeda
-
Vilnius, Lituânia, LT-08661
- Vilnius University Hospital Santariskiu Clinics
-
-
Panevėžys
-
Panevezys, Panevėžys, Lituânia, LT-35144
- Respublikine Panevezio ligonine
-
-
-
-
Kelantan
-
Kubang Kerian, Kelantan, Malásia, 16150
- Universiti Sains Malaysia
-
-
Kuala Lumpur
-
Lembah Pantai, Kuala Lumpur, Malásia, 59100
- University Malaya Medical Centre
-
-
Selangor
-
Ampang, Selangor, Malásia, 68000
- Hospital Ampang
-
-
-
-
-
Chihuahua City, México, 31203
- Scientia Investigacion Clinica S.C.
-
Veracruz, México, 91900
- Sociedad de Metabolismo y Corazon
-
-
Jalisco
-
Zapopan, Jalisco, México, 45030
- Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V.
-
-
Mexico City
-
Mexico City, Mexico City, México, 07020
- Centro de Investigación Clínica Acelerada
-
-
Sinaloa
-
Culiacán, Sinaloa, México, 80230
- Centro Para el Desarrollo de la Medicina y de Asistencia Medica S.C
-
-
-
-
-
Katowice, Polônia, 40-660
- All-Medicus
-
Olsztyn, Polônia, 10-561
- Wojewodzki Specjalistyczny Szpital w Olsztynie
-
Szczecin, Polônia, 71-434
- Twoja Przychodnia - Szczecinskie Centrum Medyczne
-
Torun, Polônia, 87-100
- Gastromed Kopoń Zmudziński I Wspólnicy Spółka Jawna Specjalistyczne Centrum Gastrologii I Endoskopii
-
Warsaw, Polônia, 00-728
- Warsaw IBD Point Profesor Kierkus
-
Warsaw, Polônia, 00635
- Centrum Zdrowia MDM
-
Warsaw, Polônia, 01-697
- Centrum Medyczne NeuroProtect
-
Wroclaw, Polônia, 52-210
- PlanetMed Sp.z o.o.
-
Zamość, Polônia, 22-400
- ETG Zamość
-
-
Kuyavian-Pomeranian Voivodeship
-
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Polônia, 85-168
- Szpital Uniwersytecki Nr 2 im. dr J. Biziela w Bydgoszczy
-
-
Lesser Poland Voivodeship
-
Krakow, Lesser Poland Voivodeship, Polônia, 31-506
- Topolowa Medicenter
-
Nowy Targ, Lesser Poland Voivodeship, Polônia, 34-400
- Medicenter Nowy Targ
-
Wadowice, Lesser Poland Voivodeship, Polônia, 34-100
- NZOZ Formed
-
-
Lower Silesian Voivodeship
-
Wroclaw, Lower Silesian Voivodeship, Polônia, 53-114
- LexMedica
-
-
Lublin Voivodeship
-
Lublin, Lublin Voivodeship, Polônia, 20-954
- Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
-
Lublin, Lublin Voivodeship, Polônia, 20-582
- ZOZ Gastromed
-
-
Masovian Voivodeship
-
Warsaw, Masovian Voivodeship, Polônia, 03-580
- NZOZ Vivamed
-
-
Silesian Voivodeship
-
Będzin, Silesian Voivodeship, Polônia, 42-500
- Promedica Dental Clinic
-
-
West Pomeranian Voivodeship
-
Szczecin, West Pomeranian Voivodeship, Polônia, 71-685
- SONOMED Centrum Medyczne
-
-
Świętokrzyskie Voivodeship
-
Straszów, Świętokrzyskie Voivodeship, Polônia, 28-200
- KO-Med Centrum Medyczne
-
-
-
-
Essex
-
Romford, Essex, Reino Unido, RM7 0AG
- Queens Hospital
-
-
Great Britain
-
Bury, Great Britain, Reino Unido, BL9 7TD
- Fairfield General Hospital
-
-
London
-
Great Maze Pond, London, Reino Unido, SE1 9RT
- St Thomas' Hospital
-
-
Surrey
-
London, Surrey, Reino Unido, E11 1NR
- Whipps Cross University Hospital
-
-
Swansea [Abertawe Gb-ata]
-
Swansea, Swansea [Abertawe Gb-ata], Reino Unido, SA6 6SG
- Morriston Hospital
-
-
Vinnytsia
-
Leeds, Vinnytsia, Reino Unido, LS9 7TF
- St James's University Hospital
-
-
-
-
-
Bucharest, Romênia, 022328
- Institutul Clinic Fundeni
-
Bucharest, Romênia, 020125
- Spitalul Clinic Colentina
-
Bucharest, Romênia, 010719
- MedLife Grivita
-
Bucharest, Romênia, 031864
- Hifu Terramed Conformal SRL
