此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Mirikizumab 在中度至重度活动性溃疡性结肠炎参与者中的维持研究 (LUCENT 2)

2026年5月12日 更新者:Eli Lilly and Company

Mirikizumab 在中度至重度活动性溃疡性结肠炎患者中的 3 期、多中心、随机、双盲、平行组、安慰剂对照维持研究 (LUCENT 2)

本研究的目的是评估米利珠单抗作为维持治疗的疗效和安全性,这些参与者在之前的 12 周诱导研究 LUCENT-1 (NCT03518086) 中作为临床反应者完成。

研究概览

研究类型

介入性

注册 (实际的)

1328

阶段

  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Wuhan、中国、430030
        • Tongji Hospital of Tongji University
    • Anhui
      • Hefei、Anhui、中国、230022
        • The First Affiliated Hospital of Anhui Medical University
      • Hefei、Anhui、中国、230000
        • Anhui Provincial Hospital
    • Changsha City
      • Kaifu District、Changsha City、中国、410008
        • Xiangya Hospital Central South University
    • Chongqing Municipality
      • Chongqing、Chongqing Municipality、中国、400037
        • The Affiliated 2nd Hosp. of Third Military Med. Univ. of PLA
      • Chongqing、Chongqing Municipality、中国、400038
        • The First Hospital Affiliated to AMU (SOUTHWEST HOSPITAL)
    • Guangdong
      • Guangzhou、Guangdong、中国、510655
        • The Sixth Affiliated Hospital, Sun Yat-sen University
    • Hubei
      • Wuhan、Hubei、中国、430022
        • Union Hospital Tongji Medical College Huazhong University Of Science And Technology
      • Wuhan、Hubei、中国、430060
        • Renmin Hospital of Wuhan University
    • Jiangsu
      • Nanjing、Jiangsu、中国、210008
        • The Affiliated Drum Tower Hospital of Nanjing University
      • Nanjing、Jiangsu、中国、210029
        • Zhongda Hospital Southeast University
      • Nanjing、Jiangsu、中国、211106
        • Nanjing Medical University - Nanjing Jiangning Hospital
    • Jiangxi
      • Pingxiang、Jiangxi、中国、337055
        • Jiangxi Pingxiang People's Hospital
    • Jilin
      • Jilin、Jilin、中国、132011
        • Jilin Central General Hospital
    • Shandong
      • Jinan、Shandong、中国、250021
        • Shandong Provincial Hospital
      • Jinan、Shandong、中国、250014
        • Qilu Hospital of Shandong University
      • Liaocheng、Shandong、中国、252000
        • Liaocheng People's Hospital
      • Qingdao、Shandong、中国、266000
        • The Affiliated Hospital of Qingdao University
      • Taian、Shandong、中国、271000
        • Taian City Central Hospital
    • Shanghai Municipality
      • Shanghai、Shanghai Municipality、中国、200025
        • Shanghai Jiaotong University School of Medicine Ruijin Hospital
      • Shanghai、Shanghai Municipality、中国、200127
        • Renji Hospital Affliated to Shanghai Jiaotong University
    • Sichuan
      • Chengdu、Sichuan、中国、610041
        • West China Hospital, Sichuan University
    • Yunnan
      • Kunming、Yunnan、中国、650034
        • The First People's Hospital of Yunnan Province
      • Kunming、Yunnan、中国、650032
        • Kunming Medical College Affiliated First Hospital
    • Zhejiang
      • Hangzhou、Zhejiang、中国、310016
        • Sir Run Run Shaw Hospital
      • Hangzhou、Zhejiang、中国、310003
        • First Affiliated Hosp of College of Med, Zhejiang University
      • Hangzhou、Zhejiang、中国、310000
        • The Second Affiliated Hospital of Zhejiang University School of Med
      • Wenzhou、Zhejiang、中国、325027
        • The Second Affiliated Hospital YuYing Childens Hospital of Wenzhou Medical university
      • Herlev、丹麦、2730
        • Herlev and Gentofte Hospital
      • Køge、丹麦、4600
        • Zealand University Hospital Køge
      • Kharkiv、乌克兰、61039
        • GI L.T. Malaya TI Namsu
      • Kharkiv、乌克兰、61002
        • Kharkiv City Student Hospital
      • Kropyvnytskyi、乌克兰、25006
        • Treatment-Diagnostic Center of Private Enterprise of PPC Atsynus
      • Kyiv、乌克兰、02091
        • Kyiv Municipal Clinical Hospital #1
      • Kyiv、乌克兰、04107
        • Communal institution of the Kyiv Regional Council "Kyiv Regional Clinical Oncology Dispensary"
      • Kyiv、乌克兰、04078
        • Communal institution of the Kyiv Regional Council "Kyiv Regional Clinical Oncology Dispensary"
      • Odesa、乌克兰、65000
        • Communal Enterprise "Odesa Regional Clinical Hospital"
      • Uzhhorod、乌克兰、88000
        • A. Novak Transcarpathian Regional Clinical Hospital
      • Vinnytsia、乌克兰、21029
        • CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM
      • Vinnytsia、乌克兰、21005
        • Vinnytsia RCH of Veterans of War Dept of Therapy#1 Vinnytsia M.I.Pyrogov NMU
      • Vinnytsia、乌克兰、21009
        • MCIC MC LLC Health Clinic
      • Vinnytsia、乌克兰、21018
        • M.I. Pyrogov Regional Clinical Hospital
      • Zaporizhzhia、乌克兰、69104
        • Communal Institution of Kyiv Regional Council Kyiv Regional Hospital #2
    • Ivano-Frankivsk Oblast
      • Ivano-Frankivsk、Ivano-Frankivsk Oblast、乌克兰、76008
        • Ivano-Frankivsk Regional Clinical Hospital
    • Kharkivs’ka Oblast’
      • Kharkiv、Kharkivs’ka Oblast’、乌克兰、61037
        • City Clinical Hospital No. 2
    • Kherson Oblast
      • Kherson、Kherson Oblast、乌克兰、73000
        • Kherson City Clinical Hospital
    • Kyiv Oblast
      • Kiev、Kyiv Oblast、乌克兰、4050
