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En vedligeholdelsesundersøgelse af Mirikizumab hos deltagere med moderat til svær aktiv colitis ulcerosa (LUCENT 2)

12. maj 2026 opdateret af: Eli Lilly and Company

En fase 3, multicenter, randomiseret, dobbeltblind, parallelarm, placebokontrolleret vedligeholdelsesundersøgelse af Mirikizumab hos patienter med moderat til svær aktiv colitis ulcerosa (LUCENT 2)

Formålet med denne undersøgelse er at evaluere effektiviteten og sikkerheden af ​​mirikizumab som vedligeholdelsesbehandling hos deltagere, der afsluttede som klinisk respondere i det forudgående 12-ugers induktionsstudie LUCENT-1 (NCT03518086).

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

1328

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Argentina
      • 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
  • Australien
    • Essex
      • Harlow, Essex, Australien, CM20 1QX
        • Princess Alexandra Hospital
    • Queensland
      • Maroochydore, Queensland, Australien, 4558
        • Coastal Digestive Health
      • South Brisbane, Queensland, Australien, 4101
        • Mater University Hospital
    • South Australia
      • Adelaide, South Australia, Australien, 5000
        • Royal Adelaide Hospital
    • Victoria
      • Box Hill, Victoria, Australien, 3128
        • Box Hill Hospital Outpatients
      • Malvern, Victoria, Australien, 3144
        • Melbourne Gastrointestinal Investigation Unit (MGIU)
      • Melbourne, Victoria, Australien, 3004
        • The Alfred Hospital
      • Parkville, Victoria, Australien, 3050
        • The Royal Melbourne Hospital
  • Belgien
      • Brasschaat, Belgien, 2930
        • AZ Klina
      • Leuven, Belgien, 3000
        • Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
    • Oost-Vlaanderen
      • Ghent, Oost-Vlaanderen, Belgien, 9000
        • Universitair Ziekenhuis Gent
    • Wallonne, Région
      • Tournai, Wallonne, Région, Belgien, 7500
        • Centre Hospitalier de Wallonie Picarde - Site Notre Dame
  • Canada
    • 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
  • Danmark
      • Herlev, Danmark, 2730
        • Herlev and Gentofte Hospital
      • Køge, Danmark, 4600
        • Zealand University Hospital Køge
  • Det Forenede Kongerige
    • Essex
      • Romford, Essex, Det Forenede Kongerige, RM7 0AG
        • Queens Hospital
    • Great Britain
      • Bury, Great Britain, Det Forenede Kongerige, BL9 7TD
        • Fairfield General Hospital
    • London
      • Great Maze Pond, London, Det Forenede Kongerige, SE1 9RT
        • St Thomas' Hospital
    • Surrey
      • London, Surrey, Det Forenede Kongerige, E11 1NR
        • Whipps Cross University Hospital
    • Swansea [Abertawe Gb-ata]
      • Swansea, Swansea [Abertawe Gb-ata], Det Forenede Kongerige, SA6 6SG
        • Morriston Hospital
    • Vinnytsia
      • Leeds, Vinnytsia, Det Forenede Kongerige, LS9 7TF
        • St James's University Hospital
  • Forenede Stater
    • Alabama
      • Dothan, Alabama, Forenede Stater, 36305
        • Digestive Health Specialists of the Southeast
    • Arizona
      • Litchfield Park, Arizona, Forenede Stater, 85340
        • Dcr-Pi, Pc
      • Phoenix, Arizona, Forenede Stater, 85008
        • Maricopa Integrated Health System
      • Tempe, Arizona, Forenede Stater, 85284
        • Physicians Research Group
    • California
      • Arcadia, California, Forenede Stater, 91006
        • Valley Gastroenterology
      • Berkeley, California, Forenede Stater, 94705
        • Care Access Research
      • Lancaster, California, Forenede Stater, 93534
        • Om Research, LLC
      • Northridge, California, Forenede Stater, 91324
        • California Medical Research Associates
      • San Diego, California, Forenede Stater, 92103
        • Clinical Applications Laboratories, Inc.
      • San Francisco, California, Forenede Stater, 94158
        • UCSF Medical Center at Mission Bay
    • Florida
      • Hialeah, Florida, Forenede Stater, 33012
        • Direct Helpers Research Center
      • Inverness, Florida, Forenede Stater, 34452
        • Nature Coast Clinical Research, LLC
      • Kissimmee, Florida, Forenede Stater, 34741
        • SIH Research, LLC
      • Miami, Florida, Forenede Stater, 33134
        • Research Associates of South Florida, LLC
      • Miami Lakes, Florida, Forenede Stater, 33016
        • Wellness Clinical Research
      • Orlando, Florida, Forenede Stater, 32818
        • Clintheory Healthcare
      • Orlando, Florida, Forenede Stater, 32803
        • Center for Interventional Endoscopy
      • Pensacola, Florida, Forenede Stater, 32503
        • Gastroenterology Associates of Pensacola, PA
      • Zephyrhills, Florida, Forenede Stater, 33542-7505
        • Florida Medical Clinic LLC
    • Georgia
      • Atlanta, Georgia, Forenede Stater, 30309
        • Digestive Healthcare of Georgia
    • Idaho
      • Idaho Falls, Idaho, Forenede Stater, 83404
        • Grand Teton Research Group
    • Illinois
      • Evanston, Illinois, Forenede Stater, 60201
        • NorthShore University Healthsystem
    • Indiana
      • Indianapolis, Indiana, Forenede Stater, 46202
        • Indiana University School of Medicine
    • Kansas
      • Topeka, Kansas, Forenede Stater, 66606
        • Cotton-O'Neil Clinical Research Center, Digestive Health
    • Louisiana
      • Baton Rouge, Louisiana, Forenede Stater, 70809
        • Texas Digestive Disease Consultants
      • Monroe, Louisiana, Forenede Stater, 71201
        • Delta Research Partners LLC
      • New Orleans, Louisiana, Forenede Stater, 70125
        • Nola Research Works, LLC
    • Michigan
      • Chesterfield, Michigan, Forenede Stater, 48047
        • Clinical Research Institute of Michigan, LLC
      • Novi, Michigan, Forenede Stater, 48377
        • Henry Ford Health System
      • Wyoming, Michigan, Forenede Stater, 49519
        • Gastroenterology Associates of Western Michigan, P.L.C.
      • Ypsilanti, Michigan, Forenede Stater, 48197
        • Huron Gastroenterology Associates
    • Minnesota
      • Plymouth, Minnesota, Forenede Stater, 55446
        • MNGI Digestive Health - Plymouth Endoscopy Center & Clinic
    • Mississippi
      • Jackson, Mississippi, Forenede Stater, 39206
        • Care Access Research LLC
      • Tupelo, Mississippi, Forenede Stater, 38801
        • Digestive Health Specialists
    • New York
      • Great Neck, New York, Forenede Stater, 11021
        • Northwell Health
      • New York, New York, Forenede Stater, 10021
        • Weill Cornell Medical College
    • North Carolina
      • Chapel Hill, North Carolina, Forenede Stater, 27599
        • University of North Carolina Center for Inflammatory Bowel Disease
      • Greenville, North Carolina, Forenede Stater, 27834
        • Carolina Digestive Diseases and Endoscopy Center
    • Ohio
      • Middleburg Heights, Ohio, Forenede Stater, 44130
        • Paramount Medical Research
      • Poland, Ohio, Forenede Stater, 44514
        • Care Access - Youngstown
    • Oklahoma
      • Norman, Oklahoma, Forenede Stater, 73071
        • Central Sooner Research
      • Oklahoma City, Oklahoma, Forenede Stater, 73104
        • University of Oklahoma Health Sciences Center
    • Pennsylvania
      • Wyomissing, Pennsylvania, Forenede Stater, 19610
        • Digestive Disease Associates
    • South Dakota
      • Sioux Falls, South Dakota, Forenede Stater, 57108
        • Midwest Medical Care
    • Tennessee
      • Germantown, Tennessee, Forenede Stater, 38138
        • Gastro One
      • Hixson, Tennessee, Forenede Stater, 37343
        • Galen Medical Group
    • Texas
      • Garland, Texas, Forenede Stater, 75044
        • Digestive Health Associates of Texas
      • Houston, Texas, Forenede Stater, 77043
        • Biopharma Informatic, LLC
      • Houston, Texas, Forenede Stater, 77030
        • Houston Methodist Research Ins
      • San Antonio, Texas, Forenede Stater, 78229
        • Southern Star Research Institute, LLC
      • San Antonio, Texas, Forenede Stater, 78229
        • Gastroenterology Research of San Antonio
      • Southlake, Texas, Forenede Stater, 76092
        • Texas Digestive Disease Consultants
    • Utah
      • Ogden, Utah, Forenede Stater, 84403
        • Care Access Research LLC - Salt Lake City
    • Virginia
      • Leesburg, Virginia, Forenede Stater, 20176
        • Emeritas Research Group
      • Reston, Virginia, Forenede Stater, 20191
        • The Gastroenterology Group, P.C.
      • Roanoke, Virginia, Forenede Stater, 24016
        • Carilion Clinic
    • Wisconsin
      • Milwaukee, Wisconsin, Forenede Stater, 53215
        • Wisconsin Center for Advanced Research
  • Frankrig
      • Chambray-lès-Tours, Frankrig, 37170
        • CHU Tours - Hôpital Trousseau
      • Marseille, Frankrig, 13915
        • Assistance Publique Hôpitaux de Marseille - Hôpital Nord
      • Montpellier, Frankrig, 34295
        • CHRU de Montpellier-Hopital St Eloi
      • Nice, Frankrig, 06200
        • Hopital L'Archet 2
      • Pessac, Frankrig, 33604
        • CHU Bordeaux - Hôpital Haut-Lévêque
      • Reims, Frankrig, 51092
        • Robert Debré Hospital
      • Saint-Priest-en-Jarez, Frankrig, 42270
        • CHU de Saint Etienne Hopital Nord
      • Vandœuvre-lès-Nancy, Frankrig, 54500
        • CHRU Nancy Brabois - Hôpital d'Enfants
    • Bas Rhin
      • Strasbourg, Bas Rhin, Frankrig, 67098
        • Hopital de Hautepierre - Service d'Hépatogastroentérolgie
    • Cedex 10
      • Paris, Cedex 10, Frankrig, 75475
        • Hôpital Saint-Louis
    • Nord
      • Lille, Nord, Frankrig, 59037
        • CHU Lille - Hôpital Claude Huriez
    • Paris
      • Clichy, Paris, Frankrig, 92110
        • Hôpital Beaujon
    • Pyrénées-Atlantiques
      • Pau, Pyrénées-Atlantiques, Frankrig, 64046
        • Centre Hospitalier de Pau
    • Rhone
      • Pierre-Bénite, Rhone, Frankrig, 69495
        • Hospices Civils de Lyon - Centre Hospitalier Lyon Sud -
    • Somme
      • Amiens, Somme, Frankrig, 80480
        • CHU Amiens Picardie-Site Sud - RDC Service Hépato gastro
  • Holland
      • Uden, Holland, 5406 PT
        • Bernhoven Ziekenhuis
      • Utrecht, Holland, 3584 CX
        • UMC Utrecht, Dept. of Internal Medicine, MDL
    • North Brabant
      • Tilburg, North Brabant, Holland, 5022 GC
        • St Elisabeth Ziekenhuis
    • North Holland
      • Amsterdam, North Holland, Holland, 1105 AZ
        • Amsterdam UMC, locatie AMC
  • Indien
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, Indien, 500058
        • Centre for Liver Research & Diagnostics, Deccan College of Medical Sciences, Owaisi Hospital & Research Centre
    • Gujarat
      • Gandhinagar, Gujarat, Indien, 382428
        • Apollo Research and Innovations, Apollo Hospitals International Ltd
      • Rajkot, Gujarat, Indien, 360005
        • Shree Giriraj Multispeciality Hospital
      • Surat, Gujarat, Indien, 395002
        • Nirmal Hospital Pvt Ltd.
    • Karnataka
      • Bangalore, Karnataka, Indien, 560054
        • M S Ramaiah Medical College and Hospitals
      • Bangalore, Karnataka, Indien, 560 002
        • Bangalore Medical College and Research Institute
    • Maharashtra
      • Nagpur, Maharashtra, Indien, 440010
        • Midas Multispeciality Hospital Pvt.Ltd.
      • Pune, Maharashtra, Indien, 411 001
        • Poona Medical Foundation. Ruby Hall Clinic
      • Wardha, Maharashtra, Indien, 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, Indien, 110 025
        • Escorts Heart Institute and Research Centre Ltd
    • Punjab
      • Ludhiana, Punjab, Indien, 141001
        • Dayanand Medical College and Hospital
    • Rajasthan
      • Jaipur, Rajasthan, Indien, 302001
        • SR Kalla Memorial Gastro & General Hospital
    • Telangana
      • Hyderabad, Telangana, Indien, 500003
        • Gandhi Hospital
    • Uttar Pradesh
      • Lucknow, Uttar Pradesh, Indien, 226003
        • King George Medical University
  • Irland
      • Dublin, Irland, 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
  • Italien
      • Brescia, Italien, 25123
        • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
      • Catanzaro, Italien, 88100
        • Azienda ospedaliero-universitaria Mater Domini
      • Genova, Italien, 16132
        • Azienda Ospedaliero Universitaria San Martino
      • Milan, Italien, 20122
        • Gastroenterology and Endoscopy Unit IRCCS Ca' Granda Ospedale Maggiore Policlinico Foundation
      • Modena, Italien, 41124
        • Azienda Ospedaliera Universitaria Policlinico de Modena
      • Pisa, Italien, 56124
        • Azienda Ospedaliera Universitaria Pisana
      • Roma, Italien, 00168
        • Policlinico Gemelli - Università Cattolica del Sacro Cuore
      • Torino, Italien, 10128
        • Ospedale Mauriziano Umberto I
      • Udine, Italien, 33100
        • Azienda Ospedaliero-Universitaria Santa Maria della Misericordia Gastroenterologia
    • Milano
      • Rho, Milano, Italien, 20017
        • Presidio di Rho
      • Rozzano, Milano, Italien, 20089
        • Istituto Clinico Humanitas
      • San Donato Milanese, Milano, Italien, 20097
        • Istituti di Ricovero e Cura a Carattere Scientifico Policlinico San Donato Gastroenterologia
    • Roma
      • Rome, Roma, Italien, 00157
        • Ospedale Sandro Pertini
      • Torre, Roma, Italien, 00133
        • Azienda Ospedaliera Universitaria Policlinico Tor Vergata
  • Japan
      • Fukuoka, Japan, 814-0180
        • Fukuoka University Hospital
      • Hiroshima, Japan, 734-8551
        • Hiroshima University Hospital
      • Kagoshima, Japan, 892-0846
        • Sameshima Hospital
      • Kyoto, Japan, 612-8555
        • National Hospital Organization Kyoto Medical Center
      • Okayama, Japan, 700-8558
        • Okayama University Hospital
      • Saitama, Japan, 336-0963
        • Tokitokai Tokito Clinic
      • Toyama, Japan, 930-0975
        • Toyama Prefectural Central Hospital
    • Aichi-ken
      • Nagakute-shi, Aichi-ken, Japan, 480-1195
        • Aichi Medical University Hospital
      • Toyoake, Aichi-ken, Japan, 470-1192
        • Fujita Health University
    • Aomori
      • Hirosaki, Aomori, Japan, 036-8545
        • National Hospital Organization Hirosaki National Hospital
    • Chiba
      • Sakura, Chiba, Japan, 285-8741
        • Toho University Sakura Medical Center
    • Fukoka
      • Kitakyusyu-shi, Fukoka, Japan, 802-0077
        • Kitakyushu Municipal Medical Center
    • Fukuoka
      • Chikushino-shi, Fukuoka, Japan, 818-8502
        • Fukuoka University Chikushi Hospital
      • Kurume-shi, Fukuoka, Japan, 839 0809
        • Hidaka Coloproctology Clinic
    • Gunma
      • Maebashi, Gunma, Japan, 371-8511
        • Gunma University Hospital
      • Takasaki, Gunma, Japan, 370-0829
        • National Hospital Organization Takasaki General Medical Centar
    • HigaShiibaraki-Gun
      • Ibaraki-machi, HigaShiibaraki-Gun, Japan, 311 3193
        • NHO Mito Medical Center
    • Hokkaido
      • Asahikawa, Hokkaido, Japan, 070-8610
        • Asahikawa City Hospital
      • Sapporo, Hokkaido, Japan, 065-0033
        • Sapporo Higashi Tokushukai Hospital
      • Sapporo, Hokkaido, Japan, 004 0041
        • Tokushukai Sapporo Tokushukai Hospital
      • Sapporo, Hokkaido, Japan, 060 0033
        • Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
    • Hyōgo
      • Kobe, Hyōgo, Japan, 650 0015
        • Aoyama Clinic GI Endoscopy & IBD Center
    • Kagawa-ken
      • Takamatsu, Kagawa-ken, Japan, 760-8557
        • Kagawa Prefectural Central Hospital
    • Kanagawa
      • Kamakura, Kanagawa, Japan, 247-0056
        • Ofuna Central Hospital
      • Kawasaki, Kanagawa, Japan, 210-0013
        • Kawasaki Municipal Hospital
      • Yokohama, Kanagawa, Japan, 232-0024
        • Yokohama City University Medical Center
      • Yokohama, Kanagawa, Japan, 234-0032
        • Showa University Northern Yokohama Hospital
      • Yokohama, Kanagawa, Japan, 226 0025
        • Sankikai Yokohama Shin midori General Hospital
    • Kumamoto
      • Kumamoto, Kumamoto, Japan, 860-0012
        • Kumamoto University Hospital
    • Mie-ken
      • Tsu, Mie-ken, Japan, 514-8507
        • Mie University Hospital
    • Miyagi
      • Sendai, Miyagi, Japan, 981 3213
        • Takagi Clinic - Sendai
    • Niigata
      • Nagaoka-shi, Niigata, Japan, 940-8653
        • Nagaoka Chuo General Hospital
    • Oita Prefecture
      • Ōita, Oita Prefecture, Japan, 870 0823
        • Ishida Clinic of IBD and Gastroenterology
    • Osaka
      • Fujiidera, Osaka, Japan, 583-0027
        • Sai Gastroenterologist Proctology
      • Osaka, Osaka, Japan, 530 0011
        • Infusion Clinic
      • Osaka, Osaka, Japan, 540 0006
        • NHO Osaka National Hospital
    • Saga-ken
      • Saga, Saga-ken, Japan, 840-8571
        • Saga-Ken Medical Center Koseikan
    • Saitama
      • Kumagaya-shi, Saitama, Japan, 360-8567
        • Kumagaya General Hospital
    • Shizuoka
      • Hamamatsu, Shizuoka, Japan, 4328061
        • Matsuda Hospital
    • Tochigi
      • Shimotsuke-shi, Tochigi, Japan, 329-0498
        • Jichi Medical University Hospital
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8431
        • Juntendo University Hospital
      • Bunkyō, Tokyo, Japan, 113-8519
        • Tokyo Medical and Dental University Hospital
      • Koto-ku, Tokyo, Japan, 135 8577
        • Showa University Koto Toyosu Hospital
      • Minato-Ku, Tokyo, Japan, 108 8642
        • Kitasato University Kitasato Institute Hospital
      • Mitaka, Tokyo, Japan, 181-8611
        • Kyorin University Hospital
      • Shinjuku-ku, Tokyo, Japan, 169-0073
        • JHCO Tokyo Yamate Medical Center
    • Tokyo-To
      • Chiyoda-ku, Tokyo-To, Japan, 101-8643
        • Mitsui Memorial Hospital
      • Shinjuku-ku, Tokyo-To, Japan, 162 8655
        • Center Hospital of the National Center for Global Health and Medicine
  • Kina
      • Wuhan, Kina, 430030
        • Tongji Hospital of Tongji University
    • Anhui
      • Hefei, Anhui, Kina, 230022
        • The First Affiliated Hospital of Anhui Medical University
      • Hefei, Anhui, Kina, 230000
        • Anhui Provincial Hospital
    • Changsha City
      • Kaifu District, Changsha City, Kina, 410008
        • Xiangya Hospital Central South University
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, Kina, 400037
        • The Affiliated 2nd Hosp. of Third Military Med. Univ. of PLA
      • Chongqing, Chongqing Municipality, Kina, 400038
        • The First Hospital Affiliated to AMU (Southwest Hospital)
    • Guangdong
      • Guangzhou, Guangdong, Kina, 510655
        • The Sixth Affiliated Hospital, Sun Yat-sen University
    • Hubei
      • Wuhan, Hubei, Kina, 430022
        • Union Hospital Tongji Medical College Huazhong University of Science and Technology
      • Wuhan, Hubei, Kina, 430060
        • Renmin Hospital of Wuhan University
    • Jiangsu
      • Nanjing, Jiangsu, Kina, 210008
        • The Affiliated Drum Tower Hospital of Nanjing University
      • Nanjing, Jiangsu, Kina, 210029
        • Zhongda Hospital Southeast University
      • Nanjing, Jiangsu, Kina, 211106
        • Nanjing Medical University - Nanjing Jiangning Hospital
    • Jiangxi
      • Pingxiang, Jiangxi, Kina, 337055
        • Jiangxi Pingxiang People's Hospital
    • Jilin
      • Jilin, Jilin, Kina, 132011
        • Jilin Central General Hospital
    • Shandong
      • Jinan, Shandong, Kina, 250021
        • Shandong Provincial Hospital
      • Jinan, Shandong, Kina, 250014
        • Qilu Hospital of Shandong University
      • Liaocheng, Shandong, Kina, 252000
        • Liaocheng People's Hospital
      • Qingdao, Shandong, Kina, 266000
        • The Affiliated Hospital of Qingdao University
      • Taian, Shandong, Kina, 271000
        • Taian City Central Hospital
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Kina, 200025
        • Shanghai Jiaotong University School of Medicine Ruijin Hospital
      • Shanghai, Shanghai Municipality, Kina, 200127
        • Renji Hospital Affliated to Shanghai Jiaotong University
    • Sichuan
      • Chengdu, Sichuan, Kina, 610041
        • West China Hospital, Sichuan University
    • Yunnan
      • Kunming, Yunnan, Kina, 650034
        • The First People's Hospital of Yunnan Province
      • Kunming, Yunnan, Kina, 650032
        • Kunming Medical College Affiliated First Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, Kina, 310016
        • Sir Run Run Shaw Hospital
      • Hangzhou, Zhejiang, Kina, 310003
        • First Affiliated Hosp of College of Med, Zhejiang University
      • Hangzhou, Zhejiang, Kina, 310000
        • The Second Affiliated Hospital of Zhejiang University School of Med
      • Wenzhou, Zhejiang, Kina, 325027
        • The Second Affiliated Hospital YuYing Childens Hospital of Wenzhou Medical university
  • Letland
      • Riga, Letland, 1079
        • Digestive Diseases Center "Gastro"
      • Riga, Letland, LV-1038
        • Riga Eastern Clinical University Hospital
    • Riga
      • Riga, Riga, Letland, LV-1002
        • Pauls Stradins Clinical Univeristy Hospital
  • Litauen
      • Kaunas, Litauen, 50009
        • Hospital of Lithuanian University of Health Sciences Kaunas
      • Klaipėda, Litauen, 92288
        • Klaipeda Seamen's Hospital
      • Klaipėda, Litauen, 92231
        • Republic Hospital of Klaipeda
      • Vilnius, Litauen, LT-08661
        • Vilnius University Hospital Santariskiu Clinics
    • Panevėžys
      • Panevezys, Panevėžys, Litauen, LT-35144
        • Respublikine Panevezio ligonine
  • Malaysia
    • 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
  • Mexico
      • Chihuahua City, Mexico, 31203
        • Scientia Investigacion Clinica S.C.
      • Veracruz, Mexico, 91900
        • Sociedad de Metabolismo y Corazon
    • Jalisco
      • Zapopan, Jalisco, Mexico, 45030
        • Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.
    • Mexico City
      • Mexico City, Mexico City, Mexico, 07020
        • Centro de Investigación Clínica Acelerada
    • Sinaloa
      • Culiacán, Sinaloa, Mexico, 80230
        • Centro Para el Desarrollo de la Medicina y de Asistencia Medica S.C
  • Polen
      • Katowice, Polen, 40-660
        • All-Medicus
      • Olsztyn, Polen, 10-561
        • Wojewodzki Specjalistyczny Szpital w Olsztynie
      • Szczecin, Polen, 71-434
        • Twoja Przychodnia - Szczecinskie Centrum Medyczne
      • Torun, Polen, 87-100
        • Gastromed Kopoń Zmudziński I Wspólnicy Spółka Jawna Specjalistyczne Centrum Gastrologii I Endoskopii
      • Warsaw, Polen, 00-728
        • Warsaw IBD Point Profesor Kierkus
      • Warsaw, Polen, 00635
        • Centrum Zdrowia MDM
      • Warsaw, Polen, 01-697
        • Centrum Medyczne NeuroProtect
      • Wroclaw, Polen, 52-210
        • PlanetMed Sp.z o.o.
      • Zamość, Polen, 22-400
        • ETG Zamosc
    • Kuyavian-Pomeranian Voivodeship
      • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Polen, 85-168
        • Szpital Uniwersytecki Nr 2 im. dr J. Biziela w Bydgoszczy
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Polen, 31-506
        • Topolowa Medicenter
      • Nowy Targ, Lesser Poland Voivodeship, Polen, 34-400
        • Medicenter Nowy Targ
      • Wadowice, Lesser Poland Voivodeship, Polen, 34-100
        • NZOZ Formed
    • Lower Silesian Voivodeship
      • Wroclaw, Lower Silesian Voivodeship, Polen, 53-114
        • LexMedica
    • Lublin Voivodeship
      • Lublin, Lublin Voivodeship, Polen, 20-954
        • Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
      • Lublin, Lublin Voivodeship, Polen, 20-582
        • ZOZ Gastromed
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Polen, 03-580
        • NZOZ Vivamed
    • Silesian Voivodeship
      • Będzin, Silesian Voivodeship, Polen, 42-500
        • Promedica Dental Clinic
    • West Pomeranian Voivodeship
      • Szczecin, West Pomeranian Voivodeship, Polen, 71-685
        • SONOMED Centrum Medyczne
    • Świętokrzyskie Voivodeship
      • Straszów, Świętokrzyskie Voivodeship, Polen, 28-200
        • KO-Med Centrum Medyczne
  • Rumænien
      • Bucharest, Rumænien, 022328
        • Institutul Clinic Fundeni
      • Bucharest, Rumænien, 020125
        • Spitalul Clinic Colentina
      • Bucharest, Rumænien, 010719
        • MedLife Grivita
      • Bucharest, Rumænien, 031864
        • Hifu Terramed Conformal SRL
      • Oradea, Rumænien, 410469
        • Spital Pelican Oradea
    • Bucharest
      • Bucharest, Bucharest, Rumænien, 030463
        • CCBR Clinical Research
  • Rusland
      • Barnaul, Rusland, 656043
        • Multidisciplinary Medical Clinic "Anthurium"
      • Cherepovets, Rusland, 162600
        • Medical and Sanitary Division of Severstal
      • Izhevsk, Rusland, 426061
        • Alliance Biomedical URAL Group
      • Kaliningrad, Rusland, 236035
        • Clinical Trials Center of Medical Institute
      • Kazan', Rusland, 420064
        • State Autonomous Institution of Healthcare "Republican Clinical Hospital of the Ministry of Healthcare of Republic Tatarstan
      • Kemerovo, Rusland, 650066
        • SIH Kemerovo Regional Clinical Hosptial
      • Moscow, Rusland, 125367
        • Medical rehabilitation center
      • Novosibirsk, Rusland, 630005
        • LLC "Medicine Center SibNovoMed"
      • Omsk, Rusland, 644024
        • Clinical Diagnostic Center Ultramed
      • Saint Petersburg, Rusland, 191104
        • City Mariinskaya Hospital
      • Saint Petersburg, Rusland, 195067
        • Pokrovskaya Municipal Hospital
      • Saint Petersburg, Rusland, 195271
        • Non-state Healthcare Institution "Roadway Clinical Hospital of OJSC Russian Railways
      • Saint Petersburg, Rusland, 197022
        • Saint Petersburg State Medical University n.a. Pavlov I.P.
      • Saint Petersburg, Rusland, 197110
        • SBIH City Clinical Hospital #31
      • Samara, Rusland, 443001
        • Medical Institute REAVIZ
      • Stavropol, Rusland, 355018
        • Stavropol State Medical University
      • Yaroslavl, Rusland, 150030
        • Yaroslavl Municipal HI Clinical Hospital #8
      • Yekaterinburg, Rusland, 620109
        • LLC MA New Hospital
    • Irkutsk Oblast
      • Irkutsk, Irkutsk Oblast, Rusland, 664079
        • Scientific Centre of Reconstructive and Restorative Surgery
    • Kareliya, Respublika
      • Petrozavodsk, Kareliya, Respublika, Rusland, 185019
        • Karelia Republican Hospital V.A. Baranova
    • Nizhny Novgorod Oblast
      • Nizhny Novgorod, Nizhny Novgorod Oblast, Rusland, 603126
        • Nizhny Novgorod Regional Hospital N.A. Semashko
      • Nizhny Novgorod, Nizhny Novgorod Oblast, Rusland, 603140
        • Private Healthcare Institution Clinical Hospital Russian Railways - Medicine of Nizhniy Novgorod
    • Novosibirsk Oblast
      • Novosibirsk, Novosibirsk Oblast, Rusland, 630007
        • Novosibirski Gastrocenter
    • Rostov Oblast
      • Rostov-on-Don, Rostov Oblast, Rusland, 344091
        • Rostov State Medical University
    • Sankt-Peterburg
      • Saint Petersburg, Sankt-Peterburg, Rusland, 196143
        • Scientific research center ECO-security
  • Schweiz
      • Bern, Schweiz, 3010
        • Inselspital Bern
      • Sankt Gallen, Schweiz, 9007
        • Kantonsspital St.Gallen
      • Zurich, Schweiz, 8091
        • Universitatsspital Zurich
    • Canton of Bern
      • Bern, Canton of Bern, Schweiz, 3012
        • Gastroenterologische Praxis Balsiger, Seibold & Partner
  • Serbien
      • Kragujevac, Serbien, 34000
        • Clinical Center Kragujevac Gastroenterohepatology Clinic
    • Beograd
      • Belgrade, Beograd, Serbien, 11000
        • Clinical Hospital Center Zvezdara
    • NAP
      • Belgrade, NAP, Serbien, 11080
        • University Medical Center "Bezanijska kosa"
    • Vojvodina
      • Sombor, Vojvodina, Serbien, 25000
        • Regional Hospital Dr Radivoj Simonovic Sombor
      • Sremska Mitrovica, Vojvodina, Serbien, 22000
        • Sremska Mitrovica Health Centre
      • Zrenjanin, Vojvodina, Serbien, 23000
        • General Hospital "Djordje Joanovic"
  • Slovakiet
      • Banská Bystrica, Slovakiet, 975 17
        • Fakultna nemocnica s poliklinikou Roosevelta Banska Bystrica
      • Bratislava, Slovakiet, 82007
        • Univerzitna nemocnica Bratislava
    • Nitra Region
      • Nitra, Nitra Region, Slovakiet, 949 01
        • KM Management
    • Presov
      • Prešov, Presov, Slovakiet, 080 01
        • Gastro
      • Vranov N. Toplou, Presov, Slovakiet, 093 01
        • Endomed, s.r.o.
  • Spanien
      • A Coruña, Spanien, 15006
        • Complexo Hospitalario Universitario A Coruña, CHUAC
      • Alicante, Spanien, 3004
        • Instituto de Ciencias Médicas
      • Girona, Spanien, 17007
        • Hospital Universitari de Girona
      • Huelva, Spanien, 21005
        • Hospital Universitario Juan Ramon Jimenez
      • Las Palmas de Gran Canaria, Spanien, 35010
        • Hospital de Gran Canaria Dr. Negrín
      • Madrid, Spanien, 28046
        • Hospital Universitario La Paz
      • Oviedo, Spanien, 3306
        • Hospital Universitario Central de Asturias
    • Andalusia
      • Seville, Andalusia, Spanien, 41013
        • Hospital Universitario Virgen del Rocio
    • Baleares Islands
      • Palma de Mallorca, Baleares Islands, Spanien, 07120
        • Hospital Universitari Son Espases
    • Cantabria
      • Santander, Cantabria, Spanien, 39008
        • Hospital Universitario Marques de Valdecilla
    • Madrid
      • Fuenlabrada, Madrid, Spanien, 28942
        • Hospital De Fuenlabrada
    • Valencia
      • Sagunto, Valencia, Spanien, 46520
        • Hospital Gen. Juan Ramon Jimenez - Depto de Digestivo
  • Sydkorea
      • Busan, Sydkorea, 48108
        • Inje University Haeundae Paik Hospital
      • Daegu, Sydkorea, 42415
        • Yeungnam Univeristy Medical Center
    • Gangwon-do
      • Wŏnju, Gangwon-do, Sydkorea, 26426
        • Severance Hospital, Yonsei University Health System
    • Korea
      • Seoul, Korea, Sydkorea, 02447
        • Kyung Hee University Hospital
    • Pusan-Kwangyǒkshi
      • Busan, Pusan-Kwangyǒkshi, Sydkorea, 49201
        • Dong-A University Hospital
    • Seoul-teukbyeolsi [Seoul]
      • Seoul, Seoul-teukbyeolsi [Seoul], Sydkorea, 06351
        • Samsung Medical Center
      • Seoul, Seoul-teukbyeolsi [Seoul], Sydkorea, 05505
        • Asan Medical Center
      • Seoul, Seoul-teukbyeolsi [Seoul], Sydkorea, 03181
        • Kangbuk Samsung Hospital
    • Taejǒn-Kwangyǒkshi
      • Daejeon, Taejǒn-Kwangyǒkshi, Sydkorea, 34943
        • The Catholic University of Korea, Daejeon St. Mary's Hospital
  • Taiwan
      • Taichung, Taiwan, 40447
        • China Medical University Hospital
      • Taipei, Taiwan, 10002
        • Health management center
  • Tjekkiet
      • Brno, Tjekkiet, 65691
        • Fakultni nemocnice u sv. Anny v Brne
      • Olomouc, Tjekkiet, 779
        • PreventaMed, s.r.o.
      • Prague, Tjekkiet, 19000
        • ISCARE Clinical Centre
    • Brno-město
      • Brno, Brno-město, Tjekkiet, 636 00
        • Vojenska nemocnice Brno
    • Hl. M. Praha
      • Prague, Hl. M. Praha, Tjekkiet, 100 34
        • Fakultni nemocnice Kralovske Vinohrady
    • Hradec Králové
      • Hradec Králové, Hradec Králové, Tjekkiet, 500 12
        • Hepato-Gastroenterologie HK
    • Olomouc Region
      • Olomouc, Olomouc Region, Tjekkiet, 779 00
        • MUDr. Gregar, s.r.o.
    • Plzeň-město
      • Pilsen, Plzeň-město, Tjekkiet, 301 00
        • A-Shine
    • Praha 8
      • Prague, Praha 8, Tjekkiet, 186 00
        • MEDIENDO
  • Tyrkiet (Türkiye)
    • Antalya
      • Kocaeli, Antalya, Tyrkiet (Türkiye), 7100
        • Antalya Egitim ve Arastırma Hastanesi
    • Istanbul
      • Kadıköy, Istanbul, Tyrkiet (Türkiye), 34734
        • Acibadem Universitesi - Acibadem Kozyatagi Hastanesi
    • Kocaeli
      • İzmit, Kocaeli, Tyrkiet (Türkiye), 41380
        • Kocaeli University Medical Faculty Hospital
    • Mersin
      • Yenişehir, Mersin, Tyrkiet (Türkiye), 33110
        • Mersin University Medical Faculty
    • Turkey
      • Izmir, Turkey, Tyrkiet (Türkiye), 35100
        • Ege Universitesi Hastanesi
  • Tyskland
      • Berlin, Tyskland, 14163
        • Krankenhaus Waldfriede
      • Berlin, Tyskland, 12203
        • Charité Campus Virchow-Klinikum
      • Brandenburg, Tyskland, 14770
        • Städtisches Klinikum Brandenburg
      • Hamburg, Tyskland, 20251
        • HaFCED - Hamburgisches Forschungsinstitut für chronisch entzündliche Darmerkrankungen
      • Weyhe, Tyskland, 28844
        • Internistische Praxisgemeinschaft
    • Lower Saxony
      • Hanover, Lower Saxony, Tyskland, 30625
        • Medizinische Hochschule Hanover
    • Rhineland-Palatinate
      • Ludwigshafen am Rhein, Rhineland-Palatinate, Tyskland, 67067
        • Gemeinschaftspraxis Dr. Peter Uebel
    • Saxony-Anhalt
      • Halle, Saxony-Anhalt, Tyskland, 06108
        • Studiengesellschaft BSF Unternehmergesellschaft
      • Halle, Saxony-Anhalt, Tyskland, 06120
        • Universitätsklinikum Halle
  • Ukraine
      • Kharkiv, Ukraine, 61039
        • GI L.T. Malaya TI Namsu
      • Kharkiv, Ukraine, 61002
        • Kharkiv City Student Hospital
      • Kropyvnytskyi, Ukraine, 25006
        • Treatment-Diagnostic Center of Private Enterprise of PPC Atsynus
      • Kyiv, Ukraine, 02091
        • Kyiv Municipal Clinical Hospital #1
      • Kyiv, Ukraine, 04107
        • Communal institution of the Kyiv Regional Council "Kyiv Regional Clinical Oncology Dispensary"
      • Kyiv, Ukraine, 04078
        • Communal institution of the Kyiv Regional Council "Kyiv Regional Clinical Oncology Dispensary"
      • Odesa, Ukraine, 65000
        • Communal Enterprise "Odesa Regional Clinical Hospital"
      • Uzhhorod, Ukraine, 88000
        • A. Novak Transcarpathian Regional Clinical Hospital
      • Vinnytsia, Ukraine, 21029
        • CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM
      • Vinnytsia, Ukraine, 21005
        • Vinnytsia RCH of Veterans of War Dept of Therapy#1 Vinnytsia M.I.Pyrogov NMU
      • Vinnytsia, Ukraine, 21009
        • MCIC MC LLC Health Clinic
      • Vinnytsia, Ukraine, 21018
        • M.I. Pyrogov Regional Clinical Hospital
      • Zaporizhzhia, Ukraine, 69104
        • Communal Institution of Kyiv Regional Council Kyiv Regional Hospital #2
    • Ivano-Frankivsk Oblast
      • Ivano-Frankivsk, Ivano-Frankivsk Oblast, Ukraine, 76008
        • Ivano-Frankivsk Regional Clinical Hospital
    • Kharkivs’ka Oblast’
      • Kharkiv, Kharkivs’ka Oblast’, Ukraine, 61037
        • City Clinical Hospital No. 2
    • Kherson Oblast
      • Kherson, Kherson Oblast, Ukraine, 73000
        • Kherson City Clinical Hospital
    • Kyiv Oblast
      • Kiev, Kyiv Oblast, Ukraine, 4050
        • Medical Center of Limited Liability Company "Medical Center "Consilium Medical"
    • Lviv Oblast
      • Lviv, Lviv Oblast, Ukraine, 79000
        • Lviv Railway Clinical Hospital
      • Lviv, Lviv Oblast, Ukraine, 79000
        • Lviv Regional Endocrinology Dispensary
      • Lviv, Lviv Oblast, Ukraine, 79000
        • Municipal non-profit enterprise "Lviv Territorial Medical Union "Multidisciplinary Clinical Hospital of Em -T
    • Poltava Oblast
      • Poltava, Poltava Oblast, Ukraine, 36000
        • Poltova Oblast Clinical Hospital IM.M.V.Sklifosovskoho
    • Zaporizhzhia Oblast
      • Zaporizhia, Zaporizhzhia Oblast, Ukraine, 69076
        • Diaservis - Medical and Diagnostic Center
  • Ungarn
      • Budapest, Ungarn, 1088
        • Semmelweis Egyetem
      • Budapest, Ungarn, 1036
        • Óbudai Egészségügyi Centrum
      • Debrecen, Ungarn, 4032
        • Debreceni Egyetem Klinikai Kozpont
      • Miskolc, Ungarn, 3526
        • Endomedix Diagnosztikai Központ - Miskolc
      • Mosonmagyaróvár, Ungarn, 9200
        • Karolina Korhaz-Rendelointezet
      • Szeged, Ungarn, 6720
        • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont I. Belgyogyaszati Klinika
      • Szekszárd, Ungarn, 7100
        • CLINFAN Szolgáltató Kft
    • EU
      • Balatonfüred, EU, Ungarn, 8230
        • DRC Gyogyszervizsgalo Kozpont Kft.
    • Pest County
      • Vác, Pest County, Ungarn, 2600
        • Javorszky Odon Korhaz
  • Østrig
      • Innsbruck, Østrig, 6020
        • Medizinische Universität Innsbruck
      • Salzburg, Østrig, 5020
        • Universitätsklinikum Salzburg
      • Vienna, Østrig, 1090
        • Medical University of Vienna

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

14 år til 76 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Inklusionskriterier:

  • Har gennemført Studie AMAN (NCT03518086), med mindst 1 studiemedicinsadministration og uden tidlig afslutning af studielægemidlet.
  • Er villig og i stand til at gennemføre de planlagte undersøgelsesvurderinger, herunder endoskopi og daglig dagbogsoptagelse.
  • Hvis hun er kvinde, skal den opfylde præventionskravene.

Ekskluderingskriterier:

  • Deltagere diagnosticeret med Crohns sygdom eller inflammatorisk tarmsygdom - uklassificeret (ubestemt colitis) under induktionsstudiet AMAN (NCT03518086).
  • Deltagere med en tarmresektion eller anden operation til behandling af UC under det tidligere induktionsstudie AMAN (NCT03518086), eller vil sandsynligvis have behov for operation til behandling af UC under studie AMBG.
  • Deltagere med tegn på tyktarmsdysplasi eller er blevet diagnosticeret med kræft i mave-tarmkanalen under undersøgelse AMAN (NCT03518086).
  • Deltagere diagnosticeret med klinisk vigtig infektion, herunder, men ikke begrænset til, hepatitis B, hepatitis C, HIV/AIDS og aktiv tuberkulose (TB) under induktionsundersøgelsen AMAN (NCT03518086).
  • Deltagere, der påbegynder en ny forbudt medicin under induktionsundersøgelsen AMAN (NCT03518086).
  • Deltagere med visse laboratorieabnormiteter før påbegyndelse af AMBG, som ville kræve permanent seponering af undersøgelseslægemidlet.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Ikke-randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Placebo komparator: Vedligeholdelsesperiode: Miri Induction Responder (IR) - Placebo (PBO) Subkutan (SC)
Deltagere, der responderede på blindet mirikizumab (miri) i uge 12 i induktionsundersøgelse (LUCENT-1), randomiseret til at trække sig fra mirikizumab og begynde at modtage PBO SC hver 4. uge (Q4W) fra uge 0 af vedligeholdelsesundersøgelsen (LUCENT-2) indtil uge 40 eller indtil tab af svar blev bekræftet.
Medicin: Placebo SC
Administreret SC
Eksperimentel: Vedligeholdelsesperiode: Miri IR - 200 Milligram (mg) Miri SC
Deltagere, som responderede på blindet mirikizumab i uge 12 i induktionsstudiet (LUCENT-1), blev randomiseret til at fortsætte med at modtage 200 mg mirikizumab SC Q4W fra uge 0 af LUCENT-2 indtil uge 40 eller indtil tab af respons blev bekræftet.
Medicin: Mirikizumab SC
Administreret SC
Andre navne:
  • LY3074828
Eksperimentel: 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.
Medicin: Placebo SC
Administreret SC
Eksperimentel: 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.
Medicin: Placebo SC
Administreret SC
Eksperimentel: 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.
Medicin: Mirikizumab SC
Administreret SC
Andre navne:
  • LY3074828
Eksperimentel: 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.
Medicin: Mirikizumab IV
Administreret IV
Andre navne:
  • LY3074828
Medicin: Placebo SC
Administreret SC
Eksperimentel: 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.
Medicin: Mirikizumab IV
Administreret IV
Andre navne:
  • LY3074828
Eksperimentel: 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.
Medicin: Mirikizumab IV
Administreret IV
Andre navne:
  • LY3074828
Eksperimentel: 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.
Medicin: Mirikizumab IV
Administreret IV
Andre navne:
  • LY3074828
Eksperimentel: 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.
Medicin: Mirikizumab IV
Administreret IV
Andre navne:
  • LY3074828
Eksperimentel: 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).
Medicin: Mirikizumab SC
Administreret SC
Andre navne:
  • LY3074828
Eksperimentel: 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).
Medicin: Mirikizumab SC
Administreret SC
Andre navne:
  • LY3074828

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Percentage of Participants in Clinical Remission at Week 40 (Mirikizumab Induction Responders)
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Farmakokinetik (PK): Clearance af Mirikizumab
Tidsramme: Foruddosis: uge 0, 4, 12, 24 og 40
Clearance af mirikizumab blev evalueret.
Foruddosis: uge 0, 4, 12, 24 og 40
Percentage of Participants in Endoscopic Remission at Week 40 (Mirikizumab Induction Responders)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: Week 40
Percentage of participants hospitalized for UC. Only hospitalizations associated with an adverse event with >=24 hours stay were recorded.
Week 40

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Eli Lilly and Company

Efterforskere

  • Studieleder: 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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

19. oktober 2018

Primær færdiggørelse (Faktiske)

3. november 2021

Studieafslutning (Faktiske)

17. februar 2025

Datoer for studieregistrering

Først indsendt

10. maj 2018

Først indsendt, der opfyldte QC-kriterier

10. maj 2018

Først opslået (Faktiske)

14. maj 2018

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. maj 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 16823
  • I6T-MC-AMBG (Anden identifikator: Eli Lilly and Company)
  • 2017-003238-96 (EudraCT nummer)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

Anonymiserede individuelle data på patientniveau vil blive leveret i et sikkert adgangsmiljø efter godkendelse af et forskningsforslag og en underskrevet datadelingsaftale.

IPD-delingstidsramme

Data er tilgængelige 6 måneder efter den primære offentliggørelse og godkendelse af den undersøgte indikation i USA og EU, alt efter hvad der er senere. Data vil være tilgængelige på ubestemt tid for anmodning.

IPD-delingsadgangskriterier

Et forskningsforslag skal godkendes af et uafhængigt bedømmelsespanel, og forskere skal underskrive en datadelingsaftale.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Colitis ulcerosa

Kliniske forsøg med Mirikizumab IV

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