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Un estudio de mantenimiento de mirikizumab en participantes con colitis ulcerosa activa de moderada a grave (LUCENT 2)

12 de mayo de 2026 actualizado por: Eli Lilly and Company

Estudio de mantenimiento de fase 3, multicéntrico, aleatorizado, doble ciego, de brazos paralelos y controlado con placebo de mirikizumab en pacientes con colitis ulcerosa activa de moderada a grave (LUCENT 2)

El propósito de este estudio es evaluar la eficacia y seguridad de mirikizumab como terapia de mantenimiento en participantes que completaron como respondedores clínicos en el estudio de inducción anterior de 12 semanas LUCENT-1 (NCT03518086).

Descripción general del estudio

Estado

Terminado

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Actual)

1328

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Alemania
      • Berlin, Alemania, 14163
        • Krankenhaus Waldfriede
      • Berlin, Alemania, 12203
        • Charité Campus Virchow-Klinikum
      • Brandenburg, Alemania, 14770
        • Städtisches Klinikum Brandenburg
      • Hamburg, Alemania, 20251
        • HaFCED - Hamburgisches Forschungsinstitut für chronisch entzündliche Darmerkrankungen
      • Weyhe, Alemania, 28844
        • Internistische Praxisgemeinschaft
    • Lower Saxony
      • Hanover, Lower Saxony, Alemania, 30625
        • Medizinische Hochschule Hanover
    • Rhineland-Palatinate
      • Ludwigshafen am Rhein, Rhineland-Palatinate, Alemania, 67067
        • Gemeinschaftspraxis Dr. Peter Uebel
    • Saxony-Anhalt
      • Halle, Saxony-Anhalt, Alemania, 06108
        • Studiengesellschaft BSF Unternehmergesellschaft
      • Halle, Saxony-Anhalt, Alemania, 06120
        • Universitätsklinikum Halle
  • Argentina
      • Córdoba, Argentina, X5016KEH
        • Hospital Privado Centro Medico de Cordoba SA
    • Buenos Aires
      • CABA, Buenos Aires, Argentina, C1027AAP
        • Centro de Investigaciones Metabolicas (CINME)
      • Ciudad Autonoma de Buenos Air, Buenos Aires, Argentina, C1128AAF
        • Mautalen Salud e Investigacion-Centro de Osteopatías Médicas
      • Quilmes, Buenos Aires, Argentina, B1878DVC
        • Cer Instituto Medico
    • Santa Fe Province
      • Rosario, Santa Fe Province, Argentina, S2000DEJ
        • Fundacion de Estudios Clinicos
    • Tucumán Province
      • SAN M. de Tucuman, Tucumán Province, Argentina, T4000AXL
        • Centro de Investigaciones Médicas Tucuman
      • San Miguel de Tucumán, Tucumán Province, Argentina, 4000
        • C.I.C.E. 9 de Julio
  • Australia
    • Essex
      • Harlow, Essex, Australia, CM20 1QX
        • Princess Alexandra Hospital
    • Queensland
      • Maroochydore, Queensland, Australia, 4558
        • Coastal Digestive Health
      • South Brisbane, Queensland, Australia, 4101
        • Mater University Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Box Hill Hospital Outpatients
      • Malvern, Victoria, Australia, 3144
        • Melbourne Gastrointestinal Investigation Unit (MGIU)
      • Melbourne, Victoria, Australia, 3004
        • The Alfred Hospital
      • Parkville, Victoria, Australia, 3050
        • The Royal Melbourne Hospital
  • Austria
      • Innsbruck, Austria, 6020
        • Medizinische Universität Innsbruck
      • Salzburg, Austria, 5020
        • Universitätsklinikum Salzburg
      • Vienna, Austria, 1090
        • Medical University of Vienna
  • Bélgica
      • Brasschaat, Bélgica, 2930
        • AZ Klina
      • Leuven, Bélgica, 3000
        • Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Bélgica, 9000
        • Universitair Ziekenhuis Gent
    • Wallonne, Région
      • Tournai, Wallonne, Région, Bélgica, 7500
        • Centre Hospitalier de Wallonie Picarde - Site Notre Dame
  • Canadá
    • Alberta
      • Edmonton, Alberta, Canadá, T5R 1W2
        • West Edmonton Diabetes Center
    • British Columbia
      • Vancouver, British Columbia, Canadá, V6Z 2K5
        • GI Research Institute
      • Vancouver, British Columbia, Canadá, V5Z 1M9
        • The Gordon and Leslie Diamond Health Care Centre
      • Victoria, British Columbia, Canadá, V8V 3M9
        • PerCuro Clinical Research
    • Ontario
      • London, Ontario, Canadá, N6A 4G5
        • Victoria Hospital
      • London, Ontario, Canadá, N6A 5G1
        • University of Western Ontario
    • Quebec
      • Greenfield Park, Quebec, Canadá, J4V 2H1
        • Centre de santé et de services sociaux Champlain-Charles-Le Moyne
      • Montreal, Quebec, Canadá, H1T 2M4
        • Hopital Maisonneure-Rosemount
      • Montreal, Quebec, Canadá, H3G 1A4
        • Inflammatory Bowel Disease Centre Montreal General Hospital - MUHC
  • Chequia
      • Brno, Chequia, 65691
        • Fakultni nemocnice u sv. Anny v Brne
      • Olomouc, Chequia, 779
        • PreventaMed, s.r.o.
      • Prague, Chequia, 19000
        • ISCARE Clinical Centre
    • Brno-město
      • Brno, Brno-město, Chequia, 636 00
        • Vojenska nemocnice Brno
    • Hl. M. Praha
      • Prague, Hl. M. Praha, Chequia, 100 34
        • Fakultni nemocnice Kralovske Vinohrady
    • Hradec Králové
      • Hradec Králové, Hradec Králové, Chequia, 500 12
        • Hepato-Gastroenterologie HK
    • Olomouc Region
      • Olomouc, Olomouc Region, Chequia, 779 00
        • MUDr. Gregar, s.r.o.
    • Plzeň-město
      • Pilsen, Plzeň-město, Chequia, 301 00
        • A-Shine
    • Praha 8
      • Prague, Praha 8, Chequia, 186 00
        • MEDIENDO
  • Corea del Sur
      • Busan, Corea del Sur, 48108
        • Inje University Haeundae Paik Hospital
      • Daegu, Corea del Sur, 42415
        • Yeungnam Univeristy Medical Center
    • Gangwon-do
      • Wŏnju, Gangwon-do, Corea del Sur, 26426
        • Severance Hospital, Yonsei University Health System
    • Korea
      • Seoul, Korea, Corea del Sur, 02447
        • Kyung Hee University Hospital
    • Pusan-Kwangyǒkshi
      • Busan, Pusan-Kwangyǒkshi, Corea del Sur, 49201
        • Dong-A University Hospital
    • Seoul-teukbyeolsi [Seoul]
      • Seoul, Seoul-teukbyeolsi [Seoul], Corea del Sur, 06351
        • Samsung Medical Center
      • Seoul, Seoul-teukbyeolsi [Seoul], Corea del Sur, 05505
        • Asan Medical Center
      • Seoul, Seoul-teukbyeolsi [Seoul], Corea del Sur, 03181
        • Kangbuk Samsung Hospital
    • Taejǒn-Kwangyǒkshi
      • Daejeon, Taejǒn-Kwangyǒkshi, Corea del Sur, 34943
        • The Catholic University of Korea, Daejeon ST. Mary's Hospital
  • Dinamarca
      • Herlev, Dinamarca, 2730
        • Herlev and Gentofte Hospital
      • Køge, Dinamarca, 4600
        • Zealand University Hospital Køge
  • Eslovaquia
      • Banská Bystrica, Eslovaquia, 975 17
        • Fakultna nemocnica s poliklinikou Roosevelta Banska Bystrica
      • Bratislava, Eslovaquia, 82007
        • Univerzitna nemocnica Bratislava
    • Nitra Region
      • Nitra, Nitra Region, Eslovaquia, 949 01
        • KM Management
    • Presov
      • Prešov, Presov, Eslovaquia, 080 01
        • Gastro
      • Vranov N. Toplou, Presov, Eslovaquia, 093 01
        • Endomed, s.r.o.
  • España
      • A Coruña, España, 15006
        • Complexo Hospitalario Universitario A Coruña, CHUAC
      • Alicante, España, 3004
        • Instituto de Ciencias Médicas
      • Girona, España, 17007
        • Hospital Universitari de Girona
      • Huelva, España, 21005
        • Hospital Universitario Juan Ramón Jiménez
      • Las Palmas de Gran Canaria, España, 35010
        • Hospital de Gran Canaria Dr. Negrín
      • Madrid, España, 28046
        • Hospital Universitario La Paz
      • Oviedo, España, 3306
        • Hospital Universitario Central de Asturias
    • Andalusia
      • Seville, Andalusia, España, 41013
        • Hospital Universitario Virgen del Rocío
    • Baleares Islands
      • Palma de Mallorca, Baleares Islands, España, 07120
        • Hospital Universitari Son Espases
    • Cantabria
      • Santander, Cantabria, España, 39008
        • Hospital Universitario Marqués de Valdecilla
    • Madrid
      • Fuenlabrada, Madrid, España, 28942
        • Hospital De Fuenlabrada
    • Valencia
      • Sagunto, Valencia, España, 46520
        • Hospital Gen. Juan Ramon Jimenez - Depto de Digestivo
  • Estados Unidos
    • Alabama
      • Dothan, Alabama, Estados Unidos, 36305
        • Digestive Health Specialists Of The Southeast
    • Arizona
      • Litchfield Park, Arizona, Estados Unidos, 85340
        • Dcr-Pi, Pc
      • Phoenix, Arizona, Estados Unidos, 85008
        • Maricopa Integrated Health System
      • Tempe, Arizona, Estados Unidos, 85284
        • Physicians Research Group
    • California
      • Arcadia, California, Estados Unidos, 91006
        • Valley Gastroenterology
      • Berkeley, California, Estados Unidos, 94705
        • Care Access Research
      • Lancaster, California, Estados Unidos, 93534
        • Om Research, LLC
      • Northridge, California, Estados Unidos, 91324
        • California Medical Research Associates
      • San Diego, California, Estados Unidos, 92103
        • Clinical Applications Laboratories, Inc.
      • San Francisco, California, Estados Unidos, 94158
        • UCSF Medical Center at Mission Bay
    • Florida
      • Hialeah, Florida, Estados Unidos, 33012
        • Direct Helpers Research Center
      • Inverness, Florida, Estados Unidos, 34452
        • Nature Coast Clinical Research, LLC
      • Kissimmee, Florida, Estados Unidos, 34741
        • SIH Research, LLC
      • Miami, Florida, Estados Unidos, 33134
        • Research Associates of South Florida, LLC
      • Miami Lakes, Florida, Estados Unidos, 33016
        • Wellness Clinical Research
      • Orlando, Florida, Estados Unidos, 32818
        • Clintheory Healthcare
      • Orlando, Florida, Estados Unidos, 32803
        • Center for Interventional Endoscopy
      • Pensacola, Florida, Estados Unidos, 32503
        • Gastroenterology Associates of Pensacola, PA
      • Zephyrhills, Florida, Estados Unidos, 33542-7505
        • Florida Medical Clinic LLC
    • Georgia
      • Atlanta, Georgia, Estados Unidos, 30309
        • Digestive Healthcare of Georgia
    • Idaho
      • Idaho Falls, Idaho, Estados Unidos, 83404
        • Grand Teton Research Group
    • Illinois
      • Evanston, Illinois, Estados Unidos, 60201
        • Northshore University Healthsystem
    • Indiana
      • Indianapolis, Indiana, Estados Unidos, 46202
        • Indiana University School of Medicine
    • Kansas
      • Topeka, Kansas, Estados Unidos, 66606
        • Cotton-O'Neil Clinical Research Center, Digestive Health
    • Louisiana
      • Baton Rouge, Louisiana, Estados Unidos, 70809
        • Texas Digestive Disease Consultants
      • Monroe, Louisiana, Estados Unidos, 71201
        • Delta Research Partners LLC
      • New Orleans, Louisiana, Estados Unidos, 70125
        • Nola Research Works, LLC
    • Michigan
      • Chesterfield, Michigan, Estados Unidos, 48047
        • Clinical Research Institute of Michigan, LLC
      • Novi, Michigan, Estados Unidos, 48377
        • Henry Ford Health System
      • Wyoming, Michigan, Estados Unidos, 49519
        • Gastroenterology Associates of Western Michigan, P.L.C.
      • Ypsilanti, Michigan, Estados Unidos, 48197
        • Huron Gastroenterology Associates
    • Minnesota
      • Plymouth, Minnesota, Estados Unidos, 55446
        • MNGI Digestive Health - Plymouth Endoscopy Center & Clinic
    • Mississippi
      • Jackson, Mississippi, Estados Unidos, 39206
        • Care Access Research LLC
      • Tupelo, Mississippi, Estados Unidos, 38801
        • Digestive Health Specialists
    • New York
      • Great Neck, New York, Estados Unidos, 11021
        • Northwell Health
      • New York, New York, Estados Unidos, 10021
        • Weill Cornell Medical College
    • North Carolina
      • Chapel Hill, North Carolina, Estados Unidos, 27599
        • University of North Carolina Center for Inflammatory Bowel Disease
      • Greenville, North Carolina, Estados Unidos, 27834
        • Carolina Digestive Diseases and Endoscopy Center
    • Ohio
      • Middleburg Heights, Ohio, Estados Unidos, 44130
        • Paramount Medical Research
      • Poland, Ohio, Estados Unidos, 44514
        • Care Access - Youngstown
    • Oklahoma
      • Norman, Oklahoma, Estados Unidos, 73071
        • Central Sooner Research
      • Oklahoma City, Oklahoma, Estados Unidos, 73104
        • University of Oklahoma Health Sciences Center
    • Pennsylvania
      • Wyomissing, Pennsylvania, Estados Unidos, 19610
        • Digestive Disease Associates
    • South Dakota
      • Sioux Falls, South Dakota, Estados Unidos, 57108
        • Midwest Medical Care
    • Tennessee
      • Germantown, Tennessee, Estados Unidos, 38138
        • Gastro One
      • Hixson, Tennessee, Estados Unidos, 37343
        • Galen Medical Group
    • Texas
      • Garland, Texas, Estados Unidos, 75044
        • Digestive Health Associates of Texas
      • Houston, Texas, Estados Unidos, 77043
        • Biopharma Informatic, LLC
      • Houston, Texas, Estados Unidos, 77030
        • Houston Methodist Research Ins
      • San Antonio, Texas, Estados Unidos, 78229
        • Southern Star Research Institute, LLC
      • San Antonio, Texas, Estados Unidos, 78229
        • Gastroenterology Research of San Antonio
      • Southlake, Texas, Estados Unidos, 76092
        • Texas Digestive Disease Consultants
    • Utah
      • Ogden, Utah, Estados Unidos, 84403
        • Care Access Research LLC - Salt Lake City
    • Virginia
      • Leesburg, Virginia, Estados Unidos, 20176
        • Emeritas Research Group
      • Reston, Virginia, Estados Unidos, 20191
        • The Gastroenterology Group, P.C.
      • Roanoke, Virginia, Estados Unidos, 24016
        • Carilion Clinic
    • Wisconsin
      • Milwaukee, Wisconsin, Estados Unidos, 53215
        • Wisconsin Center for Advanced Research
  • Francia
      • Chambray-lès-Tours, Francia, 37170
        • CHU Tours - Hôpital Trousseau
      • Marseille, Francia, 13915
        • Assistance Publique Hôpitaux de Marseille - Hôpital Nord
      • Montpellier, Francia, 34295
        • CHRU de Montpellier-Hopital St Eloi
      • Nice, Francia, 06200
        • Hopital l'Archet 2
      • Pessac, Francia, 33604
        • CHU Bordeaux - Hôpital Haut-Lévêque
      • Reims, Francia, 51092
        • Robert Debre Hospital
      • Saint-Priest-en-Jarez, Francia, 42270
        • CHU de Saint Etienne Hopital Nord
      • Vandœuvre-lès-Nancy, Francia, 54500
        • CHRU Nancy Brabois - Hôpital d'Enfants
    • Bas Rhin
      • Strasbourg, Bas Rhin, Francia, 67098
        • Hopital de Hautepierre - Service d'Hépatogastroentérolgie
    • Cedex 10
      • Paris, Cedex 10, Francia, 75475
        • Hôpital Saint-Louis
    • Nord
      • Lille, Nord, Francia, 59037
        • CHU Lille - Hôpital Claude Huriez
    • Paris
      • Clichy, Paris, Francia, 92110
        • Hopital Beaujon
    • Pyrénées-Atlantiques
      • Pau, Pyrénées-Atlantiques, Francia, 64046
        • Centre Hospitalier de Pau
    • Rhone
      • Pierre-Bénite, Rhone, Francia, 69495
        • Hospices Civils de Lyon - Centre Hospitalier Lyon Sud -
    • Somme
      • Amiens, Somme, Francia, 80480
        • CHU Amiens Picardie-Site Sud - RDC Service Hépato gastro
  • Hungría
      • Budapest, Hungría, 1088
        • Semmelweis Egyetem
      • Budapest, Hungría, 1036
        • Óbudai Egészségügyi Centrum
      • Debrecen, Hungría, 4032
        • Debreceni Egyetem Klinikai Kozpont
      • Miskolc, Hungría, 3526
        • Endomedix Diagnosztikai Központ - Miskolc
      • Mosonmagyaróvár, Hungría, 9200
        • Karolina Korhaz-Rendelointezet
      • Szeged, Hungría, 6720
        • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont I. Belgyogyaszati Klinika
      • Szekszárd, Hungría, 7100
        • CLINFAN Szolgáltató Kft
    • EU
      • Balatonfüred, EU, Hungría, 8230
        • DRC Gyogyszervizsgalo Kozpont Kft.
    • Pest County
      • Vác, Pest County, Hungría, 2600
        • Jávorszky Ödön Kórház
  • India
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500058
        • Centre for Liver Research & Diagnostics, Deccan College of Medical Sciences, Owaisi Hospital & Research Centre
    • Gujarat
      • Gandhinagar, Gujarat, India, 382428
        • Apollo Research and Innovations, Apollo Hospitals International Ltd
      • Rajkot, Gujarat, India, 360005
        • Shree Giriraj Multispeciality Hospital
      • Surat, Gujarat, India, 395002
        • Nirmal Hospital Pvt Ltd.
    • Karnataka
      • Bangalore, Karnataka, India, 560054
        • M S Ramaiah Medical College and Hospitals
      • Bangalore, Karnataka, India, 560 002
        • Bangalore Medical College and Research Institute
    • Maharashtra
      • Nagpur, Maharashtra, India, 440010
        • Midas Multispeciality Hospital Pvt.Ltd.
      • Pune, Maharashtra, India, 411 001
        • Poona Medical Foundation. Ruby Hall Clinic
      • Wardha, Maharashtra, India, 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, India, 110 025
        • Escorts Heart Institute and Research Centre Ltd
    • Punjab
      • Ludhiana, Punjab, India, 141001
        • Dayanand Medical College and Hospital
    • Rajasthan
      • Jaipur, Rajasthan, India, 302001
        • SR Kalla Memorial Gastro & General Hospital
    • Telangana
      • Hyderabad, Telangana, India, 500003
        • Gandhi Hospital
    • Uttar Pradesh
      • Lucknow, Uttar Pradesh, India, 226003
        • King George Medical University
  • Irlanda
      • Dublin, Irlanda, D9
        • Beaumont Hospital, Dublin
  • Israel
      • Beersheba, Israel, 8410101
        • Soroka Medical Center - Pediatric Outpatient Clinic
      • Nahariya, Israel, 2210001
        • Galilee Medical Center Department of Internal Medicine A
      • Rehovot, Israel, 7610001
        • Kaplan Medical Center
      • Tel Aviv, Israel, 6423906
        • Tel Aviv Sourasky Medical Center
      • Ẕerifin, Israel, 70300
        • King Fahad Medical City
    • Jerusalem
      • Bait Vagan, Jerusalem, Israel, 91031
        • Shaare Zedek Medical Center
  • Italia
      • Brescia, Italia, 25123
        • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
      • Catanzaro, Italia, 88100
        • Azienda ospedaliero-universitaria Mater Domini
      • Genova, Italia, 16132
        • Azienda Ospedaliero Universitaria San Martino
      • Milan, Italia, 20122
        • Gastroenterology and Endoscopy Unit IRCCS Ca' Granda Ospedale Maggiore Policlinico Foundation
      • Modena, Italia, 41124
        • Azienda Ospedaliera Universitaria Policlinico de Modena
      • Pisa, Italia, 56124
        • Azienda Ospedaliera Universitaria Pisana
      • Roma, Italia, 00168
        • Policlinico Gemelli - Università Cattolica del Sacro Cuore
      • Torino, Italia, 10128
        • Ospedale Mauriziano Umberto I
      • Udine, Italia, 33100
        • Azienda Ospedaliero-Universitaria Santa Maria della Misericordia Gastroenterologia
    • Milano
      • Rho, Milano, Italia, 20017
        • Presidio di Rho
      • Rozzano, Milano, Italia, 20089
        • Istituto Clinico Humanitas
      • San Donato Milanese, Milano, Italia, 20097
        • Istituti di Ricovero e Cura a Carattere Scientifico Policlinico San Donato Gastroenterologia
    • Roma
      • Rome, Roma, Italia, 00157
        • Ospedale Sandro Pertini
      • Torre, Roma, Italia, 00133
        • Azienda Ospedaliera Universitaria Policlinico Tor Vergata
  • Japón
      • Fukuoka, Japón, 814-0180
        • Fukuoka University Hospital
      • Hiroshima, Japón, 734-8551
        • Hiroshima University Hospital
      • Kagoshima, Japón, 892-0846
        • Sameshima Hospital
      • Kyoto, Japón, 612-8555
        • National Hospital Organization Kyoto Medical Center
      • Okayama, Japón, 700-8558
        • Okayama University Hospital
      • Saitama, Japón, 336-0963
        • Tokitokai Tokito Clinic
      • Toyama, Japón, 930-0975
        • Toyama Prefectural Central Hospital
    • Aichi-ken
      • Nagakute-shi, Aichi-ken, Japón, 480-1195
        • Aichi Medical University Hospital
      • Toyoake, Aichi-ken, Japón, 470-1192
        • Fujita Health University
    • Aomori
      • Hirosaki, Aomori, Japón, 036-8545
        • National Hospital Organization Hirosaki National Hospital
    • Chiba
      • Sakura, Chiba, Japón, 285-8741
        • Toho University Sakura Medical Center
    • Fukoka
      • Kitakyusyu-shi, Fukoka, Japón, 802-0077
        • Kitakyushu Municipal Medical Center
    • Fukuoka
      • Chikushino-shi, Fukuoka, Japón, 818-8502
        • Fukuoka University Chikushi Hospital
      • Kurume-shi, Fukuoka, Japón, 839 0809
        • Hidaka Coloproctology Clinic
    • Gunma
      • Maebashi, Gunma, Japón, 371-8511
        • Gunma University Hospital
      • Takasaki, Gunma, Japón, 370-0829
        • National Hospital Organization Takasaki General Medical Centar
    • HigaShiibaraki-Gun
      • Ibaraki-machi, HigaShiibaraki-Gun, Japón, 311 3193
        • NHO Mito Medical Center
    • Hokkaido
      • Asahikawa, Hokkaido, Japón, 070-8610
        • Asahikawa City Hospital
      • Sapporo, Hokkaido, Japón, 065-0033
        • Sapporo Higashi Tokushukai Hospital
      • Sapporo, Hokkaido, Japón, 004 0041
        • Tokushukai Sapporo Tokushukai Hospital
      • Sapporo, Hokkaido, Japón, 060 0033
        • Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
    • Hyōgo
      • Kobe, Hyōgo, Japón, 650 0015
        • Aoyama Clinic GI Endoscopy & IBD Center
    • Kagawa-ken
      • Takamatsu, Kagawa-ken, Japón, 760-8557
        • Kagawa Prefectural Central Hospital
    • Kanagawa
      • Kamakura, Kanagawa, Japón, 247-0056
        • Ofuna Central Hospital
      • Kawasaki, Kanagawa, Japón, 210-0013
        • Kawasaki Municipal Hospital
      • Yokohama, Kanagawa, Japón, 232-0024
        • Yokohama City University Medical Center
      • Yokohama, Kanagawa, Japón, 234-0032
        • Showa University Northern Yokohama Hospital
      • Yokohama, Kanagawa, Japón, 226 0025
        • Sankikai Yokohama Shin midori General Hospital
    • Kumamoto
      • Kumamoto, Kumamoto, Japón, 860-0012
        • Kumamoto University Hospital
    • Mie-ken
      • Tsu, Mie-ken, Japón, 514-8507
        • Mie University Hospital
    • Miyagi
      • Sendai, Miyagi, Japón, 981 3213
        • Takagi Clinic - Sendai
    • Niigata
      • Nagaoka-shi, Niigata, Japón, 940-8653
        • Nagaoka Chuo General Hospital
    • Oita Prefecture
      • Ōita, Oita Prefecture, Japón, 870 0823
        • Ishida Clinic of IBD and Gastroenterology
    • Osaka
      • Fujiidera, Osaka, Japón, 583-0027
        • Sai Gastroenterologist Proctology
      • Osaka, Osaka, Japón, 530 0011
        • Infusion Clinic
      • Osaka, Osaka, Japón, 540 0006
        • NHO Osaka National Hospital
    • Saga-ken
      • Saga, Saga-ken, Japón, 840-8571
        • Saga-Ken Medical Center Koseikan
    • Saitama
      • Kumagaya-shi, Saitama, Japón, 360-8567
        • Kumagaya General Hospital
    • Shizuoka
      • Hamamatsu, Shizuoka, Japón, 4328061
        • Matsuda Hospital
    • Tochigi
      • Shimotsuke-shi, Tochigi, Japón, 329-0498
        • Jichi Medical University Hospital
    • Tokyo
      • Bunkyo-ku, Tokyo, Japón, 113-8431
        • Juntendo University Hospital
      • Bunkyō, Tokyo, Japón, 113-8519
        • Tokyo Medical and Dental University Hospital
      • Koto-ku, Tokyo, Japón, 135 8577
        • Showa University Koto Toyosu Hospital
      • Minato-Ku, Tokyo, Japón, 108 8642
        • Kitasato University Kitasato Institute Hospital
      • Mitaka, Tokyo, Japón, 181-8611
        • Kyorin University Hospital
      • Shinjuku-ku, Tokyo, Japón, 169-0073
        • JHCO Tokyo Yamate Medical Center
    • Tokyo-To
      • Chiyoda-ku, Tokyo-To, Japón, 101-8643
        • Mitsui Memorial Hospital
      • Shinjuku-ku, Tokyo-To, Japón, 162 8655
        • Center Hospital of the National Center for Global Health and Medicine
  • Letonia
      • Riga, Letonia, 1079
        • Digestive Diseases Center "Gastro"
      • Riga, Letonia, LV-1038
        • Riga Eastern Clinical University Hospital
    • Riga
      • Riga, Riga, Letonia, LV-1002
        • Pauls Stradins Clinical Univeristy Hospital
  • Lituania
      • Kaunas, Lituania, 50009
        • Hospital of Lithuanian University of Health Sciences Kaunas
      • Klaipėda, Lituania, 92288
        • Klaipeda Seamen's Hospital
      • Klaipėda, Lituania, 92231
        • Republic Hospital of Klaipeda
      • Vilnius, Lituania, LT-08661
        • Vilnius University Hospital Santariskiu Clinics
    • Panevėžys
      • Panevezys, Panevėžys, Lituania, LT-35144
        • Respublikine Panevezio ligonine
  • Malasia
    • Kelantan
      • Kubang Kerian, Kelantan, Malasia, 16150
        • Universiti Sains Malaysia
    • Kuala Lumpur
      • Lembah Pantai, Kuala Lumpur, Malasia, 59100
        • University Malaya Medical Centre
    • Selangor
      • Ampang, Selangor, Malasia, 68000
        • Hospital Ampang
  • México
      • 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
  • Países Bajos
      • Uden, Países Bajos, 5406 PT
        • Bernhoven Ziekenhuis
      • Utrecht, Países Bajos, 3584 CX
        • UMC Utrecht, Dept. of Internal Medicine, MDL
    • North Brabant
      • Tilburg, North Brabant, Países Bajos, 5022 GC
        • St Elisabeth Ziekenhuis
    • North Holland
      • Amsterdam, North Holland, Países Bajos, 1105 AZ
        • Amsterdam UMC, Locatie AMC
  • Polonia
      • Katowice, Polonia, 40-660
        • All-Medicus
      • Olsztyn, Polonia, 10-561
        • Wojewodzki Specjalistyczny Szpital w Olsztynie
      • Szczecin, Polonia, 71-434
        • Twoja Przychodnia - Szczecinskie Centrum Medyczne
      • Torun, Polonia, 87-100
        • Gastromed Kopoń Zmudziński I Wspólnicy Spółka Jawna Specjalistyczne Centrum Gastrologii I Endoskopii
      • Warsaw, Polonia, 00-728
        • Warsaw IBD Point Profesor Kierkus
      • Warsaw, Polonia, 00635
        • Centrum Zdrowia MDM
      • Warsaw, Polonia, 01-697
        • Centrum Medyczne NeuroProtect
      • Wroclaw, Polonia, 52-210
        • PlanetMed Sp.z o.o.
      • Zamość, Polonia, 22-400
        • ETG Zamość
    • Kuyavian-Pomeranian Voivodeship
      • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Polonia, 85-168
        • Szpital Uniwersytecki Nr 2 im. dr J. Biziela w Bydgoszczy
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Polonia, 31-506
        • Topolowa Medicenter
      • Nowy Targ, Lesser Poland Voivodeship, Polonia, 34-400
        • Medicenter Nowy Targ
      • Wadowice, Lesser Poland Voivodeship, Polonia, 34-100
        • NZOZ Formed
    • Lower Silesian Voivodeship
      • Wroclaw, Lower Silesian Voivodeship, Polonia, 53-114
        • LexMedica
    • Lublin Voivodeship
      • Lublin, Lublin Voivodeship, Polonia, 20-954
        • Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
      • Lublin, Lublin Voivodeship, Polonia, 20-582
        • ZOZ Gastromed
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Polonia, 03-580
        • NZOZ Vivamed
    • Silesian Voivodeship
      • Będzin, Silesian Voivodeship, Polonia, 42-500
        • Promedica Dental Clinic
    • West Pomeranian Voivodeship
      • Szczecin, West Pomeranian Voivodeship, Polonia, 71-685
        • SONOMED Centrum Medyczne
    • Świętokrzyskie Voivodeship
      • Straszów, Świętokrzyskie Voivodeship, Polonia, 28-200
        • KO-Med Centrum Medyczne
  • Porcelana
      • Wuhan, Porcelana, 430030
        • Tongji Hospital of Tongji University
    • Anhui
      • Hefei, Anhui, Porcelana, 230022
        • The First Affiliated Hospital of Anhui Medical University
      • Hefei, Anhui, Porcelana, 230000
        • Anhui Provincial Hospital
    • Changsha City
      • Kaifu District, Changsha City, Porcelana, 410008
        • Xiangya Hospital Central South University
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, Porcelana, 400037
        • The Affiliated 2nd Hosp. of Third Military Med. Univ. of PLA
      • Chongqing, Chongqing Municipality, Porcelana, 400038
        • The First Hospital Affiliated to AMU (SOUTHWEST HOSPITAL)
    • Guangdong
      • Guangzhou, Guangdong, Porcelana, 510655
        • The Sixth Affiliated Hospital, Sun Yat-sen University
    • Hubei
      • Wuhan, Hubei, Porcelana, 430022
        • Union Hospital Tongji Medical College Huazhong University Of Science And Technology
      • Wuhan, Hubei, Porcelana, 430060
        • Renmin Hospital of Wuhan University
    • Jiangsu
      • Nanjing, Jiangsu, Porcelana, 210008
        • The Affiliated Drum Tower Hospital of Nanjing University
      • Nanjing, Jiangsu, Porcelana, 210029
        • Zhongda Hospital Southeast University
      • Nanjing, Jiangsu, Porcelana, 211106
        • Nanjing Medical University - Nanjing Jiangning Hospital
    • Jiangxi
      • Pingxiang, Jiangxi, Porcelana, 337055
        • Jiangxi Pingxiang People's Hospital
    • Jilin
      • Jilin, Jilin, Porcelana, 132011
        • Jilin Central General Hospital
    • Shandong
      • Jinan, Shandong, Porcelana, 250021
        • Shandong Provincial Hospital
      • Jinan, Shandong, Porcelana, 250014
        • Qilu Hospital of Shandong University
      • Liaocheng, Shandong, Porcelana, 252000
        • Liaocheng People's Hospital
      • Qingdao, Shandong, Porcelana, 266000
        • The Affiliated Hospital of Qingdao University
      • Taian, Shandong, Porcelana, 271000
        • Taian City Central Hospital
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Porcelana, 200025
        • Shanghai Jiaotong University School of Medicine Ruijin Hospital
      • Shanghai, Shanghai Municipality, Porcelana, 200127
        • Renji Hospital Affliated to Shanghai Jiaotong University
    • Sichuan
      • Chengdu, Sichuan, Porcelana, 610041
        • West China Hospital, Sichuan University
    • Yunnan
      • Kunming, Yunnan, Porcelana, 650034
        • The First People's Hospital of Yunnan Province
      • Kunming, Yunnan, Porcelana, 650032
        • Kunming Medical College Affiliated First Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, Porcelana, 310016
        • Sir Run Run Shaw Hospital
      • Hangzhou, Zhejiang, Porcelana, 310003
        • First Affiliated Hosp of College of Med, Zhejiang University
      • Hangzhou, Zhejiang, Porcelana, 310000
        • The Second Affiliated Hospital of Zhejiang University School of Med
      • Wenzhou, Zhejiang, Porcelana, 325027
        • The Second Affiliated Hospital YuYing Childens Hospital of Wenzhou Medical university
  • Reino Unido
    • 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
  • Rumania
      • Bucharest, Rumania, 022328
        • Institutul Clinic Fundeni
      • Bucharest, Rumania, 020125
        • Spitalul Clinic Colentina
      • Bucharest, Rumania, 010719
        • MedLife Grivita
      • Bucharest, Rumania, 031864
        • Hifu Terramed Conformal SRL
      • Oradea, Rumania, 410469
        • Spital Pelican Oradea
    • Bucharest
      • Bucharest, Bucharest, Rumania, 030463
        • CCBR Clinical Research
  • Rusia
      • Barnaul, Rusia, 656043
        • Multidisciplinary Medical Clinic "Anthurium"
      • Cherepovets, Rusia, 162600
        • Medical and Sanitary Division of Severstal
      • Izhevsk, Rusia, 426061
        • Alliance Biomedical URAL Group
      • Kaliningrad, Rusia, 236035
        • Clinical Trials Center of Medical Institute
      • Kazan', Rusia, 420064
        • State Autonomous Institution of Healthcare "Republican Clinical Hospital of the Ministry of Healthcare of Republic Tatarstan
      • Kemerovo, Rusia, 650066
        • SIH Kemerovo Regional Clinical Hosptial
      • Moscow, Rusia, 125367
        • Medical rehabilitation center
      • Novosibirsk, Rusia, 630005
        • LLC "Medicine Center SibNovoMed"
      • Omsk, Rusia, 644024
        • Clinical Diagnostic Center Ultramed
      • Saint Petersburg, Rusia, 191104
        • City Mariinskaya Hospital
      • Saint Petersburg, Rusia, 195067
        • Pokrovskaya Municipal Hospital
      • Saint Petersburg, Rusia, 195271
        • Non-state Healthcare Institution "Roadway Clinical Hospital of OJSC Russian Railways
      • Saint Petersburg, Rusia, 197022
        • Saint Petersburg State Medical University n.a. Pavlov I.P.
      • Saint Petersburg, Rusia, 197110
        • SBIH City Clinical Hospital #31
      • Samara, Rusia, 443001
        • Medical Institute REAVIZ
      • Stavropol, Rusia, 355018
        • Stavropol State Medical University
      • Yaroslavl, Rusia, 150030
        • Yaroslavl Municipal HI Clinical Hospital #8
      • Yekaterinburg, Rusia, 620109
        • LLC MA New Hospital
    • Irkutsk Oblast
      • Irkutsk, Irkutsk Oblast, Rusia, 664079
        • Scientific Centre of Reconstructive and Restorative Surgery
    • Kareliya, Respublika
      • Petrozavodsk, Kareliya, Respublika, Rusia, 185019
        • Karelia Republican Hospital V.A. Baranova
    • Nizhny Novgorod Oblast
      • Nizhny Novgorod, Nizhny Novgorod Oblast, Rusia, 603126
        • Nizhny Novgorod Regional Hospital N.A. Semashko
      • Nizhny Novgorod, Nizhny Novgorod Oblast, Rusia, 603140
        • Private Healthcare Institution Clinical Hospital Russian Railways - Medicine of Nizhniy Novgorod
    • Novosibirsk Oblast
      • Novosibirsk, Novosibirsk Oblast, Rusia, 630007
        • Novosibirski Gastrocenter
    • Rostov Oblast
      • Rostov-on-Don, Rostov Oblast, Rusia, 344091
        • Rostov State Medical University
    • Sankt-Peterburg
      • Saint Petersburg, Sankt-Peterburg, Rusia, 196143
        • Scientific research center ECO-security
  • Serbia
      • Kragujevac, Serbia, 34000
        • Clinical Center Kragujevac Gastroenterohepatology Clinic
    • Beograd
      • Belgrade, Beograd, Serbia, 11000
        • Clinical Hospital Center Zvezdara
    • NAP
      • Belgrade, NAP, Serbia, 11080
        • University Medical Center "Bezanijska kosa"
    • Vojvodina
      • Sombor, Vojvodina, Serbia, 25000
        • Regional Hospital Dr Radivoj Simonovic Sombor
      • Sremska Mitrovica, Vojvodina, Serbia, 22000
        • Sremska Mitrovica Health Centre
      • Zrenjanin, Vojvodina, Serbia, 23000
        • General Hospital "Djordje Joanovic"
  • Suiza
      • Bern, Suiza, 3010
        • Inselspital Bern
      • Sankt Gallen, Suiza, 9007
        • Kantonsspital St.Gallen
      • Zurich, Suiza, 8091
        • Universitätsspital Zürich
    • Canton of Bern
      • Bern, Canton of Bern, Suiza, 3012
        • Gastroenterologische Praxis Balsiger, Seibold & Partner
  • Taiwán
      • Taichung, Taiwán, 40447
        • China Medical University Hospital
      • Taipei, Taiwán, 10002
        • Health management center
  • Turquía (Türkiye)
    • Antalya
      • Kocaeli, Antalya, Turquía (Türkiye), 7100
        • Antalya Egitim ve Arastırma Hastanesi
    • Istanbul
      • Kadıköy, Istanbul, Turquía (Türkiye), 34734
        • Acibadem Universitesi - Acibadem Kozyatagi Hastanesi
    • Kocaeli
      • İzmit, Kocaeli, Turquía (Türkiye), 41380
        • Kocaeli University Medical Faculty Hospital
    • Mersin
      • Yenişehir, Mersin, Turquía (Türkiye), 33110
        • Mersin University Medical Faculty
    • Turkey
      • Izmir, Turkey, Turquía (Türkiye), 35100
        • Ege Universitesi Hastanesi
  • Ucrania
      • Kharkiv, Ucrania, 61039
        • GI L.T. Malaya TI Namsu
      • Kharkiv, Ucrania, 61002
        • Kharkiv City Student Hospital
      • Kropyvnytskyi, Ucrania, 25006
        • Treatment-Diagnostic Center of Private Enterprise of PPC Atsynus
      • Kyiv, Ucrania, 02091
        • Kyiv Municipal Clinical Hospital #1
      • Kyiv, Ucrania, 04107
        • Communal institution of the Kyiv Regional Council "Kyiv Regional Clinical Oncology Dispensary"
      • Kyiv, Ucrania, 04078
        • Communal institution of the Kyiv Regional Council "Kyiv Regional Clinical Oncology Dispensary"
      • Odesa, Ucrania, 65000
        • Communal Enterprise "Odesa Regional Clinical Hospital"
      • Uzhhorod, Ucrania, 88000
        • A. Novak Transcarpathian Regional Clinical Hospital
      • Vinnytsia, Ucrania, 21029
        • CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM
      • Vinnytsia, Ucrania, 21005
        • Vinnytsia RCH of Veterans of War Dept of Therapy#1 Vinnytsia M.I.Pyrogov NMU
      • Vinnytsia, Ucrania, 21009
        • MCIC MC LLC Health Clinic
      • Vinnytsia, Ucrania, 21018
        • M.I. Pyrogov Regional Clinical Hospital
      • Zaporizhzhia, Ucrania, 69104
        • Communal Institution of Kyiv Regional Council Kyiv Regional Hospital #2
    • Ivano-Frankivsk Oblast
      • Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ucrania, 76008
        • Ivano-Frankivsk Regional Clinical Hospital
    • Kharkivs’ka Oblast’
      • Kharkiv, Kharkivs’ka Oblast’, Ucrania, 61037
        • City Clinical Hospital No. 2
    • Kherson Oblast
      • Kherson, Kherson Oblast, Ucrania, 73000
        • Kherson City Clinical Hospital
    • Kyiv Oblast
      • Kiev, Kyiv Oblast, Ucrania, 4050
        • Medical Center of Limited Liability Company "Medical Center "Consilium Medical"
    • Lviv Oblast
      • Lviv, Lviv Oblast, Ucrania, 79000
        • Lviv Railway Clinical Hospital
      • Lviv, Lviv Oblast, Ucrania, 79000
        • Lviv Regional Endocrinology Dispensary
      • Lviv, Lviv Oblast, Ucrania, 79000
        • Municipal non-profit enterprise "Lviv Territorial Medical Union "Multidisciplinary Clinical Hospital of Em -T
    • Poltava Oblast
      • Poltava, Poltava Oblast, Ucrania, 36000
        • Poltova Oblast Clinical Hospital IM.M.V.Sklifosovskoho
    • Zaporizhzhia Oblast
      • Zaporizhia, Zaporizhzhia Oblast, Ucrania, 69076
        • Diaservis - Medical and Diagnostic Center

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

14 años a 76 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Descripción

Criterios de inclusión:

  • Haber completado el Estudio AMAN (NCT03518086), con al menos 1 administración del fármaco del estudio y sin terminación anticipada del fármaco del estudio.
  • Están dispuestos y son capaces de completar las evaluaciones programadas del estudio, incluida la endoscopia y el registro diario.
  • Si es mujer, debe cumplir con los requisitos de anticoncepción.

Criterio de exclusión:

  • Participantes diagnosticados con enfermedad de Crohn o enfermedad inflamatoria intestinal no clasificada (colitis indeterminada) durante el estudio de inducción AMAN (NCT03518086).
  • Participantes con una resección intestinal u otra cirugía para el tratamiento de la CU durante el estudio de inducción anterior AMAN (NCT03518086), o que probablemente requieran cirugía para el tratamiento de la CU durante el estudio AMBG.
  • Participantes con evidencia de displasia colónica o que hayan sido diagnosticados con cáncer del tracto gastrointestinal durante el estudio AMAN (NCT03518086).
  • Participantes diagnosticados con una infección clínicamente importante que incluye, entre otros, hepatitis B, hepatitis C, VIH/SIDA y tuberculosis (TB) activa durante el estudio de inducción AMAN (NCT03518086).
  • Participantes que inician un nuevo medicamento prohibido durante el estudio de inducción AMAN (NCT03518086).
  • Participantes con ciertas anomalías de laboratorio antes del inicio de AMBG que requerirían la suspensión permanente del fármaco del estudio.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Comparador de placebos: Período de mantenimiento: Miri Induction Responder (IR) - Placebo (PBO) Subcutáneo (SC)
Los participantes que respondieron a mirikizumab (miri) enmascarado en la semana 12 en el estudio de inducción (LUCENT-1) se aleatorizaron para retirarse de mirikizumab y comenzar a recibir PBO SC cada 4 semanas (Q4W) desde la semana 0 del estudio de mantenimiento (LUCENT-2) hasta la semana 40 o hasta que se confirmara la pérdida de respuesta.
Droga: Placebo SC
CS administrado
Experimental: Período de mantenimiento: Miri IR - 200 miligramos (mg) Miri SC
Los participantes que respondieron a mirikizumab ciego en la semana 12 en el estudio de inducción (LUCENT-1) se aleatorizaron para continuar recibiendo 200 mg de mirikizumab SC Q4W desde la semana 0 de LUCENT-2 hasta la semana 40 o hasta que se confirmara la pérdida de respuesta.
Droga: Mirikizumab SC
CS administrado
Otros nombres:
  • LY3074828
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.
Droga: Placebo SC
CS 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.
Droga: Placebo SC
CS 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.
Droga: Mirikizumab SC
CS administrado
Otros nombres:
  • LY3074828
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.
Droga: Mirikizumab intravenoso
IV administrado
Otros nombres:
  • LY3074828
Droga: Placebo SC
CS 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.
Droga: Mirikizumab intravenoso
IV administrado
Otros nombres:
  • LY3074828
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.
Droga: Mirikizumab intravenoso
IV administrado
Otros nombres:
  • LY3074828
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.
Droga: Mirikizumab intravenoso
IV administrado
Otros nombres:
  • LY3074828
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.
Droga: Mirikizumab intravenoso
IV administrado
Otros nombres:
  • LY3074828
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).
Droga: Mirikizumab SC
CS administrado
Otros nombres:
  • LY3074828
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).
Droga: Mirikizumab SC
CS administrado
Otros nombres:
  • LY3074828

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Percentage of Participants in Clinical Remission at Week 40 (Mirikizumab Induction Responders)
Periodo de tiempo: Week 40

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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Farmacocinética (FC): Aclaramiento de Mirikizumab
Periodo de tiempo: Predosis: Semanas 0, 4, 12, 24 y 40
Se evaluó el aclaramiento de mirikizumab.
Predosis: Semanas 0, 4, 12, 24 y 40
Percentage of Participants in Endoscopic Remission at Week 40 (Mirikizumab Induction Responders)
Periodo de tiempo: Week 40
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).
Week 40
Percentage of Participants With Histologic Remission at Week 40 (Mirikizumab Induction Responders)
Periodo de tiempo: Week 40
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).
Week 40
Percentage of Participants in Symptomatic Remission at Week 40 (Mirikizumab Induction Responders)
Periodo de tiempo: Week 40

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
Percentage of Participants in Endoscopic Response at Week 40 (Mirikizumab Induction Responders)
Periodo de tiempo: Week 40
Endoscopic response at week 40 is defined as achieving at least a 1 point decrease from baseline in the Mayo endoscopic subscore.
Week 40
Percentage of Participants in Clinical Response at Week 40 (Mirikizumab Induction Responders)
Periodo de tiempo: Week 40
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).
Week 40
Change From Baseline to Week 40 in Health Related Quality of Life: Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score (Mirikizumab Induction Responders)
Periodo de tiempo: Induction Baseline, Week 40
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).
Induction Baseline, Week 40
Change From Baseline to Week 40 in Fecal Calprotectin (Mirikizumab Induction Responders)
Periodo de tiempo: Induction Baseline, Week 40
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.
Induction Baseline, Week 40
Change From Baseline to Week 40 in Bowel Urgency Based on the Urgency Numeric Rating Scale (NRS) (Mirikizumab Induction Responders)
Periodo de tiempo: Induction Baseline, Week 40
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).
Induction Baseline, Week 40
Percentage of Participants Hospitalized for Ulcerative Colitis (UC) (Mirikizumab Induction Responders)
Periodo de tiempo: Week 40
Percentage of participants hospitalized for UC. Only hospitalizations associated with an adverse event with >=24 hours stay were recorded.
Week 40

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Eli Lilly and Company

Investigadores

  • Director de estudio: 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

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Enlaces Útiles

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

19 de octubre de 2018

Finalización primaria (Actual)

3 de noviembre de 2021

Finalización del estudio (Actual)

17 de febrero de 2025

Fechas de registro del estudio

Enviado por primera vez

10 de mayo de 2018

Primero enviado que cumplió con los criterios de control de calidad

10 de mayo de 2018

Publicado por primera vez (Actual)

14 de mayo de 2018

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

13 de mayo de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

12 de mayo de 2026

Última verificación

1 de mayo de 2026

Más información

Términos relacionados con este estudio

Palabras clave

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 16823
  • I6T-MC-AMBG (Otro identificador: Eli Lilly and Company)
  • 2017-003238-96 (Número EudraCT)

Plan de datos de participantes individuales (IPD)

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SÍ

Descripción del plan IPD

Los datos anónimos a nivel de paciente individual se proporcionarán en un entorno de acceso seguro tras la aprobación de una propuesta de investigación y un acuerdo de intercambio de datos firmado.

Marco de tiempo para compartir IPD

Los datos están disponibles 6 meses después de la publicación principal y la aprobación de la indicación estudiada en los EE. UU. y la UE, lo que ocurra más tarde. Los datos estarán indefinidamente disponibles para solicitarlos.

Criterios de acceso compartido de IPD

Una propuesta de investigación debe ser aprobada por un panel de revisión independiente y los investigadores deben firmar un acuerdo de intercambio de datos.

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA
  • RSC

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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