        • Medical Center of Limited Liability Company "Medical Center "Consilium Medical"
    • Lviv Oblast
      • Lviv、Lviv Oblast、乌克兰、79000
        • Lviv Railway Clinical Hospital
      • Lviv、Lviv Oblast、乌克兰、79000
        • Lviv Regional Endocrinology Dispensary
      • Lviv、Lviv Oblast、乌克兰、79000
        • Municipal non-profit enterprise "Lviv Territorial Medical Union "Multidisciplinary Clinical Hospital of Em -T
    • Poltava Oblast
      • Poltava、Poltava Oblast、乌克兰、36000
        • Poltova Oblast Clinical Hospital IM.M.V.Sklifosovskoho
    • Zaporizhzhia Oblast
      • Zaporizhia、Zaporizhzhia Oblast、乌克兰、69076
        • Diaservis - Medical and Diagnostic Center
      • Beersheba、以色列、8410101
        • Soroka Medical Center - Pediatric Outpatient Clinic
      • Nahariya、以色列、2210001
        • Galilee Medical Center Department of Internal Medicine A
      • Rehovot、以色列、7610001
        • Kaplan Medical Center
      • Tel Aviv、以色列、6423906
        • Tel Aviv Sourasky Medical Center
      • Ẕerifin、以色列、70300
        • King Fahad Medical City
    • Jerusalem
      • Bait Vagan、Jerusalem、以色列、91031
        • Shaare Zedek Medical Center
      • Barnaul、俄罗斯、656043
        • Multidisciplinary Medical Clinic "Anthurium"
      • Cherepovets、俄罗斯、162600
        • Medical and Sanitary Division of Severstal
      • Izhevsk、俄罗斯、426061
        • Alliance Biomedical URAL Group
      • Kaliningrad、俄罗斯、236035
        • Clinical Trials Center of Medical Institute
      • Kazan'、俄罗斯、420064
        • State Autonomous Institution of Healthcare "Republican Clinical Hospital of the Ministry of Healthcare of Republic Tatarstan
      • Kemerovo、俄罗斯、650066
        • SIH Kemerovo Regional Clinical Hosptial
      • Moscow、俄罗斯、125367
        • Medical rehabilitation center
      • Novosibirsk、俄罗斯、630005
        • LLC "Medicine Center SibNovoMed"
      • Omsk、俄罗斯、644024
        • Clinical Diagnostic Center Ultramed
      • Saint Petersburg、俄罗斯、191104
        • City Mariinskaya Hospital
      • Saint Petersburg、俄罗斯、195067
        • Pokrovskaya Municipal Hospital
      • Saint Petersburg、俄罗斯、195271
        • Non-state Healthcare Institution "Roadway Clinical Hospital of OJSC Russian Railways
      • Saint Petersburg、俄罗斯、197022
        • Saint Petersburg State Medical University n.a. Pavlov I.P.
      • Saint Petersburg、俄罗斯、197110
        • SBIH City Clinical Hospital #31
      • Samara、俄罗斯、443001
        • Medical Institute REAVIZ
      • Stavropol、俄罗斯、355018
        • Stavropol State Medical University
      • Yaroslavl、俄罗斯、150030
        • Yaroslavl Municipal HI Clinical Hospital #8
      • Yekaterinburg、俄罗斯、620109
        • LLC MA New Hospital
    • Irkutsk Oblast
      • Irkutsk、Irkutsk Oblast、俄罗斯、664079
        • Scientific Centre of Reconstructive and Restorative Surgery
    • Kareliya, Respublika
      • Petrozavodsk、Kareliya, Respublika、俄罗斯、185019
        • Karelia Republican Hospital V.A. Baranova
    • Nizhny Novgorod Oblast
      • Nizhny Novgorod、Nizhny Novgorod Oblast、俄罗斯、603126
        • Nizhny Novgorod Regional Hospital N.A. Semashko
      • Nizhny Novgorod、Nizhny Novgorod Oblast、俄罗斯、603140
        • Private Healthcare Institution Clinical Hospital Russian Railways - Medicine of Nizhniy Novgorod
    • Novosibirsk Oblast
      • Novosibirsk、Novosibirsk Oblast、俄罗斯、630007
        • Novosibirski Gastrocenter
    • Rostov Oblast
      • Rostov-on-Don、Rostov Oblast、俄罗斯、344091
        • Rostov State Medical University
    • Sankt-Peterburg
      • Saint Petersburg、Sankt-Peterburg、俄罗斯、196143
        • Scientific research center ECO-security
    • Alberta
      • Edmonton、Alberta、加拿大、T5R 1W2
        • West Edmonton Diabetes Center
    • British Columbia
      • Vancouver、British Columbia、加拿大、V6Z 2K5
        • GI Research Institute
      • Vancouver、British Columbia、加拿大、V5Z 1M9
        • The Gordon and Leslie Diamond Health Care Centre
      • Victoria、British Columbia、加拿大、V8V 3M9
        • PerCuro Clinical Research
    • Ontario
      • London、Ontario、加拿大、N6A 4G5
        • Victoria Hospital
      • London、Ontario、加拿大、N6A 5G1
        • University of Western Ontario
    • Quebec
      • Greenfield Park、Quebec、加拿大、J4V 2H1
        • Centre de santé et de services sociaux Champlain-Charles-Le Moyne
      • Montreal、Quebec、加拿大、H1T 2M4
        • Hopital Maisonneure-Rosemount
      • Montreal、Quebec、加拿大、H3G 1A4
        • Inflammatory Bowel Disease Centre Montreal General Hospital - MUHC
      • Budapest、匈牙利、1088
        • Semmelweis Egyetem
      • Budapest、匈牙利、1036
        • Óbudai Egészségügyi Centrum
      • Debrecen、匈牙利、4032
        • Debreceni Egyetem Klinikai Kozpont
      • Miskolc、匈牙利、3526
        • Endomedix Diagnosztikai Központ - Miskolc
      • Mosonmagyaróvár、匈牙利、9200
        • Karolina Korhaz-Rendelointezet
      • Szeged、匈牙利、6720
        • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont I. Belgyogyaszati Klinika
      • Szekszárd、匈牙利、7100
        • CLINFAN Szolgáltató Kft
    • EU
      • Balatonfüred、EU、匈牙利、8230
        • DRC Gyogyszervizsgalo Kozpont Kft.
    • Pest County
      • Vác、Pest County、匈牙利、2600
        • Jávorszky Ödön Kórház
    • Andhra Pradesh
      • Hyderabad、Andhra Pradesh、印度、500058
        • Centre for Liver Research & Diagnostics, Deccan College of Medical Sciences, Owaisi Hospital & Research Centre
    • Gujarat
      • Gandhinagar、Gujarat、印度、382428
        • Apollo Research and Innovations, Apollo Hospitals International Ltd
      • Rajkot、Gujarat、印度、360005
        • Shree Giriraj Multispeciality Hospital
      • Surat、Gujarat、印度、395002
        • Nirmal Hospital Pvt Ltd.
    • Karnataka
      • Bangalore、Karnataka、印度、560054
        • M S Ramaiah Medical College and Hospitals
      • Bangalore、Karnataka、印度、560 002
        • Bangalore Medical College and Research Institute
    • Maharashtra
      • Nagpur、Maharashtra、印度、440010
        • Midas Multispeciality Hospital Pvt.Ltd.
      • Pune、Maharashtra、印度、411 001
        • Poona Medical Foundation. Ruby Hall Clinic
      • Wardha、Maharashtra、印度、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、印度、110 025
        • Escorts Heart Institute and Research Centre Ltd
    • Punjab
      • Ludhiana、Punjab、印度、141001
        • Dayanand Medical College and Hospital
    • Rajasthan
      • Jaipur、Rajasthan、印度、302001
        • SR Kalla Memorial Gastro & General Hospital
    • Telangana
      • Hyderabad、Telangana、印度、500003
        • Gandhi Hospital
    • Uttar Pradesh
      • Lucknow、Uttar Pradesh、印度、226003
        • King George Medical University
      • Taichung、台湾、40447
        • China Medical University Hospital
      • Taipei、台湾、10002
        • Health management center
    • Antalya
      • Kocaeli、Antalya、土耳其(türkiye)、7100
        • Antalya Egitim ve Arastırma Hastanesi
    • Istanbul
      • Kadıköy、Istanbul、土耳其(türkiye)、34734
        • Acibadem Universitesi - Acibadem Kozyatagi Hastanesi
    • Kocaeli
      • İzmit、Kocaeli、土耳其(türkiye)、41380
        • Kocaeli University Medical Faculty Hospital
    • Mersin
      • Yenişehir、Mersin、土耳其(türkiye)、33110
        • Mersin University Medical Faculty
    • Turkey
      • Izmir、Turkey、土耳其(türkiye)、35100
        • Ege Universitesi Hastanesi
      • Kragujevac、塞尔维亚、34000
        • Clinical Center Kragujevac Gastroenterohepatology Clinic
    • Beograd
      • Belgrade、Beograd、塞尔维亚、11000
        • Clinical Hospital Center Zvezdara
    • NAP
      • Belgrade、NAP、塞尔维亚、11080
        • University Medical Center "Bezanijska kosa"
    • Vojvodina
      • Sombor、Vojvodina、塞尔维亚、25000
        • Regional Hospital Dr Radivoj Simonovic Sombor
      • Sremska Mitrovica、Vojvodina、塞尔维亚、22000
        • Sremska Mitrovica Health Centre
      • Zrenjanin、Vojvodina、塞尔维亚、23000
        • General Hospital "Djordje Joanovic"
      • Chihuahua City、墨西哥、31203
        • Scientia Investigacion Clinica S.C.
      • Veracruz、墨西哥、91900
        • Sociedad de Metabolismo y Corazon
    • Jalisco
      • Zapopan、Jalisco、墨西哥、45030
        • Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V.
    • Mexico City
      • Mexico City、Mexico City、墨西哥、07020
        • Centro de Investigación Clínica Acelerada
    • Sinaloa
      • Culiacán、Sinaloa、墨西哥、80230
        • Centro Para el Desarrollo de la Medicina y de Asistencia Medica S.C
      • Innsbruck、奥地利、6020
        • Medizinische Universität Innsbruck
      • Salzburg、奥地利、5020
        • Universitätsklinikum Salzburg
      • Vienna、奥地利、1090
        • Medical University of Vienna
      • Berlin、德国、14163
        • Krankenhaus Waldfriede
      • Berlin、德国、12203
        • Charité Campus Virchow-Klinikum
      • Brandenburg、德国、14770
        • Städtisches Klinikum Brandenburg
      • Hamburg、德国、20251
        • HaFCED - Hamburgisches Forschungsinstitut für chronisch entzündliche Darmerkrankungen
      • Weyhe、德国、28844
        • Internistische Praxisgemeinschaft
    • Lower Saxony
      • Hanover、Lower Saxony、德国、30625
        • Medizinische Hochschule Hanover
    • Rhineland-Palatinate
      • Ludwigshafen am Rhein、Rhineland-Palatinate、德国、67067
        • Gemeinschaftspraxis Dr. Peter Uebel
    • Saxony-Anhalt
      • Halle、Saxony-Anhalt、德国、06108
        • Studiengesellschaft BSF Unternehmergesellschaft
      • Halle、Saxony-Anhalt、德国、06120
        • Universitätsklinikum Halle
      • Brescia、意大利、25123
        • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
      • Catanzaro、意大利、88100
        • Azienda ospedaliero-universitaria Mater Domini
      • Genova、意大利、16132
        • Azienda Ospedaliero Universitaria San Martino
      • Milan、意大利、20122
        • Gastroenterology and Endoscopy Unit IRCCS Ca' Granda Ospedale Maggiore Policlinico Foundation
      • Modena、意大利、41124
        • Azienda Ospedaliera Universitaria Policlinico de Modena
      • Pisa、意大利、56124
        • Azienda Ospedaliera Universitaria Pisana
      • Roma、意大利、00168
        • Policlinico Gemelli - Università Cattolica del Sacro Cuore
      • Torino、意大利、10128
        • Ospedale Mauriziano Umberto I
      • Udine、意大利、33100
        • Azienda Ospedaliero-Universitaria Santa Maria della Misericordia Gastroenterologia
    • Milano
      • Rho、Milano、意大利、20017
        • Presidio di Rho
      • Rozzano、Milano、意大利、20089
        • Istituto Clinico Humanitas
      • San Donato Milanese、Milano、意大利、20097
        • Istituti di Ricovero e Cura a Carattere Scientifico Policlinico San Donato Gastroenterologia
    • Roma
      • Rome、Roma、意大利、00157
        • Ospedale Sandro Pertini
      • Torre、Roma、意大利、00133
        • Azienda Ospedaliera Universitaria Policlinico Tor Vergata
      • Riga、拉脱维亚、1079
        • Digestive Diseases Center "Gastro"
      • Riga、拉脱维亚、LV-1038
        • Riga Eastern Clinical University Hospital
    • Riga
      • Riga、Riga、拉脱维亚、LV-1002
        • Pauls Stradins Clinical Univeristy Hospital
      • Brno、捷克语、65691
        • Fakultni nemocnice u sv. Anny v Brne
      • Olomouc、捷克语、779
        • PreventaMed, s.r.o.
      • Prague、捷克语、19000
        • ISCARE Clinical Centre
    • Brno-město
      • Brno、Brno-město、捷克语、636 00
        • Vojenska nemocnice Brno
    • Hl. M. Praha
      • Prague、Hl. M. Praha、捷克语、100 34
        • Fakultni nemocnice Kralovske Vinohrady
    • Hradec Králové
      • Hradec Králové、Hradec Králové、捷克语、500 12
        • Hepato-Gastroenterologie HK
    • Olomouc Region
      • Olomouc、Olomouc Region、捷克语、779 00
        • MUDr. Gregar, s.r.o.
    • Plzeň-město
      • Pilsen、Plzeň-město、捷克语、301 00
        • A-Shine
    • Praha 8
      • Prague、Praha 8、捷克语、186 00
        • MEDIENDO
      • Banská Bystrica、斯洛伐克、975 17
        • Fakultna nemocnica s poliklinikou Roosevelta Banska Bystrica
      • Bratislava、斯洛伐克、82007
        • Univerzitna nemocnica Bratislava
    • Nitra Region
      • Nitra、Nitra Region、斯洛伐克、949 01
        • KM Management
    • Presov
      • Prešov、Presov、斯洛伐克、080 01
        • Gastro
      • Vranov N. Toplou、Presov、斯洛伐克、093 01
        • Endomed, s.r.o.
      • Fukuoka、日本、814-0180
        • Fukuoka University Hospital
      • Hiroshima、日本、734-8551
        • Hiroshima University Hospital
      • Kagoshima、日本、892-0846
        • Sameshima Hospital
      • Kyoto、日本、612-8555
        • National Hospital Organization Kyoto Medical Center
      • Okayama、日本、700-8558
        • Okayama University Hospital
      • Saitama、日本、336-0963
        • Tokitokai Tokito Clinic
      • Toyama、日本、930-0975
        • Toyama Prefectural Central Hospital
    • Aichi-ken
      • Nagakute-shi、Aichi-ken、日本、480-1195
        • Aichi Medical University Hospital
      • Toyoake、Aichi-ken、日本、470-1192
        • Fujita Health University
    • Aomori
      • Hirosaki、Aomori、日本、036-8545
        • National Hospital Organization Hirosaki National Hospital
    • Chiba
      • Sakura、Chiba、日本、285-8741
        • Toho University Sakura Medical Center
    • Fukoka
      • Kitakyusyu-shi、Fukoka、日本、802-0077
        • Kitakyushu Municipal Medical Center
    • Fukuoka
      • Chikushino-shi、Fukuoka、日本、818-8502
        • Fukuoka University Chikushi Hospital
      • Kurume-shi、Fukuoka、日本、839 0809
        • Hidaka Coloproctology Clinic
    • Gunma
      • Maebashi、Gunma、日本、371-8511
        • Gunma University Hospital
      • Takasaki、Gunma、日本、370-0829
        • National Hospital Organization Takasaki General Medical Centar
    • HigaShiibaraki-Gun
      • Ibaraki-machi、HigaShiibaraki-Gun、日本、311 3193
        • NHO Mito Medical Center
    • Hokkaido
      • Asahikawa、Hokkaido、日本、070-8610
        • Asahikawa City Hospital
      • Sapporo、Hokkaido、日本、065-0033
        • Sapporo Higashi Tokushukai Hospital
      • Sapporo、Hokkaido、日本、004 0041
        • Tokushukai Sapporo Tokushukai Hospital
      • Sapporo、Hokkaido、日本、060 0033
        • Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
    • Hyōgo
      • Kobe、Hyōgo、日本、650 0015
        • Aoyama Clinic GI Endoscopy & IBD Center
    • Kagawa-ken
      • Takamatsu、Kagawa-ken、日本、760-8557
        • Kagawa Prefectural Central Hospital
    • Kanagawa
      • Kamakura、Kanagawa、日本、247-0056
        • Ofuna Central Hospital
      • Kawasaki、Kanagawa、日本、210-0013
        • Kawasaki Municipal Hospital
      • Yokohama、Kanagawa、日本、232-0024
        • Yokohama City University Medical Center
      • Yokohama、Kanagawa、日本、234-0032
        • Showa University Northern Yokohama Hospital
      • Yokohama、Kanagawa、日本、226 0025
        • Sankikai Yokohama Shin midori General Hospital
    • Kumamoto
      • Kumamoto、Kumamoto、日本、860-0012
        • Kumamoto University Hospital
    • Mie-ken
      • Tsu、Mie-ken、日本、514-8507
        • Mie University Hospital
    • Miyagi
      • Sendai、Miyagi、日本、981 3213
        • Takagi Clinic - Sendai
    • Niigata
      • Nagaoka-shi、Niigata、日本、940-8653
        • Nagaoka Chuo General Hospital
    • Oita Prefecture
      • Ōita、Oita Prefecture、日本、870 0823
        • Ishida Clinic of IBD and Gastroenterology
    • Osaka
      • Fujiidera、Osaka、日本、583-0027
        • Sai Gastroenterologist Proctology
      • Osaka、Osaka、日本、530 0011
        • Infusion Clinic
      • Osaka、Osaka、日本、540 0006
        • NHO Osaka National Hospital
    • Saga-ken
      • Saga、Saga-ken、日本、840-8571
        • Saga-Ken Medical Center Koseikan
    • Saitama
      • Kumagaya-shi、Saitama、日本、360-8567
        • Kumagaya General Hospital
    • Shizuoka
      • Hamamatsu、Shizuoka、日本、4328061
        • Matsuda Hospital
    • Tochigi
      • Shimotsuke-shi、Tochigi、日本、329-0498
        • Jichi Medical University Hospital
    • Tokyo
      • Bunkyo-ku、Tokyo、日本、113-8431
        • Juntendo University Hospital
      • Bunkyō、Tokyo、日本、113-8519
        • Tokyo Medical and Dental University Hospital
      • Koto-ku、Tokyo、日本、135 8577
        • Showa University Koto Toyosu Hospital
      • Minato-Ku、Tokyo、日本、108 8642
        • Kitasato University Kitasato Institute Hospital
      • Mitaka、Tokyo、日本、181-8611
        • Kyorin University Hospital
      • Shinjuku-ku、Tokyo、日本、169-0073
        • JHCO Tokyo Yamate Medical Center
    • Tokyo-To
      • Chiyoda-ku、Tokyo-To、日本、101-8643
        • Mitsui Memorial Hospital
      • Shinjuku-ku、Tokyo-To、日本、162 8655
        • Center Hospital of the National Center for Global Health and Medicine
      • Brasschaat、比利时、2930
        • AZ Klina
      • Leuven、比利时、3000
        • Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
    • Oost-Vlaanderen
      • Ghent、Oost-Vlaanderen、比利时、9000
        • Universitair Ziekenhuis Gent
    • Wallonne, Région
      • Tournai、Wallonne, Région、比利时、7500
        • Centre Hospitalier de Wallonie Picarde - Site Notre Dame
      • Chambray-lès-Tours、法国、37170
        • CHU Tours - Hôpital Trousseau
      • Marseille、法国、13915
        • Assistance Publique Hôpitaux de Marseille - Hôpital Nord
      • Montpellier、法国、34295
        • CHRU de Montpellier-Hopital St Eloi
      • Nice、法国、06200
        • Hopital l'Archet 2
      • Pessac、法国、33604
        • CHU Bordeaux - Hôpital Haut-Lévêque
      • Reims、法国、51092
        • Robert Debre Hospital
      • Saint-Priest-en-Jarez、法国、42270
        • CHU de Saint Etienne Hopital Nord
      • Vandœuvre-lès-Nancy、法国、54500
        • CHRU Nancy Brabois - Hôpital d'Enfants
    • Bas Rhin
      • Strasbourg、Bas Rhin、法国、67098
        • Hopital de Hautepierre - Service d'Hépatogastroentérolgie
    • Cedex 10
      • Paris、Cedex 10、法国、75475
        • Hôpital Saint-Louis
    • Nord
      • Lille、Nord、法国、59037
        • CHU Lille - Hôpital Claude Huriez
    • Paris
      • Clichy、Paris、法国、92110
        • Hopital Beaujon
    • Pyrénées-Atlantiques
      • Pau、Pyrénées-Atlantiques、法国、64046
        • Centre Hospitalier de Pau
    • Rhone
      • Pierre-Bénite、Rhone、法国、69495
        • Hospices Civils de Lyon - Centre Hospitalier Lyon Sud -
    • Somme
      • Amiens、Somme、法国、80480
        • CHU Amiens Picardie-Site Sud - RDC Service Hépato gastro
      • Katowice、波兰、40-660
        • All-Medicus
      • Olsztyn、波兰、10-561
        • Wojewodzki Specjalistyczny Szpital w Olsztynie
      • Szczecin、波兰、71-434
        • Twoja Przychodnia - Szczecinskie Centrum Medyczne
      • Torun、波兰、87-100
        • Gastromed Kopoń Zmudziński I Wspólnicy Spółka Jawna Specjalistyczne Centrum Gastrologii I Endoskopii
      • Warsaw、波兰、00-728
        • Warsaw IBD Point Profesor Kierkus
      • Warsaw、波兰、00635
        • Centrum Zdrowia MDM
      • Warsaw、波兰、01-697
        • Centrum Medyczne NeuroProtect
      • Wroclaw、波兰、52-210
        • PlanetMed Sp.z o.o.
      • Zamość、波兰、22-400
        • ETG Zamość
    • Kuyavian-Pomeranian Voivodeship
      • Bydgoszcz、Kuyavian-Pomeranian Voivodeship、波兰、85-168
        • Szpital Uniwersytecki Nr 2 im. dr J. Biziela w Bydgoszczy
    • Lesser Poland Voivodeship
      • Krakow、Lesser Poland Voivodeship、波兰、31-506
        • Topolowa Medicenter
      • Nowy Targ、Lesser Poland Voivodeship、波兰、34-400
        • Medicenter Nowy Targ
      • Wadowice、Lesser Poland Voivodeship、波兰、34-100
        • NZOZ Formed
    • Lower Silesian Voivodeship
      • Wroclaw、Lower Silesian Voivodeship、波兰、53-114
        • LexMedica
    • Lublin Voivodeship
      • Lublin、Lublin Voivodeship、波兰、20-954
        • Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
      • Lublin、Lublin Voivodeship、波兰、20-582
        • ZOZ Gastromed
    • Masovian Voivodeship
      • Warsaw、Masovian Voivodeship、波兰、03-580
        • NZOZ Vivamed
    • Silesian Voivodeship
      • Będzin、Silesian Voivodeship、波兰、42-500
        • Promedica Dental Clinic
    • West Pomeranian Voivodeship
      • Szczecin、West Pomeranian Voivodeship、波兰、71-685
        • SONOMED Centrum Medyczne
    • Świętokrzyskie Voivodeship
      • Straszów、Świętokrzyskie Voivodeship、波兰、28-200
        • KO-Med Centrum Medyczne
    • Essex
      • Harlow、Essex、澳大利亚、CM20 1QX
        • Princess Alexandra Hospital
    • Queensland
      • Maroochydore、Queensland、澳大利亚、4558
        • Coastal Digestive Health
      • South Brisbane、Queensland、澳大利亚、4101
        • Mater University Hospital
    • South Australia
      • Adelaide、South Australia、澳大利亚、5000
        • Royal Adelaide Hospital
    • Victoria
      • Box Hill、Victoria、澳大利亚、3128
        • Box Hill Hospital Outpatients
      • Malvern、Victoria、澳大利亚、3144
        • Melbourne Gastrointestinal Investigation Unit (MGIU)
      • Melbourne、Victoria、澳大利亚、3004
        • The Alfred Hospital
      • Parkville、Victoria、澳大利亚、3050
        • The Royal Melbourne Hospital
      • Dublin、爱尔兰、D9
        • Beaumont Hospital, Dublin
      • Bern、瑞士、3010
        • Inselspital Bern
      • Sankt Gallen、瑞士、9007
        • Kantonsspital St.Gallen
      • Zurich、瑞士、8091
        • Universitätsspital Zürich
    • Canton of Bern
      • Bern、Canton of Bern、瑞士、3012
        • Gastroenterologische Praxis Balsiger, Seibold & Partner
      • Kaunas、立陶宛、50009
        • Hospital of Lithuanian University of Health Sciences Kaunas
      • Klaipėda、立陶宛、92288
        • Klaipeda Seamen's Hospital
      • Klaipėda、立陶宛、92231
        • Republic Hospital of Klaipeda
      • Vilnius、立陶宛、LT-08661
        • Vilnius University Hospital Santariskiu Clinics
    • Panevėžys
      • Panevezys、Panevėžys、立陶宛、LT-35144
        • Respublikine Panevezio ligonine
      • Bucharest、罗马尼亚、022328
        • Institutul Clinic Fundeni
      • Bucharest、罗马尼亚、020125
        • Spitalul Clinic Colentina
      • Bucharest、罗马尼亚、010719
        • MedLife Grivita
      • Bucharest、罗马尼亚、031864
        • Hifu Terramed Conformal SRL
      • Oradea、罗马尼亚、410469
        • Spital Pelican Oradea
    • Bucharest
      • Bucharest、Bucharest、罗马尼亚、030463
        • CCBR Clinical Research
    • Alabama
      • Dothan、Alabama、美国、36305
        • Digestive Health Specialists Of The Southeast
    • Arizona
      • Litchfield Park、Arizona、美国、85340
        • Dcr-Pi, Pc
      • Phoenix、Arizona、美国、85008
        • Maricopa Integrated Health System
      • Tempe、Arizona、美国、85284
        • Physicians Research Group
    • California
      • Arcadia、California、美国、91006
        • Valley Gastroenterology
      • Berkeley、California、美国、94705
        • Care Access Research
      • Lancaster、California、美国、93534
        • Om Research, LLC
      • Northridge、California、美国、91324
        • California Medical Research Associates
      • San Diego、California、美国、92103
        • Clinical Applications Laboratories, Inc.
      • San Francisco、California、美国、94158
        • UCSF Medical Center at Mission Bay
    • Florida
      • Hialeah、Florida、美国、33012
        • Direct Helpers Research Center
      • Inverness、Florida、美国、34452
        • Nature Coast Clinical Research, LLC
      • Kissimmee、Florida、美国、34741
        • SIH Research, LLC
      • Miami、Florida、美国、33134
        • Research Associates of South Florida, LLC
      • Miami Lakes、Florida、美国、33016
        • Wellness Clinical Research
      • Orlando、Florida、美国、32818
        • Clintheory Healthcare
      • Orlando、Florida、美国、32803
        • Center for Interventional Endoscopy
      • Pensacola、Florida、美国、32503
        • Gastroenterology Associates of Pensacola, PA
      • Zephyrhills、Florida、美国、33542-7505
        • Florida Medical Clinic LLC
    • Georgia
      • Atlanta、Georgia、美国、30309
        • Digestive Healthcare of Georgia
    • Idaho
      • Idaho Falls、Idaho、美国、83404
        • Grand Teton Research Group
    • Illinois
      • Evanston、Illinois、美国、60201
        • Northshore University Healthsystem
    • Indiana
      • Indianapolis、Indiana、美国、46202
        • Indiana University School of Medicine
    • Kansas
      • Topeka、Kansas、美国、66606
        • Cotton-O'Neil Clinical Research Center, Digestive Health
    • Louisiana
      • Baton Rouge、Louisiana、美国、70809
        • Texas Digestive Disease Consultants
      • Monroe、Louisiana、美国、71201
        • Delta Research Partners LLC
      • New Orleans、Louisiana、美国、70125
        • Nola Research Works, LLC
    • Michigan
      • Chesterfield、Michigan、美国、48047
        • Clinical Research Institute of Michigan, LLC
      • Novi、Michigan、美国、48377
        • Henry Ford Health System
      • Wyoming、Michigan、美国、49519
        • Gastroenterology Associates of Western Michigan, P.L.C.
      • Ypsilanti、Michigan、美国、48197
        • Huron Gastroenterology Associates
    • Minnesota
      • Plymouth、Minnesota、美国、55446
        • MNGI Digestive Health - Plymouth Endoscopy Center & Clinic
    • Mississippi
      • Jackson、Mississippi、美国、39206
        • Care Access Research LLC
      • Tupelo、Mississippi、美国、38801
        • Digestive Health Specialists
    • New York
      • Great Neck、New York、美国、11021
        • Northwell Health
      • New York、New York、美国、10021
        • Weill Cornell Medical College
    • North Carolina
      • Chapel Hill、North Carolina、美国、27599
        • University of North Carolina Center for Inflammatory Bowel Disease
      • Greenville、North Carolina、美国、27834
        • Carolina Digestive Diseases and Endoscopy Center
    • Ohio
      • Middleburg Heights、Ohio、美国、44130
        • Paramount Medical Research
      • Poland、Ohio、美国、44514
        • Care Access - Youngstown
    • Oklahoma
      • Norman、Oklahoma、美国、73071
        • Central Sooner Research
      • Oklahoma City、Oklahoma、美国、73104
        • University of Oklahoma Health Sciences Center
    • Pennsylvania
      • Wyomissing、Pennsylvania、美国、19610
        • Digestive Disease Associates
    • South Dakota
      • Sioux Falls、South Dakota、美国、57108
        • Midwest Medical Care
    • Tennessee
      • Germantown、Tennessee、美国、38138
        • Gastro One
      • Hixson、Tennessee、美国、37343
        • Galen Medical Group
    • Texas
      • Garland、Texas、美国、75044
        • Digestive Health Associates of Texas
      • Houston、Texas、美国、77043
        • Biopharma Informatic, LLC
      • Houston、Texas、美国、77030
        • Houston Methodist Research Ins
      • San Antonio、Texas、美国、78229
        • Southern Star Research Institute, LLC
      • San Antonio、Texas、美国、78229
        • Gastroenterology Research of San Antonio
      • Southlake、Texas、美国、76092
        • Texas Digestive Disease Consultants
    • Utah
      • Ogden、Utah、美国、84403
        • Care Access Research LLC - Salt Lake City
    • Virginia
      • Leesburg、Virginia、美国、20176
        • Emeritas Research Group
      • Reston、Virginia、美国、20191
        • The Gastroenterology Group, P.C.
      • Roanoke、Virginia、美国、24016
        • Carilion Clinic
    • Wisconsin
      • Milwaukee、Wisconsin、美国、53215
        • Wisconsin Center for Advanced Research
    • Essex
      • Romford、Essex、英国、RM7 0AG
        • Queens Hospital
    • Great Britain
      • Bury、Great Britain、英国、BL9 7TD
        • Fairfield General Hospital
    • London
      • Great Maze Pond、London、英国、SE1 9RT
        • St Thomas' Hospital
    • Surrey
      • London、Surrey、英国、E11 1NR
        • Whipps Cross University Hospital
    • Swansea [Abertawe Gb-ata]
      • Swansea、Swansea [Abertawe Gb-ata]、英国、SA6 6SG
        • Morriston Hospital
    • Vinnytsia
      • Leeds、Vinnytsia、英国、LS9 7TF
        • St James's University Hospital
      • Uden、荷兰、5406 PT
        • Bernhoven Ziekenhuis
      • Utrecht、荷兰、3584 CX
        • UMC Utrecht, Dept. of Internal Medicine, MDL
    • North Brabant
      • Tilburg、North Brabant、荷兰、5022 GC
        • St Elisabeth Ziekenhuis
    • North Holland
      • Amsterdam、North Holland、荷兰、1105 AZ
        • Amsterdam UMC, Locatie AMC
      • A Coruña、西班牙、15006
        • Complexo Hospitalario Universitario A Coruña, CHUAC
      • Alicante、西班牙、3004
        • Instituto de Ciencias Médicas
      • Girona、西班牙、17007
        • Hospital Universitari de Girona
      • Huelva、西班牙、21005
        • Hospital Universitario Juan Ramón Jiménez
      • Las Palmas de Gran Canaria、西班牙、35010
        • Hospital de Gran Canaria Dr. Negrín
      • Madrid、西班牙、28046
        • Hospital Universitario La Paz
      • Oviedo、西班牙、3306
        • Hospital Universitario Central de Asturias
    • Andalusia
      • Seville、Andalusia、西班牙、41013
        • Hospital Universitario Virgen del Rocío
    • Baleares Islands
      • Palma de Mallorca、Baleares Islands、西班牙、07120
        • Hospital Universitari Son Espases
    • Cantabria
      • Santander、Cantabria、西班牙、39008
        • Hospital Universitario Marqués de Valdecilla
    • Madrid
      • Fuenlabrada、Madrid、西班牙、28942
        • Hospital De Fuenlabrada
    • Valencia
      • Sagunto、Valencia、西班牙、46520
        • Hospital Gen. Juan Ramon Jimenez - Depto de Digestivo
      • Córdoba、阿根廷、X5016KEH
        • Hospital Privado Centro Medico de Cordoba SA
    • Buenos Aires
      • CABA、Buenos Aires、阿根廷、C1027AAP
        • Centro de Investigaciones Metabolicas (CINME)
      • Ciudad Autonoma de Buenos Air、Buenos Aires、阿根廷、C1128AAF
        • Mautalen Salud e Investigacion-Centro de Osteopatías Médicas
      • Quilmes、Buenos Aires、阿根廷、B1878DVC
        • Cer Instituto Medico
    • Santa Fe Province
      • Rosario、Santa Fe Province、阿根廷、S2000DEJ
        • Fundacion de Estudios Clinicos
    • Tucumán Province
      • SAN M. de Tucuman、Tucumán Province、阿根廷、T4000AXL
        • Centro de Investigaciones Médicas Tucuman
      • San Miguel de Tucumán、Tucumán Province、阿根廷、4000
        • C.I.C.E. 9 de Julio
      • Busan、韩国、48108
        • Inje University Haeundae Paik Hospital
      • Daegu、韩国、42415
        • Yeungnam Univeristy Medical Center
    • Gangwon-do
      • Wŏnju、Gangwon-do、韩国、26426
        • Severance Hospital, Yonsei University Health System
    • Korea
      • Seoul、Korea、韩国、02447
        • Kyung Hee University Hospital
    • Pusan-Kwangyǒkshi
      • Busan、Pusan-Kwangyǒkshi、韩国、49201
        • Dong-A University Hospital
    • Seoul-teukbyeolsi [Seoul]
      • Seoul、Seoul-teukbyeolsi [Seoul]、韩国、06351
        • Samsung Medical Center
      • Seoul、Seoul-teukbyeolsi [Seoul]、韩国、05505
        • Asan Medical Center
      • Seoul、Seoul-teukbyeolsi [Seoul]、韩国、03181
        • Kangbuk Samsung Hospital
    • Taejǒn-Kwangyǒkshi
      • Daejeon、Taejǒn-Kwangyǒkshi、韩国、34943
        • The Catholic University of Korea, Daejeon ST. Mary's Hospital
    • Kelantan
      • Kubang Kerian、Kelantan、马来西亚、16150
        • Universiti Sains Malaysia
    • Kuala Lumpur
      • Lembah Pantai、Kuala Lumpur、马来西亚、59100
        • University Malaya Medical Centre
    • Selangor
      • Ampang、Selangor、马来西亚、68000
        • Hospital Ampang

