- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT03519945
En studie for å evaluere den langsiktige effekten og sikkerheten til Mirikizumab hos deltakere med moderat til alvorlig aktiv ulcerøs kolitt (LUCENT 3)
En fase 3, multisenter, åpen utvidelsesstudie for å evaluere langtidseffekten og sikkerheten til Mirikizumab hos pasienter med moderat til alvorlig aktiv ulcerøs kolitt LUCENT 3
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Fase 3
Kontakter og plasseringer
Studiesteder
-
-
-
Buenos Aires, Argentina, C1128AAF
- Mautalen Salud e investigación
-
Quilmes, Argentina, 1879
- CER medical Institute
-
Rosario, Argentina, S2000DEG
- Fundacion Estudios Clinicos
-
SAN M. de Tucuman, Argentina, T4000AXL
- Centro de Investigaciones Médicas Tucuman
-
San Miguel de Tucumán, Argentina, 4000
- C.I.C.E. 9 de Julio
-
-
-
-
-
Adelaide, Australia, 5000
- Royal Adelaide Hospital
-
Box Hill, Australia, 3128
- Box Hill Hospital
-
Brisbane, Australia, 4102
- Princess Alexandra Hospital
-
Brisbane, Australia, 4101
- Mater Misericordiae Limited
-
Maroochydore, Australia, 4558
- Coastal Digestive Health
-
Melbourne, Australia, 3065
- St Vincent's Hospital
-
Parkville, Australia, 3050
- The Royal Melbourne Hospital
-
-
-
-
-
Ghent, Belgia, 9000
- UZ Gent
-
Leuven, Belgia, 3000
- UZ Leuven
-
Tournai, Belgia, 7500
- Centre Hospitalier de Wallonie Picarde - Site Notre Dame
-
-
-
-
-
Greenfield Park, Canada, J4V 2H1
- CISSS de la Monteregie-Centre
-
London, Canada, N6A 5A5
- University Hospital - London Health Sciences Centre
-
London, Canada, N6A 4G5
- Victoria Hospital
-
Montreal, Canada, H3G 1A4
- Montreal General Hospital
-
Montreal, Canada, H1T 2M4
- CIUSSS de l'Est-de-l'Ile-de-Montreal
-
New Westminster, Canada, V3L 3W4
- Fraser Clinical Trials Inc
-
Vancouver, Canada, V5Z 1M9
- Vancouver General Hospital
-
Vancouver, Canada, V5Z 2K5
- GIRI GI Research Institute - Vancouver
-
Victoria, Canada, V8V 3M9
- PerCuro Clinical Research
-
-
-
-
-
Copenhagen, Danmark, 2730
- Herlev and Gentofte Hospital
-
Køge, Danmark, 4600
- Sjællands Universitetshospital Køge
-
Nyborg, Danmark, 5800
- Sygehusenheden Nyborg
-
-
-
-
Alabama
-
Dothan, Alabama, Forente stater, 36305
- Digestive Health Specialists
-
-
Arizona
-
Litchfield Park, Arizona, Forente stater, 85340
- Research Solutions of Arizona
-
Phoenix, Arizona, Forente stater, 85008
- Valleywise Health Medical Center
-
-
California
-
Arcadia, California, Forente stater, 91006
- InSite Digestive Health Care
-
Berkeley, California, Forente stater, 94705
- Care Access - Berkeley
-
Lancaster, California, Forente stater, 93534
- Om Research LLC
-
Northridge, California, Forente stater, 91324
- California Medical Research Associates
-
Rialto, California, Forente stater, 92377
- Inland Empire Clinical Trials, LLC
-
San Diego, California, Forente stater, 92103
- Clinical Applications Laboratories, Inc.
-
-
Florida
-
Hialeah, Florida, Forente stater, 33012
- Direct Helpers Research Center
-
Jacksonville, Florida, Forente stater, 32256
- Encore Borland-Groover Clinical Research
-
Miami Lakes, Florida, Forente stater, 33016
- Wellness Clinical Research
-
Orlando, Florida, Forente stater, 32803
- AdventHealth Orlando
-
Orlando, Florida, Forente stater, 32819
- Clintheory Healthcare
-
Pensacola, Florida, Forente stater, 32503
- Gastroenterology Associates of Pensacola, PA
-
Zephyrhills, Florida, Forente stater, 33542-7505
- Florida Medical Clinic LLC
-
-
Georgia
-
Atlanta, Georgia, Forente stater, 30327
- Digestive Healthcare of Georgia
-
-
Idaho
-
Idaho Falls, Idaho, Forente stater, 83404
- Grand Teton Research Group
-
-
Illinois
-
Evanston, Illinois, Forente stater, 60201
- NorthShore University HealthSystem - Evanston Hospital
-
-
Indiana
-
Indianapolis, Indiana, Forente stater, 46202
- Indiana University Health University Hospital
-
-
Kansas
-
Topeka, Kansas, Forente stater, 66606
- Cotton O'Neil Digestive Health Center
-
-
Louisiana
-
Baton Rouge, Louisiana, Forente stater, 70809
- GI Alliance Research Baton Rouge
-
Monroe, Louisiana, Forente stater, 71201
- Delta Research Partners
-
New Orleans, Louisiana, Forente stater, 70125
- Nola Research Works, LLC
-
-
Michigan
-
Ann Arbor, Michigan, Forente stater, 48109
- University of Michigan
-
Chesterfield, Michigan, Forente stater, 48047
- Clinical Research Institute of Michigan, LLC
-
Novi, Michigan, Forente stater, 48377
- Henry Ford Medical Center - Columbus Center
-
Wyoming, Michigan, Forente stater, 49519
- West Michigan Clinical Research Center
-
-
Minnesota
-
Plymouth, Minnesota, Forente stater, 55446
- MNGI Digestive Health - Plymouth Endoscopy Center & Clinic
-
-
New York
-
New York, New York, Forente stater, 10032
- Columbia University Medical Center
-
-
North Carolina
-
Chapel Hill, North Carolina, Forente stater, 27599-7080
- Clinical & Translational Research Center (CTRC)
-
Greenville, North Carolina, Forente stater, 27834
- Carolina Digestive Diseases and Endoscopy Center
-
-
Ohio
-
Poland, Ohio, Forente stater, 44514
- Care Access - Youngstown
-
-
Oklahoma
-
Oklahoma City, Oklahoma, Forente stater, 73104-5008
- The University of Oklahoma Health Sciences Center
-
Oklahoma City, Oklahoma, Forente stater, 73118
- Central Sooner Research - Oklahoma - Northwest 47th Street
-
-
Pennsylvania
-
Pottsville, Pennsylvania, Forente stater, 17901
- Care Access - Pottsville
-
Wyomissing, Pennsylvania, Forente stater, 19610
- Digestive Disease Associates
-
-
South Dakota
-
Sioux Falls, South Dakota, Forente stater, 57108
- Midwest Medical Care
-
-
Texas
-
Garland, Texas, Forente stater, 75044
- GI Alliance
-
Houston, Texas, Forente stater, 77084
- Biopharma Informatic, LLC
-
San Antonio, Texas, Forente stater, 78229
- Gastroenterology Research of San Antonio
-
San Antonio, Texas, Forente stater, 78229
- Southern Star Research Institute
-
Southlake, Texas, Forente stater, 76092
- Texas Digestive Disease Consultants
-
Southlake, Texas, Forente stater, 76092
- GI Alliance
-
-
Utah
-
Ogden, Utah, Forente stater, 84403
- Care Access-Ogden
-
Salt Lake City, Utah, Forente stater, 84124
- Care Access Research LLC - Salt Lake City
-
-
Virginia
-
Roanoke, Virginia, Forente stater, 24014
- Carilion Clinic
-
-
Washington
-
Tacoma, Washington, Forente stater, 98405
- Washington Gastroenterology - Tacoma
-
-
-
-
-
Amiens, Frankrike, 80054
- Chu D'Amiens-Picardie - Hopital Sud
-
Chambray-lès-Tours, Frankrike, 37170
- CHRU Troussau
-
Lille, Frankrike, 59037
- Hopital Claude Huriez - CHU de Lille
-
Montpellier, Frankrike, 34295
- CHU Saint Eloi
-
Neuilly-sur-Seine, Frankrike, 92200
- Centres Médico Chirurgicaux - Clinique Ambroise Paré
-
Nice, Frankrike, 06202
- Centre Hospitalier Universitaire de Nice - Hopital l'Archet
-
Paris, Frankrike, 75010
- Hôpital Saint-Louis
-
Pau, Frankrike, 64000
- Centre Hospitalier de Pau
-
Pessac, Frankrike, 33600
- CHU Bordeaux Haut-Leveque
-
Pierre-Bénite, Frankrike, 69310
- Centre Hospitalier LYON SUD
-
Saint-Priest-en-Jarez, Frankrike, 42270
- Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord
-
Strasbourg, Frankrike, 67091
- Nouvel Hôpital Civil (NHC)
-
Vandœuvre-lès-Nancy, Frankrike, 54511
- Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois
-
-
-
-
-
Tbilisi, Georgia, 0112
- LLC Arensia Exploratory Medicine
-
-
-
-
-
Ahmedabad, India, 382428
- Apollo Hospitals Ahmedabad
-
Bangalore, India, 560054
- M S Ramaiah Medical College and Hospitals
-
Hyderabad, India, 500058
- Owaisi Hospital and Research Center
-
Jaipur, India, 302006
- SR Kalla Memorial Gastro & General Hospital
-
Ludhiana, India, 141001
- Dayanand Medical College and Hospital
-
Nagpur, India, 440010
- Midas Multispeciality Hospital Pvt.Ltd.
-
Noida, India, 201301
- Fortis Hospital
-
Pune, India, 411001
- Grant Medical Foundation - Ruby Hall Clinic
-
Rajkot, India, 360005
- Shree Giriraj Multispeciality Hospital
-
Secunderabad, India, 500003
- Gandhi Hospital
-
Surat, India, 395002
- Nirmal Hospital
-
Wardha, India, 442004
- Acharya Vinoba Bhave Rural Hospital
-
-
-
-
-
Dublin, Irland, D9
- Beaumont Hospital, Dublin
-
-
-
-
-
Beersheba, Israel, 8410101
- Soroka Medical Center
-
Jerusalem, Israel, 9778419
- Shaare Zedek Medical Center
-
Nahariya, Israel, 2210001
- Galilee Medical Center
-
Rehovot, Israel, 7610001
- Kaplan Medical Center
-
Tel Aviv, Israel, 6423906
- Sourasky Medical Center
-
Ẕerifin, Israel, 70300
- Yitzhak Shamir Medical Center
-
-
-
-
-
Catanzaro, Italia, 88100
- Azienda Ospedaliera Mater Domini
-
Genova, Italia, 16132
- Ospedale San Martino
-
Pisa, Italia, 56124
- Azienda Ospedaliera Universitaria Pisana
-
Rho, Italia, 20017
- Ospedale di Circolo
-
Roma, Italia, 00168
- Fondazione Policlinico Universitario Agostino Gemelli
-
Roma, Italia, 00133
- Fondazione Policlinico Tor Vergata
-
Rome, Italia, 00157
- Ospedale Sandro Pertini
-
Rozzano, Italia, 20089
- Humanitas
-
Torino, Italia, 10128
- Ospedale Mauriziano
-
-
-
-
-
Asahikawa, Japan, 070-8610
- Asahikawa City Hospital
-
Bunkyō, Japan, 113-8519
- Tokyo Medical and Dental University Hospital
-
Bunkyō City, Japan, 113-8431
- Juntendo University Hospital
-
Chiyoda-ku, Japan, 101-8643
- Mitsui Memorial Hospital
-
Chuo-ku, Sapporo-shi, Japan, 060-0033
- Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
-
Fujiidera, Japan, 583-0027
- Sai Gastroenterologist Proctology
-
Fukuoka, Japan, 814-0180
- Fukuoka University Hospital
-
Hamamatsu, Japan, 432-8061
- Matsuaikai Matsuda Hospital
-
Higashiibaraki, Japan, 311-3117
- Mito Medical Center
-
Hirosaki, Japan, 036-8545
- National Hospital Organization Hirosaki National Hospital
-
Kagoshima, Japan, 892-0846
- Sameshima Hospital
-
Kamakura, Japan, 247-0056
- Ofuna Central Hospital
-
Kawasaki, Japan, 210-0013
- Kawasaki Municipal Hospital
-
Kitakyusyu-shi, Japan, 802-0077
- Kitakyushu Municipal Medical Center
-
Kobe, Japan, 650 0015
- Aoyama Clinic GI Endoscopy & IBD Center
-
Kumagaya-shi, Japan, 360-8567
- Kumagaya General Hospital
-
Kurume-shi, Japan, 839 0809
- Hidaka Coloproctology Clinic
-
Kyoto, Japan, 612-8555
- National Hospital Organization Kyoto Medical Center
-
Kōtoku, Japan, 135 8577
- Showa University Koto Toyosu Hospital
-
Maebashi, Japan, 371-8511
- Gunma University Hospital
-
Minatoku, Japan, 108 8642
- Kitasato University Kitasato Institute Hospital
-
Mitaka, Japan, 181-8611
- Kyorin University Hospital
-
Nagaoka, Japan, 940-8653
- Nagaoka Chuo General Hospital
-
Nishinomiya, Japan, 663-8501
- Hyogo College of Medicine
-
Okayama, Japan, 700-8558
- Okayama University Hospital
-
Osaka, Japan, 540-0006
- National Hospital Organization - Osaka National Hospital - Institute For Clinical Research
-
Osaka, Japan, 530-0011
- Infusion Clinic
-
Saga, Japan, 840-8571
- Saga-Ken Medical Center Koseikan
-
Saitama, Japan, 336-0963
- Tokitokai Tokito Clinic Coloproctology Center
-
Sakura, Japan, 285-0841
- Toho University Sakura Medical Center
-
Sapporo, Japan, 065-0033
- Sapporo Higashi Tokushukai Hospital
-
Sapporo, Japan, 004 0041
- Tokushukai Sapporo Tokushukai Hospital
-
Sendai, Japan, 981-3213
- Takagi Clinic - Sendai
-
Shimotsuke, Japan, 329-0498
- Jichi Medical University Hospital
-
Shinjyuku-ku, Japan, 162-8655
- Center Hospital of the National Center for Global Health and Medicine
-
Takamatsu, Japan, 760-8557
- Kagawa Prefectural Central Hospital
-
Takasaki, Japan, 370-0829
- National Hospital Organization Takasaki General Medical Centar
-
Tokyo, Japan, 169-0073
- Tokyo Yamate Medical Center
-
Toyama, Japan, 930-8550
- Toyama Prefectural Central Hospital
-
Tsu, Japan, 514-8507
- Mie University Hospital
-
Yokohama, Japan, 232-0024
- Yokohama City University Medical Center
-
Yokohama, Japan, 220-0041
- Matsushima Hospital
-
Yokohama, Japan, 234-0032
- Showa University Northern Yokohama Hospital
-
Ōita, Japan, 870 0823
- Ishida Clinic of IBD and Gastroenterology
-
-
-
-
-
Changsha, Kina, 410008
- Xiangya Hospital Central South University
-
Changzhou, Kina
- Changzhou No.2 People's Hospital
-
Chengdu, Kina, 610041
- West China Hospital of Sichuan University
-
Fuzhou, Kina, 350005
- The First Affiliated Hospital of Fujian Medical University
-
Guangzhou, Kina, 510655
- The Sixth Affiliated Hospital of Sun Yat-sen University
-
Haikou, Kina, 570311
- Hainan General Hospital
-
Hangzhou, Kina, 310016
- Sir Run Run Shaw Hospital
-
Hangzhou, Kina, 310003
- The First Affiliated Hospital, Zhejiang University
-
Hangzhou, Kina, 310052
- The Second Affiliated Hospital of Zhejiang University School of Medicine
-
Hefei, Kina, 230022
- The First Affiliated Hospital of Anhui Medical University
-
Hefei, Kina, 230071
- Anhui Provincial Hospital
-
Jilin, Kina, 132011
- Center-Jilin Center Hospital
-
Jinan, Kina, 250012
- Qilu Hospital of Shandong University
-
Jinan, Kina, 250001
- Shandong Provincial Hospital
-
Kunming, Kina, 650034
- The First People's Hospital of Yunnan Province
-
Kunming, Kina, 650032
- First Affiliated Hospital of Kunming Medical University
-
Liaocheng, Kina, 252000
- Liaocheng People's Hospital
-
Nanchang, Kina, 330006
- The First Affiliated Hospital of Nanchang University
-
Nanjing, Kina, 210009
- Zhongda Hospital Southeast University
-
Nanjing, Kina, 211100
- Nanjing Medical University - Nanjing Jiangning Hospital
-
Nanjing, Kina, 210000
- Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
-
Qingdao, Kina, 266003
- The Affiliated Hospital of Qingdao University
-
Shanghai, Kina
- Shanghai Jiaotong University School of Medicine Ruijin Hospital
-
Shanghai, Kina, 200001
- Renji Hospital Shanghai Jiao Tong University School of Medicine
-
Shenyang, Kina, 110004
- Shengjing Hospital of China Medical University
-
Shijiazhuang, Kina, 050000
- The Second Afilliated Hospital of Hebei Medical University
-
Taian, Kina, 271000
- Taian City Central Hospital
-
Wenzhou, Kina, 315100
- The 2nd Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
-
Wuhan, Kina, 430060
- Renmin Hospital of Wuhan University
-
Wuhan, Kina, 430022
- Wuhan Union Hospital
-
Wuhan, Kina, 430030
- Tongji Hospital Tongji Medical,Science & Technology
-
Zhengzhou, Kina, 450014
- The Second Affiliated Hospital of Zhengzhou University
-
Zhuzhou, Kina, 412007
- Zhuzhou Central Hospital
-
-
-
-
-
Riga, Latvia, 1079
- Digestive Diseases Center "Gastro"
-
Riga, Latvia, LV-1002
- Pauls Stradins Clinical Univeristy Hospital
-
Riga, Latvia, LV1079
- RIGA EAST UNIVERSITY HOSPITAL ,Oncology Centre of Latvia
-
-
-
-
-
Kaunas, Litauen, 50161
- Hospital of Lithuanian University of Health Sciences Kaunas
-
Klaipėda, Litauen, 93200
- Viesoji Istaiga Klaipedos Miesto Poliklinika
-
Klaipėda, Litauen, LT-91251
- Republic Hospital of Klaipeda
-
Panevezys, Litauen, LT-35144
- Respublikine Panevezio ligonine
-
Vilnius, Litauen, LT-08661
- Vilnius University Hospital Santaros Klinikos
-
-
-
-
-
Kuala Selangor, Malaysia, 43300
- Hospital Serdang
-
Kubang Kerian, Malaysia, 16150
- Hospital Universiti Sains Malaysia
-
Lembah Pantai, Malaysia, 59100
- University Malaya Medical Centre
-
-
-
-
-
Chihuahua City, Mexico, 31207
- Scientia Investigacion Clinica S.C.
-
Culiacán, Mexico, 80230
- Centro para el Desarrollo de la Medicina y de Asistencia Medica Especializada S.C.
-
Veracruz, Mexico, 91900
- Sociedad de Metabolismo y Corazon
-
-
-
-
-
Chisinau, Moldova, MD2025
- Republican Clinical Hospital
-
-
-
-
-
Amsterdam, Nederland, 1081 HZ
- Amsterdam UMC, locatie VUmc
-
Tilburg, Nederland, 5022 GC
- Elisabeth-TweeSteden Ziekenhuis
-
Uden, Nederland, 5406 PT
- Ziekenhuis Bernhoven
-
Utrecht, Nederland, 3584 CX
- Universitair Medisch Centrum Utrecht
-
-
-
-
-
Bydgoszcz, Polen, 85-796
- Centrum medyczne Pratia Bydgoszcz
-
Bydgoszcz, Polen, 85-229
- Centrum Medyczne "Medis" Manermed
-
Będzin, Polen, 42-500
- Promedica Dental Clinic
-
Elblag, Polen, 02-300
- Szpital Miejski im. Jana Pawła II w Elblagu
-
Katowice, Polen, 40-659
- All-Medicus
-
Krakow, Polen, 31-009
- Gabinet Endoskopii Przewodu Pokarmowego
-
Krakow, Polen, 31-506
- Topolowa Medicenter
-
Lublin, Polen, 20-090
- Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
-
Lublin, Polen, 20-582
- ZOZ Gastromed
-
Nowy Targ, Polen, 34-400
- Medicenter Nowy Targ
-
Olsztyn, Polen, 11-041
- Wojewodzki Szpital Specjalistyczny w Olsztynie
-
Rzeszów, Polen, 35-068
- Centrum Medyczne LUX MED - Rzeszow
-
Sopot, Polen, 81-756
- Endoskopia Sp. z.o.o.
-
Szczecin, Polen, 71-434
- Twoja Przychodnia - Szczecinskie Centrum Medyczne
-
Szczecin, Polen, 71-685
- SONOMED Centrum Medyczne
-
Torun, Polen, 87-100
- Gastromed
-
Wadowice, Polen, 34-100
- NZOZ Formed
-
Warsaw, Polen, 02-507
- Centralny Szpital Kliniczny MSWiA w Warszawie
-
Warsaw, Polen, 04-501
- WIP Warsaw IBD Point Profesor Kierkus
-
Warsaw, Polen, 00-189
- Centrum Zdrowia MDM
-
Warsaw, Polen, 03-580
- Vivamed Sp. z o.o.
-
Wroclaw, Polen, 53-114
- LexMedica
-
Wroclaw, Polen, 52-210
- Planetmed
-
Zamość, Polen, 22-400
- ETG Zamość
-
-
-
-
-
Bucharest, Romania, 20125
- Spitalul Clinic Colentina
-
Bucharest, Romania, 30463
- CCBR Clinical Research
-
Bucharest, Romania, 021967
- Monza - Ares
-
Bucharest, Romania, 013823
- SC Memorial Healthcare International SRL
-
Oradea, Romania, 410469
- Spitalul Pelican
-
-
-
-
-
Barnaul, Russland, 656038
- Poliklinika Agmu "Konsul'tativno-Diagnosticheskiy Tsentr"
-
Irkutsk, Russland, 664079
- Scientific Centre of Reconstructive and Restorative Surgery
-
Izhevsk, Russland, 426061
- Alliance Biomedical URAL Group
-
Kazan', Russland, 420064
- Kazan State Medical University
-
Kemerovo, Russland, 620109
- SIH Kemerovo Regional Clinical Hosptial
-
Nizhny Novgorod, Russland, 603126
- Nizhny Novgorod Regional Hospital N.A. Semashko
-
Novosibirsk, Russland, 630008
- Medical Center SibNovoMed
-
Novosibirsk, Russland, 630117
- Research Institute of Physiology and Fundamental Medicine
-
Omsk, Russland, 644024
- Ultramed
-
Petrozavodsk, Russland, 620109
- Karelia Republican Hospital V.A. Baranova
-
Rostov-on-Don, Russland, 344022
- Rostov State Medical University
-
Saint Petersburg, Russland, 191015
- North-Western State Medical University named after I.I.Mechnikov
-
Saint Petersburg, Russland, 191104
- City Mariinskaya Hospital
-
Saint Petersburg, Russland, 196143
- Scientific research center ECO-security
-
Saint Petersburg, Russland, 197022
- First Pavlov State Medical University of Saint Petersburg
-
Saint Petersburg, Russland, 197110
- Saint Petersburg State Budgetary Healthcare Institution City Clinical Hospital No.31
-
Stavropol, Russland, 355017
- Stavropol State Medical University
-
Yaroslavl, Russland, 150030
- SHI of Yaroslavl Region Clinical Hospital #8
-
Yekaterinburg, Russland, 620109
- LLC MA New Hospital
-
-
-
-
-
Belgrade, Serbia, 11000
- Clinical Hospital Center Zvezdara
-
Belgrade, Serbia, 11080
- University Medical Center "Bezanijska kosa"
-
Kragujevac, Serbia, 34000
- Clinical Center Kragujevac
-
Sombor, Serbia, 25000
- Regional Hospital Dr Radivoj Simonovic Sombor
-
Sremska Mitrovica, Serbia, 22000
- Sremska Mitrovica Health Centre
-
Zrenjanin, Serbia, 23000
- General Hospital "Djordje Joanovic"
-
-
-
-
-
Banská Bystrica, Slovakia, 97517
- Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica
-
Bratislava, Slovakia, 81109
- Cliniq s.r.o.
-
Nitra, Slovakia, 949 01
- KM Management
-
Prešov, Slovakia, 080 01
- Gastro
-
Vranov N. Toplou, Slovakia, 093 01
- Endomed, s.r.o.
-
-
-
-
-
Alicante, Spania, 3004
- Instituto de Ciencias Médicas
-
Fuenlabrada, Spania, 28942
- Hospital Universitario de Fuenlabrada
-
Girona, Spania, 17007
- Hospital Universitari de Girona Doctor Josep Trueta
-
Huelva, Spania, 21005
- Hospital Universitario Juan Ramón Jiménez
-
Las Palmas de GC, Spania, 35019
- Hospital Universitario de Gran Canaria Doctor Negrin
-
Madrid, Spania, 28046
- Hospital Universitario La Paz
-
Oviedo, Spania, 33011
- Hospital Universitario Central de Asturias
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Sagunto, Spania, 46520
- Hospital de Sagunto y C.E.
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Santander, Spania, 39008
- Hospital Universitario Marqués de Valdecilla
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-
-
-
-
Bury, Storbritannia, BL9 7TD
- Fairfield General Hospital
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London, Storbritannia, E1 1RD
- Barts Health NHS Trust
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London, Storbritannia, NW1 2PG
- Guy's & St Thomas' NHS Foundation Trust
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Oxford, Storbritannia, OX3 9DU
- The John Radcliffe Hospital
-
-
-
-
-
Bern, Sveits, 3010
- Inselspital Bern
-
Bern, Sveits, 3012
- Gastroenterologische Praxis Balsiger, Seibold & Partner
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Sankt Gallen, Sveits, 9007
- Cantonal Hospital St.Gallen
-
Zurich, Sveits, 8091
- Universitätsspital Zürich
-
-
-
-
-
Busan, Sør -Korea, 49201
- Dong-A University Hospital
-
Daejeon, Sør -Korea, 34943
- The Catholic University of Korea, Daejeon ST. Mary's Hospital
-
Gyeongsan-si, Sør -Korea, 42415
- Yeungnam Univeristy Medical Center
-
Haeundae-gu, Sør -Korea, 48108
- Inje University Haeundae Paik Hospital
-
Seoul, Sør -Korea, 05505
- Asan Medical Center
-
Seoul, Sør -Korea, 02447
- Kyung Hee University Hospital
-
Seoul, Sør -Korea, 6351
- Samsung Medical Center
-
Seoul, Sør -Korea, 3181
- Kangbuk Samsung Hospital
-
Wŏnju, Sør -Korea, 26426
- Yonsei University-Wonju Severance Christian Hospital
-
-
-
-
-
Taichung, Taiwan, 40447
- China Medical University Hospital
-
Taipei, Taiwan, 10002
- National Taiwan University Hospital
-
-
-
-
-
Brno, Tsjekkia, 656 91
- Fakultni nemocnice u sv. Anny v Brne
-
Brno, Tsjekkia, 636 00
- Vojenska nemocnice Brno
-
Hradec Králové, Tsjekkia, 500 12
- Hepato-Gastroenterologie HK
-
Olomouc, Tsjekkia, 779 00
- MUDr. Gregar, s.r.o.
-
Olomouc, Tsjekkia, 779 00
- PreventaMed
-
Pilsen, Tsjekkia, 312 00
- A-Shine
-
Prague, Tsjekkia, 10034
- Fakultni nemocnice Kralovske Vinohrady
-
Prague, Tsjekkia, 186 00
- MEDIENDO
-
Prague, Tsjekkia
- ISCARE klinické centrum
-
-
-
-
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Antalya, Tyrkia (Türkiye), 7100
- Antalya Egitim ve Arastırma Hastanesi
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Bornova, Tyrkia (Türkiye), 35100
- Ege University Medicine of Faculty
-
Kocaeli, Tyrkia (Türkiye), 41380
- Kocaeli Üniversitesi
-
Mersin, Tyrkia (Türkiye), 33110
- Mersin University
-
-
-
-
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Berlin, Tyskland, 14163
- Krankenhaus Waldfriede
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Berlin, Tyskland, 12203
- Charite Universitatsmedizin Berlin Campus Benjamin Franklin
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Brandenburg, Tyskland, 14770
- Städtisches Klinikum Brandenburg
-
Halle, Tyskland, 06108
- Studiengesellschaft BSF Unternehmergesellschaft
-
Halle, Tyskland, 6120
- Universitätsklinikum Halle
-
Hamburg, Tyskland, 20251
- HaFCED e.K. - Hamburgisches Forschungsinstitut für chronisch entzündliche Darmerkrankungen
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Hanover, Tyskland, 30625
- Medizinische Hochschule Hannover
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Ludwigshafen, Tyskland, 67067
- Haus der Gesundheit
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-
-
-
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Ivano-Frankivsk, Ukraina, 76008
- Communal Non-Profit Enterprise "Regional Clinical Hospital of Ivano-Frankivsk Regional Council"
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Kharkiv, Ukraina, 61037
- City Clinical Hospital No. 2
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Kharkiv, Ukraina, 61039
- L.T. Mala National Institute of Therapy of NAMS of Ukraine
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Kherson, Ukraina, 73000
- Kherson City Clinical Hospital
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Kiev, Ukraina, 4050
- Medical Center of Limited Liability Company "Medical Center "Consilium Medical"
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Kropyvnytskyi, Ukraina, 25006
- Private Enterprise Private Manufacturing Company Acinus
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Kyiv, Ukraina, 2091
- Medical Center Ok!Clinic+
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Kyiv, Ukraina, 04106
- Municipal Nonprofit Enterprise of Kyiv Region Council "Kyiv Regional Clinical Hospital"
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Kyiv, Ukraina, 4078
- Municipal non-profit enterprise of Kyiv Regional Council "Kyiv Regional Center for Rehabilitation Medicine"
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Lviv, Ukraina, 79000
- Lviv Railway Clinical Hospital
-
Lviv, Ukraina, 79000
- Municipal non-profit enterprise "Lviv Territorial Medical Union "Multidisciplinary Clinical Hospital of Em -T
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Lviv, Ukraina, 79010
- Lviv Regional Clinical Hospital - Lviv National Medical University named Danylo Galician
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Odesa, Ukraina, 65025
- Municipal non-profit enterprise'Odesa Regional Clinical Hospital'of Odesa Regional Council
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Poltava, Ukraina, 36000
- Poltova Oblast Clinical Hospital IM.M.V.Sklifosovskoho
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Uzhhorod, Ukraina, 88000
- Transcarpathian Regional Hospital im.Andriya Novak
-
Vinnytsia, Ukraina, 21000
- City Clinical Hospital #1, Vinnitsya National Medical University
-
Vinnytsia, Ukraina, 21009
- Medical Clinical Investigational Center of Medical Center Health Clinic
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Vinnytsia, Ukraina, 21018
- VNMU
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Zaporizhzhia, Ukraina, 69076
- Diacenter
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Zaporizhzhia, Ukraina, 69059
- NOVA Hospital
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-
-
-
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Budapest, Ungarn, 1088
- Semmelweis University
-
Budapest, Ungarn, 1125
- Eszak-budai Szent Janos Centrumkorhaz
-
Békéscsaba, Ungarn, 5600
- Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház
-
Győr, Ungarn, 9024
- Petz Aladar Egyetemi Oktato Korhaz
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Miskolc, Ungarn, 3526
- Endomedix Diagnosztikai Központ - Miskolc
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Szeged, Ungarn, 6725
- Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
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Szekszárd, Ungarn, 7100
- CLINFAN Szolgáltató Kft
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Vác, Ungarn, 2600
- Jávorszky Ödön Kórház
-
-
-
-
-
Innsbruck, Østerrike, 6020
- Medizinische Universitaet Innsbruck
-
Salzburg, Østerrike, 5020
- Uniklinikum Salzburg
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Vienna, Østerrike, 1090
- Universitaetsklinikum Allgemeines Krankenhaus Wien
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Beskrivelse
Inklusjonskriterier
- Deltakere fra studie AMAC (NCT02589665) eller AMBG (NCT03524092) som har hatt minst én studielegemiddeladministrasjon og ikke har hatt tidlig avslutning av studiemedikamentet.
- Kvinnelige deltakere må godta prevensjonskrav.
Eksklusjonskriterier
- Deltakerne må ikke ha utviklet en ny tilstand, inkludert kreft i originalstudien.
- Deltakere må ikke ha noen viktige infeksjoner, inkludert, men ikke begrenset til, hepatitt B, hepatitt C, HIV/AIDS og aktiv tuberkulose (TB) under noen av studiene.
- Det kan hende at deltakerne ikke har mottatt kirurgi for UC i originalstudien eller vil sannsynligvis trenge kirurgi for behandling av UC under studien.
- Deltakerne må ikke ha utviklet adenomatøse polypper under originalstudien som ikke har blitt fjernet før starten av denne studien.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Mirikizumab
Mirikizumab administrert subkutant (SC).
|
Administrert SC.
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Prosentandel av deltakere i klinisk remisjon
Tidsramme: Uke 52
|
Klinisk remisjon basert på modifisert Mayo Score (MMS).
|
Uke 52
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Prosentandel av deltakere i endoskopisk remisjon
Tidsramme: Uke 52
|
Endoskopisk remisjon basert på MMS Endoscopic Subscore (ES).
|
Uke 52
|
|
Prosentandel av deltakere i kortikosteroidfri remisjon
Tidsramme: Uke 52
|
Deltakere i kortikosteroidfri remisjon.
|
Uke 52
|
|
Prosentandel av deltakere med histologisk-endoskopisk slimhinneremisjon ved uke 52
Tidsramme: Uke 52
|
Endoskopisk remisjon basert på MMS ES og histologisk remisjon basert på histologisk sykdomsaktivitetsindeks.
|
Uke 52
|
|
Helserelatert livskvalitet: Score for inflammatorisk tarmsykdom (IBDQ).
Tidsramme: Grunnlinje til uke 52
|
Helserelatert livskvalitet basert på IBDQ-score.
|
Grunnlinje til uke 52
|
|
UC-symptomer: Numerisk vurderingspoeng
Tidsramme: Uke 160
|
UC-symptomer basert på numerisk rangering.
|
Uke 160
|
|
Prosentandel av deltakere som er innlagt på sykehus på grunn av UC
Tidsramme: Baseline til uke 160
|
Deltakere som er innlagt på sykehus på grunn av UC.
|
Baseline til uke 160
|
|
Prosentandel av deltakere som gjennomgår UC-operasjoner, inkludert kolektomi
Tidsramme: Baseline til uke 160
|
Deltakere som gjennomgår UC-operasjoner inkludert kolektomi.
|
Baseline til uke 160
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Studieleder: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
Publikasjoner og nyttige lenker
Generelle publikasjoner
- 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.
- 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.
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Tarmsykdommer
- Sykdommer i fordøyelsessystemet
- Gastrointestinale sykdommer
- Kolonsykdommer
- Gastroenteritt
- Kolitt
- Kolitt, ulcerøs
- Inflammatoriske tarmsykdommer
- Fysiologiske effekter av legemidler
- Anti-inflammatoriske midler
- Agenter i det perifere nervesystemet
- Gastrointestinale midler
- Antirevmatiske midler
- Sensoriske systemagenter
- Analgetika, ikke-narkotisk
- Analgetika
- Anti-inflammatoriske midler, ikke-steroide
- Anti-ulcus midler
- mirikizumab
Andre studie-ID-numre
- 16596
- I6T-MC-AMAP (Annen identifikator: Eli Lilly and Company)
- 2017 004092 31 (EudraCT-nummer)
- 2023-507657-15-00 (Annen identifikator: EUCTR)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Lilly gir tilgang til individuelle pasientdata fra studier på godkjente medisiner og indikasjoner som definert av sponsorspesifikk informasjon på ClinicalStudyDataRequest.com.
Denne tilgangen gis i tide etter at den primære publikasjonen er akseptert. Forskere må ha et godkjent forskningsforslag sendt gjennom ClinicalStudyDataRequest.com. Tilgang til dataene vil bli gitt i et sikkert datadelingsmiljø etter signering av en datadelingsavtale.
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .