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Uno studio di mantenimento del mirikizumab nei partecipanti con colite ulcerosa da moderatamente a gravemente attiva (LUCENT 2)

12 maggio 2026 aggiornato da: Eli Lilly and Company

Uno studio di mantenimento di fase 3, multicentrico, randomizzato, in doppio cieco, a braccio parallelo, controllato con placebo su mirikizumab in pazienti con colite ulcerosa da moderatamente a gravemente attiva (LUCENT 2)

Lo scopo di questo studio è valutare l'efficacia e la sicurezza di mirikizumab come terapia di mantenimento nei partecipanti che hanno completato come responder clinici nel precedente studio di induzione di 12 settimane LUCENT-1 (NCT03518086).

Panoramica dello studio

Tipo di studio

Interventistico

Iscrizione (Effettivo)

1328

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

      • Córdoba, Argentina, X5016KEH
        • Hospital Privado Centro Medico de Cordoba SA
    • Buenos Aires
      • CABA, Buenos Aires, Argentina, C1027AAP
        • Centro de Investigaciones Metabólicas (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 Medicas Tucuman
      • San Miguel de Tucumán, Tucumán Province, Argentina, 4000
        • C.I.C.E. 9 de Julio
    • 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
      • Innsbruck, Austria, 6020
        • Medizinische Universitat Innsbruck
      • Salzburg, Austria, 5020
        • Universitätsklinikum Salzburg
      • Vienna, Austria, 1090
        • Medical University of Vienna
      • Brasschaat, Belgio, 2930
        • AZ Klina
      • Leuven, Belgio, 3000
        • Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgio, 9000
        • Universitair Ziekenhuis Gent
    • Wallonne, Région
      • Tournai, Wallonne, Région, Belgio, 7500
        • Centre Hospitalier de Wallonie Picarde - Site Notre Dame
    • Alberta
      • Edmonton, Alberta, Canada, T5R 1W2
        • West Edmonton Diabetes Center
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 2K5
        • GI Research Institute
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • The Gordon and Leslie Diamond Health Care Centre
      • Victoria, British Columbia, Canada, V8V 3M9
        • PerCuro Clinical Research
    • Ontario
      • London, Ontario, Canada, N6A 4G5
        • Victoria Hospital
      • London, Ontario, Canada, N6A 5G1
        • University of Western Ontario
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2H1
        • Centre de santé et de services sociaux Champlain-Charles-Le Moyne
      • Montreal, Quebec, Canada, H1T 2M4
        • Hopital Maisonneure-Rosemount
      • Montreal, Quebec, Canada, H3G 1A4
        • Inflammatory Bowel Disease Centre Montreal General Hospital - MUHC
      • Brno, Cechia, 65691
        • Fakultni nemocnice u sv. Anny v Brne
      • Olomouc, Cechia, 779
        • PreventaMed, s.r.o.
      • Prague, Cechia, 19000
        • ISCARE Clinical Centre
    • Brno-město
      • Brno, Brno-město, Cechia, 636 00
        • Vojenska nemocnice Brno
    • Hl. M. Praha
      • Prague, Hl. M. Praha, Cechia, 100 34
        • Fakultni nemocnice Kralovske Vinohrady
    • Hradec Králové
      • Hradec Králové, Hradec Králové, Cechia, 500 12
        • Hepato-Gastroenterologie HK
    • Olomouc Region
      • Olomouc, Olomouc Region, Cechia, 779 00
        • MUDr. Gregar, s.r.o.
    • Plzeň-město
      • Pilsen, Plzeň-město, Cechia, 301 00
        • A-Shine
    • Praha 8
      • Prague, Praha 8, Cechia, 186 00
        • MEDIENDO
      • Wuhan, Cina, 430030
        • Tongji Hospital of Tongji University
    • Anhui
      • Hefei, Anhui, Cina, 230022
        • The First Affiliated Hospital of Anhui Medical University
      • Hefei, Anhui, Cina, 230000
        • Anhui Provincial Hospital
    • Changsha City
      • Kaifu District, Changsha City, Cina, 410008
        • Xiangya Hospital Central South University
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, Cina, 400037
        • The Affiliated 2nd Hosp. of Third Military Med. Univ. of PLA
      • Chongqing, Chongqing Municipality, Cina, 400038
        • The First Hospital Affiliated to AMU (Southwest Hospital)
    • Guangdong
      • Guangzhou, Guangdong, Cina, 510655
        • The Sixth Affiliated Hospital, Sun Yat-sen University
    • Hubei
      • Wuhan, Hubei, Cina, 430022
        • Union Hospital Tongji Medical College Huazhong University of Science and Technology
      • Wuhan, Hubei, Cina, 430060
        • Renmin Hospital of Wuhan University
    • Jiangsu
      • Nanjing, Jiangsu, Cina, 210008
        • The Affiliated Drum Tower Hospital of Nanjing University
      • Nanjing, Jiangsu, Cina, 210029
        • Zhongda Hospital Southeast University
      • Nanjing, Jiangsu, Cina, 211106
        • Nanjing Medical University - Nanjing Jiangning Hospital
    • Jiangxi
      • Pingxiang, Jiangxi, Cina, 337055
        • Jiangxi Pingxiang People's Hospital
    • Jilin
      • Jilin, Jilin, Cina, 132011
        • Jilin Central General Hospital
    • Shandong
      • Jinan, Shandong, Cina, 250021
        • Shandong Provincial Hospital
      • Jinan, Shandong, Cina, 250014
        • Qilu Hospital of Shandong University
      • Liaocheng, Shandong, Cina, 252000
        • Liaocheng People's Hospital
      • Qingdao, Shandong, Cina, 266000
        • The Affiliated Hospital Of Qingdao University
      • Taian, Shandong, Cina, 271000
        • Taian City Central Hospital
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Cina, 200025
        • Shanghai Jiaotong University School of Medicine Ruijin Hospital
      • Shanghai, Shanghai Municipality, Cina, 200127
        • Renji Hospital Affliated to Shanghai Jiaotong University
    • Sichuan
      • Chengdu, Sichuan, Cina, 610041
        • West China Hospital, Sichuan University
    • Yunnan
      • Kunming, Yunnan, Cina, 650034
        • The First People's Hospital of Yunnan Province
      • Kunming, Yunnan, Cina, 650032
        • Kunming Medical College Affiliated First Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, Cina, 310016
        • Sir Run Run Shaw Hospital
      • Hangzhou, Zhejiang, Cina, 310003
        • First Affiliated Hosp of College of Med, Zhejiang University
      • Hangzhou, Zhejiang, Cina, 310000
        • The Second Affiliated Hospital of Zhejiang University School of Med
      • Wenzhou, Zhejiang, Cina, 325027
        • The Second Affiliated Hospital YuYing Childens Hospital of Wenzhou Medical university
      • Busan, Corea del Sud, 48108
        • Inje University Haeundae Paik Hospital
      • Daegu, Corea del Sud, 42415
        • Yeungnam Univeristy Medical Center
    • Gangwon-do
      • Wŏnju, Gangwon-do, Corea del Sud, 26426
        • Severance Hospital, Yonsei University Health System
    • Korea
      • Seoul, Korea, Corea del Sud, 02447
        • Kyung Hee University Hospital
    • Pusan-Kwangyǒkshi
      • Busan, Pusan-Kwangyǒkshi, Corea del Sud, 49201
        • Dong-A University Hospital
    • Seoul-teukbyeolsi [Seoul]
      • Seoul, Seoul-teukbyeolsi [Seoul], Corea del Sud, 06351
        • Samsung Medical Center
      • Seoul, Seoul-teukbyeolsi [Seoul], Corea del Sud, 05505
        • Asan Medical Center
      • Seoul, Seoul-teukbyeolsi [Seoul], Corea del Sud, 03181
        • Kangbuk Samsung Hospital
    • Taejǒn-Kwangyǒkshi
      • Daejeon, Taejǒn-Kwangyǒkshi, Corea del Sud, 34943
        • The Catholic University of Korea, Daejeon St. Mary's Hospital
      • Herlev, Danimarca, 2730
        • Herlev and Gentofte Hospital
      • Køge, Danimarca, 4600
        • Zealand University Hospital Køge
      • 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 Debré 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
        • Hôpital 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
      • Berlin, Germania, 14163
        • Krankenhaus Waldfriede
      • Berlin, Germania, 12203
        • Charité Campus Virchow-Klinikum
      • Brandenburg, Germania, 14770
        • Städtisches Klinikum Brandenburg
      • Hamburg, Germania, 20251
        • HaFCED - Hamburgisches Forschungsinstitut für chronisch entzündliche Darmerkrankungen
      • Weyhe, Germania, 28844
        • Internistische Praxisgemeinschaft
    • Lower Saxony
      • Hanover, Lower Saxony, Germania, 30625
        • Medizinische Hochschule Hanover
    • Rhineland-Palatinate
      • Ludwigshafen am Rhein, Rhineland-Palatinate, Germania, 67067
        • Gemeinschaftspraxis Dr. Peter Uebel
    • Saxony-Anhalt
      • Halle, Saxony-Anhalt, Germania, 06108
        • Studiengesellschaft BSF Unternehmergesellschaft
      • Halle, Saxony-Anhalt, Germania, 06120
        • Universitatsklinikum Halle
      • Fukuoka, Giappone, 814-0180
        • Fukuoka University Hospital
      • Hiroshima, Giappone, 734-8551
        • Hiroshima University Hospital
      • Kagoshima, Giappone, 892-0846
        • Sameshima Hospital
      • Kyoto, Giappone, 612-8555
        • National Hospital Organization Kyoto Medical Center
      • Okayama, Giappone, 700-8558
        • Okayama University Hospital
      • Saitama, Giappone, 336-0963
        • Tokitokai Tokito Clinic
      • Toyama, Giappone, 930-0975
        • Toyama Prefectural Central Hospital
    • Aichi-ken
      • Nagakute-shi, Aichi-ken, Giappone, 480-1195
        • Aichi Medical University Hospital
      • Toyoake, Aichi-ken, Giappone, 470-1192
        • Fujita Health University
    • Aomori
      • Hirosaki, Aomori, Giappone, 036-8545
        • National Hospital Organization Hirosaki National Hospital
    • Chiba
      • Sakura, Chiba, Giappone, 285-8741
        • Toho University Sakura Medical Center
    • Fukoka
      • Kitakyusyu-shi, Fukoka, Giappone, 802-0077
        • Kitakyushu Municipal Medical Center
    • Fukuoka
      • Chikushino-shi, Fukuoka, Giappone, 818-8502
        • Fukuoka University Chikushi Hospital
      • Kurume-shi, Fukuoka, Giappone, 839 0809
        • Hidaka Coloproctology Clinic
    • Gunma
      • Maebashi, Gunma, Giappone, 371-8511
        • Gunma University Hospital
      • Takasaki, Gunma, Giappone, 370-0829
        • National Hospital Organization Takasaki General Medical Centar
    • HigaShiibaraki-Gun
      • Ibaraki-machi, HigaShiibaraki-Gun, Giappone, 311 3193
        • NHO Mito Medical Center
    • Hokkaido
      • Asahikawa, Hokkaido, Giappone, 070-8610
        • Asahikawa City Hospital
      • Sapporo, Hokkaido, Giappone, 065-0033
        • Sapporo Higashi Tokushukai Hospital
      • Sapporo, Hokkaido, Giappone, 004 0041
        • Tokushukai Sapporo Tokushukai Hospital
      • Sapporo, Hokkaido, Giappone, 060 0033
        • Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
    • Hyōgo
      • Kobe, Hyōgo, Giappone, 650 0015
        • Aoyama Clinic GI Endoscopy & IBD Center
    • Kagawa-ken
      • Takamatsu, Kagawa-ken, Giappone, 760-8557
        • Kagawa Prefectural Central Hospital
    • Kanagawa
      • Kamakura, Kanagawa, Giappone, 247-0056
        • Ofuna Central Hospital
      • Kawasaki, Kanagawa, Giappone, 210-0013
        • Kawasaki Municipal Hospital
      • Yokohama, Kanagawa, Giappone, 232-0024
        • Yokohama City University Medical Center
      • Yokohama, Kanagawa, Giappone, 234-0032
        • Showa University Northern Yokohama Hospital
      • Yokohama, Kanagawa, Giappone, 226 0025
        • Sankikai Yokohama Shin midori General Hospital
    • Kumamoto
      • Kumamoto, Kumamoto, Giappone, 860-0012
        • Kumamoto University Hospital
    • Mie-ken
      • Tsu, Mie-ken, Giappone, 514-8507
        • Mie University Hospital
    • Miyagi
      • Sendai, Miyagi, Giappone, 981 3213
        • Takagi Clinic - Sendai
    • Niigata
      • Nagaoka-shi, Niigata, Giappone, 940-8653
        • Nagaoka Chuo General Hospital
    • Oita Prefecture
      • Ōita, Oita Prefecture, Giappone, 870 0823
        • Ishida Clinic of IBD and Gastroenterology
    • Osaka
      • Fujiidera, Osaka, Giappone, 583-0027
        • Sai Gastroenterologist Proctology
      • Osaka, Osaka, Giappone, 530 0011
        • Infusion Clinic
      • Osaka, Osaka, Giappone, 540 0006
        • NHO Osaka National Hospital
    • Saga-ken
      • Saga, Saga-ken, Giappone, 840-8571
        • Saga-Ken Medical Center Koseikan
    • Saitama
      • Kumagaya-shi, Saitama, Giappone, 360-8567
        • Kumagaya General Hospital
    • Shizuoka
      • Hamamatsu, Shizuoka, Giappone, 4328061
        • Matsuda Hospital
    • Tochigi
      • Shimotsuke-shi, Tochigi, Giappone, 329-0498
        • Jichi Medical University Hospital
    • Tokyo
      • Bunkyo-ku, Tokyo, Giappone, 113-8431
        • Juntendo University Hospital
      • Bunkyō, Tokyo, Giappone, 113-8519
        • Tokyo Medical and Dental University Hospital
      • Koto-ku, Tokyo, Giappone, 135 8577
        • Showa University Koto Toyosu Hospital
      • Minato-Ku, Tokyo, Giappone, 108 8642
        • Kitasato University Kitasato Institute Hospital
      • Mitaka, Tokyo, Giappone, 181-8611
        • Kyorin University Hospital
      • Shinjuku-ku, Tokyo, Giappone, 169-0073
        • JHCO Tokyo Yamate Medical Center
    • Tokyo-To
      • Chiyoda-ku, Tokyo-To, Giappone, 101-8643
        • Mitsui Memorial Hospital
      • Shinjuku-ku, Tokyo-To, Giappone, 162 8655
        • Center Hospital of the National Center for Global Health and Medicine
    • 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
      • Dublin, Irlanda, D9
        • Beaumont Hospital, Dublin
      • Beersheba, Israele, 8410101
        • Soroka Medical Center - Pediatric Outpatient Clinic
      • Nahariya, Israele, 2210001
        • Galilee Medical Center Department of Internal Medicine A
      • Rehovot, Israele, 7610001
        • Kaplan Medical Center
      • Tel Aviv, Israele, 6423906
        • Tel Aviv Sourasky Medical Center
      • Ẕerifin, Israele, 70300
        • King Fahad Medical City
    • Jerusalem
      • Bait Vagan, Jerusalem, Israele, 91031
        • Shaare Zedek Medical Center
      • 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
      • Riga, Lettonia, 1079
        • Digestive Diseases Center "Gastro"
      • Riga, Lettonia, LV-1038
        • Riga Eastern Clinical University Hospital
    • Riga
      • Riga, Riga, Lettonia, LV-1002
        • Pauls Stradins Clinical Univeristy Hospital
      • 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
    • Kelantan
      • Kubang Kerian, Kelantan, Malaysia, 16150
        • Universiti Sains Malaysia
    • Kuala Lumpur
      • Lembah Pantai, Kuala Lumpur, Malaysia, 59100
        • University Malaya Medical Centre
    • Selangor
      • Ampang, Selangor, Malaysia, 68000
        • Hospital Ampang
      • Chihuahua City, Messico, 31203
        • Scientia Investigacion Clinica S.C.
      • Veracruz, Messico, 91900
        • Sociedad de Metabolismo y Corazon
    • Jalisco
      • Zapopan, Jalisco, Messico, 45030
        • Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.
    • Mexico City
      • Mexico City, Mexico City, Messico, 07020
        • Centro de Investigación Clínica Acelerada
    • Sinaloa
      • Culiacán, Sinaloa, Messico, 80230
        • Centro Para el Desarrollo de la Medicina y de Asistencia Medica S.C
      • Uden, Olanda, 5406 PT
        • Bernhoven Ziekenhuis
      • Utrecht, Olanda, 3584 CX
        • UMC Utrecht, Dept. of Internal Medicine, MDL
    • North Brabant
      • Tilburg, North Brabant, Olanda, 5022 GC
        • St Elisabeth Ziekenhuis
    • North Holland
      • Amsterdam, North Holland, Olanda, 1105 AZ
        • Amsterdam UMC, locatie AMC
      • 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 Zamosc
    • 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
    • Essex
      • Romford, Essex, Regno Unito, RM7 0AG
        • Queens Hospital
    • Great Britain
      • Bury, Great Britain, Regno Unito, BL9 7TD
        • Fairfield General Hospital
    • London
      • Great Maze Pond, London, Regno Unito, SE1 9RT
        • St Thomas' Hospital
    • Surrey
      • London, Surrey, Regno Unito, E11 1NR
        • Whipps Cross University Hospital
    • Swansea [Abertawe Gb-ata]
      • Swansea, Swansea [Abertawe Gb-ata], Regno Unito, SA6 6SG
        • Morriston Hospital
    • Vinnytsia
      • Leeds, Vinnytsia, Regno Unito, LS9 7TF
        • St James's University Hospital
      • Bucharest, Romania, 022328
        • Institutul Clinic Fundeni
      • Bucharest, Romania, 020125
        • Spitalul Clinic Colentina
      • Bucharest, Romania, 010719
        • MedLife Grivita
      • Bucharest, Romania, 031864
        • Hifu Terramed Conformal SRL
      • Oradea, Romania, 410469
        • Spital Pelican Oradea
    • Bucharest
      • Bucharest, Bucharest, Romania, 030463
        • CCBR Clinical Research
      • Barnaul, Russia, 656043
        • Multidisciplinary Medical Clinic "Anthurium"
      • Cherepovets, Russia, 162600
        • Medical and Sanitary Division of Severstal
      • Izhevsk, Russia, 426061
        • Alliance Biomedical URAL Group
      • Kaliningrad, Russia, 236035
        • Clinical Trials Center of Medical Institute
      • Kazan', Russia, 420064
        • State Autonomous Institution of Healthcare "Republican Clinical Hospital of the Ministry of Healthcare of Republic Tatarstan
      • Kemerovo, Russia, 650066
        • SIH Kemerovo Regional Clinical Hosptial
      • Moscow, Russia, 125367
        • Medical rehabilitation center
      • Novosibirsk, Russia, 630005
        • LLC "Medicine Center SibNovoMed"
      • Omsk, Russia, 644024
        • Clinical Diagnostic Center Ultramed
      • Saint Petersburg, Russia, 191104
        • City Mariinskaya Hospital
      • Saint Petersburg, Russia, 195067
        • Pokrovskaya Municipal Hospital
      • Saint Petersburg, Russia, 195271
        • Non-state Healthcare Institution "Roadway Clinical Hospital of OJSC Russian Railways
      • Saint Petersburg, Russia, 197022
        • Saint Petersburg State Medical University n.a. Pavlov I.P.
      • Saint Petersburg, Russia, 197110
        • SBIH City Clinical Hospital #31
      • Samara, Russia, 443001
        • Medical Institute REAVIZ
      • Stavropol, Russia, 355018
        • Stavropol State Medical University
      • Yaroslavl, Russia, 150030
        • Yaroslavl Municipal HI Clinical Hospital #8
      • Yekaterinburg, Russia, 620109
        • LLC MA New Hospital
    • Irkutsk Oblast
      • Irkutsk, Irkutsk Oblast, Russia, 664079
        • Scientific Centre of Reconstructive and Restorative Surgery
    • Kareliya, Respublika
      • Petrozavodsk, Kareliya, Respublika, Russia, 185019
        • Karelia Republican Hospital V.A. Baranova
    • Nizhny Novgorod Oblast
      • Nizhny Novgorod, Nizhny Novgorod Oblast, Russia, 603126
        • Nizhny Novgorod Regional Hospital N.A. Semashko
      • Nizhny Novgorod, Nizhny Novgorod Oblast, Russia, 603140
        • Private Healthcare Institution Clinical Hospital Russian Railways - Medicine of Nizhniy Novgorod
    • Novosibirsk Oblast
      • Novosibirsk, Novosibirsk Oblast, Russia, 630007
        • Novosibirski Gastrocenter
    • Rostov Oblast
      • Rostov-on-Don, Rostov Oblast, Russia, 344091
        • Rostov State Medical University
    • Sankt-Peterburg
      • Saint Petersburg, Sankt-Peterburg, Russia, 196143
        • Scientific research center ECO-security
      • 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"
      • Banská Bystrica, Slovacchia, 975 17
        • Fakultna nemocnica s poliklinikou Roosevelta Banska Bystrica
      • Bratislava, Slovacchia, 82007
        • Univerzitna nemocnica Bratislava
    • Nitra Region
      • Nitra, Nitra Region, Slovacchia, 949 01
        • KM Management
    • Presov
      • Prešov, Presov, Slovacchia, 080 01
        • Gastro
      • Vranov N. Toplou, Presov, Slovacchia, 093 01
        • Endomed, s.r.o.
      • A Coruña, Spagna, 15006
        • Complexo Hospitalario Universitario A Coruña, CHUAC
      • Alicante, Spagna, 3004
        • Instituto de Ciencias Médicas
      • Girona, Spagna, 17007
        • Hospital Universitari de Girona
      • Huelva, Spagna, 21005
        • Hospital Universitario Juan Ramon Jimenez
      • Las Palmas de Gran Canaria, Spagna, 35010
        • Hospital de Gran Canaria Dr. Negrín
      • Madrid, Spagna, 28046
        • Hospital Universitario La Paz
      • Oviedo, Spagna, 3306
        • Hospital Universitario Central de Asturias
    • Andalusia
      • Seville, Andalusia, Spagna, 41013
        • Hospital Universitario Virgen del Rocío
    • Baleares Islands
      • Palma de Mallorca, Baleares Islands, Spagna, 07120
        • Hospital Universitari Son Espases
    • Cantabria
      • Santander, Cantabria, Spagna, 39008
        • Hospital Universitario Marqués de Valdecilla
    • Madrid
      • Fuenlabrada, Madrid, Spagna, 28942
        • Hospital De Fuenlabrada
    • Valencia
      • Sagunto, Valencia, Spagna, 46520
        • Hospital Gen. Juan Ramon Jimenez - Depto de Digestivo
    • Alabama
      • Dothan, Alabama, Stati Uniti, 36305
        • Digestive Health Specialists of the Southeast
    • Arizona
      • Litchfield Park, Arizona, Stati Uniti, 85340
        • Dcr-Pi, Pc
      • Phoenix, Arizona, Stati Uniti, 85008
        • Maricopa Integrated Health System
      • Tempe, Arizona, Stati Uniti, 85284
        • Physicians Research Group
    • California
      • Arcadia, California, Stati Uniti, 91006
        • Valley Gastroenterology
      • Berkeley, California, Stati Uniti, 94705
        • Care Access Research
      • Lancaster, California, Stati Uniti, 93534
        • Om Research, LLC
      • Northridge, California, Stati Uniti, 91324
        • California Medical Research Associates
      • San Diego, California, Stati Uniti, 92103
        • Clinical Applications Laboratories, Inc.
      • San Francisco, California, Stati Uniti, 94158
        • UCSF Medical Center at Mission Bay
    • Florida
      • Hialeah, Florida, Stati Uniti, 33012
        • Direct Helpers Research Center
      • Inverness, Florida, Stati Uniti, 34452
        • Nature Coast Clinical Research, LLC
      • Kissimmee, Florida, Stati Uniti, 34741
        • SIH Research, LLC
      • Miami, Florida, Stati Uniti, 33134
        • Research Associates of South Florida, LLC
      • Miami Lakes, Florida, Stati Uniti, 33016
        • Wellness Clinical Research
      • Orlando, Florida, Stati Uniti, 32818
        • Clintheory Healthcare
      • Orlando, Florida, Stati Uniti, 32803
        • Center for Interventional Endoscopy
      • Pensacola, Florida, Stati Uniti, 32503
        • Gastroenterology Associates of Pensacola, PA
      • Zephyrhills, Florida, Stati Uniti, 33542-7505
        • Florida Medical Clinic LLC
    • Georgia
      • Atlanta, Georgia, Stati Uniti, 30309
        • Digestive Healthcare of Georgia
    • Idaho
      • Idaho Falls, Idaho, Stati Uniti, 83404
        • Grand Teton Research Group
    • Illinois
      • Evanston, Illinois, Stati Uniti, 60201
        • NorthShore University Healthsystem
    • Indiana
      • Indianapolis, Indiana, Stati Uniti, 46202
        • Indiana University School of Medicine
    • Kansas
      • Topeka, Kansas, Stati Uniti, 66606
        • Cotton-O'Neil Clinical Research Center, Digestive Health
    • Louisiana
      • Baton Rouge, Louisiana, Stati Uniti, 70809
        • Texas Digestive Disease Consultants
      • Monroe, Louisiana, Stati Uniti, 71201
        • Delta Research Partners LLC
      • New Orleans, Louisiana, Stati Uniti, 70125
        • Nola Research Works, LLC
    • Michigan
      • Chesterfield, Michigan, Stati Uniti, 48047
        • Clinical Research Institute of Michigan, LLC
      • Novi, Michigan, Stati Uniti, 48377
        • Henry Ford Health System
      • Wyoming, Michigan, Stati Uniti, 49519
        • Gastroenterology Associates of Western Michigan, P.L.C.
      • Ypsilanti, Michigan, Stati Uniti, 48197
        • Huron Gastroenterology Associates
    • Minnesota
      • Plymouth, Minnesota, Stati Uniti, 55446
        • MNGI Digestive Health - Plymouth Endoscopy Center & Clinic
    • Mississippi
      • Jackson, Mississippi, Stati Uniti, 39206
        • Care Access Research LLC
      • Tupelo, Mississippi, Stati Uniti, 38801
        • Digestive Health Specialists
    • New York
      • Great Neck, New York, Stati Uniti, 11021
        • Northwell Health
      • New York, New York, Stati Uniti, 10021
        • Weill Cornell Medical College
    • North Carolina
      • Chapel Hill, North Carolina, Stati Uniti, 27599
        • University of North Carolina Center for Inflammatory Bowel Disease
      • Greenville, North Carolina, Stati Uniti, 27834
        • Carolina Digestive Diseases and Endoscopy Center
    • Ohio
      • Middleburg Heights, Ohio, Stati Uniti, 44130
        • Paramount Medical Research
      • Poland, Ohio, Stati Uniti, 44514
        • Care Access - Youngstown
    • Oklahoma
      • Norman, Oklahoma, Stati Uniti, 73071
        • Central Sooner Research
      • Oklahoma City, Oklahoma, Stati Uniti, 73104
        • University of Oklahoma Health Sciences Center
    • Pennsylvania
      • Wyomissing, Pennsylvania, Stati Uniti, 19610
        • Digestive Disease Associates
    • South Dakota
      • Sioux Falls, South Dakota, Stati Uniti, 57108
        • Midwest Medical Care
    • Tennessee
      • Germantown, Tennessee, Stati Uniti, 38138
        • Gastro One
      • Hixson, Tennessee, Stati Uniti, 37343
        • Galen Medical Group
    • Texas
      • Garland, Texas, Stati Uniti, 75044
        • Digestive Health Associates of Texas
      • Houston, Texas, Stati Uniti, 77043
        • Biopharma Informatic, LLC
      • Houston, Texas, Stati Uniti, 77030
        • Houston Methodist Research Ins
      • San Antonio, Texas, Stati Uniti, 78229
        • Southern Star Research Institute, LLC
      • San Antonio, Texas, Stati Uniti, 78229
        • Gastroenterology Research of San Antonio
      • Southlake, Texas, Stati Uniti, 76092
        • Texas Digestive Disease Consultants
    • Utah
      • Ogden, Utah, Stati Uniti, 84403
        • Care Access Research LLC - Salt Lake City
    • Virginia
      • Leesburg, Virginia, Stati Uniti, 20176
        • Emeritas Research Group
      • Reston, Virginia, Stati Uniti, 20191
        • The Gastroenterology Group, P.C.
      • Roanoke, Virginia, Stati Uniti, 24016
        • Carilion Clinic
    • Wisconsin
      • Milwaukee, Wisconsin, Stati Uniti, 53215
        • Wisconsin Center for Advanced Research
      • Bern, Svizzera, 3010
        • Inselspital Bern
      • Sankt Gallen, Svizzera, 9007
        • Kantonsspital St.Gallen
      • Zurich, Svizzera, 8091
        • Universitatsspital Zurich
    • Canton of Bern
      • Bern, Canton of Bern, Svizzera, 3012
        • Gastroenterologische Praxis Balsiger, Seibold & Partner
      • Taichung, Taiwan, 40447
        • China Medical University Hospital
      • Taipei, Taiwan, 10002
        • Health management center
    • Antalya
      • Kocaeli, Antalya, Turchia (Türkiye), 7100
        • Antalya Egitim ve Arastırma Hastanesi
    • Istanbul
      • Kadıköy, Istanbul, Turchia (Türkiye), 34734
        • Acibadem Universitesi - Acibadem Kozyatagi Hastanesi
    • Kocaeli
      • İzmit, Kocaeli, Turchia (Türkiye), 41380
        • Kocaeli University Medical Faculty Hospital
    • Mersin
      • Yenişehir, Mersin, Turchia (Türkiye), 33110
        • Mersin University Medical Faculty
    • Turkey
      • Izmir, Turkey, Turchia (Türkiye), 35100
        • Ege Universitesi Hastanesi
      • Kharkiv, Ucraina, 61039
        • GI L.T. Malaya TI Namsu
      • Kharkiv, Ucraina, 61002
        • Kharkiv City Student Hospital
      • Kropyvnytskyi, Ucraina, 25006
        • Treatment-Diagnostic Center of Private Enterprise of PPC Atsynus
      • Kyiv, Ucraina, 02091
        • Kyiv Municipal Clinical Hospital #1
      • Kyiv, Ucraina, 04107
        • Communal institution of the Kyiv Regional Council "Kyiv Regional Clinical Oncology Dispensary"
      • Kyiv, Ucraina, 04078
        • Communal institution of the Kyiv Regional Council "Kyiv Regional Clinical Oncology Dispensary"
      • Odesa, Ucraina, 65000
        • Communal Enterprise "Odesa Regional Clinical Hospital"
      • Uzhhorod, Ucraina, 88000
        • A. Novak Transcarpathian Regional Clinical Hospital
      • Vinnytsia, Ucraina, 21029
        • CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM
      • Vinnytsia, Ucraina, 21005
        • Vinnytsia RCH of Veterans of War Dept of Therapy#1 Vinnytsia M.I.Pyrogov NMU
      • Vinnytsia, Ucraina, 21009
        • MCIC MC LLC Health Clinic
      • Vinnytsia, Ucraina, 21018
        • M.I. Pyrogov Regional Clinical Hospital
      • Zaporizhzhia, Ucraina, 69104
        • Communal Institution of Kyiv Regional Council Kyiv Regional Hospital #2
    • Ivano-Frankivsk Oblast
      • Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ucraina, 76008
        • Ivano-Frankivsk Regional Clinical Hospital
    • Kharkivs’ka Oblast’
      • Kharkiv, Kharkivs’ka Oblast’, Ucraina, 61037
        • City Clinical Hospital No. 2
    • Kherson Oblast
      • Kherson, Kherson Oblast, Ucraina, 73000
        • Kherson City Clinical Hospital
    • Kyiv Oblast
      • Kiev, Kyiv Oblast, Ucraina, 4050
        • Medical Center of Limited Liability Company "Medical Center "Consilium Medical"
    • Lviv Oblast
      • Lviv, Lviv Oblast, Ucraina, 79000
        • Lviv Railway Clinical Hospital
      • Lviv, Lviv Oblast, Ucraina, 79000
        • Lviv Regional Endocrinology Dispensary
      • Lviv, Lviv Oblast, Ucraina, 79000
        • Municipal non-profit enterprise "Lviv Territorial Medical Union "Multidisciplinary Clinical Hospital of Em -T
    • Poltava Oblast
      • Poltava, Poltava Oblast, Ucraina, 36000
        • Poltova Oblast Clinical Hospital IM.M.V.Sklifosovskoho
    • Zaporizhzhia Oblast
      • Zaporizhia, Zaporizhzhia Oblast, Ucraina, 69076
        • Diaservis - Medical and Diagnostic Center
      • Budapest, Ungheria, 1088
        • Semmelweis Egyetem
      • Budapest, Ungheria, 1036
        • Óbudai Egészségügyi Centrum
      • Debrecen, Ungheria, 4032
        • Debreceni Egyetem Klinikai Kozpont
      • Miskolc, Ungheria, 3526
        • Endomedix Diagnosztikai Központ - Miskolc
      • Mosonmagyaróvár, Ungheria, 9200
        • Karolina Korhaz-Rendelointezet
      • Szeged, Ungheria, 6720
        • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont I. Belgyogyaszati Klinika
      • Szekszárd, Ungheria, 7100
        • CLINFAN Szolgáltató Kft
    • EU
      • Balatonfüred, EU, Ungheria, 8230
        • DRC Gyogyszervizsgalo Kozpont Kft.
    • Pest County
      • Vác, Pest County, Ungheria, 2600
        • Javorszky Odon Korhaz

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 14 anni a 76 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Descrizione

Criterio di inclusione:

  • Aver completato lo studio AMAN (NCT03518086), con almeno 1 somministrazione del farmaco in studio e senza interruzione anticipata del farmaco in studio.
  • Sono disposti e in grado di completare le valutazioni dello studio programmate, inclusa l'endoscopia e l'inserimento nel diario giornaliero.
  • Se femmina, deve soddisfare i requisiti di contraccezione.

Criteri di esclusione:

  • Partecipanti con diagnosi di malattia di Crohn o malattia infiammatoria intestinale non classificata (colite indeterminata) durante lo studio di induzione AMAN (NCT03518086).
  • - Partecipanti con resezione intestinale o altro intervento chirurgico per il trattamento della CU durante il precedente studio di induzione AMAN (NCT03518086), o che potrebbero richiedere un intervento chirurgico per il trattamento della CU durante lo studio AMBG.
  • - Partecipanti con evidenza di displasia del colon o a cui è stato diagnosticato un cancro del tratto gastrointestinale durante lo studio AMAN (NCT03518086).
  • - Partecipanti con diagnosi di infezione clinicamente importante inclusa, ma non limitata a, epatite B, epatite C, HIV/AIDS e tubercolosi attiva (TBC) durante lo studio di induzione AMAN (NCT03518086).
  • Partecipanti che iniziano un nuovo farmaco proibito durante lo studio di induzione AMAN (NCT03518086).
  • - Partecipanti con determinate anomalie di laboratorio prima dell'inizio dell'AMBG che richiederebbero l'interruzione permanente del farmaco oggetto dello studio.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Comparatore placebo: Periodo di mantenimento: Miri Induction Responder (IR) - Placebo (PBO) Sottocutaneo (SC)
Partecipanti che rispondevano a mirikizumab (miri) in cieco alla settimana 12 nello studio di induzione (LUCENT-1) randomizzati a ritirarsi da mirikizumab e iniziare a ricevere PBO SC ogni 4 settimane (Q4W) dalla settimana 0 dello studio di mantenimento (LUCENT-2) fino alla settimana 40 o fino alla conferma della perdita di risposta.
SC amministrato
Sperimentale: Periodo di mantenimento: Miri IR - 200 milligrammi (mg) Miri SC
I partecipanti che hanno risposto a mirikizumab in cieco alla settimana 12 nello studio di induzione (LUCENT-1) sono stati randomizzati per continuare a ricevere 200 mg di mirikizumab SC Q4W dalla settimana 0 di LUCENT-2 fino alla settimana 40 o fino alla conferma della perdita di risposta.
SC amministrato
Altri nomi:
  • LY3074828
Sperimentale: 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 amministrato
Sperimentale: 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 amministrato
Sperimentale: 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 amministrato
Altri nomi:
  • LY3074828
Sperimentale: 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.
Amministrato IV
Altri nomi:
  • LY3074828
SC amministrato
Sperimentale: 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.
Amministrato IV
Altri nomi:
  • LY3074828
Sperimentale: 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.
Amministrato IV
Altri nomi:
  • LY3074828
Sperimentale: 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.
Amministrato IV
Altri nomi:
  • LY3074828
Sperimentale: 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.
Amministrato IV
Altri nomi:
  • LY3074828
Sperimentale: 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).
SC amministrato
Altri nomi:
  • LY3074828
Sperimentale: 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).
SC amministrato
Altri nomi:
  • LY3074828

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Percentage of Participants in Clinical Remission at Week 40 (Mirikizumab Induction Responders)
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Farmacocinetica (PK): clearance di Mirikizumab
Lasso di tempo: Predose: settimane 0, 4, 12, 24 e 40
È stata valutata la clearance di mirikizumab.
Predose: settimane 0, 4, 12, 24 e 40
Percentage of Participants in Endoscopic Remission at Week 40 (Mirikizumab Induction Responders)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: 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)
Lasso di tempo: Week 40
Percentage of participants hospitalized for UC. Only hospitalizations associated with an adverse event with >=24 hours stay were recorded.
Week 40

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Investigatori

  • Direttore dello studio: 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

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

19 ottobre 2018

Completamento primario (Effettivo)

3 novembre 2021

Completamento dello studio (Effettivo)

17 febbraio 2025

Date di iscrizione allo studio

Primo inviato

10 maggio 2018

Primo inviato che soddisfa i criteri di controllo qualità

10 maggio 2018

Primo Inserito (Effettivo)

14 maggio 2018

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

13 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

12 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

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Descrizione del piano IPD

I dati anonimi a livello di singolo paziente saranno forniti in un ambiente di accesso sicuro previa approvazione di una proposta di ricerca e di un accordo di condivisione dei dati firmato.

Periodo di condivisione IPD

I dati sono disponibili 6 mesi dopo la pubblicazione primaria e l'approvazione dell'indicazione studiata negli Stati Uniti e nell'UE, se successiva. I dati saranno disponibili a tempo indeterminato per la richiesta.

Criteri di accesso alla condivisione IPD

Una proposta di ricerca deve essere approvata da un comitato di revisione indipendente e i ricercatori devono firmare un accordo di condivisione dei dati.

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • RSI

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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