- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03519945
A Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 3)
A Phase 3, Multicenter, Open-Label Extension Study to Evaluate the Long Term Efficacy and Safety of Mirikizumab in Patients With Moderately to Severely Active Ulcerative Colitis LUCENT 3
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Buenos Aires, Argentina, C1128AAF
- Mautalen Salud e Investigación
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Quilmes, Argentina, 1879
- CER medical Institute
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Rosario, Argentina, S2000DEG
- Fundacion Estudios Clinicos
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SAN M. de Tucuman, Argentina, T4000AXL
- Centro de Investigaciones Médicas Tucuman
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San Miguel de Tucumán, Argentina, 4000
- C.I.C.E. 9 de Julio
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Adelaide, Australia, 5000
- Royal Adelaide Hospital
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Box Hill, Australia, 3128
- Box Hill Hospital
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Brisbane, Australia, 4102
- Princess Alexandra Hospital
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Brisbane, Australia, 4101
- Mater Misericordiae Limited
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Maroochydore, Australia, 4558
- Coastal Digestive Health
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Melbourne, Australia, 3065
- St Vincent's Hospital
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Parkville, Australia, 3050
- The Royal Melbourne Hospital
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Innsbruck, Austria, 6020
- Medizinische Universitaet Innsbruck
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Salzburg, Austria, 5020
- Uniklinikum Salzburg
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Vienna, Austria, 1090
- Universitaetsklinikum Allgemeines Krankenhaus Wien
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Ghent, Belgium, 9000
- UZ Gent
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Leuven, Belgium, 3000
- UZ Leuven
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Tournai, Belgium, 7500
- Centre Hospitalier de Wallonie Picarde - Site Notre Dame
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Greenfield Park, Canada, J4V 2H1
- CISSS de la Monteregie-Centre
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London, Canada, N6A 5A5
- University Hospital - London Health Sciences Centre
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London, Canada, N6A 4G5
- Victoria Hospital
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Montreal, Canada, H3G 1A4
- Montreal General Hospital
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Montreal, Canada, H1T 2M4
- CIUSSS de l'Est-de-l'Île-de-Montréal
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New Westminster, Canada, V3L 3W4
- Fraser Clinical Trials Inc
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Vancouver, Canada, V5Z 1M9
- Vancouver General Hospital
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Vancouver, Canada, V5Z 2K5
- GIRI GI Research Institute - Vancouver
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Victoria, Canada, V8V 3M9
- PerCuro Clinical Research
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Changsha, China, 410008
- Xiangya Hospital Central South University
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Changzhou, China
- Changzhou No.2 People's Hospital
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Chengdu, China, 610041
- West China Hospital of Sichuan University
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Fuzhou, China, 350005
- The First Affiliated Hospital of Fujian Medical University
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Guangzhou, China, 510655
- The Sixth Affiliated Hospital of Sun Yat-sen University
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Haikou, China, 570311
- Hainan General Hospital
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Hangzhou, China, 310016
- Sir Run Run Shaw Hospital
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Hangzhou, China, 310003
- The First Affiliated Hospital, Zhejiang University
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Hangzhou, China, 310052
- The Second Affiliated Hospital of Zhejiang University School of Medicine
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Hefei, China, 230022
- The First Affiliated Hospital of Anhui Medical University
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Hefei, China, 230071
- Anhui Provincial Hospital
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Jilin, China, 132011
- Center-Jilin Center Hospital
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Jinan, China, 250012
- Qilu Hospital of Shandong University
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Jinan, China, 250001
- Shandong Provincial Hospital
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Kunming, China, 650034
- The First People's Hospital of Yunnan Province
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Kunming, China, 650032
- First Affiliated Hospital of Kunming Medical University
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Liaocheng, China, 252000
- Liaocheng People's Hospital
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Nanchang, China, 330006
- The First Affiliated Hospital of Nanchang University
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Nanjing, China, 210009
- Zhongda Hospital Southeast University
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Nanjing, China, 211100
- Nanjing Medical University - Nanjing Jiangning Hospital
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Nanjing, China, 210000
- Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
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Qingdao, China, 266003
- The Affiliated Hospital of Qingdao University
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Shanghai, China
- Shanghai Jiaotong University School of Medicine Ruijin Hospital
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Shanghai, China, 200001
- Renji Hospital Shanghai Jiao Tong University School of Medicine
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Shenyang, China, 110004
- Shengjing Hospital of China Medical University
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Shijiazhuang, China, 050000
- The Second Afilliated Hospital of Hebei Medical University
-
Taian, China, 271000
- Taian City Central Hospital
-
Wenzhou, China, 315100
- The 2nd Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
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Wuhan, China, 430060
- Renmin Hospital of Wuhan University
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Wuhan, China, 430022
- Wuhan Union Hospital
-
Wuhan, China, 430030
- Tongji Hospital Tongji Medical,Science & Technology
-
Zhengzhou, China, 450014
- The Second Affiliated Hospital of Zhengzhou University
-
Zhuzhou, China, 412007
- ZhuZhou Central Hospital
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-
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Brno, Czechia, 656 91
- Fakultni nemocnice u sv. Anny v Brne
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Brno, Czechia, 636 00
- Vojenska nemocnice Brno
-
Hradec Králové, Czechia, 500 12
- Hepato-Gastroenterologie HK
-
Olomouc, Czechia, 779 00
- MUDr. Gregar, s.r.o.
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Olomouc, Czechia, 779 00
- PreventaMed
-
Pilsen, Czechia, 312 00
- A-Shine
-
Prague, Czechia, 10034
- Fakultní Nemocnice Královské Vinohrady
-
Prague, Czechia, 186 00
- MEDIENDO
-
Prague, Czechia
- ISCARE klinické centrum
-
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Copenhagen, Denmark, 2730
- Herlev and Gentofte Hospital
-
Køge, Denmark, 4600
- Sjællands Universitetshospital Køge
-
Nyborg, Denmark, 5800
- Sygehusenheden Nyborg
-
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-
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Amiens, France, 80054
- CHU d'Amiens-Picardie - Hôpital Sud
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Chambray-lès-Tours, France, 37170
- CHRU Troussau
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Lille, France, 59037
- Hopital Claude Huriez - CHU de Lille
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Montpellier, France, 34295
- Chu Saint Eloi
-
Neuilly-sur-Seine, France, 92200
- Centres Médico Chirurgicaux - Clinique Ambroise Paré
-
Nice, France, 06202
- Centre Hospitalier Universitaire de Nice - Hôpital l'Archet
-
Paris, France, 75010
- Hopital Saint-Louis
-
Pau, France, 64000
- Centre Hospitalier de Pau
-
Pessac, France, 33600
- CHU Bordeaux Haut-Leveque
-
Pierre-Bénite, France, 69310
- Centre Hospitalier Lyon Sud
-
Saint-Priest-en-Jarez, France, 42270
- Centre Hospitalier Universitaire de Saint Etienne - Hopital Nord
-
Strasbourg, France, 67091
- Nouvel Hôpital Civil (NHC)
-
Vandœuvre-lès-Nancy, France, 54511
- Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois
-
-
-
-
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Tbilisi, Georgia, 0112
- LLC Arensia Exploratory Medicine
-
-
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-
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Berlin, Germany, 14163
- Krankenhaus Waldfriede
-
Berlin, Germany, 12203
- Charité Universitätsmedizin Berlin Campus Benjamin Franklin
-
Brandenburg, Germany, 14770
- Städtisches Klinikum Brandenburg
-
Halle, Germany, 06108
- Studiengesellschaft BSF Unternehmergesellschaft
-
Halle, Germany, 6120
- Universitatsklinikum Halle
-
Hamburg, Germany, 20251
- HaFCED e.K. - Hamburgisches Forschungsinstitut für chronisch entzündliche Darmerkrankungen
-
Hanover, Germany, 30625
- Medizinische Hochschule Hannover
-
Ludwigshafen, Germany, 67067
- Haus der Gesundheit
-
-
-
-
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Budapest, Hungary, 1088
- Semmelweis University
-
Budapest, Hungary, 1125
- Eszak-budai Szent Janos Centrumkorhaz
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Békéscsaba, Hungary, 5600
- Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház
-
Győr, Hungary, 9024
- Petz Aladar Egyetemi Oktato Korhaz
-
Miskolc, Hungary, 3526
- Endomedix Diagnosztikai Központ - Miskolc
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Szeged, Hungary, 6725
- Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
-
Szekszárd, Hungary, 7100
- CLINFAN Szolgáltató Kft
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Vác, Hungary, 2600
- Jávorszky Ödön Kórház
-
-
-
-
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Ahmedabad, India, 382428
- Apollo Hospitals Ahmedabad
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Bangalore, India, 560054
- M S Ramaiah Medical College and Hospitals
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Hyderabad, India, 500058
- Owaisi Hospital and Research Center
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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
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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
-
-
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Dublin, Ireland, D9
- Beaumont Hospital, Dublin
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-
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Beersheba, Israel, 8410101
- Soroka Medical Center
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Jerusalem, Israel, 9778419
- Shaare Zedek Medical Center
-
Nahariya, Israel, 2210001
- Galilee Medical Center
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Rehovot, Israel, 7610001
- Kaplan Medical Center
-
Tel Aviv, Israel, 6423906
- Sourasky Medical Center
-
Ẕerifin, Israel, 70300
- Yitzhak Shamir Medical Center
-
-
-
-
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Catanzaro, Italy, 88100
- Azienda Ospedaliera Mater Domini
-
Genova, Italy, 16132
- Ospedale San Martino
-
Pisa, Italy, 56124
- Azienda Ospedaliera Universitaria Pisana
-
Rho, Italy, 20017
- Ospedale Di Circolo
-
Roma, Italy, 00168
- Fondazione Policlinico Universitario Agostino Gemelli
-
Roma, Italy, 00133
- Fondazione Policlinico Tor Vergata
-
Rome, Italy, 00157
- Ospedale Sandro Pertini
-
Rozzano, Italy, 20089
- Humanitas
-
Torino, Italy, 10128
- Ospedale Mauriziano
-
-
-
-
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Asahikawa, Japan, 070-8610
- Asahikawa City Hospital
-
Bunkyō, Japan, 113-8519
- Tokyo Medical and Dental University Hospital
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Bunkyō City, Japan, 113-8431
- Juntendo University Hospital
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Chiyoda-ku, Japan, 101-8643
- Mitsui Memorial Hospital
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Chuo-ku, Sapporo-shi, Japan, 060-0033
- Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
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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
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Mitaka, Japan, 181-8611
- Kyorin University Hospital
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Nagaoka, Japan, 940-8653
- Nagaoka Chuo General Hospital
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Nishinomiya, Japan, 663-8501
- Hyogo College of Medicine
-
Okayama, Japan, 700-8558
- Okayama University Hospital
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Osaka, Japan, 540-0006
- National Hospital Organization - Osaka National Hospital - Institute For Clinical Research
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Osaka, Japan, 530-0011
- Infusion Clinic
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Saga, Japan, 840-8571
- Saga-Ken Medical Center Koseikan
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Saitama, Japan, 336-0963
- Tokitokai Tokito Clinic Coloproctology Center
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Sakura, Japan, 285-0841
- Toho University Sakura Medical Center
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Sapporo, Japan, 065-0033
- Sapporo Higashi Tokushukai Hospital
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Sapporo, Japan, 004 0041
- Tokushukai Sapporo Tokushukai Hospital
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Sendai, Japan, 981-3213
- Takagi Clinic - Sendai
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Shimotsuke, Japan, 329-0498
- Jichi Medical University Hospital
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Shinjyuku-ku, Japan, 162-8655
- Center Hospital of the National Center for Global Health and Medicine
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Takamatsu, Japan, 760-8557
- Kagawa Prefectural Central Hospital
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Takasaki, Japan, 370-0829
- National Hospital Organization Takasaki General Medical Centar
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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
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-
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-
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Riga, Latvia, 1079
- Digestive Diseases Center "Gastro"
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Riga, Latvia, LV-1002
- Pauls Stradins Clinical Univeristy Hospital
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Riga, Latvia, LV1079
- RIGA EAST UNIVERSITY HOSPITAL ,Oncology Centre of Latvia
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-
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Kaunas, Lithuania, 50161
- Hospital of Lithuanian University of Health Sciences Kaunas
-
Klaipėda, Lithuania, 93200
- Viesoji Istaiga Klaipedos Miesto Poliklinika
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Klaipėda, Lithuania, LT-91251
- Republic Hospital of Klaipeda
-
Panevezys, Lithuania, LT-35144
- Respublikine Panevezio ligonine
-
Vilnius, Lithuania, LT-08661
- Vilnius University Hospital Santaros Klinikos
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-
-
-
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Kuala Selangor, Malaysia, 43300
- Hospital Serdang
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Kubang Kerian, Malaysia, 16150
- Hospital Universiti Sains Malaysia
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Lembah Pantai, Malaysia, 59100
- University Malaya Medical Centre
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Chihuahua City, Mexico, 31207
- Scientia Investigacion Clinica S.C.
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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
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-
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-
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Chisinau, Moldova, MD2025
- Republican Clinical Hospital
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-
-
-
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Amsterdam, Netherlands, 1081 HZ
- Amsterdam UMC, locatie VUmc
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Tilburg, Netherlands, 5022 GC
- Elisabeth-TweeSteden Ziekenhuis
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Uden, Netherlands, 5406 PT
- Ziekenhuis Bernhoven
-
Utrecht, Netherlands, 3584 CX
- Universitair Medisch Centrum Utrecht
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-
-
-
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Bydgoszcz, Poland, 85-796
- Centrum medyczne Pratia Bydgoszcz
-
Bydgoszcz, Poland, 85-229
- Centrum Medyczne "Medis" Manermed
-
Będzin, Poland, 42-500
- Promedica Dental Clinic
-
Elblag, Poland, 02-300
- Szpital Miejski im. Jana Pawła II w Elblagu
-
Katowice, Poland, 40-659
- All-Medicus
-
Krakow, Poland, 31-009
- Gabinet Endoskopii Przewodu Pokarmowego
-
Krakow, Poland, 31-506
- Topolowa Medicenter
-
Lublin, Poland, 20-090
- Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
-
Lublin, Poland, 20-582
- ZOZ Gastromed
-
Nowy Targ, Poland, 34-400
- Medicenter Nowy Targ
-
Olsztyn, Poland, 11-041
- Wojewodzki Szpital Specjalistyczny w Olsztynie
-
Rzeszów, Poland, 35-068
- Centrum Medyczne LUX MED - Rzeszow
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Sopot, Poland, 81-756
- Endoskopia Sp. z.o.o.
-
Szczecin, Poland, 71-434
- Twoja Przychodnia - Szczecinskie Centrum Medyczne
-
Szczecin, Poland, 71-685
- SONOMED Centrum Medyczne
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Torun, Poland, 87-100
- Gastromed
-
Wadowice, Poland, 34-100
- NZOZ Formed
-
Warsaw, Poland, 02-507
- Centralny Szpital Kliniczny MSWiA w Warszawie
-
Warsaw, Poland, 04-501
- WIP Warsaw IBD Point Profesor Kierkus
-
Warsaw, Poland, 00-189
- Centrum Zdrowia MDM
-
Warsaw, Poland, 03-580
- Vivamed Sp. z o.o.
-
Wroclaw, Poland, 53-114
- LexMedica
-
Wroclaw, Poland, 52-210
- Planetmed
-
Zamość, Poland, 22-400
- ETG Zamość
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-
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-
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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
-
-
-
-
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Barnaul, Russia, 656038
- Poliklinika Agmu "Konsul'tativno-Diagnosticheskiy Tsentr"
-
Irkutsk, Russia, 664079
- Scientific Centre of Reconstructive and Restorative Surgery
-
Izhevsk, Russia, 426061
- Alliance Biomedical URAL Group
-
Kazan', Russia, 420064
- Kazan State Medical University
-
Kemerovo, Russia, 620109
- SIH Kemerovo Regional Clinical Hosptial
-
Nizhny Novgorod, Russia, 603126
- Nizhny Novgorod Regional Hospital N.A. Semashko
-
Novosibirsk, Russia, 630008
- Medical Center SibNovoMed
-
Novosibirsk, Russia, 630117
- Research Institute of Physiology and Fundamental Medicine
-
Omsk, Russia, 644024
- Ultramed
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Petrozavodsk, Russia, 620109
- Karelia Republican Hospital V.A. Baranova
-
Rostov-on-Don, Russia, 344022
- Rostov State Medical University
-
Saint Petersburg, Russia, 191015
- North-Western State Medical University named after I.I.Mechnikov
-
Saint Petersburg, Russia, 191104
- City Mariinskaya Hospital
-
Saint Petersburg, Russia, 196143
- Scientific research center ECO-security
-
Saint Petersburg, Russia, 197022
- First Pavlov State Medical University of Saint Petersburg
-
Saint Petersburg, Russia, 197110
- Saint Petersburg State Budgetary Healthcare Institution City Clinical Hospital No.31
-
Stavropol, Russia, 355017
- Stavropol State Medical University
-
Yaroslavl, Russia, 150030
- SHI of Yaroslavl Region Clinical Hospital #8
-
Yekaterinburg, Russia, 620109
- LLC MA New Hospital
-
-
-
-
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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"
-
-
-
-
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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.
-
-
-
-
-
Busan, South Korea, 49201
- Dong-A University Hospital
-
Daejeon, South Korea, 34943
- The Catholic University of Korea, Daejeon St. Mary's Hospital
-
Gyeongsan-si, South Korea, 42415
- Yeungnam Univeristy Medical Center
-
Haeundae-gu, South Korea, 48108
- Inje University Haeundae Paik Hospital
-
Seoul, South Korea, 05505
- Asan Medical Center
-
Seoul, South Korea, 02447
- Kyung Hee University Hospital
-
Seoul, South Korea, 6351
- Samsung Medical Center
-
Seoul, South Korea, 3181
- Kangbuk Samsung Hospital
-
Wŏnju, South Korea, 26426
- Yonsei University-Wonju Severance Christian Hospital
-
-
-
-
-
Alicante, Spain, 3004
- Instituto de Ciencias Médicas
-
Fuenlabrada, Spain, 28942
- Hospital Universitario de Fuenlabrada
-
Girona, Spain, 17007
- Hospital Universitari de Girona Doctor Josep Trueta
-
Huelva, Spain, 21005
- Hospital Universitario Juan Ramon Jimenez
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Las Palmas de GC, Spain, 35019
- Hospital Universitario de Gran Canaria Doctor Negrín
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Madrid, Spain, 28046
- Hospital Universitario La Paz
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Oviedo, Spain, 33011
- Hospital Universitario Central de Asturias
-
Sagunto, Spain, 46520
- Hospital de Sagunto y C.E.
-
Santander, Spain, 39008
- Hospital Universitario Marqués de Valdecilla
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Bern, Switzerland, 3010
- Inselspital Bern
-
Bern, Switzerland, 3012
- Gastroenterologische Praxis Balsiger, Seibold & Partner
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Sankt Gallen, Switzerland, 9007
- Cantonal Hospital St.Gallen
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Zurich, Switzerland, 8091
- UniversitätsSpital Zürich
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-
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-
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Taichung, Taiwan, 40447
- China Medical University Hospital
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Taipei, Taiwan, 10002
- National Taiwan University Hospital
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-
-
-
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Antalya, Turkey (Türkiye), 7100
- Antalya Egitim ve Arastırma Hastanesi
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Bornova, Turkey (Türkiye), 35100
- Ege University Medicine of Faculty
-
Kocaeli, Turkey (Türkiye), 41380
- Kocaeli Üniversitesi
-
Mersin, Turkey (Türkiye), 33110
- Mersin University
-
-
-
-
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Ivano-Frankivsk, Ukraine, 76008
- Communal non-profit enterprise "Regional clinical hospital of Ivano-Frankivsk Regional Council"
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Kharkiv, Ukraine, 61037
- City Clinical Hospital No. 2
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Kharkiv, Ukraine, 61039
- L.T. Mala National Institute of Therapy of NAMS of Ukraine
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Kherson, Ukraine, 73000
- Kherson City Clinical Hospital
-
Kiev, Ukraine, 4050
- Medical Center of Limited Liability Company "Medical Center "Consilium Medical"
-
Kropyvnytskyi, Ukraine, 25006
- Private Enterprise Private Manufacturing Company Acinus
-
Kyiv, Ukraine, 2091
- Medical Center Ok!Clinic+
-
Kyiv, Ukraine, 04106
- Municipal Nonprofit Enterprise of Kyiv Region Council "Kyiv Regional Clinical Hospital"
-
Kyiv, Ukraine, 4078
- Municipal non-profit enterprise of Kyiv Regional Council "Kyiv Regional Center for Rehabilitation Medicine"
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Lviv, Ukraine, 79000
- Lviv Railway Clinical Hospital
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Lviv, Ukraine, 79000
- Municipal non-profit enterprise "Lviv Territorial Medical Union "Multidisciplinary Clinical Hospital of Em -T
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Lviv, Ukraine, 79010
- Lviv Regional Clinical Hospital - Lviv National Medical University named Danylo Galician
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Odesa, Ukraine, 65025
- Municipal non-profit enterprise'Odesa Regional Clinical Hospital'of Odesa Regional Council
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Poltava, Ukraine, 36000
- Poltova Oblast Clinical Hospital IM.M.V.Sklifosovskoho
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Uzhhorod, Ukraine, 88000
- Transcarpathian Regional Hospital im.Andriya Novak
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Vinnytsia, Ukraine, 21000
- City Clinical Hospital #1, Vinnitsya National Medical University
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Vinnytsia, Ukraine, 21009
- Medical Clinical Investigational Center of Medical Center Health Clinic
-
Vinnytsia, Ukraine, 21018
- VNMU
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Zaporizhzhia, Ukraine, 69076
- Diacenter
-
Zaporizhzhia, Ukraine, 69059
- NOVA Hospital
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-
-
-
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Bury, United Kingdom, BL9 7TD
- Fairfield General Hospital
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London, United Kingdom, E1 1RD
- Barts Health NHS Trust
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London, United Kingdom, NW1 2PG
- Guy's & St Thomas' NHS Foundation Trust
-
Oxford, United Kingdom, OX3 9DU
- The John Radcliffe Hospital
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-
-
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Alabama
-
Dothan, Alabama, United States, 36305
- Digestive Health Specialists
-
-
Arizona
-
Litchfield Park, Arizona, United States, 85340
- Research Solutions of Arizona
-
Phoenix, Arizona, United States, 85008
- Valleywise Health Medical Center
-
-
California
-
Arcadia, California, United States, 91006
- InSite Digestive Health Care
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Berkeley, California, United States, 94705
- Care Access - Berkeley
-
Lancaster, California, United States, 93534
- Om Research LLC
-
Northridge, California, United States, 91324
- California Medical Research Associates
-
Rialto, California, United States, 92377
- Inland Empire Clinical Trials, LLC
-
San Diego, California, United States, 92103
- Clinical Applications Laboratories, Inc.
-
-
Florida
-
Hialeah, Florida, United States, 33012
- Direct Helpers Research Center
-
Jacksonville, Florida, United States, 32256
- Encore Borland-Groover Clinical Research
-
Miami Lakes, Florida, United States, 33016
- Wellness Clinical Research
-
Orlando, Florida, United States, 32803
- AdventHealth Orlando
-
Orlando, Florida, United States, 32819
- Clintheory Healthcare
-
Pensacola, Florida, United States, 32503
- Gastroenterology Associates of Pensacola, PA
-
Zephyrhills, Florida, United States, 33542-7505
- Florida Medical Clinic LLC
-
-
Georgia
-
Atlanta, Georgia, United States, 30327
- Digestive Healthcare of Georgia
-
-
Idaho
-
Idaho Falls, Idaho, United States, 83404
- Grand Teton Research Group
-
-
Illinois
-
Evanston, Illinois, United States, 60201
- NorthShore University HealthSystem - Evanston Hospital
-
-
Indiana
-
Indianapolis, Indiana, United States, 46202
- Indiana University Health University Hospital
-
-
Kansas
-
Topeka, Kansas, United States, 66606
- Cotton O'Neil Digestive Health Center
-
-
Louisiana
-
Baton Rouge, Louisiana, United States, 70809
- GI Alliance Research Baton Rouge
-
Monroe, Louisiana, United States, 71201
- Delta Research Partners
-
New Orleans, Louisiana, United States, 70125
- Nola Research Works, LLC
-
-
Michigan
-
Ann Arbor, Michigan, United States, 48109
- University of Michigan
-
Chesterfield, Michigan, United States, 48047
- Clinical Research Institute of Michigan, LLC
-
Novi, Michigan, United States, 48377
- Henry Ford Medical Center - Columbus Center
-
Wyoming, Michigan, United States, 49519
- West Michigan Clinical Research Center
-
-
Minnesota
-
Plymouth, Minnesota, United States, 55446
- MNGI Digestive Health - Plymouth Endoscopy Center & Clinic
-
-
New York
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New York, New York, United States, 10032
- Columbia University Medical Center
-
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North Carolina
-
Chapel Hill, North Carolina, United States, 27599-7080
- Clinical & Translational Research Center (CTRC)
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Greenville, North Carolina, United States, 27834
- Carolina Digestive Diseases and Endoscopy Center
-
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Ohio
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Poland, Ohio, United States, 44514
- Care Access - Youngstown
-
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Oklahoma
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Oklahoma City, Oklahoma, United States, 73104-5008
- The University of Oklahoma Health Sciences Center
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Oklahoma City, Oklahoma, United States, 73118
- Central Sooner Research - Oklahoma - Northwest 47th Street
-
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Pennsylvania
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Pottsville, Pennsylvania, United States, 17901
- Care Access - Pottsville
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Wyomissing, Pennsylvania, United States, 19610
- Digestive Disease Associates
-
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South Dakota
-
Sioux Falls, South Dakota, United States, 57108
- Midwest Medical Care
-
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Texas
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Garland, Texas, United States, 75044
- GI Alliance
-
Houston, Texas, United States, 77084
- Biopharma Informatic, LLC
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San Antonio, Texas, United States, 78229
- Gastroenterology Research of San Antonio
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San Antonio, Texas, United States, 78229
- Southern Star Research Institute
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Southlake, Texas, United States, 76092
- Texas Digestive Disease Consultants
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Southlake, Texas, United States, 76092
- GI Alliance
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Utah
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Ogden, Utah, United States, 84403
- Care Access-Ogden
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Salt Lake City, Utah, United States, 84124
- Care Access Research LLC - Salt Lake City
-
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Virginia
-
Roanoke, Virginia, United States, 24014
- Carilion Clinic
-
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Washington
-
Tacoma, Washington, United States, 98405
- Washington Gastroenterology - Tacoma
-
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria
- Participants from Study AMAC (NCT02589665) or AMBG (NCT03524092) who have had at least one study drug administration and have not had early termination of study drug.
- Female participants must agree to contraception requirements.
Exclusion Criteria
- Participants must not have developed a new condition, including cancer in the originator study.
- Participants must not have any important infections including, but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during either originator study
- Participants may not have received surgery for UC in the originator study or are likely to require surgery for treatment of UC during the study.
- Participants must not have developed adenomatous polyps during the originator study that have not been removed prior to the start of this study.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Mirikizumab
Mirikizumab administered subcutaneously (SC).
|
Administered SC.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of Participants in Clinical Remission
Time Frame: Week 52
|
Clinical remission based on the modified Mayo Score (MMS).
|
Week 52
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Percentage of Participants in Endoscopic Remission
Time Frame: Week 52
|
Endoscopic remission based on the MMS Endoscopic Subscore (ES).
|
Week 52
|
|
Percentage of Participants in Corticosteroid-free Remission
Time Frame: Week 52
|
Participants in corticosteroid-free remission.
|
Week 52
|
|
Percentage of Participants with Histologic-Endoscopic Mucosal Remission at Week 52
Time Frame: Week 52
|
Endoscopic remission based on the MMS ES and histologic remission based on histologic disease activity index.
|
Week 52
|
|
Health Related Quality of Life: Inflammatory Bowel Disease Questionnaire (IBDQ) Score
Time Frame: Baseline to Week 52
|
Health Related Quality of Life based on IBDQ score.
|
Baseline to Week 52
|
|
UC Symptoms: Numeric Rating Score
Time Frame: Week 160
|
UC symptoms based on numeric rating score.
|
Week 160
|
|
Percentage of Participants Who are Hospitalized Due to UC
Time Frame: Baseline to Week 160
|
Participants who are hospitalized due to UC.
|
Baseline to Week 160
|
|
Percentage of Participants Who Undergo UC Surgeries Including Colectomy
Time Frame: Baseline to Week 160
|
Participants who undergo UC surgeries including colectomy.
|
Baseline to Week 160
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: 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
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Intestinal Diseases
- Digestive System Diseases
- Gastrointestinal Diseases
- Colonic Diseases
- Gastroenteritis
- Colitis
- Colitis, Ulcerative
- Inflammatory Bowel Diseases
- Physiological Effects of Drugs
- Anti-Inflammatory Agents
- Peripheral Nervous System Agents
- Gastrointestinal Agents
- Antirheumatic Agents
- Sensory System Agents
- Analgesics, Non-Narcotic
- Analgesics
- Anti-Inflammatory Agents, Non-Steroidal
- Anti-Ulcer Agents
- mirikizumab
Other Study ID Numbers
- 16596
- I6T-MC-AMAP (Other Identifier: Eli Lilly and Company)
- 2017 004092 31 (EudraCT Number)
- 2023-507657-15-00 (Other Identifier: EUCTR)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Lilly provides access to the individual patient data from studies on approved medicines and indications as defined by the sponsor specific information on ClinicalStudyDataRequest.com.
This access is provided in a timely fashion after the primary publication is accepted. Researchers need to have an approved research proposal submitted through ClinicalStudyDataRequest.com. Access to the data will be provided in a secure data sharing environment after signing a data sharing agreement.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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