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

14年 至 76年 (成人、年长者)

接受健康志愿者

不

描述

纳入标准:

  • 已完成研究 AMAN (NCT03518086),至少服用 1 种研究药物并且没有提前终止研究药物。
  • 愿意并能够完成预定的研究评估,包括内窥镜检查和每日日记输入。
  • 如果是女性,必须符合避孕要求。

排除标准:

  • 在诱导研究 AMAN (NCT03518086) 期间被诊断患有克罗恩病或未分类炎症性肠病(不确定性结肠炎)的参与者。
  • 在之前的诱导研究 AMAN (NCT03518086) 期间接受过肠切除术或其他治疗 UC 手术的参与者,或者在研究 AMBG 期间可能需要手术治疗 UC 的参与者。
  • 有结肠发育不良证据或在研究 AMAN (NCT03518086) 期间被诊断患有胃肠道癌症的参与者。
  • 在诱导研究 AMAN (NCT03518086) 期间被诊断患有临床重要感染的参与者,包括但不限于乙型肝炎、丙型肝炎、HIV/AIDS 和活动性结核病 (TB)。
  • 在入门研究 AMAN (NCT03518086) 期间开始使用新的禁用药物的参与者。
  • 在开始 AMBG 之前出现某些实验室异常的参与者需要永久停用研究药物。

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:非随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
安慰剂比较:维持期:Miri Induction Responder (IR) - 安慰剂 (PBO) 皮下注射 (SC)
在诱导研究 (LUCENT-1) 的第 12 周对盲法 mirikizumab (miri) 有反应的参与者随机退出 mirikizumab 并从维持研究 (LUCENT-2) 的第 0 周开始每 4 周 (Q4W) 接受一次 PBO SC 直到第40 或直到确认失去反应。
施行 SC
实验性的:保养期:Miri IR - 200 毫克 (mg) Miri SC
在诱导研究 (LUCENT-1) 的第 12 周对盲法米利珠单抗有反应的参与者被随机分配到从 LUCENT-2 的第 0 周开始连续接受 200 mg 米利珠单抗 SC Q4W 直到第 40 周或直到确认失去反应。
施行 SC
其他名称:
  • LY3074828
实验性的: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.
施行 SC
实验性的: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.
施行 SC
实验性的: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.
施行 SC
其他名称:
  • LY3074828
实验性的: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.
管理IV
其他名称:
  • LY3074828
施行 SC
实验性的: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.
管理IV
其他名称:
  • LY3074828
实验性的: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.
管理IV
其他名称:
  • LY3074828
实验性的: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.
管理IV
其他名称:
  • LY3074828
实验性的: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.
管理IV
其他名称:
  • LY3074828
实验性的: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).
施行 SC
其他名称:
  • LY3074828
实验性的: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).
施行 SC
其他名称:
  • LY3074828

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Percentage of Participants in Clinical Remission at Week 40 (Mirikizumab Induction Responders)
大体时间: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

次要结果测量

结果测量
措施说明
大体时间
药代动力学 (PK):Mirikizumab 的清除率
大体时间:给药前:第 0、4、12、24 和 40 周
评估了 mirikizumab 的清除率。
给药前:第 0、4、12、24 和 40 周
Percentage of Participants in Endoscopic Remission at Week 40 (Mirikizumab Induction Responders)
大体时间: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)
大体时间: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)
大体时间: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)
大体时间: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)
大体时间: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)
大体时间: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)
大体时间: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)
大体时间: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)
大体时间:Week 40
Percentage of participants hospitalized for UC. Only hospitalizations associated with an adverse event with >=24 hours stay were recorded.
Week 40

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 研究主任: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

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2018年10月19日

初级完成 (实际的)

2021年11月3日

研究完成 (实际的)

2025年2月17日

研究注册日期

首次提交

2018年5月10日

首先提交符合 QC 标准的

2018年5月10日

首次发布 (实际的)

2018年5月14日

研究记录更新

最后更新发布 (实际的)

2026年5月13日

上次提交的符合 QC 标准的更新

2026年5月12日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

在批准研究计划和签署数据共享协议后,将在安全访问环境中提供匿名的个人患者级别数据。

IPD 共享时间框架

数据在美国和欧盟研究的适应症首次公布和批准后 6 个月提供,以较晚者为准。 数据将无限期地可供请求。

IPD 共享访问标准

研究提案必须得到独立审查小组的批准,研究人员必须签署数据共享协议。

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