-
Oradea, Romênia, 410469
- Spital Pelican Oradea
-
-
Bucharest
-
Bucharest, Bucharest, Romênia, 030463
- CCBR Clinical Research
-
-
-
-
-
Barnaul, Rússia, 656043
- Multidisciplinary Medical Clinic "Anthurium"
-
Cherepovets, Rússia, 162600
- Medical and Sanitary Division of Severstal
-
Izhevsk, Rússia, 426061
- Alliance Biomedical URAL Group
-
Kaliningrad, Rússia, 236035
- Clinical Trials Center of Medical Institute
-
Kazan', Rússia, 420064
- State Autonomous Institution of Healthcare "Republican Clinical Hospital of the Ministry of Healthcare of Republic Tatarstan
-
Kemerovo, Rússia, 650066
- SIH Kemerovo Regional Clinical Hosptial
-
Moscow, Rússia, 125367
- Medical rehabilitation center
-
Novosibirsk, Rússia, 630005
- LLC "Medicine Center SibNovoMed"
-
Omsk, Rússia, 644024
- Clinical Diagnostic Center Ultramed
-
Saint Petersburg, Rússia, 191104
- City Mariinskaya Hospital
-
Saint Petersburg, Rússia, 195067
- Pokrovskaya Municipal Hospital
-
Saint Petersburg, Rússia, 195271
- Non-state Healthcare Institution "Roadway Clinical Hospital of OJSC Russian Railways
-
Saint Petersburg, Rússia, 197022
- Saint Petersburg State Medical University n.a. Pavlov I.P.
-
Saint Petersburg, Rússia, 197110
- SBIH City Clinical Hospital #31
-
Samara, Rússia, 443001
- Medical Institute REAVIZ
-
Stavropol, Rússia, 355018
- Stavropol State Medical University
-
Yaroslavl, Rússia, 150030
- Yaroslavl Municipal HI Clinical Hospital #8
-
Yekaterinburg, Rússia, 620109
- LLC MA New Hospital
-
-
Irkutsk Oblast
-
Irkutsk, Irkutsk Oblast, Rússia, 664079
- Scientific Centre of Reconstructive and Restorative Surgery
-
-
Kareliya, Respublika
-
Petrozavodsk, Kareliya, Respublika, Rússia, 185019
- Karelia Republican Hospital V.A. Baranova
-
-
Nizhny Novgorod Oblast
-
Nizhny Novgorod, Nizhny Novgorod Oblast, Rússia, 603126
- Nizhny Novgorod Regional Hospital N.A. Semashko
-
Nizhny Novgorod, Nizhny Novgorod Oblast, Rússia, 603140
- Private Healthcare Institution Clinical Hospital Russian Railways - Medicine of Nizhniy Novgorod
-
-
Novosibirsk Oblast
-
Novosibirsk, Novosibirsk Oblast, Rússia, 630007
- Novosibirski Gastrocenter
-
-
Rostov Oblast
-
Rostov-on-Don, Rostov Oblast, Rússia, 344091
- Rostov State Medical University
-
-
Sankt-Peterburg
-
Saint Petersburg, Sankt-Peterburg, Rússia, 196143
- Scientific research center ECO-security
-
-
-
-
-
Bern, Suíça, 3010
- Inselspital Bern
-
Sankt Gallen, Suíça, 9007
- Kantonsspital St.Gallen
-
Zurich, Suíça, 8091
- Universitätsspital Zürich
-
-
Canton of Bern
-
Bern, Canton of Bern, Suíça, 3012
- Gastroenterologische Praxis Balsiger, Seibold & Partner
-
-
-
-
-
Kragujevac, Sérvia, 34000
- Clinical Center Kragujevac Gastroenterohepatology Clinic
-
-
Beograd
-
Belgrade, Beograd, Sérvia, 11000
- Clinical Hospital Center Zvezdara
-
-
NAP
-
Belgrade, NAP, Sérvia, 11080
- University Medical Center "Bezanijska kosa"
-
-
Vojvodina
-
Sombor, Vojvodina, Sérvia, 25000
- Regional Hospital Dr Radivoj Simonovic Sombor
-
Sremska Mitrovica, Vojvodina, Sérvia, 22000
- Sremska Mitrovica Health Centre
-
Zrenjanin, Vojvodina, Sérvia, 23000
- General Hospital "Djordje Joanovic"
-
-
-
-
-
Taichung, Taiwan, 40447
- China Medical University Hospital
-
Taipei, Taiwan, 10002
- Health management center
-
-
-
-
-
Brno, Tcheca, 65691
- Fakultni nemocnice u sv. Anny v Brne
-
Olomouc, Tcheca, 779
- PreventaMed, s.r.o.
-
Prague, Tcheca, 19000
- ISCARE Clinical Centre
-
-
Brno-město
-
Brno, Brno-město, Tcheca, 636 00
- Vojenska nemocnice Brno
-
-
Hl. M. Praha
-
Prague, Hl. M. Praha, Tcheca, 100 34
- Fakultni nemocnice Kralovske Vinohrady
-
-
Hradec Králové
-
Hradec Králové, Hradec Králové, Tcheca, 500 12
- Hepato-Gastroenterologie HK
-
-
Olomouc Region
-
Olomouc, Olomouc Region, Tcheca, 779 00
- MUDr. Gregar, s.r.o.
-
-
Plzeň-město
-
Pilsen, Plzeň-město, Tcheca, 301 00
- A-Shine
-
-
Praha 8
-
Prague, Praha 8, Tcheca, 186 00
- MEDIENDO
-
-
-
-
Antalya
-
Kocaeli, Antalya, Turquia (Türkiye), 7100
- Antalya Egitim ve Arastırma Hastanesi
-
-
Istanbul
-
Kadıköy, Istanbul, Turquia (Türkiye), 34734
- Acibadem Universitesi - Acibadem Kozyatagi Hastanesi
-
-
Kocaeli
-
İzmit, Kocaeli, Turquia (Türkiye), 41380
- Kocaeli University Medical Faculty Hospital
-
-
Mersin
-
Yenişehir, Mersin, Turquia (Türkiye), 33110
- Mersin University Medical Faculty
-
-
Turkey
-
Izmir, Turkey, Turquia (Türkiye), 35100
- Ege Universitesi Hastanesi
-
-
-
-
-
Kharkiv, Ucrânia, 61039
- GI L.T. Malaya TI Namsu
-
Kharkiv, Ucrânia, 61002
- Kharkiv City Student Hospital
-
Kropyvnytskyi, Ucrânia, 25006
- Treatment-Diagnostic Center of Private Enterprise of PPC Atsynus
-
Kyiv, Ucrânia, 02091
- Kyiv Municipal Clinical Hospital #1
-
Kyiv, Ucrânia, 04107
- Communal institution of the Kyiv Regional Council "Kyiv Regional Clinical Oncology Dispensary"
-
Kyiv, Ucrânia, 04078
- Communal institution of the Kyiv Regional Council "Kyiv Regional Clinical Oncology Dispensary"
-
Odesa, Ucrânia, 65000
- Communal Enterprise "Odesa Regional Clinical Hospital"
-
Uzhhorod, Ucrânia, 88000
- A. Novak Transcarpathian Regional Clinical Hospital
-
Vinnytsia, Ucrânia, 21029
- CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM
-
Vinnytsia, Ucrânia, 21005
- Vinnytsia RCH of Veterans of War Dept of Therapy#1 Vinnytsia M.I.Pyrogov NMU
-
Vinnytsia, Ucrânia, 21009
- MCIC MC LLC Health Clinic
-
Vinnytsia, Ucrânia, 21018
- M.I. Pyrogov Regional Clinical Hospital
-
Zaporizhzhia, Ucrânia, 69104
- Communal Institution of Kyiv Regional Council Kyiv Regional Hospital #2
-
-
Ivano-Frankivsk Oblast
-
Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ucrânia, 76008
- Ivano-Frankivsk Regional Clinical Hospital
-
-
Kharkivs’ka Oblast’
-
Kharkiv, Kharkivs’ka Oblast’, Ucrânia, 61037
- City Clinical Hospital No. 2
-
-
Kherson Oblast
-
Kherson, Kherson Oblast, Ucrânia, 73000
- Kherson City Clinical Hospital
-
-
Kyiv Oblast
-
Kiev, Kyiv Oblast, Ucrânia, 4050
- Medical Center of Limited Liability Company "Medical Center "Consilium Medical"
-
-
Lviv Oblast
-
Lviv, Lviv Oblast, Ucrânia, 79000
- Lviv Railway Clinical Hospital
-
Lviv, Lviv Oblast, Ucrânia, 79000
- Lviv Regional Endocrinology Dispensary
-
Lviv, Lviv Oblast, Ucrânia, 79000
- Municipal non-profit enterprise "Lviv Territorial Medical Union "Multidisciplinary Clinical Hospital of Em -T
-
-
Poltava Oblast
-
Poltava, Poltava Oblast, Ucrânia, 36000
- Poltova Oblast Clinical Hospital IM.M.V.Sklifosovskoho
-
-
Zaporizhzhia Oblast
-
Zaporizhia, Zaporizhzhia Oblast, Ucrânia, 69076
- Diaservis - Medical and Diagnostic Center
-
-
-
-
-
Innsbruck, Áustria, 6020
- Medizinische Universität Innsbruck
-
Salzburg, Áustria, 5020
- Universitätsklinikum Salzburg
-
Vienna, Áustria, 1090
- Medical University of Vienna
-
-
-
-
Andhra Pradesh
-
Hyderabad, Andhra Pradesh, Índia, 500058
- Centre for Liver Research & Diagnostics, Deccan College of Medical Sciences, Owaisi Hospital & Research Centre
-
-
Gujarat
-
Gandhinagar, Gujarat, Índia, 382428
- Apollo Research and Innovations, Apollo Hospitals International Ltd
-
Rajkot, Gujarat, Índia, 360005
- Shree Giriraj Multispeciality Hospital
-
Surat, Gujarat, Índia, 395002
- Nirmal Hospital Pvt Ltd.
-
-
Karnataka
-
Bangalore, Karnataka, Índia, 560054
- M S Ramaiah Medical College and Hospitals
-
Bangalore, Karnataka, Índia, 560 002
- Bangalore Medical College and Research Institute
-
-
Maharashtra
-
Nagpur, Maharashtra, Índia, 440010
- Midas Multispeciality Hospital Pvt.Ltd.
-
Pune, Maharashtra, Índia, 411 001
- Poona Medical Foundation. Ruby Hall Clinic
-
Wardha, Maharashtra, Índia, 442004
- Datta Meghe Institute of Medical Sciences (DU), Acharya Vinoba Bhave Rural Hospital
-
-
National Capital Territory of Delhi
-
New Delhi, National Capital Territory of Delhi, Índia, 110 025
- Escorts Heart Institute and Research Centre Ltd
-
-
Punjab
-
Ludhiana, Punjab, Índia, 141001
- Dayanand Medical College and Hospital
-
-
Rajasthan
-
Jaipur, Rajasthan, Índia, 302001
- SR Kalla Memorial Gastro & General Hospital
-
-
Telangana
-
Hyderabad, Telangana, Índia, 500003
- Gandhi Hospital
-
-
Uttar Pradesh
-
Lucknow, Uttar Pradesh, Índia, 226003
- King George Medical University
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
14 anos a 76 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Descrição
Critério de inclusão:
- Ter concluído o Estudo AMAN (NCT03518086), com pelo menos 1 administração do medicamento do estudo e sem rescisão antecipada do medicamento do estudo.
- Estão dispostos e aptos a concluir as avaliações programadas do estudo, incluindo endoscopia e entrada diária no diário.
- Se for do sexo feminino, deve atender aos requisitos de contracepção.
Critério de exclusão:
- Participantes diagnosticados com doença de Crohn ou doença inflamatória intestinal não classificada (colite indeterminada) durante o estudo de indução AMAN (NCT03518086).
- Participantes com uma ressecção intestinal ou outra cirurgia para o tratamento de UC durante o estudo de indução anterior AMAN (NCT03518086), ou provavelmente necessitarão de cirurgia para o tratamento de UC durante o estudo AMBG.
- Participantes com evidência de displasia colônica ou diagnosticados com câncer do trato gastrointestinal durante o estudo AMAN (NCT03518086).
- Participantes diagnosticados com infecção clinicamente importante, incluindo, entre outros, hepatite B, hepatite C, HIV/AIDS e tuberculose ativa (TB) durante o estudo de indução AMAN (NCT03518086).
- Participantes que iniciam uma nova medicação proibida durante o estudo de indução AMAN (NCT03518086).
- Participantes com certas anormalidades laboratoriais antes do início do AMBG que exigiriam a descontinuação permanente do medicamento do estudo.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Comparador de Placebo: Período de manutenção: Miri Induction Responder (IR) - Placebo (PBO) Subcutâneo (SC)
Os participantes que responderam ao mirikizumab (miri) às cegas na semana 12 no estudo de indução (LUCENT-1) foram randomizados para retirar o mirikizumab e começar a receber PBO SC a cada 4 semanas (Q4W) a partir da semana 0 do estudo de manutenção (LUCENT-2) até a semana 40 ou até que a perda de resposta seja confirmada.
|
SC administrado
|
|
Experimental: Período de manutenção: Miri IR - 200 miligramas (mg) Miri SC
Os participantes que responderam ao mirikizumabe cego na semana 12 no estudo de indução (LUCENT-1) foram randomizados para continuar a receber 200 mg de mirikizumabe SC Q4W da semana 0 do LUCENT-2 até a semana 40 ou até que a perda de resposta fosse confirmada.
|
SC administrado
Outros nomes:
|
|
Experimental: Maintenance Period: PBO IR - PBO SC
Participants who were responders to blinded placebo at Week 12 in induction study (LUCENT-1) continue to receive blinded placebo SC Q4W from Week 0 of LUCENT-2 until Week 40 or until loss of response was confirmed.
|
SC administrado
|
|
Experimental: Maintenance Period: Miri IR - PBO SC - ME2 Cohort
Participants in the ME2 Cohort who were responders to blinded mirikizumab (miri) at Week 12 in induction study (LUCENT-1) randomized to withdraw from mirikizumab and start receiving PBO SC every 4 weeks (Q4W) from Week 0 of maintenance study (LUCENT-2) until Week 40 or until loss of response was confirmed.
|
SC administrado
|
|
Experimental: Maintenance Period: Miri IR - 200 mg Miri SC - ME2 Cohort
Participants in the ME2 Cohort who were responders to blinded mirikizumab at Week 12 in induction study (LUCENT-1) randomized to continue to receive 200 mg mirikizumab SC Q4W from Week 0 of LUCENT-2 until Week 40 or until loss of response was confirmed.
|
SC administrado
Outros nomes:
|
|
Experimental: Maintenance Period: PBO IR - PBO SC - ME2 Cohort
Participants in the ME2 Cohort who were responders to blinded placebo at Week 12 in induction study (LUCENT-1) continue to receive blinded placebo SC Q4W from Week 0 of LUCENT-2 until Week 40 or until loss of response was confirmed.
|
Administrado IV
Outros nomes:
SC administrado
|
|
Experimental: Loss of Response (LOR) Rescue Period: LOR Cohort-300 mg Miri IV
Participants who received blinded PBO SC or blinded 200 mg mirikizumab SC Q4W during maintenance period and experienced a loss of response at or after Week 12, received rescue therapy with open label 300 mg mirikizumab intravenous (IV) Q4W for 3 doses.
|
Administrado IV
Outros nomes:
|
|
Experimental: LOR Rescue Period: LOR Cohort-300 mg Miri IV - ME2 Cohort
Participants in the ME2 Cohort who received blinded PBO SC or blinded 200 mg mirikizumab SC Q4W during maintenance period and experienced a loss of response at or after Week 12, received rescue therapy with open label 300 mg mirikizumab intravenous (IV) Q4W for 3 doses.
|
Administrado IV
Outros nomes:
|
|
Experimental: Extended Induction: Induction Nonresponders - 300mg Miri IV
Participants who were nonresponders to blinded mirikizumab or placebo in induction study (LUCENT-1), received additional 3 doses of open label 300 mg mirikizumab IV Q4W during extended induction period from Week 0 of LUCENT-2 until Week 12.
|
Administrado IV
Outros nomes:
|
|
Experimental: Extended Induction: Induction Nonresponders - 300mg Miri IV - ME2 Cohort
Participants in the ME2 Cohort who were nonresponders to blinded mirikizumab or placebo in induction study (LUCENT-1), received additional 3 doses of open label 300 mg mirikizumab IV Q4W during extended induction period from Week 0 of LUCENT-2 until Week 12.
|
Administrado IV
Outros nomes:
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Experimental: Open Label Maintenance: Delayed Responders - 200 mg Miri SC
Participants who initially did not respond to induction study (LUCENT-1), but responded to extended induction therapy at Week 12 of LUCENT-2 (delayed responders), received 200 mg mirikizumab SC Q4W during open label maintenance period from Week 12 until Week 40 or until early termination (rescue was not available for these participants).
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SC administrado
Outros nomes:
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Experimental: Open Label Maintenance: Delayed Responders - 200 mg Miri SC - ME2 Cohort
Participants in the ME2 Cohort who initially did not respond to induction study (LUCENT-1), but responded to extended induction therapy at Week 12 of LUCENT-2 (delayed responders), received 200 mg mirikizumab SC Q4W during open label maintenance period from Week 12 until Week 40 or until early termination (rescue was not available for these participants).
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SC administrado
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Percentage of Participants in Clinical Remission at Week 40 (Mirikizumab Induction Responders)
Prazo: Week 40
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Clinical remission at week 40 is defined as achieving a 9-point modified Mayo score for rectal bleeding=0, stool frequency=0 or 1 with ≥ 1 point decrease from baseline, and endoscopy=0 or 1 (excluding friability). Stool Frequency Subscore, based on the participant's diary and scored from 0 (normal number of stools) to 3 (5 or more stools than normal); Rectal Bleeding Subscore, based on the participant's diary and scored from 0 (no blood) to 3 (blood only passed); Endoscopy Subscore, based on central reading of colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration). Modified Intention-to-treat population (mITT): All randomized participants who received at least one dose of mirikizumab and who had a correctly measured Modified Mayo Score at baseline. Participants were analyzed according to the treatment arm to which they were randomized, regardless of the treatment actually received. |
Week 40
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Farmacocinética (PK): Depuração de Mirikizumabe
Prazo: Pré-dose: Semanas 0, 4, 12, 24 e 40
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A depuração de mirikizumab foi avaliada.
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Pré-dose: Semanas 0, 4, 12, 24 e 40
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Percentage of Participants in Endoscopic Remission at Week 40 (Mirikizumab Induction Responders)
Prazo: Week 40
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Endoscopic remission at week 40 is defined as achieving a Mayo endoscopic subscore of 0 or 1 (excluding friability) at Week 40.
Endoscopy subscore is based on colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration).
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Week 40
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Percentage of Participants With Histologic Remission at Week 40 (Mirikizumab Induction Responders)
Prazo: Week 40
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Histologic remission was assessed using the Geboes histologic scoring system developed for assessment of histologic disease activity in ulcerative colitis.
Remission was defined as Geboes histological subscore of 0 for grades: 2b (lamina propria neutrophils), and 3 (neutrophils in epithelium), and 4 (crypt destruction), and 5 (erosion or ulceration).
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Week 40
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Percentage of Participants in Symptomatic Remission at Week 40 (Mirikizumab Induction Responders)
Prazo: Week 40
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Symptomatic remission at week 40 is defined as a Mayo score for rectal bleeding=0, stool frequency=0 or 1 with ≥ 1 point decrease from baseline. Stool frequency subscore, based on the participant's diary and scored from 0 (normal number of stools) to 3 (5 or more stools than normal). Rectal bleeding subscore, based on the participant's diary and scored from 0 (no blood seen) to 3 (blood alone passed). |
Week 40
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Percentage of Participants in Endoscopic Response at Week 40 (Mirikizumab Induction Responders)
Prazo: Week 40
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Endoscopic response at week 40 is defined as achieving at least a 1 point decrease from baseline in the Mayo endoscopic subscore.
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Week 40
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Percentage of Participants in Clinical Response at Week 40 (Mirikizumab Induction Responders)
Prazo: Week 40
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Clinical response at week 40 is defined as a decrease in the 9-point modified Mayo score (MMS) [rectal bleeding, stool frequency and the endoscopic findings] inclusive of >= 2 points and >=30% from baseline with either a decrease of rectal bleeding subscore of >=1 or rectal bleeding subscore of 0 or 1.The MMS is a composite score of ulcerative colitis disease activity calculated as the sum of three subscores: Stool frequency subscore, based on the participant's diary and scored from 0 (normal number of stools) to 3 (5 or more stools than normal); Rectal bleeding subscore, based on the participant's diary and scored from 0 (no blood seen) to 3 (blood alone passed); Endoscopy subscore, based on colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding,ulceration).
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Week 40
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Change From Baseline to Week 40 in Health Related Quality of Life: Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score (Mirikizumab Induction Responders)
Prazo: Induction Baseline, Week 40
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The IBDQ is a 32-item participant-completed questionnaire that measures 4 aspects of subjects' lives: symptoms directly related to the primary bowel disturbance, systemic symptoms, emotional function, and social function.
Responses are graded on a 7-point.
Likert scale in which 7 denotes "not a problem at all" and 1 denotes "a very severe problem."
Scores range from 32 to 224; a higher score indicates a better quality of life.
Least square (LS) Mean was calculated using analysis of covariance (ANCOVA) model for post-baseline measures: The ANCOVA model includes: treatment, baseline value, prior biologic or tofacitinib failure (yes/no), clinical remission status (yes/no) at AMAN Week 12, and region (North America/Europe/Other).
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Induction Baseline, Week 40
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Change From Baseline to Week 40 in Fecal Calprotectin (Mirikizumab Induction Responders)
Prazo: Induction Baseline, Week 40
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Fecal calprotectin is an indicator of inflammation in the colon with higher levels indicative of higher levels of inflammation.
Least square (LS) Mean was calculated using ANCOVA model for post-baseline measures: The ANCOVA model includes treatment, baseline value, prior biologic or tofacitinib failure (yes/no), corticosteroid use (yes/no) at AMAN baseline, region (North America/Europe/Other), Clinical Remission status (yes/no) at AMAN Week 12.
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Induction Baseline, Week 40
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Change From Baseline to Week 40 in Bowel Urgency Based on the Urgency Numeric Rating Scale (NRS) (Mirikizumab Induction Responders)
Prazo: Induction Baseline, Week 40
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The Urgency NRS is a single participant reported item that measures the severity for the urgency (sudden or immediate need) to have a bowel movement in the past 24 hours using an 11-point NRS ranging from 0 (no urgency) to 10 (worst possible urgency).
Higher scores indicate more severe urgency.
Least square (LS) Mean was calculated using mixed model repeated measures (MMRM) model for post-baseline measures: The MMRM model includes treatment, baseline value, visit, interaction of baseline value-by-visit, interaction of treatment-by-visit, prior biologic or tofacitinib failure (yes/no), baseline corticosteroid use (yes/no), clinical remission status (yes/no) at AMAN Week 12, and region (North America/Europe/Other).
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Induction Baseline, Week 40
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Percentage of Participants Hospitalized for Ulcerative Colitis (UC) (Mirikizumab Induction Responders)
Prazo: Week 40
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Percentage of participants hospitalized for UC.
Only hospitalizations associated with an adverse event with >=24 hours stay were recorded.
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Week 40
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Diretor de estudo: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- Sands BE, D'Haens G, Clemow DB, Irving PM, Johns JT, Gibble TH, Abreu MT, Lee SD, Hisamatsu T, Kobayashi T, Dubinsky MC, Vermeire S, Siegel CA, Peyrin-Biroulet L, Moses RE, Milata J, Panaccione R, Dignass A. Three-Year Efficacy and Safety of Mirikizumab Following 152 Weeks of Continuous Treatment for Ulcerative Colitis: Results From the LUCENT-3 Open-Label Extension Study. Inflamm Bowel Dis. 2025 Jul 7;31(7):1876-1890. doi: 10.1093/ibd/izae253.
- Clemow DB, Dubinsky MC, Baygani SK, Sands BE, Keohane A, Danese S, Schreiber S, Walsh AJ, Hibi T, Gibble TH, Moses RE, Travis SPL. Bowel urgency in ulcerative colitis: effect of baseline urgency and change in urgency in response to mirikizumab. J Patient Rep Outcomes. 2025 Jul 1;9(1):75. doi: 10.1186/s41687-025-00906-0.
- Panaccione R, Chan-Diehl F, Baygani S, Fisher DA, Moses RE, Siegmund B, Walsh A, Kobayashi T, Dulai PS, Travis S. Fecal Calprotectin and C-Reactive Protein Association With Histologic and Endoscopic Endpoints in Mirikizumab-Treated Patients With Ulcerative Colitis. Crohns Colitis 360. 2025 Jun 14;7(2):otaf043. doi: 10.1093/crocol/otaf043. eCollection 2025 Apr.
- Danese S, Dignass A, Matsuoka K, Ferrante M, Long M, Redondo I, Moses R, Maier S, Hunter Gibble T, Morris N, Milch C, Abreu MT. Early and Sustained Symptom Control with Mirikizumab in Patients with Ulcerative Colitis in the Phase 3 LUCENT Programme. J Crohns Colitis. 2024 Nov 4;18(11):1845-1856. doi: 10.1093/ecco-jcc/jjae088.
- Long MD, Schreiber S, Hibi T, Gibble TH, Fisher DA, Park G, Moses RE, Higgins PDR, Lindsay JO, Lee SD, Escobar R, Jairath V. Association of Bowel Urgency With Quality-of-Life Measures in Patients With Moderately-to-Severely Active Ulcerative Colitis: Results From Phase 3 LUCENT-1 (Induction) and LUCENT-2 (Maintenance) Studies. Crohns Colitis 360. 2024 Jan 6;6(1):otae001. doi: 10.1093/crocol/otae001. eCollection 2024 Jan.
- Sands BE, Feagan BG, Hunter Gibble T, Traxler KA, Morris N, Eastman WJ, Schreiber S, Jairath V, Long MD, Armuzzi A. Mirikizumab Improves Quality of Life in Patients With Moderately-to-Severely Active Ulcerative Colitis: Results From the Phase 3 LUCENT-1 Induction and LUCENT-2 Maintenance Studies. Crohns Colitis 360. 2023 Nov 7;5(4):otad070. doi: 10.1093/crocol/otad070. eCollection 2023 Oct.
- Chua L, Friedrich S, Zhang XC. Mirikizumab Pharmacokinetics in Patients with Moderately to Severely Active Ulcerative Colitis: Results from Phase III LUCENT Studies. Clin Pharmacokinet. 2023 Oct;62(10):1479-1491. doi: 10.1007/s40262-023-01281-z. Epub 2023 Aug 23.
- D'Haens G, Dubinsky M, Kobayashi T, Irving PM, Howaldt S, Pokrotnieks J, Krueger K, Laskowski J, Li X, Lissoos T, Milata J, Morris N, Arora V, Milch C, Sandborn W, Sands BE; LUCENT Study Group. Mirikizumab as Induction and Maintenance Therapy for Ulcerative Colitis. N Engl J Med. 2023 Jun 29;388(26):2444-2455. doi: 10.1056/NEJMoa2207940.
- Magro F, Pai RK, Kobayashi T, Jairath V, Rieder F, Redondo I, Lissoos T, Morris N, Shan M, Park M, Peyrin-Biroulet L. Resolving Histological Inflammation in Ulcerative Colitis With Mirikizumab in the LUCENT Induction and Maintenance Trial Programmes. J Crohns Colitis. 2023 Oct 20;17(9):1457-1470. doi: 10.1093/ecco-jcc/jjad050.
- Lee SD, Ehrlich AC, Pellanda P, Kaiser C, Todd K, Moses R, Walsh A. Long-Term Safety of Mirikizumab in Patients With Moderately to Severely Active Ulcerative Colitis: An Integrated 2-Year Safety Analysis. Am J Gastroenterol. 2025 Dec 1;120(12):2857-2866. doi: 10.14309/ajg.0000000000003407. Epub 2025 Mar 12.
- Hart A, Navabi S, D'Haens G, Matsuoka K, Martin-Arranz MD, Atreya R, Samaan KH, Dhesi E, Redondo I, Zhu B, Paulissen J, Zaremba-Pechmann L, Baygani S, Limdi J, Laharie D, Danese S. Effect of Mirikizumab on Clinical and Endoscopic Outcomes Based on Prior Advanced Therapy Failure in Patients With Moderately to Severely Active Ulcerative Colitis. United European Gastroenterol J. 2026 May;14(4):e70214. doi: 10.1002/ueg2.70214.
- Ran Z, Chen Y, Miao Y, Wang Y, Gao X, Zhong J, Ding X, Wang C, Zhang X, Ding Y, Hu N, Tang D, Yu J, Qian C, Shen J. Mirikizumab as Induction and Maintenance Therapy in Chinese Patients with Ulcerative Colitis: A Subpopulation Analysis of the Randomized, Global Phase 3 LUCENT-1 and LUCENT-2 Trials. BioDrugs. 2026 May 12. doi: 10.1007/s40259-026-00776-y. Online ahead of print.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
19 de outubro de 2018
Conclusão Primária (Real)
3 de novembro de 2021
Conclusão do estudo (Real)
17 de fevereiro de 2025
Datas de inscrição no estudo
Enviado pela primeira vez
10 de maio de 2018
Enviado pela primeira vez que atendeu aos critérios de CQ
10 de maio de 2018
Primeira postagem (Real)
14 de maio de 2018
Atualizações de registro de estudo
Última Atualização Postada (Real)
13 de maio de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
12 de maio de 2026
Última verificação
1 de maio de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Doenças Intestinais
- Doenças do aparelho digestivo
- Doenças Gastrointestinais
- Doenças do cólon
- Gastroenterite
- Colite
- Colite ulcerativa
- Doenças Inflamatórias Intestinais
- Efeitos fisiológicos das drogas
- Agentes Antiinflamatórios
- Agentes do Sistema Nervoso Periférico
- Agentes gastrointestinais
- Agentes Antirreumáticos
- Agentes do Sistema Sensorial
- Analgésicos Não Narcóticos
- Analgésicos
- Agentes Antiinflamatórios Não Esteroidais
- Agentes antiúlceras
- Mirikizumab
Outros números de identificação do estudo
- 16823
- I6T-MC-AMBG (Outro identificador: Eli Lilly and Company)
- 2017-003238-96 (Número EudraCT)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
SIM
Descrição do plano IPD
Os dados anônimos individuais do nível do paciente serão fornecidos em um ambiente de acesso seguro após a aprovação de uma proposta de pesquisa e um acordo de compartilhamento de dados assinado.
Prazo de Compartilhamento de IPD
Os dados estão disponíveis 6 meses após a publicação primária e aprovação da indicação estudada nos EUA e na UE, o que ocorrer mais tarde.
Os dados ficarão indefinidamente disponíveis para solicitação.
Critérios de acesso de compartilhamento IPD
Uma proposta de pesquisa deve ser aprovada por um painel de revisão independente e os pesquisadores devem assinar um acordo de compartilhamento de dados.
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CSR
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Sim
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .