중등도 내지 중증 활동성 궤양성 대장염 환자를 대상으로 한 Mirikizumab의 유지 연구 (LUCENT 2)
2026년 5월 12일 업데이트: Eli Lilly and Company
중등도에서 중증의 활동성 궤양성 대장염 환자를 대상으로 한 미리키주맙의 제3상, 다기관, 무작위, 이중맹검, 평행군, 위약 대조 유지 연구(LUCENT 2)
이 연구의 목적은 이전 12주 유도 연구 LUCENT-1(NCT03518086)에서 임상 반응자로 완료된 참가자를 대상으로 유지 요법으로서 mirikizumab의 효능과 안전성을 평가하는 것입니다.
연구 개요
연구 유형
중재적
등록 (실제)
1328
단계
- 3단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
-
-
-
Uden, 네덜란드, 5406 PT
- Bernhoven Ziekenhuis
-
Utrecht, 네덜란드, 3584 CX
- UMC Utrecht, Dept. of Internal Medicine, MDL
-
-
North Brabant
-
Tilburg, North Brabant, 네덜란드, 5022 GC
- St Elisabeth Ziekenhuis
-
-
North Holland
-
Amsterdam, North Holland, 네덜란드, 1105 AZ
- Amsterdam UMC, locatie AMC
-
-
-
-
-
Taichung, 대만, 40447
- China Medical University Hospital
-
Taipei, 대만, 10002
- Health management center
-
-
-
-
-
Busan, 대한민국, 48108
- Inje University Haeundae Paik Hospital
-
Daegu, 대한민국, 42415
- Yeungnam Univeristy Medical Center
-
-
Gangwon-do
-
Wŏnju, Gangwon-do, 대한민국, 26426
- Severance Hospital, Yonsei University Health System
-
-
Korea
-
Seoul, Korea, 대한민국, 02447
- Kyung Hee University Hospital
-
-
Pusan-Kwangyǒkshi
-
Busan, Pusan-Kwangyǒkshi, 대한민국, 49201
- Dong-A University Hospital
-
-
Seoul-teukbyeolsi [Seoul]
-
Seoul, Seoul-teukbyeolsi [Seoul], 대한민국, 06351
- Samsung Medical Center
-
Seoul, Seoul-teukbyeolsi [Seoul], 대한민국, 05505
- Asan Medical Center
-
Seoul, Seoul-teukbyeolsi [Seoul], 대한민국, 03181
- Kangbuk Samsung Hospital
-
-
Taejǒn-Kwangyǒkshi
-
Daejeon, Taejǒn-Kwangyǒkshi, 대한민국, 34943
- The Catholic University of Korea, Daejeon ST. Mary's Hospital
-
-
-
-
-
Herlev, 덴마크, 2730
- Herlev and Gentofte Hospital
-
Køge, 덴마크, 4600
- Zealand University Hospital Køge
-
-
-
-
-
Berlin, 독일, 14163
- Krankenhaus Waldfriede
-
Berlin, 독일, 12203
- Charité Campus Virchow-Klinikum
-
Brandenburg, 독일, 14770
- Städtisches Klinikum Brandenburg
-
Hamburg, 독일, 20251
- HaFCED - Hamburgisches Forschungsinstitut für chronisch entzündliche Darmerkrankungen
-
Weyhe, 독일, 28844
- Internistische Praxisgemeinschaft
-
-
Lower Saxony
-
Hanover, Lower Saxony, 독일, 30625
- Medizinische Hochschule Hanover
-
-
Rhineland-Palatinate
-
Ludwigshafen am Rhein, Rhineland-Palatinate, 독일, 67067
- Gemeinschaftspraxis Dr. Peter Uebel
-
-
Saxony-Anhalt
-
Halle, Saxony-Anhalt, 독일, 06108
- Studiengesellschaft BSF Unternehmergesellschaft
-
Halle, Saxony-Anhalt, 독일, 06120
- Universitätsklinikum Halle
-
-
-
-
-
Riga, 라트비아, 1079
- Digestive Diseases Center "Gastro"
-
Riga, 라트비아, LV-1038
- Riga Eastern Clinical University Hospital
-
-
Riga
-
Riga, Riga, 라트비아, LV-1002
- Pauls Stradins Clinical Univeristy Hospital
-
-
-
-
-
Barnaul, 러시아 제국, 656043
- Multidisciplinary Medical Clinic "Anthurium"
-
Cherepovets, 러시아 제국, 162600
- Medical and Sanitary Division of Severstal
-
Izhevsk, 러시아 제국, 426061
- Alliance Biomedical URAL Group
-
Kaliningrad, 러시아 제국, 236035
- Clinical Trials Center of Medical Institute
-
Kazan', 러시아 제국, 420064
- State Autonomous Institution of Healthcare "Republican Clinical Hospital of the Ministry of Healthcare of Republic Tatarstan
-
Kemerovo, 러시아 제국, 650066
- SIH Kemerovo Regional Clinical Hosptial
-
Moscow, 러시아 제국, 125367
- Medical rehabilitation center
-
Novosibirsk, 러시아 제국, 630005
- LLC "Medicine Center SibNovoMed"
-
Omsk, 러시아 제국, 644024
- Clinical Diagnostic Center Ultramed
-
Saint Petersburg, 러시아 제국, 191104
- City Mariinskaya Hospital
-
Saint Petersburg, 러시아 제국, 195067
- Pokrovskaya Municipal Hospital
-
Saint Petersburg, 러시아 제국, 195271
- Non-state Healthcare Institution "Roadway Clinical Hospital of OJSC Russian Railways
-
Saint Petersburg, 러시아 제국, 197022
- Saint Petersburg State Medical University n.a. Pavlov I.P.
-
Saint Petersburg, 러시아 제국, 197110
- SBIH City Clinical Hospital #31
-
Samara, 러시아 제국, 443001
- Medical Institute REAVIZ
-
Stavropol, 러시아 제국, 355018
- Stavropol State Medical University
-
Yaroslavl, 러시아 제국, 150030
- Yaroslavl Municipal HI Clinical Hospital #8
-
Yekaterinburg, 러시아 제국, 620109
- LLC MA New Hospital
-
-
Irkutsk Oblast
-
Irkutsk, Irkutsk Oblast, 러시아 제국, 664079
- Scientific Centre of Reconstructive and Restorative Surgery
-
-
Kareliya, Respublika
-
Petrozavodsk, Kareliya, Respublika, 러시아 제국, 185019
- Karelia Republican Hospital V.A. Baranova
-
-
Nizhny Novgorod Oblast
-
Nizhny Novgorod, Nizhny Novgorod Oblast, 러시아 제국, 603126
- Nizhny Novgorod Regional Hospital N.A. Semashko
-
Nizhny Novgorod, Nizhny Novgorod Oblast, 러시아 제국, 603140
- Private Healthcare Institution Clinical Hospital Russian Railways - Medicine of Nizhniy Novgorod
-
-
Novosibirsk Oblast
-
Novosibirsk, Novosibirsk Oblast, 러시아 제국, 630007
- Novosibirski Gastrocenter
-
-
Rostov Oblast
-
Rostov-on-Don, Rostov Oblast, 러시아 제국, 344091
- Rostov State Medical University
-
-
Sankt-Peterburg
-
Saint Petersburg, Sankt-Peterburg, 러시아 제국, 196143
- Scientific research center ECO-security
-
-
-
-
-
Bucharest, 루마니아, 022328
- Institutul Clinic Fundeni
-
Bucharest, 루마니아, 020125
- Spitalul Clinic Colentina
-
Bucharest, 루마니아, 010719
- MedLife Grivita
-
Bucharest, 루마니아, 031864
- Hifu Terramed Conformal SRL
-
Oradea, 루마니아, 410469
- Spital Pelican Oradea
-
-
Bucharest
-
Bucharest, Bucharest, 루마니아, 030463
- CCBR Clinical Research
-
-
-
-
-
Kaunas, 리투아니아, 50009
- Hospital of Lithuanian University of Health Sciences Kaunas
-
Klaipėda, 리투아니아, 92288
- Klaipeda Seamen's Hospital
-
Klaipėda, 리투아니아, 92231
- Republic Hospital of Klaipeda
-
Vilnius, 리투아니아, LT-08661
- Vilnius University Hospital Santariskiu Clinics
-
-
Panevėžys
-
Panevezys, Panevėžys, 리투아니아, LT-35144
- Respublikine Panevezio ligonine
-
-
-
-
Kelantan
-
Kubang Kerian, Kelantan, 말레이시아, 16150
- Universiti Sains Malaysia
-
-
Kuala Lumpur
-
Lembah Pantai, Kuala Lumpur, 말레이시아, 59100
- University Malaya Medical Centre
-
-
Selangor
-
Ampang, Selangor, 말레이시아, 68000
- Hospital Ampang
-
-
-
-
-
Chihuahua City, 멕시코, 31203
- Scientia Investigacion Clinica S.C.
-
Veracruz, 멕시코, 91900
- Sociedad de Metabolismo y Corazon
-
-
Jalisco
-
Zapopan, Jalisco, 멕시코, 45030
- Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V.
-
-
Mexico City
-
Mexico City, Mexico City, 멕시코, 07020
- Centro de Investigación Clínica Acelerada
-
-
Sinaloa
-
Culiacán, Sinaloa, 멕시코, 80230
- Centro Para el Desarrollo de la Medicina y de Asistencia Medica S.C
-
-
-
-
Alabama
-
Dothan, Alabama, 미국, 36305
- Digestive Health Specialists of the Southeast
-
-
Arizona
-
Litchfield Park, Arizona, 미국, 85340
- Dcr-Pi, Pc
-
Phoenix, Arizona, 미국, 85008
- Maricopa Integrated Health System
-
Tempe, Arizona, 미국, 85284
- Physicians Research Group
-
-
California
-
Arcadia, California, 미국, 91006
- Valley Gastroenterology
-
Berkeley, California, 미국, 94705
- Care Access Research
-
Lancaster, California, 미국, 93534
- Om Research, LLC
-
Northridge, California, 미국, 91324
- California Medical Research Associates
-
San Diego, California, 미국, 92103
- Clinical Applications Laboratories, Inc.
-
San Francisco, California, 미국, 94158
- UCSF Medical Center at Mission Bay
-
-
Florida
-
Hialeah, Florida, 미국, 33012
- Direct Helpers Research Center
-
Inverness, Florida, 미국, 34452
- Nature Coast Clinical Research, LLC
-
Kissimmee, Florida, 미국, 34741
- SIH Research, LLC
-
Miami, Florida, 미국, 33134
- Research Associates of South Florida, LLC
-
Miami Lakes, Florida, 미국, 33016
- Wellness Clinical Research
-
Orlando, Florida, 미국, 32818
- Clintheory Healthcare
-
Orlando, Florida, 미국, 32803
- Center for Interventional Endoscopy
-
Pensacola, Florida, 미국, 32503
- Gastroenterology Associates of Pensacola, PA
-
Zephyrhills, Florida, 미국, 33542-7505
- Florida Medical Clinic LLC
-
-
Georgia
-
Atlanta, Georgia, 미국, 30309
- Digestive Healthcare of Georgia
-
-
Idaho
-
Idaho Falls, Idaho, 미국, 83404
- Grand Teton Research Group
-
-
Illinois
-
Evanston, Illinois, 미국, 60201
- NorthShore University HealthSystem
-
-
Indiana
-
Indianapolis, Indiana, 미국, 46202
- Indiana University School of Medicine
-
-
Kansas
-
Topeka, Kansas, 미국, 66606
- Cotton-O'Neil Clinical Research Center, Digestive Health
-
-
Louisiana
-
Baton Rouge, Louisiana, 미국, 70809
- Texas Digestive Disease Consultants
-
Monroe, Louisiana, 미국, 71201
- Delta Research Partners LLC
-
New Orleans, Louisiana, 미국, 70125
- Nola Research Works, LLC
-
-
Michigan
-
Chesterfield, Michigan, 미국, 48047
- Clinical Research Institute of Michigan, LLC
-
Novi, Michigan, 미국, 48377
- Henry Ford Health System
-
Wyoming, Michigan, 미국, 49519
- Gastroenterology Associates of Western Michigan, P.L.C.
-
Ypsilanti, Michigan, 미국, 48197
- Huron Gastroenterology Associates
-
-
Minnesota
-
Plymouth, Minnesota, 미국, 55446
- MNGI Digestive Health - Plymouth Endoscopy Center & Clinic
-
-
Mississippi
-
Jackson, Mississippi, 미국, 39206
- Care Access Research LLC
-
Tupelo, Mississippi, 미국, 38801
- Digestive Health Specialists
-
-
New York
-
Great Neck, New York, 미국, 11021
- Northwell Health
-
New York, New York, 미국, 10021
- Weill Cornell Medical College
-
-
North Carolina
-
Chapel Hill, North Carolina, 미국, 27599
- University of North Carolina Center for Inflammatory Bowel Disease
-
Greenville, North Carolina, 미국, 27834
- Carolina Digestive Diseases and Endoscopy Center
-
-
Ohio
-
Middleburg Heights, Ohio, 미국, 44130
- Paramount Medical Research
-
Poland, Ohio, 미국, 44514
- Care Access - Youngstown
-
-
Oklahoma
-
Norman, Oklahoma, 미국, 73071
- Central Sooner Research
-
Oklahoma City, Oklahoma, 미국, 73104
- University of Oklahoma Health Sciences Center
-
-
Pennsylvania
-
Wyomissing, Pennsylvania, 미국, 19610
- Digestive Disease Associates
-
-
South Dakota
-
Sioux Falls, South Dakota, 미국, 57108
- Midwest Medical Care
-
-
Tennessee
-
Germantown, Tennessee, 미국, 38138
- Gastro One
-
Hixson, Tennessee, 미국, 37343
- Galen Medical Group
-
-
Texas
-
Garland, Texas, 미국, 75044
- Digestive Health Associates of Texas
-
Houston, Texas, 미국, 77043
- Biopharma Informatic, LLC
-
Houston, Texas, 미국, 77030
- Houston Methodist Research Ins
-
San Antonio, Texas, 미국, 78229
- Southern Star Research Institute, LLC
-
San Antonio, Texas, 미국, 78229
- Gastroenterology Research of San Antonio
-
Southlake, Texas, 미국, 76092
- Texas Digestive Disease Consultants
-
-
Utah
-
Ogden, Utah, 미국, 84403
- Care Access Research LLC - Salt Lake City
-
-
Virginia
-
Leesburg, Virginia, 미국, 20176
- Emeritas Research Group
-
Reston, Virginia, 미국, 20191
- The Gastroenterology Group, P.C.
