An Induction Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 1)

May 14, 2025 updated by: Eli Lilly and Company

A Phase 3, Multicenter, Randomized, Double-Blind, Parallel, Placebo-Controlled Induction Study of Mirikizumab in Conventional-Failed and Biologic-Failed Patients With Moderately to Severely Active Ulcerative Colitis (LUCENT 1)

The purpose of this study is to evaluate the safety and efficacy of Mirikizumab in participants with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to, loss of response, or intolerant to conventional or biologic therapy for UC.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1281

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Cordoba, Argentina, X5016KEH
        • Hospital Privado Centro Medico de Cordoba SA
    • Buenos Aires
      • Caba, Buenos Aires, Argentina, C1027AAP
        • Centro de Investigaciones Metabolicas (CINME)
      • Ciudad Autonoma De Buenos Air, Buenos Aires, Argentina, C1128AAF
        • Mautalen Salud e Investigacion-Centro de Osteopatías Médicas
      • Quilmes, Buenos Aires, Argentina, B1878DVC
        • Cer Instituto Medico
      • Quilmes, Buenos Aires, Argentina, B1878GEG
        • Instituto de Investigaciones Clinicas Quilmes
    • Santa Fe
      • Rosario, Santa Fe, Argentina, S2000DEJ
        • Fundacion de Estudios Clinicos
    • Tucuman
      • San Miguel de Tucuman, Tucuman, Argentina, 4000
        • C.I.C.E. 9 de Julio
    • Tucumán
      • SAN M. DE Tucuman, Tucumán, Argentina, T4000AXL
        • Centro de Investigaciones Médicas Tucuman
  • Australia
    • Essex
      • Harlow, Essex, Australia, CM20 1QX
        • Princess Alexandra Hospital
    • New South Wales
      • Newcastle, New South Wales, Australia, 2305
        • John Hunter Hospital
    • Queensland
      • Maroochydore, Queensland, Australia, 4558
        • Coastal Digestive Health
      • South Brisbane, Queensland, Australia, 4101
        • Mater University Hospital
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Royal Adelaide Hospital
    • Victoria
      • Box Hill, Victoria, Australia, 3128
        • Box Hill Hospital Outpatients
      • Malvern, Victoria, Australia, 3144
        • Melbourne Gastrointestinal Investigation Unit (MGIU)
      • Melbourne, Victoria, Australia, 3004
        • The Alfred Hospital
      • Melbourne, Victoria, Australia, 3076
        • Northern Hospital
      • Parkville, Victoria, Australia, 3050
        • The Royal Melbourne Hospital
  • Austria
      • Innsbruck, Austria, 6020
        • Medizinische Universität Innsbruck
      • Salzburg, Austria, 5020
        • Universitätsklinikum Salzburg
      • Vienna, Austria, 1090
        • Medical University of Vienna
    • Wien
      • Vienna, Wien, Austria, 1060
        • Krankenhaus der Barmherzigen Schwestern Wien
  • Belgium
      • Brasschaat, Belgium, 2930
        • AZ Klina
      • Kortrijk, Belgium, 8500
        • AZ Groeninge
      • Leuven, Belgium, 3000
        • Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
    • Oost-Vlaanderen
      • Gent, Oost-Vlaanderen, Belgium, 9000
        • Universitair Ziekenhuis Gent
    • Wallonne, Région
      • Tournai, Wallonne, Région, Belgium, 7500
        • Centre Hospitalier de Wallonie Picarde - Site Notre Dame
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T5R 1W2
        • Gastroenterology and Internal Medicine Research Institute
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 2K5
        • GI Research Institute
      • Vancouver, British Columbia, Canada, V5Z 1M9
        • The Gordon and Leslie Diamond Health Care Centre
      • Victoria, British Columbia, Canada, V8V 3M9
        • PerCuro Clinical Research
    • Ontario
      • London, Ontario, Canada, N6A 4G5
        • Victoria Hospital
      • London, Ontario, Canada, N6A 5G1
        • University of Western Ontario
    • Quebec
      • Greenfield Park, Quebec, Canada, J4V 2H1
        • Centre de santé et de services sociaux Champlain-Charles-Le Moyne
      • Montreal, Quebec, Canada, H1T 2M4
        • Hopital Maisonneure-Rosemount
      • Montreal, Quebec, Canada, H3G 1A4
        • Inflammatory Bowel Disease Centre Montreal General Hospital - MUHC
  • China
      • Wuhan, China, 430030
        • Tongji Hospital of Tongji University
    • Anhui
      • Hefei City, Anhui, China, 230000
        • Anhui Provincial Hospital
      • HefeiCity, Anhui, China, 230022
        • The First Affiliated Hospital of Anhui Medical University
    • Beijing
      • Beijing, Beijing, China, 100050
        • Beijing Friendship Hospital
    • Changsha City
      • Kaifu District, Changsha City, China, 410008
        • Xiangya Hospital Central South University
    • Chongqing
      • Chongqing, Chongqing, China, 400038
        • The First Hospital Affiliated to AMU (SOUTHWEST HOSPITAL)
      • Chongqing, Chongqing, China, 400037
        • The Affiliated 2nd Hosp. of Third Military Med. Univ. of PLA
    • Fujian
      • Fuzhou, Fujian, China, 350001
        • Fujian Province Hospital
    • Fuzhou
      • Fujian, Fuzhou, China, 350005
        • The First Affiliated Hospital of Fujian Medical University
    • Guangdong
      • Guangzhou, Guangdong, China, 510655
        • The Sixth Affiliated Hospital, Sun Yat-sen University
      • Shenzhen, Guangdong, China, 518053
        • The University of Hong Kong-Shenzhen Hospital
    • Hainan
      • Haikou, Hainan, China, 570311
        • Hainan General Hospital
    • Henan
      • Zhengzhou, Henan, China, 450014
        • The Second Affiliated Hospital of Zhengzhou University
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Union Hospital Tongji Medical College Huazhong University Of Science And Technology
      • Wuhan, Hubei, China, 430060
        • Renmin Hospital of Wuhan University
    • Hunan
      • Zhuzhou, Hunan, China, 412007
        • Zhuzhou Central Hospital
    • Jiangsu
      • Changzhou, Jiangsu, China, 213003
        • Changzhou No.2 People's Hospital
      • Nanjing, Jiangsu, China, 210029
        • Jiangsu Province Hospital
      • Nanjing, Jiangsu, China, 210008
        • The Affiliated Drum Tower Hospital of Nanjing University
      • Nanjing, Jiangsu, China, 210029
        • Jiangsu Province Hospital of Chinese Medicine
      • Nanjing, Jiangsu, China, 210029
        • Zhongda Hospital Southeast University
      • Nanjing, Jiangsu, China, 211106
        • Nanjing Medical University - Nanjing Jiangning Hospital
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • The First Affiliated Hospital of Nanchang University
      • Pingxiang, Jiangxi, China, 337055
        • Jiangxi Pingxiang People's Hospital
    • Jilin
      • Changchun, Jilin, China, 130021
        • The First Hospital of Jilin University
      • Jilin, Jilin, China, 132011
        • Jilin Central General Hospital
    • Lianing
      • Dalian, Lianing, China, 116000
        • The Second Hospital of Dalian Medical University
    • Liaoning
      • Shenyang, Liaoning, China, 110004
        • Shengjing Hospital of China Medical University
      • Shenyang City, Liaoning, China, 110022
        • Shengjing Hospital of China Medical University
    • Shandong
      • Jinan, Shandong, China, 250014
        • Qilu Hospital of Shandong University
      • Jinan, Shandong, China, 250001
        • Shandong Provincial Hospital
      • Liaocheng, Shandong, China, 252000
        • Liaocheng People's Hospital
      • Qingdao, Shandong, China, 266000
        • The Affiliated Hospital of Qingdao University
      • Taian, Shandong, China, 271000
        • Taian City Central Hospital
    • Shanghai
      • Shanghai, Shanghai, China, 200025
        • Shanghai Jiaotong University School of Medicine Ruijin Hospital
      • Shanghai, Shanghai, China, 200127
        • Renji Hospital Affliated to Shanghai Jiaotong University
    • Sichuan
      • Chengdu, Sichuan, China, 610041
        • West China Hospital Sichuan University
    • Urumchi
      • Urumchi, Urumchi, China, 830054
        • No.1 Hospital Affiliated to Xinjiang Medical University
    • Yunnan
      • Kunming, Yunnan, China, 650034
        • The First People's Hospital of Yunnan Province
      • Kunming, Yunnan, China, 650032
        • Kunming Medical College Affiliated First Hospital
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310016
        • Sir Run Run Shaw Hospital
      • Hangzhou, Zhejiang, China, 310003
        • First Affiliated Hosp of College of Med, Zhejiang University
      • Hangzhou, Zhejiang, China, 310000
        • The Second Affiliated Hospital of Zhejiang University School of Med
      • Wenzhou, Zhejiang, China, 325027
        • The Second Affiliated Hospital YuYing Childens Hospital of Wenzhou Medical university
  • Croatia
      • Osijek, Croatia, 31000
        • University Hospital Center Osijek
      • Zagreb, Croatia, 10000
        • CHC Zagreb
      • Zagreb, Croatia, 10000
        • Polyclinic Bonifarm
  • Czechia
      • Brno, Czechia, 65691
        • Fakultni nemocnice u sv. Anny v Brne
      • Olomouc, Czechia, 779
        • PreventaMed, s.r.o.
      • Praha 9, Czechia, 19000
        • ISCARE Clinical Centre
    • Brno-město
      • Brno, Brno-město, Czechia, 636 00
        • Vojenska nemocnice Brno
    • Hl. M. Praha
      • Praha 10, Hl. M. Praha, Czechia, 100 34
        • Fakultni nemocnice Kralovske Vinohrady
    • Hradec Králové
      • Hradec Kralove, Hradec Králové, Czechia, 50012
        • Hepato-Gastroenterologie HK
    • Modrany
      • Praha, Modrany, Czechia, 14300
        • Klinika ResTrial
    • Olomoucký Kraj
      • Olomouc, Olomoucký Kraj, Czechia, 779 00
        • MUDr. Gregar, s.r.o.
    • Plzeň-město
      • Plzen, Plzeň-město, Czechia, 301 00
        • A-Shine
    • Praha 8
      • Prague, Praha 8, Czechia, 18600
        • MEDIENDO
  • Denmark
      • Esbjerg, Denmark, 6700
        • Sydvestjysk Sygehus Esbjerg
      • Herlev, Denmark, 2730
        • Herlev and Gentofte Hospital
      • Køge, Denmark, 4600
        • Zealand University Hospital Køge
  • France
      • Chambray les Tours, France, 37170
        • CHU Tours - Hôpital Trousseau
      • Marseille Cedex 20, France, 13915
        • Assistance Publique Hôpitaux de Marseille - Hôpital Nord
      • Montpellier, France, 34295
        • Hopital Saint Eloi
      • Nice Cedex, France, 06200
        • Hopital l'Archet 2
      • Pessac Cedex, France, 33604
        • CHU Bordeaux - Hôpital Haut-Lévêque
      • Poitiers Cedex, France, 86021
        • CHU de Poitiers- Service d'Hépato-gastro-entérologie,
      • Reims, France, 51092
        • Robert Debre Hospital
      • Saint Priest en Jarez, France, 42270
        • CHU de Saint Etienne Hopital Nord
      • Vandoeuvre les Nancy, France, 54500
        • CHRU Nancy Brabois - Hôpital d'Enfants
    • Bas Rhin
      • Strasbourg Cedex, Bas Rhin, France, 67098
        • Hopital de Hautepierre - Service d'Hépatogastroentérolgie
    • Cedex 10
      • Paris, Cedex 10, France, 75475
        • Hôpital Saint-Louis
    • Nord
      • Lille cedex, Nord, France, 59037
        • CHU Lille - Hôpital Claude Huriez
    • Paris
      • Clichy, Paris, France, 92110
        • Hopital Beaujon
    • Pyrénées-Atlantiques
      • Pau, Pyrénées-Atlantiques, France, 64046
        • Centre Hospitalier de Pau
    • Rhone
      • Pierre Benite cedex, Rhone, France, 69495
        • Hospices Civils de Lyon - Centre Hospitalier Lyon Sud -
    • Somme
      • Amiens Cedex, Somme, France, 80480
        • CHU Amiens Picardie-Site Sud - RDC Service Hépato gastro
  • Germany
      • Berlin, Germany, 14163
        • Krankenhaus Waldfriede
      • Berlin, Germany, 12203
        • Charité Campus Virchow-Klinikum
      • Brandenburg, Germany, 14770
        • Staedisches Klinikum Brandenburg
      • Hamburg, Germany, 20251
        • HaFCED - Hamburgisches Forschungsinstitut für chronisch entzündliche Darmerkrankungen
      • Regensburg, Germany, 93053
        • Praxiszentrum Alte Maelzerei
      • Weyhe, Germany, 28844
        • Internistische Praxisgemeinschaft
    • Niedersachsen
      • Hannover, Niedersachsen, Germany, 30625
        • Medizinische Hochschule Hanover
    • Nordrhein Westfalen
      • Muenster, Nordrhein Westfalen, Germany, 48159
        • Gastro Campus Research GbR
    • Rheinland-Pfalz
      • Ludwigshafen, Rheinland-Pfalz, Germany, 67067
        • Haus der Gesundheit
    • Sachsen Anhalt
      • Halle (Saale), Sachsen Anhalt, Germany, 06108
        • Studiengesellschaft BSF Unternehmergesellschaft
    • Sachsen-Anhalt
      • Halle (Saale), Sachsen-Anhalt, Germany, 06120
        • Universitätsklinikum Halle
  • Hungary
      • Budapest, Hungary, 1088
        • Semmelweis Egyetem
      • Budapest, Hungary, 1036
        • Óbudai Egészségügyi Centrum
      • Debrecen, Hungary, 4032
        • Debreceni Egyetem Klinikai Kozpont
      • Miskolc, Hungary, 3526
        • Endomedix Diagnosztikai Központ - Miskolc
      • Mosonmagyarovar, Hungary, 9200
        • Karolina Korhaz-Rendelointezet
      • Szeged, Hungary, 6720
        • Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont I. Belgyogyaszati Klinika
      • Szekszard, Hungary, 7100
        • Clinfan Szolgaltato Kft.
    • EU
      • Balatonfüred, EU, Hungary, 8230
        • DRC Gyogyszervizsgalo Kozpont Kft.
    • Pest
      • Vac, Pest, Hungary, 2600
        • Jávorszky Ödön Kórház
  • India
      • Telangana, India, 500003
        • Gandhi Hospital
    • Andhra Pradesh
      • Hyderabad, Andhra Pradesh, India, 500058
        • Centre for Liver Research & Diagnostics, Deccan College of Medical Sciences, Owaisi Hospital & Research Centre
    • Assam
      • Guwahati, Assam, India, 781 006
        • Institute of Digestive and Liver Diseases
    • Delhi
      • New Delhi, Delhi, India, 110060
        • Sir Ganga Ram Hospital
      • New Delhi, Delhi, India, 110 025
        • Escorts Heart Institute and Research Centre Ltd
    • Gujarat
      • Gandhinagar, Gujarat, India, 382428
        • Apollo Research and Innovations, Apollo Hospitals International Ltd
      • Rajkot, Gujarat, India, 360005
        • Shree Giriraj Multispeciality Hospital
      • Surat, Gujarat, India, 395002
        • Nirmal Hospital
    • Karnataka
      • Bangalore, Karnataka, India, 560 002
        • Bangalore Medical College and Research Institute
      • Bangalore, Karnataka, India, 560054
        • M S Ramaiah Medical College Hospital
    • Maharashtra
      • Mumbai, Maharashtra, India, 400022
        • Lokmanya Hospital
      • Nagpur, Maharashtra, India, 440010
        • Midas Multispecilaity Hopsital Pvt Ltd
      • Pune, Maharashtra, India, 411 001
        • Poona Medical Foundation. Ruby Hall Clinic
      • Pune, Maharashtra, India, 411011
        • K E M Hospital and Research Centre
      • Wardha, Maharashtra, India, 442004
        • Datta Meghe Institute of Medical Sciences (DU), Acharya Vinoba Bhave Rural Hospital
    • Punjab
      • Ludhiana, Punjab, India, 141001
        • Dayanand Medical College and Hospital
    • Rajasthan
      • Jaipur, Rajasthan, India, 302001
        • SR Kalla Memorial Gastro & General Hospital
    • Telangana
      • Hyderabad, Telangana, India, 500032
        • Asian Institute of Gastroenterology
    • Uttar Pradesh
      • Lucknow, Uttar Pradesh, India, 226003
        • King George Medical University
      • Noida, Uttar Pradesh, India, 201301
        • Fortis Hospital
    • West Bengal
      • Kolkata, West Bengal, India, 700020
        • SSKM Post Graduate Hospital
      • Kolkata, West Bengal, India, 700073
        • Nil Ratan Sircar Medical College
  • Ireland
      • Dublin, Ireland, D9
        • Beaumont Hospital, Dublin
  • Israel
      • Beer-Sheva, Israel, 8410101
        • Soroka Medical Center - Pediatric Outpatient Clinic
      • Nahariya, Israel, 2210001
        • Galilee Medical Center Department of Internal Medicine A
      • Ramat Gan, Israel, 5262100
        • Chaim Sheba Medical Center
      • Rehovot, Israel, 7610001
        • Kaplan Medical Center
      • Tel Aviv, Israel, 6423906
        • Tel Aviv Sourasky Medical Center
      • Zerifin, Israel, 70300
        • King Fahad Medical City
    • HaMerkaz
      • Kfar Saba, HaMerkaz, Israel, 4428164
        • Meir Medical Center
    • Jerusalem
      • Bait Vagan, Jerusalem, Israel, 91031
        • Shaare Zedek Medical Center
  • Italy
      • Brescia, Italy, 25123
        • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
      • Catanzaro, Italy, 88100
        • Azienda ospedaliero-universitaria Mater Domini
      • Firenze, Italy, 50134
        • Azienda Ospedaliera Universitaria Careggi
      • Genova, Italy, 16132
        • Azienda Ospedaliero Universitaria San Martino
      • Milano, Italy, 20122
        • Gastroenterology and Endoscopy Unit IRCCS Ca' Granda Ospedale Maggiore Policlinico Foundation
      • Modena, Italy, 41124
        • Azienda Ospedaliera Universitaria Policlinico de Modena
      • Pisa, Italy, 56124
        • Azienda Ospedaliera Universitaria Pisana
      • Roma, Italy, 00168
        • Policlinico Gemelli - Università Cattolica del Sacro Cuore
      • Salerno, Italy, 84131
        • Azienda Ospedaliera Universitaria OO. RR. S. Giovanni di Dio e Ruggi D'Aragona Medicina Interna
      • San Donato Milanese (MI), Italy, 20097
        • I.R.C.C.S Policlinico San Donato
      • Torino, Italy, 10128
        • Ospedale Mauriziano Umberto I
      • Udine, Italy, 33100
        • Azienda Ospedaliero-Universitaria Santa Maria della Misericordia Gastroenterologia
    • Milano
      • Rho, Milano, Italy, 20017
        • Presidio di Rho
      • Rozzano, Milano, Italy, 20089
        • Istituto Clinico Humanitas
    • Roma
      • Rome, Roma, Italy, 00157
        • Ospedale Sandro Pertini
      • Torre, Roma, Italy, 00133
        • Azienda Ospedaliera Universitaria Policlinico Tor Vergata
  • Japan
      • Fukuoka, Japan, 814-0180
        • Fukuoka University Hospital
      • Kagoshima, Japan, 892-0846
        • Sameshima Hospital
      • Kyoto, Japan, 612-8555
        • National Hospital Organization Kyoto Medical Center
      • Okayama, Japan, 700-8558
        • Okayama University Hospital
      • Osaka, Japan, 530-0011
        • Infusion Clinic
      • Saitama, Japan, 336 0963
        • Tokitokai Tokito Clinic
      • Toyama, Japan, 930-8550
        • Toyama Prefectural Central Hospital
    • Aichi
      • Toyoake, Aichi, Japan, 470-1192
        • Fujita Health University
    • Aichi-ken
      • Nagakute-shi, Aichi-ken, Japan, 480-1195
        • Aichi Medical University Hospital
    • Aomori
      • Hirosaki, Aomori, Japan, 036-8545
        • National Hospital Organization Hirosaki National Hospital
    • Chiba
      • Sakura, Chiba, Japan, 285-8741
        • Toho University Sakura Medical Center
    • Fukoka
      • Kitakyusyu-shi, Fukoka, Japan, 802-0077
        • Kitakyushu Municipal Medical Center
    • Fukuoka
      • Chikushino, Fukuoka, Japan, 818 8502
        • Fukuoka University Chikushi Hospital
    • Fukuoka-Ken
      • Kurume-shi, Fukuoka-Ken, Japan, 839 0809
        • Hidaka Coloproctology Clinic
      • Kurume-shi, Fukuoka-Ken, Japan, 830 8543
        • Yukinoseibokai St. Mary's Hospital
    • Gunma
      • Maebashi, Gunma, Japan, 371-8511
        • Gunma University Hosptial
      • Takasaki, Gunma, Japan, 370-0829
        • National Hospital Organization Takasaki General Medical Centar
    • HigaShiibaraki-Gun
      • Ibaraki-machi, HigaShiibaraki-Gun, Japan, 311 3193
        • NHO Mito Medical Center
    • Hiroshima-ken
      • Hiroshima-shi, Hiroshima-ken, Japan, 734-8551
        • Hiroshima University Hospital
    • Hokkaido
      • Asahikawa, Hokkaido, Japan, 070-8610
        • Asahikawa City Hospital
      • Sapporo-shi, Hokkaido, Japan, 004 0041
        • Tokushukai Sapporo Tokushukai Hospital
      • Sapporo-shi, Hokkaido, Japan, 060 0033
        • Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
      • Sapporo-shi, Hokkaido, Japan, 065-0033
        • Sapporo Higashi Tokushukai Hospital
    • Hyogo-Ken
      • Kobe-shi, Hyogo-Ken, Japan, 650 0015
        • Aoyama Clinic GI Endoscopy & IBD Center
    • Kagawa
      • Takamatsu, Kagawa, Japan, 760-8557
        • Kagawa Prefectural Central Hospital
      • Takamatsu, Kagawa, Japan, 760-0017
        • Takamatsu Red Cross Hospital
    • Kanagawa
      • Kamakura, Kanagawa, Japan, 247-0056
        • Ofuna Central Hospital
      • Kawasaki, Kanagawa, Japan, 210-0013
        • Kawasaki Municipal Hospital
      • Sagamihara, Kanagawa, Japan, 252-0375
        • Kitasato University Hospital
      • Yokohama, Kanagawa, Japan, 232-0024
        • Yokohama City University Medical Center
      • Yokohama, Kanagawa, Japan, 234-0032
        • Showa University Northern Yokohama Hospital
    • Kanagawa-Ken
      • Yokohama-shi, Kanagawa-Ken, Japan, 226 0025
        • Sankikai Yokohama Shin midori General Hospital
    • Kumamoto
      • Kumamoto-shi, Kumamoto, Japan, 860-0012
        • Kumamoto University Hospital
    • Mie
      • Tsu, Mie, Japan, 514-8507
        • Mie University Hospital
    • Miyagi-Ken
      • Sendai-shi, Miyagi-Ken, Japan, 981 3213
        • Takagi Clinic - Sendai
    • Niigata
      • Nagaoka-shi, Niigata, Japan, 940-8653
        • Nagaoka Chuo General Hospital
    • Oita-Ken
      • Oita-shi, Oita-Ken, Japan, 870 0823
        • Ishida Clinic of IBD and Gastroenterology
    • Osaka
      • Fujiidera, Osaka, Japan, 583-0027
        • Sai Gastroenterology, proctology
      • Osaka-shi, Osaka, Japan, 540 0006
        • NHO Osaka National Hospital
      • Suita, Osaka, Japan, 565-0871
        • Osaka University Hospital
    • Saga-Ken
      • Saga-Shi, Saga-Ken, Japan, 840-8571
        • Saga-Ken Medical Center Koseikan
    • Saitama-Ken
      • Kumagaya-shi, Saitama-Ken, Japan, 360-8567
        • Kumagaya General Hospital
    • Shizuoka-Ken
      • Hamamatsu-shi, Shizuoka-Ken, Japan, 4328061
        • Matsuda Hospital
    • Tochigi-Ken
      • Shimotsuke-shi, Tochigi-Ken, Japan, 329-0498
        • Jichi Medical University Hospital
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8431
        • Juntendo University Hospital
      • Bunkyō, Tokyo, Japan, 113-8519
        • Tokyo Medical and Dental University Medical Hospital
      • Koto-ku, Tokyo, Japan, 135 8577
        • Showa University Koto Toyosu Hospital
      • Minato-Ku, Tokyo, Japan, 108 8642
        • Kitasato University Kitasato Institute Hospital
      • Mitaka, Tokyo, Japan, 181-8611
        • Kyorin University Hospital
      • Shinjuku-ku, Tokyo, Japan, 169-0073
        • JHCO Tokyo Yamate Medical Center
    • Tokyo-To
      • Chiyoda-ku, Tokyo-To, Japan, 101-8643
        • Mitsui Memorial Hospital
      • Shinjuku-ku, Tokyo-To, Japan, 162 8655
        • Center Hospital of the National Center for Global Health and Medicine
  • Korea, Republic of
      • Busan, Korea, Republic of, 48108
        • Inje University Haeundae Paik Hospital
      • Daegu, Korea, Republic of, 41404
        • Kyungpook National University Medical Center Chilgok Hospital
      • Daegu, Korea, Republic of, 42415
        • Yeungnam Univeristy Medical Center
    • Gangwon-do
      • Wonju-si, Gangwon-do, Korea, Republic of, 26426
        • Severance Hospital, Yonsei University Health System
    • Gyeonggi-do
      • Suwon-si, Gyeonggi-do, Korea, Republic of, 16247
        • The Catholic University of Korea, St. Vincent's Hospital
    • Korea
      • Seoul, Korea, Korea, Republic of, 02447
        • Kyung Hee University Hospital
      • Seoul, Korea, Korea, Republic of, 05505
        • Asan Medical Center
    • Pusan-Kwangyǒkshi
      • Busan, Pusan-Kwangyǒkshi, Korea, Republic of, 49201
        • Dong-A University Hospital
    • Seoul-teukbyeolsi [Seoul]
      • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 06351
        • Samsung Medical Center
      • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 03181
        • Kangbuk Samsung Hospital
    • Taejǒn-Kwangyǒkshi
      • Daejeon, Taejǒn-Kwangyǒkshi, Korea, Republic of, 34943
        • The Catholic University of Korea, Daejeon ST. Mary's Hospital
  • Latvia
      • Riga, Latvia, 1079
        • Digestive Diseases Center "Gastro"
      • Riga, Latvia, LV-1038
        • Riga Eastern Clinical University Hospital
    • Rīga
      • Riga, Rīga, Latvia, LV-1002
        • Pauls Stradins Clinical Univeristy Hospital
  • Lithuania
      • Kaunas, Lithuania, 50009
        • Hospital of Lithuanian University of Health Sciences Kaunas
      • Klaipeda, Lithuania, 92231
        • Republic Hospital of Klaipeda
      • Klaipeda, Lithuania, 92288
        • Klaipeda Seamen's Hospital
      • Vilnius, Lithuania, LT-08661
        • Vilnius University Hospital Santariskiu Clinics
    • Panevėžio Apskritis
      • Panevezys, Panevėžio Apskritis, Lithuania, LT-35144
        • Respublikine Panevezio ligonine
  • Malaysia
    • Kedah
      • Alor Star, Kedah, Malaysia, 05460
        • Hospital Sultanah Bahiyah
    • Kelantan
      • Kubang Kerian, Kelantan, Malaysia, 16150
        • Universiti Sains Malaysia
    • Kuala Lumpur
      • Lembah Pantai, Kuala Lumpur, Malaysia, 59100
        • University Malaya Medical Centre
    • Penang
      • Georgetown, Penang, Malaysia, 10450
        • Hospital Pulau Pinang
    • Selangor
      • Ampang, Selangor, Malaysia, 68000
        • Hospital Ampang
  • Mexico
      • Chihuahua, Mexico, 31203
        • Scientia Investigacion Clinica S.C.
      • Veracruz, Mexico, 91900
        • Sociedad de Metabolismo y Corazon
    • DF
      • Mexico, DF, Mexico, 03300
        • Clinicos Asociados Bocm, S.C.
    • Distrito Federal
      • Mexico City, Distrito Federal, Mexico, 07020
        • Centro de Investigación Clínica Acelerada
    • Edo De Mex
      • Tlalnepantla, Edo De Mex, Mexico, 54055
        • Clinical Research Institute S C
    • Jalisco
      • Zapopan, Jalisco, Mexico, 45030
        • Investigación Biomédica para el Desarrollo de Fármacos S.A. de C.V.
    • Sinaloa
      • Culiacan, Sinaloa, Mexico, 80230
        • Centro Para el Desarrollo de la Medicina y de Asistencia Med S.C
  • Netherlands
      • Uden, Netherlands, 5406 PT
        • Bernhoven Ziekenhuis
      • Utrecht, Netherlands, 3584 CX
        • UMC Utrecht, Dept. of Internal Medicine, MDL
    • Noord Brabant
      • Tilburg, Noord Brabant, Netherlands, 5022 GC
        • St Elisabeth Ziekenhuis
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands, 1105 AZ
        • Amsterdam UMC, Locatie AMC
  • Poland
      • Bedzin, Poland, 42-500
        • Promedica Dental Clinic
      • Katowice, Poland, 40-660
        • All-Medicus
      • Knurow, Poland, 44-190
        • Indywidualna Specjalistyczna Praktyka Lekarska
      • Olsztyn, Poland, 10-561
        • Wojewodzki Specjalistyczny Szpital w Olsztynie
      • Szczecin, Poland, 71-434
        • Twoja Przychodnia-Szczecinskie Centrum Medyczne
      • Torun, Poland, 87-100
        • Gastromed Kopoń Zmudziński I Wspólnicy Spółka Jawna Specjalistyczne Centrum Gastrologii I Endoskopii
      • Warszawa, Poland, 02-507
        • Centralny Szpital Kliniczny MSWiA
      • Warszawa, Poland, 01-697
        • Centrum Medyczne NeuroProtect
      • Warszawa, Poland, 00635
        • Centrum Zdrowia MDM
      • Warszawa, Poland, 00-728
        • Warsaw IBD Point Profesor Kierkus
      • Wroclaw, Poland, 52-210
        • PlanetMed Sp.z o.o.
      • Zamosc, Poland, 22-400
        • ETG Zamość
    • Dolnośląskie
      • Wroclaw, Dolnośląskie, Poland, 53-114
        • LexMedica
    • Kujawsko-pomorskie
      • Bydgoszcz, Kujawsko-pomorskie, Poland, 85-168
        • Szpital Uniwersytecki Nr 2 im. dr J. Biziela w Bydgoszczy
      • Bydgoszcz, Kujawsko-pomorskie, Poland, 85-796
        • Centrum medyczne Pratia Bydgoszcz
    • Lubelskie
      • Lublin, Lubelskie, Poland, 20-582
        • ZOZ Gastromed
      • Lublin, Lubelskie, Poland, 20-954
        • Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
    • Mazowieckie
      • Warszawa, Mazowieckie, Poland, 03-580
        • NZOZ Vivamed
    • Małopolskie
      • Krakow, Małopolskie, Poland, 31-506
        • Topolowa Medicenter
      • Nowy Targ, Małopolskie, Poland, 34-400
        • Medicenter Nowy Targ
      • Wadowice, Małopolskie, Poland, 34-100
        • NZOZ Formed
    • Pomorskie
      • Sopot, Pomorskie, Poland, 81-756
        • Endoskopia sp z o. o
    • Zachodniopomorskie
      • Szczecin, Zachodniopomorskie, Poland, 71-685
        • SONOMED Centrum Medyczne
    • Świętokrzyskie
      • Staszow, Świętokrzyskie, Poland, 28-200
        • KO-Med Centrum Medyczne
  • Romania
      • Bucuresti, Romania, 020125
        • Spitalul Clinic Colentina
      • Bucuresti, Romania, 022328
        • Institutul Clinic Fundeni
      • Bucuresti, Romania, 010719
        • MedLife Grivita
      • Bucuresti, Romania, 031864
        • Hifu Terramed Conformal SRL
      • Bucuresti, Romania, 040055
        • Centrul Medical Unirea SRL
      • Oradea, Romania, 410469
        • Spital Pelican Oradea
    • București
      • Bucharest, București, Romania, 030463
        • CCBR Clinical Research
  • Russian Federation
      • Barnaul, Russian Federation, 656043
        • Multidisciplinary Medical Clinic "Anthurium"
      • Cherepovets, Russian Federation, 162600
        • Medical and Sanitary Division of Severstal
      • Ekaterinburg, Russian Federation, 620109
        • LLC MA New Hospital
      • Izhevsk, Russian Federation, 426061
        • Alliance Biomedical URAL Group
      • Kaliningrad, Russian Federation, 236035
        • Clinical Trials Center of Medical Institute
      • Kazan, Russian Federation, 420064
        • State Autonomous Institution of Healthcare "Republican Clinical Hospital of the Ministry of Healthcare of Republic Tatarstan"
      • Kemerovo, Russian Federation, 650066
        • SIH Kemerovo Regional Clinical Hosptial
      • Krasnodar, Russian Federation, 350000
        • SBHI Regional Clinical Hospital #2 MoH of Krasnodar region
      • Moscow, Russian Federation, 125367
        • Medical rehabilitation center
      • Novosibirsk, Russian Federation, 630005
        • LLC "Medicine Center SibNovoMed"
      • Omsk, Russian Federation, 644024
        • Clinical Diagnostic Center Ultramed
      • Saint Petersburg, Russian Federation, 197022
        • Saint Petersburg State Medical University n.a. Pavlov I.P.
      • Saint-Petersburg, Russian Federation, 195067
        • Pokrovskaya Municipal Hospital
      • Saint-Petersburg, Russian Federation, 197110
        • SBIH City Clinical Hospital #31
      • Saint-Petersburg, Russian Federation, 197110
        • LLC Gastroenterology Centre Expert
      • Saint-Petersburg, Russian Federation, 195271
        • Non-state Healthcare Institution "Roadway Clinical Hospital of OJSC Russian Railways"
      • Samara, Russian Federation, 443001
        • Medical Institute REAVIZ
      • St. Petersburg, Russian Federation, 191104
        • City Mariinskaya Hospital
      • St. Petersburg, Russian Federation, 195257
        • Saint-Petersburg City Hospital of Saint Elizabeth
      • St. Petersburg, Russian Federation, 199147
        • OOO "OrKli"
      • Stavropol, Russian Federation, 355018
        • Stavropol State Medical Academy
      • Tosno, Russian Federation, 187000
        • SBI of Healthcare of Leningrad region "Clinical Interregional Hospital of Tosno
      • Yaroslavl, Russian Federation, 150030
        • Yaroslavl Municipal HI Clinical Hospital #8
    • Irkutskaya Oblast'
      • Irkutsk, Irkutskaya Oblast', Russian Federation, 664079
        • Scientific Centre of Reconstructive and Restorative Surgery
    • Kareliya, Respublika
      • Petrozavodsk, Kareliya, Respublika, Russian Federation, 185019
        • Karelia Republican Hospital V.A. Baranova
    • Nizhegorodskaya Oblast'
      • Nizhniy Novgorod, Nizhegorodskaya Oblast', Russian Federation, 603126
        • Nizhny Novgorod Regional Hospital N.A. Semashko
      • Nizhniy Novgorod, Nizhegorodskaya Oblast', Russian Federation, 603140
        • Private Healthcare Institution Clinical Hospital Russian Railways - Medicine of Nizhniy Novgorod
    • Novosibirskaya Oblast'
      • Novosibirsk, Novosibirskaya Oblast', Russian Federation, 630007
        • Novosibirsk GastroCenter
    • Rostovskaya Oblast'
      • Rostov-on-Don, Rostovskaya Oblast', Russian Federation, 344091
        • Rostov State Medical University
    • Sankt-Peterburg
      • St. Petersburg, Sankt-Peterburg, Russian Federation, 196143
        • Scientific research center ECO-security
  • Serbia
      • Belgrade, Serbia, 11000
        • Clinical Hospital Center Zvezdara
      • Kragujevac, Serbia, 34000
        • Clinical Center Kragujevac
      • Kragujevac, Serbia, 34000
        • Clinical Center Kragujevac Gastroenterohepatology Clinic
      • Uzice, Serbia, 31000
        • General Hospital Uzice
    • Beograd
      • Zemun, Beograd, Serbia, 11080
        • Zemun Medical Centre
    • NAP
      • Belgrade, NAP, Serbia, 11080
        • University Medical Center "Bezanijska kosa"
    • Vojvodina
      • Sombor, Vojvodina, Serbia, 25000
        • Regional Hospital Dr Radivoj Simonovic Sombor
      • Sremska Mitrovica, Vojvodina, Serbia, 22000
        • Sremska Mitrovica Health Centre
      • Zrenjanin, Vojvodina, Serbia, 23000
        • General Hospital "Djordje Joanovic"
  • Slovakia
      • Banska Bystrica, Slovakia, 975 17
        • Fakultna nemocnica s poliklinikou Roosevelta Banska Bystrica
      • Bratislava, Slovakia, 82007
        • Univerzitna nemocnica Bratislava
      • Bratislava, Slovakia, 813 69
        • Univerzitna nemocnica Bratislava-Nemocnica Stare Mesteo
    • Nitriansky Kraj
      • Nitra, Nitriansky Kraj, Slovakia, 94901
        • KM Management
    • Prešovský Kraj
      • Prešov, Prešovský Kraj, Slovakia, 08001
        • Gastro
      • Vranov N. Toplou, Prešovský Kraj, Slovakia, 09301
        • Endomed, s.r.o.
    • Slovak Republic
      • Bardejov, Slovak Republic, Slovakia, 08501
        • ALIAN, s.r.o.
  • Spain
      • Alicante, Spain, 03004
        • Instituto de Ciencias Médicas
      • Cordoba, Spain, 14004
        • Hospital Universitario Reina Sofia Comite Etico
      • Girona, Spain, 17007
        • Hospital Universitari de Girona
      • Huelva, Spain, 21005
        • Hospital Universitario Juan Ramón Jiménez
      • La Coruña, Spain, 15006
        • Complexo Hospitalario Universitario A Coruña, CHUAC
      • Las Palmas de Gran Canaria, Spain, 35010
        • Hospital de Gran Canaria Dr. Negrín
      • Madrid, Spain, 28046
        • Hospital Universitario La Paz
    • Andalucía
      • Sevilla, Andalucía, Spain, 41013
        • Hospital Universitario Virgen del Rocío
    • Asturias
      • Oviedo, Asturias, Spain, 3306
        • Hospital Universitario Central de Asturias
    • Baleares Islands
      • Palma de Mallorca, Baleares Islands, Spain, 07120
        • Hospital Universitari Son Espases
    • Cantabria
      • Santander, Cantabria, Spain, 39008
        • Hospital Universitario Marqués de Valdecilla
    • Madrid
      • Fuenlabrada, Madrid, Spain, 28942
        • Hospital De Fuenlabrada
    • Navarra
      • Pamplona, Navarra, Spain, 31008
        • Complejo Hospitalario de Navarra
    • Valencia
      • Sagunto, Valencia, Spain, 46520
        • Hospital de Sagunto y C.E.
  • Switzerland
      • Bern, Switzerland, 3010
        • Inselspital Bern
      • Bern, Switzerland, 3012
        • Gastroenterologische Praxis Balsiger, Seibold & Partner
      • St.Gallen, Switzerland, 9007
        • Kantonsspital St.Gallen
      • Zürich, Switzerland, 8091
        • Universitätsspital Zürich
  • Taiwan
      • Changhua, Taiwan, 500
        • Changhua Christian Hospital
      • Taichung, Taiwan, 40447
        • China Medical University Hospital
      • Taipei, Taiwan, 10002
        • Health management center
  • Turkey
      • Izmir, Turkey, 35100
        • Ege Universitesi Hastanesi
    • Ankara
      • Besevler, Ankara, Turkey, 65600
        • Gazi University Faculty of Medicine
      • Sihhiye, Ankara, Turkey, 6100
        • Hacettepe University Faculty of Medicine
    • Antayla
      • Kocaeli, Antayla, Turkey, 7100
        • Antalya Egitim ve Arastırma Hastanesi
    • Istanbul
      • Kadıkoy, Istanbul, Turkey, 34734
        • Acibadem Universitesi - Acibadem Kozyatagi Hastanesi
    • Kocaeli
      • Izmit, Kocaeli, Turkey, 41380
        • Kocaeli University Medical Faculty Hospital
    • Mersin
      • Yenişehir, Mersin, Turkey, 33110
        • Mersin University Medical Faculty
  • Ukraine
      • Dnipro, Ukraine, 49038
        • Medical Center of Limited Liability Company Medical Center Clinic of Family Medicine
      • Kharkiv, Ukraine, 61039
        • GI L.T. Malaya TI Namsu
      • Kharkiv, Ukraine, 61002
        • Kharkiv City Student Hospital
      • Kropyvnytskyi, Ukraine, 25006
        • Treatment-Diagnostic Center of Private Enterprise of PPC Atsynus
      • Kyiv, Ukraine, 02091
        • Kyiv Municipal Clinical Hospital #1
      • Kyiv, Ukraine, 04107
        • Communal institution of the Kyiv Regional Council "Kyiv Regional Clinical Oncology Dispensary"
      • Kyiv, Ukraine, 04078
        • Communal institution of the Kyiv Regional Council "Kyiv Regional Clinical Oncology Dispensary"
      • Odesa, Ukraine, 65000
        • Communal Enterprise "Odesa Regional Clinical Hospital"
      • Uzhgorod, Ukraine, 88000
        • A. Novak Transcarpathian Regional Clinical Hospital
      • Vinnytsia, Ukraine, 21029
        • CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM
      • Vinnytsia, Ukraine, 21005
        • Vinnytsia RCH of Veterans of War Dept of Therapy#1 Vinnytsia M.I.Pyrogov NMU
      • Vinnytsia, Ukraine, 21009
        • MCIC MC LLC Health Clinic
      • Vinnytsia, Ukraine, 21029
        • Private Small Enterprise, Medical Center Pulse
      • Vinnytsya, Ukraine, 21018
        • M.I. Pyrogov Regional Clinical Hospital
      • Zaporizhzhia, Ukraine, 69104
        • Communal Institution of Kyiv Regional Council Kyiv Regional Hospital #2
    • Ivano-Frankivsk Region
      • Ivano-Frankivsk, Ivano-Frankivsk Region, Ukraine, 76008
        • Ivano-Frankivsk Regional Clinical Hospital
    • Kharkivska Oblast
      • Kharkiv, Kharkivska Oblast, Ukraine, 61037
        • City Clinical Hospital #2
    • Khersonska Oblast
      • Kherson, Khersonska Oblast, Ukraine, 73000
        • Kherson City Clinical Hospital
    • Kyiv
      • Kiev, Kyiv, Ukraine, 04050
        • Medical Center of Limited Liability Company "Medical Center "Consilium Medical"
    • Lvivska Oblast
      • Liviv, Lvivska Oblast, Ukraine, 79000
        • Lviv Regional Endocrinology Dispensary
      • Lviv, Lvivska Oblast, Ukraine, 79000
        • Lviv Railway Clinical Hospital
      • Lviv, Lvivska Oblast, Ukraine, 79000
        • Municipal non-profit enterprise "Lviv Territorial Medical Union "Multidisciplinary Clinical Hospital of Em -T
    • Poltavska Oblast
      • Poltava, Poltavska Oblast, Ukraine, 36000
        • Poltova Oblast Clinical Hospital IM.M.V.Sklifosovskoho
    • Zaporizka Oblast
      • Zaporizhzhia, Zaporizka Oblast, Ukraine, 69076
        • Diaservis - Medical and Diagnostic Center
  • United Kingdom
      • Glasgow, United Kingdom, G51 4TF
        • Queen Elizabeth University Hospital
    • Essex
      • Romford, Essex, United Kingdom, RM7 0AG
        • Queens Hospital
    • Great Britain
      • Bury, Great Britain, United Kingdom, BL9 7TD
        • Fairfield General Hospital
    • Hants
      • Winchester, Hants, United Kingdom, SO22 5DG
        • Royal Hampshire County Hospital
    • London
      • Great Maze Pond, London, United Kingdom, SE1 9RT
        • St Thomas' Hospital
    • Scotland
      • Dundee, Scotland, United Kingdom, DD1 9SY
        • Ninewells Hospital
    • Surrey
      • London, Surrey, United Kingdom, E11 1NR
        • Whipps Cross University Hospital
    • Swansea [Abertawe Gb-ata]
      • Swansea, Swansea [Abertawe Gb-ata], United Kingdom, SA6 6SG
        • Morriston Hospital
    • Vinnytsia
      • Leeds, Vinnytsia, United Kingdom, LS9 7TF
        • St James's University Hospital
  • United States
    • Alabama
      • Dothan, Alabama, United States, 36305
        • Digestive Health Specialists Of The Southeast
    • Arizona
      • Litchfield Park, Arizona, United States, 85340
        • Dcr-Pi, Pc
      • Phoenix, Arizona, United States, 85008
        • Maricopa Integrated Health System
      • Tempe, Arizona, United States, 85284
        • Physicians Research Group
      • Yuma, Arizona, United States, 85364
        • Yuma Gastro LLC
    • California
      • Arcadia, California, United States, 91006
        • Valley Gastroenterology
      • Berkeley, California, United States, 94705
        • Care Access Research
      • Covina, California, United States, 91722
        • Citrus Valley Health Partners
      • Garden Grove, California, United States, 92843
        • Valley View Internal Medicine
      • Lancaster, California, United States, 93534
        • Om Research, LLC
      • Montclair, California, United States, 91763
        • Catalina Research Institute, LLC
      • Northridge, California, United States, 91324
        • California Medical Research Associates
      • Pasadena, California, United States, 91105
        • Gastroenterology Associates
      • San Diego, California, United States, 92103
        • Clinical Applications Laboratories, Inc.
      • San Francisco, California, United States, 94158
        • UCSF Medical Center at Mission Bay
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado
      • Colorado Springs, Colorado, United States, 80918
        • Delta Waves Sleep Disorders and Research Center
    • Florida
      • Clearwater, Florida, United States, 33756
        • Gastroenterology Consultants of Clearwater
      • Clearwater, Florida, United States, 33761
        • West Central Gastroenterology d/b/a Gastro Florida
      • Clearwater, Florida, United States, 33765
        • Clinical Research of West Florida, Inc. (Clearwater)
      • Coral Springs, Florida, United States, 33067
        • Pioneer Clinical Research
      • Hialeah, Florida, United States, 33012
        • Direct Helpers Medical Center
      • Hollywood, Florida, United States, 33021
        • The Center for Gastrointestinal Disorders
      • Inverness, Florida, United States, 34452
        • Nature Coast Clinical Research, LLC
      • Kissimmee, Florida, United States, 34741
        • SIH Research, LLC
      • Miami, Florida, United States, 33134
        • Research Associates of South Florida, LLC
      • Miami, Florida, United States, 33125
        • Columbus Clinical Services, LLC
      • Miami, Florida, United States, 33176
        • IMIC, Inc.
      • Miami Lakes, Florida, United States, 33016
        • Wellness Clinical Research
      • Miami Lakes, Florida, United States, 33014
        • Life Medical Center & Research, Inc
      • Miami Lakes, Florida, United States, 33014
        • Inpatient Research Clinic, LLC
      • Naples, Florida, United States, 34110
        • Pharma Research International, Inc.
      • Orlando, Florida, United States, 32818
        • Clintheory Healthcare
      • Orlando, Florida, United States, 32803
        • Center for Interventional Endoscopy
      • Pensacola, Florida, United States, 32503
        • Gastroenterology Associates of Pensacola, PA
      • Saint Petersburg, Florida, United States, 33709
        • Florida Digestive Specialist
      • Zephyrhills, Florida, United States, 33542-7505
        • Florida Medical Clinic LLC
    • Georgia
      • Atlanta, Georgia, United States, 30309
        • Digestive Healthcare of Georgia
      • Columbus, Georgia, United States, 31904
        • Gastrointestinal Diseases Research
      • Suwanee, Georgia, United States, 30024
        • Atlanta Gastroenterology Specialists, PC
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Grand Teton Research Group
    • Illinois
      • Evanston, Illinois, United States, 60201
        • Northshore University Healthsystem
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University School of Medicine
    • Iowa
      • Clive, Iowa, United States, 50325
        • Iowa Digestive Disease Center
    • Kansas
      • Topeka, Kansas, United States, 66606
        • Cotton-O'Neil Clinical Research Center, Digestive Health
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Texas Digestive Disease Consultants
      • Lake Charles, Louisiana, United States, 70601
        • Clinical Trials of SWLA, LLC
      • Monroe, Louisiana, United States, 71201
        • Delta Research Partners LLC
      • New Orleans, Louisiana, United States, 70125
        • Nola Research Works, LLC
      • New Orleans, Louisiana, United States, 70112 2715
        • Tulane Univ School of Med
    • Michigan
      • Chesterfield, Michigan, United States, 48047
        • Clinical Research Institute of Michigan, LLC
      • Novi, Michigan, United States, 48377
        • Henry Ford Health System
      • Wyoming, Michigan, United States, 49519
        • Gastroenterology Associates of Western Michigan, P.L.C.
      • Ypsilanti, Michigan, United States, 48197
        • Huron Gastroenterology Associates
    • Minnesota
      • Plymouth, Minnesota, United States, 55446
        • MNGI Digestive Health - Plymouth Endoscopy Center & Clinic
    • Mississippi
      • Jackson, Mississippi, United States, 39206
        • Care Access Research LLC
      • Tupelo, Mississippi, United States, 38801
        • Digestive Health Specialists
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University Medical School
    • New Jersey
      • Pennington, New Jersey, United States, 08534
        • Capital Health Medical Center Hopewell
    • New York
      • Great Neck, New York, United States, 11021
        • Northwell Health
      • Lake Success, New York, United States, 11042
        • NYU Langone Long Island Clinical Research Associates
      • New York, New York, United States, 10021
        • Weill Cornell Medical College
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina
      • Greenville, North Carolina, United States, 27834
        • Carolina Digestive Diseases and Endoscopy Center
      • Winston-Salem, North Carolina, United States, 27157-1045
        • Wake Forest University School of Medicine
    • North Dakota
      • Minot, North Dakota, United States, 58701
        • Trinity Health Center Medical Arts
    • Ohio
      • Dayton, Ohio, United States, 45432
        • Meta Medical Research Institute, LLC
      • Middleburg Heights, Ohio, United States, 44130
        • Paramount Medical Research
      • Poland, Ohio, United States, 44514
        • Care Access Research - Youngstown
      • Westlake, Ohio, United States, 44145
        • Great Lakes Medical Research, LLC
    • Oklahoma
      • Norman, Oklahoma, United States, 73071
        • Central Sooner Research
      • Oklahoma City, Oklahoma, United States, 73104
        • University of Oklahoma Health Sciences Center
    • Pennsylvania
      • Wyomissing, Pennsylvania, United States, 19610
        • Digestive Disease Associates
    • Rhode Island
      • Lincoln, Rhode Island, United States, 02865
        • Ocean State Clinical Research Partners
    • South Carolina
      • Mauldin, South Carolina, United States, 29662
        • Invocare Clinical Research Center
      • West Columbia, South Carolina, United States, 29169
        • Invocare Clinical Research Center
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57108
        • Midwest Medical Care
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Gastro One
      • Hixson, Tennessee, United States, 37343
        • Galen Medical Group
      • Nashville, Tennessee, United States, 37232
        • Vanderbilt University Medical Center
    • Texas
      • Galveston, Texas, United States, 77555
        • University of Texas Medical Branch at Galveston
      • Garland, Texas, United States, 75044
        • Digestive Health Associates of Texas
      • Houston, Texas, United States, 77030
        • Houston Methodist Research Ins
      • Houston, Texas, United States, 77043
        • Biopharma Informatic, Inc.
      • San Antonio, Texas, United States, 78229
        • Southern Star Research Institute, LLC
      • San Antonio, Texas, United States, 78249
        • Bandera Family Health Care
      • San Antonio, Texas, United States, 78229
        • Gastroenterology Research of San Antonio
      • Southlake, Texas, United States, 76092
        • Texas Digestive Disease Consultants
      • Webster, Texas, United States, 77598
        • GI and Liver Research, LLC
    • Utah
      • Ogden, Utah, United States, 84403
        • Care Access Research LLC - Salt Lake City
      • Salt Lake City, Utah, United States, 84124
        • Care Access Research LLC - Salt Lake City
    • Virginia
      • Leesburg, Virginia, United States, 20176
        • Emeritas Research Group
      • Lynchburg, Virginia, United States, 24502
        • Blue Ridge Medical Research
      • Reston, Virginia, United States, 20191
        • The Gastroenterology Group, P.C.
      • Roanoke, Virginia, United States, 24016
        • Carilion Clinic
    • Washington
      • Seattle, Washington, United States, 98195-6424
        • University of Washington Medical Center
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Wisconsin Center for Advanced Research
      • Milwaukee, Wisconsin, United States, 53226
        • Allegiance Research Specialists, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 76 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Diagnosis of UC for at least 3 months prior to baseline.
  • Confirmed diagnosis of moderately or severely active UC, as assessed by the modified Mayo score (MMS).
  • Demonstrated an inadequate response to, a loss of response to, or an intolerance to conventional or to biologic therapy for UC.
  • If female, must meet the contraception requirements.

Exclusion Criteria:

  • Participants with a current diagnosis of Crohn's disease or inflammatory bowel disease-unclassified (indeterminate colitis).
  • Participants with a previous colectomy.
  • Participants with current evidence of toxic megacolon.
  • Prior exposure to anti-IL12p40 antibodies (e.g. ustekinumab) or anti-IL-23p19 antibodies (e.g. risankizumab, brazikumab, guselkumab or tildrakizumab).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo Intravenous (IV) Every 4 Weeks (Q4W)
Placebo given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.
Drug: Placebo
Administered IV
Experimental: 300 Milligram (mg) Mirikizumab IV Q4W
300 mg mirikizumab given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.
Drug: Mirikizumab
Administered IV
Other Names:
  • LY3074828
Placebo Comparator: Placebo IV Q4W Maximum Extended Enrollment (ME2)
Placebo given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.
Drug: Placebo
Administered IV
Experimental: 300 mg Mirikizumab IV Q4W ME2
300 mg mirikizumab given as an IV infusion Q4W on Weeks 0, 4, 8 for 12 weeks.
Drug: Mirikizumab
Administered IV
Other Names:
  • LY3074828

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Clinical Remission at Week 12
Time Frame: Week 12

Clinical remission at week 12 is defined as achieving a modified Mayo score (MMS) subscore for rectal bleeding=0, stool frequency=0 or 1 with ≥ 1 point decrease from baseline, and endoscopy=0 or 1 (excluding friability), excluding consideration of Physician's Global Assessment (PGA).

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).

The confidence interval of 99.88% was chosen to match the significance level.
Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Symptomatic Response at Week 12
Time Frame: Week 12

Symptomatic response at week 12 is defined as ≥30% decrease from baseline in the sum of stool frequency and rectal bleeding 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). The sum of stool frequency and rectal bleeding subscores ranges from 0 to 6.
Week 12
Percentage of Participants With Histologic Remission at Week 12
Time Frame: Week 12
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 12
Percentage of Participants With Endoscopic Response at Week 12
Time Frame: Week 12

Endoscopic response at week 12 is defined as achieving at least a 1 point decrease from baseline in the Mayo endoscopic subscore.

The Mayo endoscopic subscore ranges from 0 to 3 points, with higher scores representing more severe disease.
Week 12
Change From Baseline to Week 12 in Bowel Urgency Based on the Urgency Numeric Rating Scale (NRS)
Time Frame: Baseline, Week 12
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), baseline disease activity (MMS: [4-6] or [7-9]), and region (North America/Europe/Other).
Baseline, Week 12
Change From Baseline to Week 12 in Health Related Quality of Life: Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score
Time Frame: Baseline, Week 12
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 (Guyatt et al. 1989). 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), baseline corticosteroid use (yes/no), baseline disease activity (MMS: [4-6] or [7-9]), and region (North America/Europe/Other).
Baseline, Week 12
Change From Baseline to Week 12 in Fecal Calprotectin
Time Frame: Baseline, Week 12
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 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), baseline disease activity (MMS: [4-6] or [7-9]), and region (North America/Europe/Other).
Baseline, Week 12
Pharmacokinetics (PK): Clearance of Mirikizumab
Time Frame: Predose on week 0, week 4, week 8 and post dose on week 0, 4 and 12
Clearance of mirikizumab was evaluated. Clearance is estimated based on concentration data collected in the time frame of 0-12 weeks.
Predose on week 0, week 4, week 8 and post dose on week 0, 4 and 12
Percentage of Participants With Clinical Response at Week 12
Time Frame: Week 12
Clinical response at week 12 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).The MMS ranges from 0 to 9 points,with higher scores representing more severe disease. The confidence interval of 99.88% was chosen to match the significance level.
Week 12
Percentage of Participants With Endoscopic Remission at Week 12
Time Frame: Week 12

Endoscopic remission at week 12 is defined as achieving a Mayo endoscopic subscore of 0 or 1 (excluding friability) at Week 12. Endoscopy subscore is based on colonoscopy or sigmoidoscopy and scored from 0 (normal or inactive disease) to 3 (severe disease, spontaneous bleeding, ulceration);

The Mayo endoscopic score ranges from 0 to 3 points, with higher scores representing more severe disease.

The confidence interval of 99.88% was chosen to match the significance level.
Week 12
Percentage of Participants With Symptomatic Remission at Week 12
Time Frame: Week 12

Symptomatic remission at week 12 is defined as a Mayo subscore 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).

The confidence interval of 99.88% was chosen to match the significance level.
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

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

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 18, 2018

Primary Completion (Actual)

January 21, 2021

Study Completion (Actual)

May 15, 2024

Study Registration Dates

First Submitted

May 4, 2018

First Submitted That Met QC Criteria

May 4, 2018

First Posted (Actual)

May 8, 2018

Study Record Updates

Last Update Posted (Actual)

May 31, 2025

Last Update Submitted That Met QC Criteria

May 14, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16591
  • I6T-MC-AMAN (Other Identifier: Eli Lilly and Company)
  • 2017-003229-14 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

IPD Sharing Time Frame

Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

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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