-
Roanoke, Virginia, 미국, 24016
- Carilion Clinic
-
-
Wisconsin
-
Milwaukee, Wisconsin, 미국, 53215
- Wisconsin Center for Advanced Research
-
-
-
-
-
Brasschaat, 벨기에, 2930
- AZ KLINA
-
Leuven, 벨기에, 3000
- Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
-
-
Oost-Vlaanderen
-
Ghent, Oost-Vlaanderen, 벨기에, 9000
- Universitair Ziekenhuis Gent
-
-
Wallonne, Région
-
Tournai, Wallonne, Région, 벨기에, 7500
- Centre Hospitalier de Wallonie Picarde - Site Notre Dame
-
-
-
-
-
Kragujevac, 세르비아, 34000
- Clinical Center Kragujevac Gastroenterohepatology Clinic
-
-
Beograd
-
Belgrade, Beograd, 세르비아, 11000
- Clinical Hospital Center Zvezdara
-
-
NAP
-
Belgrade, NAP, 세르비아, 11080
- University Medical Center "Bezanijska kosa"
-
-
Vojvodina
-
Sombor, Vojvodina, 세르비아, 25000
- Regional Hospital Dr Radivoj Simonovic Sombor
-
Sremska Mitrovica, Vojvodina, 세르비아, 22000
- Sremska Mitrovica Health Centre
-
Zrenjanin, Vojvodina, 세르비아, 23000
- General Hospital "Djordje Joanovic"
-
-
-
-
-
Bern, 스위스, 3010
- Inselspital Bern
-
Sankt Gallen, 스위스, 9007
- Kantonsspital St.Gallen
-
Zurich, 스위스, 8091
- UniversitätsSpital Zürich
-
-
Canton of Bern
-
Bern, Canton of Bern, 스위스, 3012
- Gastroenterologische Praxis Balsiger, Seibold & Partner
-
-
-
-
-
A Coruña, 스페인, 15006
- Complexo Hospitalario Universitario A Coruña, CHUAC
-
Alicante, 스페인, 3004
- Instituto de Ciencias Médicas
-
Girona, 스페인, 17007
- Hospital Universitari de Girona
-
Huelva, 스페인, 21005
- Hospital Universitario Juan Ramon Jimenez
-
Las Palmas de Gran Canaria, 스페인, 35010
- Hospital de Gran Canaria Dr. Negrín
-
Madrid, 스페인, 28046
- Hospital Universitario La Paz
-
Oviedo, 스페인, 3306
- Hospital Universitario Central de Asturias
-
-
Andalusia
-
Seville, Andalusia, 스페인, 41013
- Hospital Universitario Virgen del Rocio
-
-
Baleares Islands
-
Palma de Mallorca, Baleares Islands, 스페인, 07120
- Hospital Universitari Son Espases
-
-
Cantabria
-
Santander, Cantabria, 스페인, 39008
- Hospital Universitario Marqués de Valdecilla
-
-
Madrid
-
Fuenlabrada, Madrid, 스페인, 28942
- Hospital De Fuenlabrada
-
-
Valencia
-
Sagunto, Valencia, 스페인, 46520
- Hospital Gen. Juan Ramon Jimenez - Depto de Digestivo
-
-
-
-
-
Banská Bystrica, 슬로바키아, 975 17
- Fakultna nemocnica s poliklinikou Roosevelta Banska Bystrica
-
Bratislava, 슬로바키아, 82007
- Univerzitna nemocnica Bratislava
-
-
Nitra Region
-
Nitra, Nitra Region, 슬로바키아, 949 01
- KM Management
-
-
Presov
-
Prešov, Presov, 슬로바키아, 080 01
- Gastro
-
Vranov N. Toplou, Presov, 슬로바키아, 093 01
- ENDOMED, s.r.o.
-
-
-
-
-
Córdoba, 아르헨티나, X5016KEH
- Hospital Privado Centro Medico de Cordoba SA
-
-
Buenos Aires
-
CABA, Buenos Aires, 아르헨티나, C1027AAP
- Centro de Investigaciones Metabolicas (CINME)
-
Ciudad Autonoma de Buenos Air, Buenos Aires, 아르헨티나, C1128AAF
- Mautalen Salud e Investigacion-Centro de Osteopatías Médicas
-
Quilmes, Buenos Aires, 아르헨티나, B1878DVC
- Cer Instituto Medico
-
-
Santa Fe Province
-
Rosario, Santa Fe Province, 아르헨티나, S2000DEJ
- Fundacion de Estudios Clinicos
-
-
Tucumán Province
-
SAN M. de Tucuman, Tucumán Province, 아르헨티나, T4000AXL
- Centro de Investigaciones Médicas Tucuman
-
San Miguel de Tucumán, Tucumán Province, 아르헨티나, 4000
- C.I.C.E. 9 de Julio
-
-
-
-
-
Dublin, 아일랜드, D9
- Beaumont Hospital, Dublin
-
-
-
-
Essex
-
Romford, Essex, 영국, RM7 0AG
- Queens Hospital
-
-
Great Britain
-
Bury, Great Britain, 영국, BL9 7TD
- Fairfield General Hospital
-
-
London
-
Great Maze Pond, London, 영국, SE1 9RT
- St Thomas' Hospital
-
-
Surrey
-
London, Surrey, 영국, E11 1NR
- Whipps Cross University Hospital
-
-
Swansea [Abertawe Gb-ata]
-
Swansea, Swansea [Abertawe Gb-ata], 영국, SA6 6SG
- Morriston Hospital
-
-
Vinnytsia
-
Leeds, Vinnytsia, 영국, LS9 7TF
- St James's University Hospital
-
-
-
-
-
Innsbruck, 오스트리아, 6020
- Medizinische Universität Innsbruck
-
Salzburg, 오스트리아, 5020
- Universitätsklinikum Salzburg
-
Vienna, 오스트리아, 1090
- Medical University of Vienna
-
-
-
-
-
Kharkiv, 우크라이나, 61039
- GI L.T. Malaya TI Namsu
-
Kharkiv, 우크라이나, 61002
- Kharkiv City Student Hospital
-
Kropyvnytskyi, 우크라이나, 25006
- Treatment-Diagnostic Center of Private Enterprise of PPC Atsynus
-
Kyiv, 우크라이나, 02091
- Kyiv Municipal Clinical Hospital #1
-
Kyiv, 우크라이나, 04107
- Communal institution of the Kyiv Regional Council "Kyiv Regional Clinical Oncology Dispensary"
-
Kyiv, 우크라이나, 04078
- Communal institution of the Kyiv Regional Council "Kyiv Regional Clinical Oncology Dispensary"
-
Odesa, 우크라이나, 65000
- Communal Enterprise "Odesa Regional Clinical Hospital"
-
Uzhhorod, 우크라이나, 88000
- A. Novak Transcarpathian Regional Clinical Hospital
-
Vinnytsia, 우크라이나, 21029
- CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM
-
Vinnytsia, 우크라이나, 21005
- Vinnytsia RCH of Veterans of War Dept of Therapy#1 Vinnytsia M.I.Pyrogov NMU
-
Vinnytsia, 우크라이나, 21009
- MCIC MC LLC Health Clinic
-
Vinnytsia, 우크라이나, 21018
- M.I. Pyrogov Regional Clinical Hospital
-
Zaporizhzhia, 우크라이나, 69104
- Communal Institution of Kyiv Regional Council Kyiv Regional Hospital #2
-
-
Ivano-Frankivsk Oblast
-
Ivano-Frankivsk, Ivano-Frankivsk Oblast, 우크라이나, 76008
- Ivano-Frankivsk Regional Clinical Hospital
-
-
Kharkivs’ka Oblast’
-
Kharkiv, Kharkivs’ka Oblast’, 우크라이나, 61037
- City Clinical Hospital No. 2
-
-
Kherson Oblast
-
Kherson, Kherson Oblast, 우크라이나, 73000
- Kherson City Clinical Hospital
-
-
Kyiv Oblast
-
Kiev, Kyiv Oblast, 우크라이나, 4050
- Medical Center of Limited Liability Company "Medical Center "Consilium Medical"
-
-
Lviv Oblast
-
Lviv, Lviv Oblast, 우크라이나, 79000
- Lviv Railway Clinical Hospital
-
Lviv, Lviv Oblast, 우크라이나, 79000
- Lviv Regional Endocrinology Dispensary
-
Lviv, Lviv Oblast, 우크라이나, 79000
- Municipal non-profit enterprise "Lviv Territorial Medical Union "Multidisciplinary Clinical Hospital of Em -T
-
-
Poltava Oblast
-
Poltava, Poltava Oblast, 우크라이나, 36000
- Poltova Oblast Clinical Hospital IM.M.V.Sklifosovskoho
-
-
Zaporizhzhia Oblast
-
Zaporizhia, Zaporizhzhia Oblast, 우크라이나, 69076
- Diaservis - Medical and Diagnostic Center
-
-
-
-
-
Beersheba, 이스라엘, 8410101
- Soroka Medical Center - Pediatric Outpatient Clinic
-
Nahariya, 이스라엘, 2210001
- Galilee Medical Center Department of Internal Medicine A
-
Rehovot, 이스라엘, 7610001
- Kaplan Medical Center
-
Tel Aviv, 이스라엘, 6423906
- Tel Aviv Sourasky Medical Center
-
Ẕerifin, 이스라엘, 70300
- King Fahad Medical City
-
-
Jerusalem
-
Bait Vagan, Jerusalem, 이스라엘, 91031
- Shaare Zedek Medical Center
-
-
-
-
-
Brescia, 이탈리아, 25123
- Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
-
Catanzaro, 이탈리아, 88100
- Azienda ospedaliero-universitaria Mater Domini
-
Genova, 이탈리아, 16132
- Azienda Ospedaliero Universitaria San Martino
-
Milan, 이탈리아, 20122
- Gastroenterology and Endoscopy Unit IRCCS Ca' Granda Ospedale Maggiore Policlinico Foundation
-
Modena, 이탈리아, 41124
- Azienda Ospedaliera Universitaria Policlinico de Modena
-
Pisa, 이탈리아, 56124
- Azienda Ospedaliera Universitaria Pisana
-
Roma, 이탈리아, 00168
- Policlinico Gemelli - Università Cattolica del Sacro Cuore
-
Torino, 이탈리아, 10128
- Ospedale Mauriziano Umberto I
-
Udine, 이탈리아, 33100
- Azienda Ospedaliero-Universitaria Santa Maria della Misericordia Gastroenterologia
-
-
Milano
-
Rho, Milano, 이탈리아, 20017
- Presidio di Rho
-
Rozzano, Milano, 이탈리아, 20089
- Istituto Clinico Humanitas
-
San Donato Milanese, Milano, 이탈리아, 20097
- Istituti di Ricovero e Cura a Carattere Scientifico Policlinico San Donato Gastroenterologia
-
-
Roma
-
Rome, Roma, 이탈리아, 00157
- Ospedale Sandro Pertini
-
Torre, Roma, 이탈리아, 00133
- Azienda Ospedaliera Universitaria Policlinico Tor Vergata
-
-
-
-
Andhra Pradesh
-
Hyderabad, Andhra Pradesh, 인도, 500058
- Centre for Liver Research & Diagnostics, Deccan College of Medical Sciences, Owaisi Hospital & Research Centre
-
-
Gujarat
-
Gandhinagar, Gujarat, 인도, 382428
- Apollo Research and Innovations, Apollo Hospitals International Ltd
-
Rajkot, Gujarat, 인도, 360005
- Shree Giriraj Multispeciality Hospital
-
Surat, Gujarat, 인도, 395002
- Nirmal Hospital Pvt Ltd.
-
-
Karnataka
-
Bangalore, Karnataka, 인도, 560054
- M S Ramaiah Medical College and Hospitals
-
Bangalore, Karnataka, 인도, 560 002
- Bangalore Medical College and Research Institute
-
-
Maharashtra
-
Nagpur, Maharashtra, 인도, 440010
- Midas Multispeciality Hospital Pvt.Ltd.
-
Pune, Maharashtra, 인도, 411 001
- Poona Medical Foundation. Ruby Hall Clinic
-
Wardha, Maharashtra, 인도, 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, 인도, 110 025
- Escorts Heart Institute and Research Centre Ltd
-
-
Punjab
-
Ludhiana, Punjab, 인도, 141001
- Dayanand Medical College and Hospital
-
-
Rajasthan
-
Jaipur, Rajasthan, 인도, 302001
- SR Kalla Memorial Gastro & General Hospital
-
-
Telangana
-
Hyderabad, Telangana, 인도, 500003
- Gandhi Hospital
-
-
Uttar Pradesh
-
Lucknow, Uttar Pradesh, 인도, 226003
- King George Medical University
-
-
-
-
-
Fukuoka, 일본, 814-0180
- Fukuoka University Hospital
-
Hiroshima, 일본, 734-8551
- Hiroshima University Hospital
-
Kagoshima, 일본, 892-0846
- Sameshima Hospital
-
Kyoto, 일본, 612-8555
- National Hospital Organization Kyoto Medical Center
-
Okayama, 일본, 700-8558
- Okayama University Hospital
-
Saitama, 일본, 336-0963
- Tokitokai Tokito Clinic
-
Toyama, 일본, 930-0975
- Toyama Prefectural Central Hospital
-
-
Aichi-ken
-
Nagakute-shi, Aichi-ken, 일본, 480-1195
- Aichi Medical University Hospital
-
Toyoake, Aichi-ken, 일본, 470-1192
- Fujita Health University
-
-
Aomori
-
Hirosaki, Aomori, 일본, 036-8545
- National Hospital Organization Hirosaki National Hospital
-
-
Chiba
-
Sakura, Chiba, 일본, 285-8741
- Toho University Sakura Medical Center
-
-
Fukoka
-
Kitakyusyu-shi, Fukoka, 일본, 802-0077
- Kitakyushu Municipal Medical Center
-
-
Fukuoka
-
Chikushino-shi, Fukuoka, 일본, 818-8502
- Fukuoka University Chikushi Hospital
-
Kurume-shi, Fukuoka, 일본, 839 0809
- Hidaka Coloproctology Clinic
-
-
Gunma
-
Maebashi, Gunma, 일본, 371-8511
- Gunma University Hospital
-
Takasaki, Gunma, 일본, 370-0829
- National Hospital Organization Takasaki General Medical Centar
-
-
HigaShiibaraki-Gun
-
Ibaraki-machi, HigaShiibaraki-Gun, 일본, 311 3193
- NHO Mito Medical Center
-
-
Hokkaido
-
Asahikawa, Hokkaido, 일본, 070-8610
- Asahikawa City Hospital
-
Sapporo, Hokkaido, 일본, 065-0033
- Sapporo Higashi Tokushukai Hospital
-
Sapporo, Hokkaido, 일본, 004 0041
- Tokushukai Sapporo Tokushukai Hospital
-
Sapporo, Hokkaido, 일본, 060 0033
- Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
-
-
Hyōgo
-
Kobe, Hyōgo, 일본, 650 0015
- Aoyama Clinic GI Endoscopy & IBD Center
-
-
Kagawa-ken
-
Takamatsu, Kagawa-ken, 일본, 760-8557
- Kagawa Prefectural Central Hospital
-
-
Kanagawa
-
Kamakura, Kanagawa, 일본, 247-0056
- Ofuna Central Hospital
-
Kawasaki, Kanagawa, 일본, 210-0013
- Kawasaki Municipal Hospital
-
Yokohama, Kanagawa, 일본, 232-0024
- Yokohama City University Medical Center
-
Yokohama, Kanagawa, 일본, 234-0032
- Showa University Northern Yokohama Hospital
-
Yokohama, Kanagawa, 일본, 226 0025
- Sankikai Yokohama Shin midori General Hospital
-
-
Kumamoto
-
Kumamoto, Kumamoto, 일본, 860-0012
- Kumamoto University Hospital
-
-
Mie-ken
-
Tsu, Mie-ken, 일본, 514-8507
- Mie University Hospital
-
-
Miyagi
-
Sendai, Miyagi, 일본, 981 3213
- Takagi Clinic - Sendai
-
-
Niigata
-
Nagaoka-shi, Niigata, 일본, 940-8653
- Nagaoka Chuo General Hospital
-
-
Oita Prefecture
-
Ōita, Oita Prefecture, 일본, 870 0823
- Ishida Clinic of IBD and Gastroenterology
-
-
Osaka
-
Fujiidera, Osaka, 일본, 583-0027
- Sai Gastroenterologist Proctology
-
Osaka, Osaka, 일본, 530 0011
- Infusion Clinic
-
Osaka, Osaka, 일본, 540 0006
- NHO Osaka National Hospital
-
-
Saga-ken
-
Saga, Saga-ken, 일본, 840-8571
- Saga-Ken Medical Center Koseikan
-
-
Saitama
-
Kumagaya-shi, Saitama, 일본, 360-8567
- Kumagaya General Hospital
-
-
Shizuoka
-
Hamamatsu, Shizuoka, 일본, 4328061
- Matsuda Hospital
-
-
Tochigi
-
Shimotsuke-shi, Tochigi, 일본, 329-0498
- Jichi Medical University Hospital
-
-
Tokyo
-
Bunkyo-ku, Tokyo, 일본, 113-8431
- Juntendo University Hospital
-
Bunkyō, Tokyo, 일본, 113-8519
- Tokyo Medical and Dental University Hospital
-
Koto-ku, Tokyo, 일본, 135 8577
- Showa University Koto Toyosu Hospital
-
Minato-Ku, Tokyo, 일본, 108 8642
- Kitasato University Kitasato Institute Hospital
-
Mitaka, Tokyo, 일본, 181-8611
- Kyorin University Hospital
-
Shinjuku-ku, Tokyo, 일본, 169-0073
- JHCO Tokyo Yamate Medical Center
-
-
Tokyo-To
-
Chiyoda-ku, Tokyo-To, 일본, 101-8643
- Mitsui Memorial Hospital
-
Shinjuku-ku, Tokyo-To, 일본, 162 8655
- Center Hospital of the National Center for Global Health and Medicine
-
-
-
-
-
Wuhan, 중국, 430030
- Tongji Hospital of Tongji University
-
-
Anhui
-
Hefei, Anhui, 중국, 230022
- The First Affiliated Hospital of Anhui Medical University
-
Hefei, Anhui, 중국, 230000
- Anhui Provincial Hospital
-
-
Changsha City
-
Kaifu District, Changsha City, 중국, 410008
- Xiangya Hospital Central South University
-
-
Chongqing Municipality
-
Chongqing, Chongqing Municipality, 중국, 400037
- The Affiliated 2nd Hosp. of Third Military Med. Univ. of PLA
-
Chongqing, Chongqing Municipality, 중국, 400038
- The First Hospital Affiliated to AMU (SOUTHWEST HOSPITAL)
-
-
Guangdong
-
Guangzhou, Guangdong, 중국, 510655
- The Sixth Affiliated Hospital, Sun Yat-sen University
-
-
Hubei
-
Wuhan, Hubei, 중국, 430022
- Union Hospital Tongji Medical College Huazhong University of Science and Technology
-
Wuhan, Hubei, 중국, 430060
- Renmin Hospital of Wuhan University
-
-
Jiangsu
-
Nanjing, Jiangsu, 중국, 210008
- The Affiliated Drum Tower Hospital of Nanjing University
-
Nanjing, Jiangsu, 중국, 210029
- Zhongda Hospital Southeast University
-
Nanjing, Jiangsu, 중국, 211106
- Nanjing Medical University - Nanjing Jiangning Hospital
-
-
Jiangxi
-
Pingxiang, Jiangxi, 중국, 337055
- Jiangxi Pingxiang People's Hospital
-
-
Jilin
-
Jilin, Jilin, 중국, 132011
- Jilin Central General Hospital
-
-
Shandong
-
Jinan, Shandong, 중국, 250021
- Shandong Provincial Hospital
-
Jinan, Shandong, 중국, 250014
- Qilu Hospital of Shandong University
-
Liaocheng, Shandong, 중국, 252000
- Liaocheng People's Hospital
-
Qingdao, Shandong, 중국, 266000
- The Affiliated Hospital of Qingdao University
-
Taian, Shandong, 중국, 271000
- Taian City Central Hospital
-
-
Shanghai Municipality
-
Shanghai, Shanghai Municipality, 중국, 200025
- Shanghai Jiaotong University School of Medicine Ruijin Hospital
-
Shanghai, Shanghai Municipality, 중국, 200127
- Renji Hospital Affliated to Shanghai Jiaotong University
-
-
Sichuan
-
Chengdu, Sichuan, 중국, 610041
- West China Hospital, Sichuan University
-
-
Yunnan
-
Kunming, Yunnan, 중국, 650034
- The First People's Hospital of Yunnan Province
-
Kunming, Yunnan, 중국, 650032
- Kunming Medical College Affiliated First Hospital
-
-
Zhejiang
-
Hangzhou, Zhejiang, 중국, 310016
- Sir Run Run Shaw Hospital
-
Hangzhou, Zhejiang, 중국, 310003
- First Affiliated Hosp of College of Med, Zhejiang University
-
Hangzhou, Zhejiang, 중국, 310000
- The Second Affiliated Hospital of Zhejiang University School of Med
-
Wenzhou, Zhejiang, 중국, 325027
- The Second Affiliated Hospital YuYing Childens Hospital of Wenzhou Medical university
-
-
-
-
-
Brno, 체코, 65691
- Fakultni nemocnice u sv. Anny v Brne
-
Olomouc, 체코, 779
- PreventaMed, s.r.o.
-
Prague, 체코, 19000
- ISCARE Clinical Centre
-
-
Brno-město
-
Brno, Brno-město, 체코, 636 00
- Vojenska nemocnice Brno
-
-
Hl. M. Praha
-
Prague, Hl. M. Praha, 체코, 100 34
- Fakultni nemocnice Kralovske Vinohrady
-
-
Hradec Králové
-
Hradec Králové, Hradec Králové, 체코, 500 12
- Hepato-Gastroenterologie HK
-
-
Olomouc Region
-
Olomouc, Olomouc Region, 체코, 779 00
- MUDr. Gregar, s.r.o.
-
-
Plzeň-město
-
Pilsen, Plzeň-město, 체코, 301 00
- A-Shine
-
-
Praha 8
-
Prague, Praha 8, 체코, 186 00
- MEDIENDO
-
-
-
-
Alberta
-
Edmonton, Alberta, 캐나다, T5R 1W2
- West Edmonton Diabetes Center
-
-
British Columbia
-
Vancouver, British Columbia, 캐나다, V6Z 2K5
- GI Research Institute
-
Vancouver, British Columbia, 캐나다, V5Z 1M9
- The Gordon and Leslie Diamond Health Care Centre
-
Victoria, British Columbia, 캐나다, V8V 3M9
- PerCuro Clinical Research
-
-
Ontario
-
London, Ontario, 캐나다, N6A 4G5
- Victoria Hospital
-
London, Ontario, 캐나다, N6A 5G1
- University of Western Ontario
-
-
Quebec
-
Greenfield Park, Quebec, 캐나다, J4V 2H1
- Centre de santé et de services sociaux Champlain-Charles-Le Moyne
-
Montreal, Quebec, 캐나다, H1T 2M4
- Hopital Maisonneure-Rosemount
-
Montreal, Quebec, 캐나다, H3G 1A4
- Inflammatory Bowel Disease Centre Montreal General Hospital - MUHC
-
-
-
-
Antalya
-
Kocaeli, Antalya, 터키 (Türkiye), 7100
- Antalya Egitim ve Arastırma Hastanesi
-
-
Istanbul
-
Kadıköy, Istanbul, 터키 (Türkiye), 34734
- Acibadem Universitesi - Acibadem Kozyatagi Hastanesi
-
-
Kocaeli
-
İzmit, Kocaeli, 터키 (Türkiye), 41380
- Kocaeli University Medical Faculty Hospital
-
-
Mersin
-
Yenişehir, Mersin, 터키 (Türkiye), 33110
- Mersin University Medical Faculty
-
-
Turkey
-
Izmir, Turkey, 터키 (Türkiye), 35100
- Ege Universitesi Hastanesi
-
-
-
-
-
Katowice, 폴란드, 40-660
- All-Medicus
-
Olsztyn, 폴란드, 10-561
- Wojewodzki Specjalistyczny Szpital w Olsztynie
-
Szczecin, 폴란드, 71-434
- Twoja Przychodnia - Szczecinskie Centrum Medyczne
-
Torun, 폴란드, 87-100
- Gastromed Kopoń Zmudziński I Wspólnicy Spółka Jawna Specjalistyczne Centrum Gastrologii I Endoskopii
-
Warsaw, 폴란드, 00-728
- Warsaw IBD Point Profesor Kierkus
-
Warsaw, 폴란드, 00635
- Centrum Zdrowia MDM
-
Warsaw, 폴란드, 01-697
- Centrum Medyczne NeuroProtect
-
Wroclaw, 폴란드, 52-210
- PlanetMed Sp.z o.o.
-
Zamość, 폴란드, 22-400
- ETG Zamość
-
-
Kuyavian-Pomeranian Voivodeship
-
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 폴란드, 85-168
- Szpital Uniwersytecki nr 2 im. dr J. Biziela w Bydgoszczy
-
-
Lesser Poland Voivodeship
-
Krakow, Lesser Poland Voivodeship, 폴란드, 31-506
- Topolowa Medicenter
-
Nowy Targ, Lesser Poland Voivodeship, 폴란드, 34-400
- Medicenter Nowy Targ
-
Wadowice, Lesser Poland Voivodeship, 폴란드, 34-100
- NZOZ Formed
-
-
Lower Silesian Voivodeship
-
Wroclaw, Lower Silesian Voivodeship, 폴란드, 53-114
- LexMedica
-
-
Lublin Voivodeship
-
Lublin, Lublin Voivodeship, 폴란드, 20-954
- Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
-
Lublin, Lublin Voivodeship, 폴란드, 20-582
- ZOZ Gastromed
-
-
Masovian Voivodeship
-
Warsaw, Masovian Voivodeship, 폴란드, 03-580
- NZOZ Vivamed
-
-
Silesian Voivodeship
-
Będzin, Silesian Voivodeship, 폴란드, 42-500
- Promedica Dental Clinic
-
-
West Pomeranian Voivodeship
-
Szczecin, West Pomeranian Voivodeship, 폴란드, 71-685
- SONOMED Centrum Medyczne
-
-
Świętokrzyskie Voivodeship
-
Straszów, Świętokrzyskie Voivodeship, 폴란드, 28-200
- KO-Med Centrum Medyczne
-
-
-
-
-
Chambray-lès-Tours, 프랑스, 37170
- CHU Tours - Hôpital Trousseau
-
Marseille, 프랑스, 13915
- Assistance Publique Hôpitaux de Marseille - Hôpital Nord
-
Montpellier, 프랑스, 34295
- CHRU de Montpellier-Hopital St Eloi
-
Nice, 프랑스, 06200
- Hopital l'Archet 2
-
Pessac, 프랑스, 33604
- CHU Bordeaux - Hôpital Haut-Lévêque
-
Reims, 프랑스, 51092
- Robert Debre Hospital
-
Saint-Priest-en-Jarez, 프랑스, 42270
- CHU de Saint Etienne Hopital Nord
-
Vandœuvre-lès-Nancy, 프랑스, 54500
- CHRU Nancy Brabois - Hôpital d'Enfants
-
-
Bas Rhin
-
Strasbourg, Bas Rhin, 프랑스, 67098
- Hopital de Hautepierre - Service d'Hépatogastroentérolgie
-
-
Cedex 10
-
Paris, Cedex 10, 프랑스, 75475
- Hôpital Saint-Louis
-
-
Nord
-
Lille, Nord, 프랑스, 59037
- CHU Lille - Hôpital Claude Huriez
-
-
Paris
-
Clichy, Paris, 프랑스, 92110
- Hôpital Beaujon
-
-
Pyrénées-Atlantiques
-
Pau, Pyrénées-Atlantiques, 프랑스, 64046
- Centre Hospitalier de Pau
-
-
Rhone
-
Pierre-Bénite, Rhone, 프랑스, 69495
- Hospices Civils de Lyon - Centre Hospitalier Lyon Sud -
-
-
Somme
-
Amiens, Somme, 프랑스, 80480
- CHU Amiens Picardie-Site Sud - RDC Service Hépato gastro
-
-
-
-
-
Budapest, 헝가리, 1088
- Semmelweis Egyetem
-
Budapest, 헝가리, 1036
- Óbudai Egészségügyi Centrum
-
Debrecen, 헝가리, 4032
- Debreceni Egyetem Klinikai Kozpont
-
Miskolc, 헝가리, 3526
- Endomedix Diagnosztikai Központ - Miskolc
-
Mosonmagyaróvár, 헝가리, 9200
- Karolina Korhaz-Rendelointezet
-
Szeged, 헝가리, 6720
- Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont I. Belgyogyaszati Klinika
-
Szekszárd, 헝가리, 7100
- CLINFAN Szolgáltató Kft
-
-
EU
-
Balatonfüred, EU, 헝가리, 8230
- DRC Gyogyszervizsgalo Kozpont Kft.
-
-
Pest County
-
Vác, Pest County, 헝가리, 2600
- Javorszky Odon Korhaz
-
-
-
-
Essex
-
Harlow, Essex, 호주, CM20 1QX
- Princess Alexandra Hospital
-
-
Queensland
-
Maroochydore, Queensland, 호주, 4558
- Coastal Digestive Health
-
South Brisbane, Queensland, 호주, 4101
- Mater University Hospital
-
-
South Australia
-
Adelaide, South Australia, 호주, 5000
- Royal Adelaide Hospital
-
-
Victoria
-
Box Hill, Victoria, 호주, 3128
- Box Hill Hospital Outpatients
-
Malvern, Victoria, 호주, 3144
- Melbourne Gastrointestinal Investigation Unit (MGIU)
-
Melbourne, Victoria, 호주, 3004
- The Alfred Hospital
-
Parkville, Victoria, 호주, 3050
- The Royal Melbourne Hospital
-
-
참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
14년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
설명
포함 기준:
- 연구 AMAN(NCT03518086)을 완료했으며, 최소 1회의 연구 약물 투여와 연구 약물의 조기 종료 없이 완료했습니다.
- 내시경 검사 및 일일 일지 입력을 포함하여 예정된 연구 평가를 완료할 의지와 능력이 있는 자.
- 여성인 경우 피임 요건을 충족해야 합니다.
제외 기준:
- 유도 연구 AMAN(NCT03518086) 동안 크론병 또는 분류되지 않은 염증성 장 질환(불확정 대장염) 진단을 받은 참가자.
- 이전 유도 연구 AMAN(NCT03518086) 동안 UC 치료를 위해 장 절제 또는 기타 수술을 받았거나 연구 AMBG 동안 UC 치료를 위해 수술이 필요할 가능성이 있는 참가자.
- 결장 이형성증의 증거가 있거나 AMAN 연구(NCT03518086) 동안 위장관 암 진단을 받은 참가자.
- 유도 연구 AMAN(NCT03518086) 동안 B형 간염, C형 간염, HIV/AIDS 및 활동성 결핵(TB)을 포함하되 이에 국한되지 않는 임상적으로 중요한 감염으로 진단된 참가자.
- 유도 연구 AMAN(NCT03518086) 중에 새로운 금지 약물을 시작하는 참가자.
- 연구 약물을 영구적으로 중단해야 하는 AMBG 시작 전에 특정 검사실 이상이 있는 참가자.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
위약 비교기: 유지기간 : 미리유도반응기(IR) - 위약(PBO) 피하주사(SC)
유도 연구(LUCENT-1)에서 12주차에 맹검 mirikizumab(miri)에 반응한 참가자는 무작위로 mirikizumab을 중단하고 유지 연구(LUCENT-2) 0주차부터 다음 주까지 4주마다(Q4W) PBO SC를 받기 시작했습니다. 40 또는 응답 손실이 확인될 때까지.
|
관리 SC
|
|
실험적: 유지 기간: Miri IR - 200 밀리그램(mg) Miri SC
유도 연구(LUCENT-1)에서 12주차에 맹검 미리키주맙에 반응한 참가자는 LUCENT-2의 0주차부터 40주차까지 또는 반응 상실이 확인될 때까지 200mg mirikizumab SC Q4W를 계속 투여하도록 무작위 배정되었습니다.
|
관리 SC
다른 이름들:
|
|
실험적: 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.
|
관리 SC
|
|
실험적: 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.
|
관리 SC
|
|
실험적: 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.
|
관리 SC
다른 이름들:
|
|
실험적: 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.
|
IV 투여
다른 이름들:
관리 SC
|
|
실험적: 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.
|
IV 투여
다른 이름들:
|
|
실험적: 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.
|
IV 투여
다른 이름들:
|
|
실험적: 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.
|
IV 투여
다른 이름들:
|
|
실험적: 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.
|
IV 투여
다른 이름들:
|
|
실험적: 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).
|
관리 SC
다른 이름들:
|
|
실험적: 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).
|
관리 SC
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Percentage of Participants in Clinical Remission at Week 40 (Mirikizumab Induction Responders)
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
약동학(PK): Mirikizumab의 클리어런스
기간: 투여 전: 0주, 4주, 12주, 24주 및 40주
|
Mirikizumab의 청소율을 평가했습니다.
|
투여 전: 0주, 4주, 12주, 24주 및 40주
|
|
Percentage of Participants in Endoscopic Remission at Week 40 (Mirikizumab Induction Responders)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: 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)
기간: Week 40
|
Percentage of participants hospitalized for UC.
Only hospitalizations associated with an adverse event with >=24 hours stay were recorded.
|
Week 40
|
공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 연구 책임자: 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
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Sands BE, D'Haens G, Clemow DB, Irving PM, Johns JT, Gibble TH, Abreu MT, Lee SD, Hisamatsu T, Kobayashi T, Dubinsky MC, Vermeire S, Siegel CA, Peyrin-Biroulet L, Moses RE, Milata J, Panaccione R, Dignass A. Three-Year Efficacy and Safety of Mirikizumab Following 152 Weeks of Continuous Treatment for Ulcerative Colitis: Results From the LUCENT-3 Open-Label Extension Study. Inflamm Bowel Dis. 2025 Jul 7;31(7):1876-1890. doi: 10.1093/ibd/izae253.
- Clemow DB, Dubinsky MC, Baygani SK, Sands BE, Keohane A, Danese S, Schreiber S, Walsh AJ, Hibi T, Gibble TH, Moses RE, Travis SPL. Bowel urgency in ulcerative colitis: effect of baseline urgency and change in urgency in response to mirikizumab. J Patient Rep Outcomes. 2025 Jul 1;9(1):75. doi: 10.1186/s41687-025-00906-0.
- Panaccione R, Chan-Diehl F, Baygani S, Fisher DA, Moses RE, Siegmund B, Walsh A, Kobayashi T, Dulai PS, Travis S. Fecal Calprotectin and C-Reactive Protein Association With Histologic and Endoscopic Endpoints in Mirikizumab-Treated Patients With Ulcerative Colitis. Crohns Colitis 360. 2025 Jun 14;7(2):otaf043. doi: 10.1093/crocol/otaf043. eCollection 2025 Apr.
- Danese S, Dignass A, Matsuoka K, Ferrante M, Long M, Redondo I, Moses R, Maier S, Hunter Gibble T, Morris N, Milch C, Abreu MT. Early and Sustained Symptom Control with Mirikizumab in Patients with Ulcerative Colitis in the Phase 3 LUCENT Programme. J Crohns Colitis. 2024 Nov 4;18(11):1845-1856. doi: 10.1093/ecco-jcc/jjae088.
- Long MD, Schreiber S, Hibi T, Gibble TH, Fisher DA, Park G, Moses RE, Higgins PDR, Lindsay JO, Lee SD, Escobar R, Jairath V. Association of Bowel Urgency With Quality-of-Life Measures in Patients With Moderately-to-Severely Active Ulcerative Colitis: Results From Phase 3 LUCENT-1 (Induction) and LUCENT-2 (Maintenance) Studies. Crohns Colitis 360. 2024 Jan 6;6(1):otae001. doi: 10.1093/crocol/otae001. eCollection 2024 Jan.
- Sands BE, Feagan BG, Hunter Gibble T, Traxler KA, Morris N, Eastman WJ, Schreiber S, Jairath V, Long MD, Armuzzi A. Mirikizumab Improves Quality of Life in Patients With Moderately-to-Severely Active Ulcerative Colitis: Results From the Phase 3 LUCENT-1 Induction and LUCENT-2 Maintenance Studies. Crohns Colitis 360. 2023 Nov 7;5(4):otad070. doi: 10.1093/crocol/otad070. eCollection 2023 Oct.
- Chua L, Friedrich S, Zhang XC. Mirikizumab Pharmacokinetics in Patients with Moderately to Severely Active Ulcerative Colitis: Results from Phase III LUCENT Studies. Clin Pharmacokinet. 2023 Oct;62(10):1479-1491. doi: 10.1007/s40262-023-01281-z. Epub 2023 Aug 23.
- D'Haens G, Dubinsky M, Kobayashi T, Irving PM, Howaldt S, Pokrotnieks J, Krueger K, Laskowski J, Li X, Lissoos T, Milata J, Morris N, Arora V, Milch C, Sandborn W, Sands BE; LUCENT Study Group. Mirikizumab as Induction and Maintenance Therapy for Ulcerative Colitis. N Engl J Med. 2023 Jun 29;388(26):2444-2455. doi: 10.1056/NEJMoa2207940.
- Magro F, Pai RK, Kobayashi T, Jairath V, Rieder F, Redondo I, Lissoos T, Morris N, Shan M, Park M, Peyrin-Biroulet L. Resolving Histological Inflammation in Ulcerative Colitis With Mirikizumab in the LUCENT Induction and Maintenance Trial Programmes. J Crohns Colitis. 2023 Oct 20;17(9):1457-1470. doi: 10.1093/ecco-jcc/jjad050.
- Lee SD, Ehrlich AC, Pellanda P, Kaiser C, Todd K, Moses R, Walsh A. Long-Term Safety of Mirikizumab in Patients With Moderately to Severely Active Ulcerative Colitis: An Integrated 2-Year Safety Analysis. Am J Gastroenterol. 2025 Dec 1;120(12):2857-2866. doi: 10.14309/ajg.0000000000003407. Epub 2025 Mar 12.
- Hart A, Navabi S, D'Haens G, Matsuoka K, Martin-Arranz MD, Atreya R, Samaan KH, Dhesi E, Redondo I, Zhu B, Paulissen J, Zaremba-Pechmann L, Baygani S, Limdi J, Laharie D, Danese S. Effect of Mirikizumab on Clinical and Endoscopic Outcomes Based on Prior Advanced Therapy Failure in Patients With Moderately to Severely Active Ulcerative Colitis. United European Gastroenterol J. 2026 May;14(4):e70214. doi: 10.1002/ueg2.70214.
- Ran Z, Chen Y, Miao Y, Wang Y, Gao X, Zhong J, Ding X, Wang C, Zhang X, Ding Y, Hu N, Tang D, Yu J, Qian C, Shen J. Mirikizumab as Induction and Maintenance Therapy in Chinese Patients with Ulcerative Colitis: A Subpopulation Analysis of the Randomized, Global Phase 3 LUCENT-1 and LUCENT-2 Trials. BioDrugs. 2026 May 12. doi: 10.1007/s40259-026-00776-y. Online ahead of print.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2018년 10월 19일
기본 완료 (실제)
2021년 11월 3일
연구 완료 (실제)
2025년 2월 17일
연구 등록 날짜
최초 제출
2018년 5월 10일
QC 기준을 충족하는 최초 제출
2018년 5월 10일
처음 게시됨 (실제)
2018년 5월 14일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2026년 5월 13일
QC 기준을 충족하는 마지막 업데이트 제출
2026년 5월 12일
마지막으로 확인됨
2026년 5월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- 16823
- I6T-MC-AMBG (기타 식별자: Eli Lilly and Company)
- 2017-003238-96 (EudraCT 번호)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
익명화된 개별 환자 수준 데이터는 연구 제안 및 서명된 데이터 공유 계약의 승인 시 안전한 액세스 환경에서 제공됩니다.
IPD 공유 기간
데이터는 미국과 EU에서 연구된 적응증의 1차 출판 및 승인 중 더 늦은 시점으로부터 6개월 후에 사용할 수 있습니다.
요청 시 데이터를 무기한 사용할 수 있습니다.
IPD 공유 액세스 기준
연구 제안은 독립적인 검토 패널의 승인을 받아야 하며 연구자는 데이터 공유 계약에 서명해야 합니다.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- CSR
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
예
미국 FDA 규제 기기 제품 연구
아니
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .