A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease (VIVID-2)

April 16, 2024 updated by: Eli Lilly and Company

A Phase 3, Multicenter, Open-Label, Long-Term Extension Study to Evaluate the Long-Term Efficacy and Safety of Mirikizumab in Patients With Crohn's Disease

The reason for this study is to determine the long-term efficacy and safety of the study drug mirikizumab in participants with Crohn's disease.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

778

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 Contact

  • Name: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
  • Phone Number: 1-317-615-4559
  • Email: clinicaltrials.gov@lilly.com

Study Locations

  • Argentina
      • Ciudad Autónoma de Buenos Aires, Argentina, C1111
        • Recruiting
        • DOM Centro de Reumatología
        • Principal Investigator:
          • Fernanda Dorado
  • Australia
    • New South Wales
      • Concord, New South Wales, Australia, 2139
        • Recruiting
        • Concord Repatriation General Hospital
        • Principal Investigator:
          • Rupert Leong
      • Sydney, New South Wales, Australia, 2010
        • Recruiting
        • St Vincent's Hospital
        • Principal Investigator:
          • Simon Ghaly
    • Queensland
      • Brisbane, Queensland, Australia, 4029
        • Recruiting
        • Royal Brisbane and Women'S Hospital
        • Principal Investigator:
          • Anthony Croft
      • Maroochydore, Queensland, Australia, 4558
        • Recruiting
        • Coastal Digestive Health
        • Principal Investigator:
          • Hansjoerg Seltenreich
    • South Australia
      • Adelaide, South Australia, Australia, 5000
        • Recruiting
        • Royal Adelaide Hospital
        • Principal Investigator:
          • Abdul Shaikh
    • Victoria
      • Parkville, Victoria, Australia, 3050
        • Recruiting
        • The Royal Melbourne Hospital
        • Principal Investigator:
          • Britt Christensen
        • Contact:
          • Phone Number: 61393479911
    • Western Australia
      • Murdoch, Western Australia, Australia, 6150
        • Recruiting
        • Fiona Stanley Hospital
        • Principal Investigator:
          • Lena Thin
  • Austria
      • Salzburg, Austria, 5020
        • Active, not recruiting
        • Uniklinikum Salzburg
    • Tirol
      • Innsbruck, Tirol, Austria, 6020
        • Active, not recruiting
        • Medizinische Universitaet Innsbruck
    • Wien
      • Vienna, Wien, Austria, 1090
        • Active, not recruiting
        • Medizinische Universität Wien
  • Belgium
    • Antwerpen
      • Bonheiden, Antwerpen, Belgium, 2930
        • Active, not recruiting
        • Imelda General Hospital
    • Bruxelles-Capitale, Région De
      • Brussels, Bruxelles-Capitale, Région De, Belgium, 1070
        • Active, not recruiting
        • Université Libre de Bruxelles - Hôpital Erasme
    • Oost-Vlaanderen
      • Gent, Oost-Vlaanderen, Belgium, 9000
        • Active, not recruiting
        • UZ Gent
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • Completed
        • UZ Leuven
  • Brazil
      • São Paulo, Brazil, 01228-000
        • Recruiting
        • CPQuali Pesquisa Clínica
        • Principal Investigator:
          • Alexandre de Sousa Carlos
      • São Paulo, Brazil, 04543-011
        • Recruiting
        • Clínica Hepatogastro JK
        • Principal Investigator:
          • Rodrigo Andrey Rocco
      • São Paulo, Brazil, 04038-034
        • Recruiting
        • Instituto de Assistência Médica ao Servidor Público Estadual - IAMSPE/HSPE-FMO Conhecer Centro de Oncolog -T
        • Principal Investigator:
          • Debora Dourado Poli
    • Bahia
      • Salvador, Bahia, Brazil, 41500-300
        • Recruiting
        • CLIAGEN Clínica de Atenção em Gastroenterologia, Especialidades e Nutrição
        • Principal Investigator:
          • Genoile Oliveira Santana Silva
    • Distrito Federal
      • Brasília, Distrito Federal, Brazil, 72145-450
        • Recruiting
        • Chronos Pesquisa Clínica
        • Principal Investigator:
          • Cintia Mendes Clemente
      • Brasília, Distrito Federal, Brazil, 70200-730
        • Recruiting
        • L2IP - Instituto de Pesquisas Clínicas - FC072920211954380192
        • Principal Investigator:
          • Luciana Campos Teixeira de Campos
    • Minas Gerais
      • Belo Horizonte, Minas Gerais, Brazil, 30110-934
        • Recruiting
        • Hospital Felicio Rocho
        • Principal Investigator:
          • Carolina de Paula Guimaraes Baia
    • Rio Grande Do Sul
      • Caxias do sul, Rio Grande Do Sul, Brazil, 95070-560
        • Recruiting
        • Instituto de Pesquisas em Saúde (IPS)
        • Principal Investigator:
          • Eduardo Brambilla
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
        • Recruiting
        • Hospital de Clinicas de Porto Alegre
        • Principal Investigator:
          • Carlos Francesconi
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90560-030
        • Recruiting
        • Hospital Moinhos de Vento
        • Principal Investigator:
          • Jonathas Stifft
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90430-001
        • Not yet recruiting
        • Núcleo de Pesquisa Clínica do Rio Grande do Sul
        • Principal Investigator:
          • Cristina Flores
    • São Paulo
      • Botucatu, São Paulo, Brazil, 18618-686
        • Recruiting
        • Faculdade de Medicina da UNESP
        • Principal Investigator:
          • LIGIA SASSAKI
      • Campinas, São Paulo, Brazil, 13034-685
        • Recruiting
        • Centro de Pesquisa Sao Lucas
        • Principal Investigator:
          • Joaquim Simoes Neto
      • Santo Andre, São Paulo, Brazil, 09790790
        • Recruiting
        • Praxis Pesquisa Medica
        • Principal Investigator:
          • Marcelo Rodrigues Bacci
      • Santo André, São Paulo, Brazil, 09080-110
        • Recruiting
        • Pesquisare Saude
        • Principal Investigator:
          • ALEXANDER DE SA ROLIM
      • Sao Bernardo do Campo, São Paulo, Brazil, 09715-090
        • Recruiting
        • Centro Multidisciplinar de Estudos Clinicos
        • Principal Investigator:
          • Sandra Di Felice Boratto
      • Sao Paulo, São Paulo, Brazil, 01308-060
        • Recruiting
        • Hospital Sírio Libanês
        • Principal Investigator:
          • Alexandre de Sousa Carlos
  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T5R 1W2
        • Recruiting
        • Gastroenterology and internal medicine research institute
        • Principal Investigator:
          • Allen Lim
    • British Columbia
      • Vancouver, British Columbia, Canada, V5Z 2K5
        • Recruiting
        • GIRI GI Research Institute - Vancouver
        • Principal Investigator:
          • Greg Rosenfeld
    • Nova Scotia
      • Kentville, Nova Scotia, Canada, B4N 0A3
        • Recruiting
        • Private Practice- Dr Chadwick Williams
        • Principal Investigator:
          • Bruce Musgrave
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • Recruiting
        • Victoria Hospital
        • Contact:
          • Phone Number: 5196675977
        • Principal Investigator:
          • Terry Ponich
      • North Bay, Ontario, Canada, P1B 2H3
        • Recruiting
        • Private Practice - Dr. Stephane M. Gauthier
        • Principal Investigator:
          • Stephane Gauthier
  • China
      • Fuzhou, China, 350005
        • Recruiting
        • The First Affiliated Hospital of Fujian Medical University
        • Principal Investigator:
          • Chengdang Wang
    • Anhui
      • Hefei, Anhui, China, 230071
        • Recruiting
        • Anhui Provincial Hospital
        • Principal Investigator:
          • Kaiguang Zhang
    • Chongqing
      • Chongqing, Chongqing, China, 400014
        • Recruiting
        • Chongqing General Hospital
        • Principal Investigator:
          • Hong Guo
    • Fujian
      • Xiamen, Fujian, China, 350001
        • Recruiting
        • Zhongshan Hospital Affiliated to Xiamen University
        • Principal Investigator:
          • Lin WANG
    • Guangdong
      • Foshan, Guangdong, China, 528041
        • Recruiting
        • The First People's Hospital of Foshan
        • Principal Investigator:
          • Zhaotao Li
      • Guangzhou, Guangdong, China, 510655
        • Recruiting
        • The Sixth Affiliated Hospital of Sun Yat-sen University
        • Principal Investigator:
          • Xiang Gao
      • Guangzhou, Guangdong, China
        • Recruiting
        • The First Affiliated Hospital, Sun Yat-sen University
        • Principal Investigator:
          • Baili Chen
    • Hubei
      • Wuhan, Hubei, China, 430030
        • Recruiting
        • Tongji Hospital Tongji Medical,Science & Technology
        • Principal Investigator:
          • Mei Liu
    • Hunan
      • Changsha, Hunan, China, 410008
        • Recruiting
        • Xiangya Hospital Central South University
        • Principal Investigator:
          • Xiaowei Liu
      • Changsha, Hunan, China, 410013
        • Recruiting
        • The Third Xiangya Hospital of Central South University
        • Principal Investigator:
          • Xiaoyan WANG
      • Changsha, Hunan, China, 410011
        • Recruiting
        • The Second Xiangya Hospital of Central South University
        • Principal Investigator:
          • Deliang Liu
    • Jiangsu
      • Changzhou, Jiangsu, China, 213003
        • Recruiting
        • The First People's Hospital of Changzhou
        • Principal Investigator:
          • Mei WANG
      • Changzhou, Jiangsu, China, 213004
        • Recruiting
        • Changzhou No.2 People's Hospital
        • Contact:
          • Phone Number: 0086051988104931
        • Principal Investigator:
          • Wenjia LIU
      • Nanjing, Jiangsu, China, 210029
        • Recruiting
        • Jiangsu Province Hospital of Chinese Medicine
        • Principal Investigator:
          • Hong SHEN
      • Suzhou, Jiangsu, China, 215004
        • Recruiting
        • The Second Affiliated Hospital of Soochow University
        • Principal Investigator:
          • Wen Tang
      • Wuxi, Jiangsu, China, 214023
        • Recruiting
        • Wuxi People's Hospital
        • Principal Investigator:
          • Qiang Zhan
      • Zhenjiang, Jiangsu, China, 212000
        • Recruiting
        • Affiliated Hospital of Jiangsu University
        • Principal Investigator:
          • Min Xu
    • Jiangxi
      • Nanchang, Jiangxi, China, 330006
        • Recruiting
        • The first affiliated Hospital of Nanchang University
        • Principal Investigator:
          • Youxiang Chen
    • Liaoning
      • Shenyang, Liaoning, China, 110004
        • Recruiting
        • Shengjing Hospital of China Medical University
        • Principal Investigator:
          • Chang Qing ZHENG
    • Shanghai
      • Shanghai, Shanghai, China
        • Recruiting
        • Shanghai Jiaotong University School of Medicine Ruijin Hospital
        • Principal Investigator:
          • Jie Zhong
    • Sichuan
      • Cheng Du, Sichuan, China, 610041
        • Recruiting
        • West China Hospital of Sichuan University
        • Principal Investigator:
          • Yufang WANG
    • Yunnan
      • Kunming, Yunnan, China, 650032
        • Recruiting
        • First Affiliated Hospital of Kunming Medical University
        • Principal Investigator:
          • hairong zhang
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310016
        • Recruiting
        • Sir Run Run Shaw Hospital
        • Principal Investigator:
          • Qian Cao
      • Hangzhou, Zhejiang, China, 310003
        • Recruiting
        • The First Affiliated Hospital, Zhejiang University
        • Principal Investigator:
          • Chunxiao Chen
      • Hangzhou, Zhejiang, China, 310052
        • Recruiting
        • The Second Affiliated Hospital of Zhejiang University School of Medicine
        • Principal Investigator:
          • Yan Chen
      • Wenzhou, Zhejiang, China, 325000
        • Recruiting
        • The Second Affiliated Hospital YuYing Childens Hospital of Wenzhou Medical university
        • Principal Investigator:
          • yi Jiang
  • Croatia
      • Osijek, Croatia, 31000
        • Recruiting
        • Klinicki bolnicki centar Osijek
        • Principal Investigator:
          • Vladimir Borzan
    • Grad Zagreb
      • Zagreb, Grad Zagreb, Croatia, 10000
        • Recruiting
        • Klinički bolnički centar Zagreb
        • Principal Investigator:
          • Zeljko Krznaric
  • Czechia
      • Nachod, Czechia, 547 69
        • Active, not recruiting
        • Oblastni nemocnice Nachod
      • Olomouc, Czechia, 779 00
        • Active, not recruiting
        • PreventaMed
    • Brno-město
      • Brno, Brno-město, Czechia, 656 91
        • Active, not recruiting
        • Fakultni Nemocnice u sv. Anny v Brne
      • Brno, Brno-město, Czechia, 636 00
        • Active, not recruiting
        • Vojenská Nemocnice Brno
    • Hradec Králové
      • Hradec Kralove, Hradec Králové, Czechia, 500 12
        • Active, not recruiting
        • Hepato-gastroenterologie HK
    • Olomoucký Kraj
      • Olomouc, Olomoucký Kraj, Czechia, 779 00
        • Active, not recruiting
        • MUDr. Gregar, s.r.o.
    • Ostrava Město
      • Ostrava, Ostrava Město, Czechia, 712 00
        • Active, not recruiting
        • MUDr. Radka Koskova, s.r.o.
    • Praha 2
      • Prague, Praha 2, Czechia, 120 00
        • Active, not recruiting
        • Synexus Czech
    • Praha 5
      • Praha, Praha 5, Czechia, 150 00
        • Active, not recruiting
        • AXON Clinical
      • Praha, Praha 5, Czechia, 150 06
        • Active, not recruiting
        • Fakultni nemocnice Motol
    • Praha 9
      • Prague, Praha 9, Czechia, 19000
        • Active, not recruiting
        • ISCARE klinické centrum
    • Zlínský Kraj
      • Zlín, Zlínský Kraj, Czechia, 762 75
        • Active, not recruiting
        • Nemocnice Tomase Bati ve Zline
    • Ústí Nad Labem
      • Usti nad Labem, Ústí Nad Labem, Czechia, 40113
        • Active, not recruiting
        • Masarykova Nemocnice V Usti Nad Labem
  • Denmark
    • Nordjylland
      • Aalborg, Nordjylland, Denmark, 9000
        • Recruiting
        • Aalborg Universitetshospital, Syd
        • Principal Investigator:
          • Jan Fallingborg
  • France
    • Languedoc-Roussillon
      • Montpellier, Languedoc-Roussillon, France, 34295
        • Completed
        • Chu Saint Eloi
    • Meurthe-et-Moselle
      • Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France, 54511
        • Active, not recruiting
        • Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois
    • Vienne
      • Poitiers, Vienne, France, 86021
        • Active, not recruiting
        • Centre Hospitalier Universitaire de Poitiers
  • Germany
    • Baden-Württemberg
      • Pforzheim, Baden-Württemberg, Germany, 75179
        • Active, not recruiting
        • Siloah St. Trudpert Klinikum
    • Bayern
      • Wuerzburg, Bayern, Germany, 97080
        • Active, not recruiting
        • Universitaetsklinikum Wuerzburg
    • Hessen
      • Frankfurt am Main, Hessen, Germany, 60313
        • Active, not recruiting
        • Synexus Clinical Research GmbH
    • Nordrhein-Westfalen
      • Bottrop, Nordrhein-Westfalen, Germany, 52074
        • Recruiting
        • Knappschaftskrankenhaus Bottrop
        • Principal Investigator:
          • Jean Haroun
      • Wipperfürth, Nordrhein-Westfalen, Germany, 51688
        • Active, not recruiting
        • Gemeinschaftspraxis Jakobeit
    • Sachsen
      • Leipzig, Sachsen, Germany, 4103
        • Active, not recruiting
        • Synexus Leipzig Clinical Research Centre
    • Sachsen-Anhalt
      • Halle (Saale), Sachsen-Anhalt, Germany, 06108
        • Active, not recruiting
        • Studiengesellschaft BSF Unternehmergesellschaft
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24105
        • Active, not recruiting
        • Universitätsklinikum Schleswig-Holstein
      • Oldenburg, Schleswig-Holstein, Germany, 23758
        • Active, not recruiting
        • RED-Institut GmbH
    • Thüringen
      • Nordhausen, Thüringen, Germany, 52074
        • Active, not recruiting
        • Tumorzentrum Nordthüringen Medizinisches Versorgungszentrum
  • Hungary
      • Budapest, Hungary, 1033
        • Recruiting
        • Clinexpert Tatabánya Ltd.
        • Principal Investigator:
          • Zsanett Heringh
      • Budapest, Hungary, 1036
        • Recruiting
        • SYNEXUS Magyarország Kft. Eü.
        • Principal Investigator:
          • Ferenc Izbeki
      • Budapest, Hungary
        • Recruiting
        • Pannónia Magánorvosi Centrum
        • Principal Investigator:
          • Robert Schnabel
      • Békéscsaba, Hungary, 5600
        • Recruiting
        • Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház
        • Principal Investigator:
          • Marta Varga
    • Békés
      • Gyula, Békés, Hungary, 5700
        • Recruiting
        • Synexus Magyarország Kft
        • Principal Investigator:
          • LASZLO SZALAI
    • Heves
      • Gyöngyös, Heves, Hungary
        • Recruiting
        • Bugát Pál Kórház
        • Principal Investigator:
          • Gyula Horvat
    • Komárom-Esztergom
      • Tatabánya, Komárom-Esztergom, Hungary, 2800
        • Recruiting
        • Szent Borbala Korhaz
        • Principal Investigator:
          • András Káfony
    • Pest
      • Vác, Pest, Hungary, 2600
        • Recruiting
        • Jávorszky Ödön Kórház
        • Principal Investigator:
          • Tibor Szaloki
    • Tolna
      • Szekszárd, Tolna, Hungary, 7100
        • Recruiting
        • CLINFAN Szolgáltató Kft
        • Principal Investigator:
          • Agnes Salamon
    • Veszprém
      • Balatonfüred, Veszprém, Hungary, 8230
        • Recruiting
        • DRC Gyógyszervizsgáló Központ
        • Principal Investigator:
          • Katalin Bezzegh
  • India
      • Chandigarh, India, 160012
        • Recruiting
        • Postgraduate Institute of Medical Education & Research
        • Principal Investigator:
          • Jayanta Samanta
    • Gujarat
      • Surat, Gujarat, India, 395009
        • Recruiting
        • Gujarat Hospital - Gastro & Vascular Centre
        • Principal Investigator:
          • Saumin Prakashbhai Shah
    • Maharashtra
      • Pune, Maharashtra, India, 411001
        • Recruiting
        • Grant Medical Foundation - Ruby Hall Clinic
        • Principal Investigator:
          • Nitin Pai
    • Punjab
      • Ludhiana, Punjab, India, 141001
        • Recruiting
        • Dayanand Medical College and Hospital
        • Principal Investigator:
          • Ajit Sood
    • Rajasthan
      • Jaipur, Rajasthan, India, 302001
        • Recruiting
        • SR Kalla Memorial Gastro & General Hospital
        • Principal Investigator:
          • Pankaj Kumar Shrimal
    • Tamil Nadu
      • Chennai, Tamil Nadu, India, 600035
        • Recruiting
        • Apollo Speciality Hospital - Teynampet
        • Principal Investigator:
          • Ganesh Subramanian
  • Israel
    • HaDarom
      • Be'er Sheva, HaDarom, Israel, 8410101
        • Recruiting
        • Soroka Medical Center
        • Principal Investigator:
          • Arik Segal
    • HaMerkaz
      • Ramat Gan, HaMerkaz, Israel, 5262100
        • Recruiting
        • Sheba Medical Center
        • Principal Investigator:
          • Adi Lahat-Zok
      • Rehovot, HaMerkaz, Israel, 7610001
        • Recruiting
        • Kaplan Medical Center
        • Principal Investigator:
          • Nachum Bruce Benjamin Mosenkis
        • Contact:
          • Phone Number: 90097289441272
      • Zerifin, HaMerkaz, Israel, 70300
        • Recruiting
        • Yitzhak Shamir Medical Center
        • Principal Investigator:
          • Haim Shirin
    • HaTsafon
      • Nahariya, HaTsafon, Israel, 2210001
        • Recruiting
        • Galilee Medical Center
        • Principal Investigator:
          • Nimer Assy
    • Yerushalayim
      • Jerusalem, Yerushalayim, Israel, 9778419
        • Recruiting
        • Shaare Zedek Medical Center
        • Principal Investigator:
          • Eran Goldin
  • Italy
    • Lombardia
      • Milano, Lombardia, Italy, 20122
        • Completed
        • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
    • Milano
      • Milan, Milano, Italy, 20097
        • Active, not recruiting
        • IRCCS Policlinico San Donato
      • Rho, Milano, Italy, 20017
        • Active, not recruiting
        • Ospedale Di Circolo
  • Japan
      • Fukuoka, Japan, 814-0180
        • Active, not recruiting
        • Fukuoka University Hospital
      • Kagoshima, Japan, 890-8520
        • Active, not recruiting
        • Kagoshima University Hospital
      • Kagoshima, Japan, 892-0846
        • Active, not recruiting
        • Sameshima Hospital
      • Kumamoto, Japan, 860-8556
        • Active, not recruiting
        • Kumamoto University
      • Kyoto, Japan, 602-8566
        • Recruiting
        • University Hospital,Kyoto Prefectural University of Medicine
        • Principal Investigator:
          • Tomohisa Takagi
      • Okayama, Japan, 700-0013
        • Recruiting
        • Okayama Saiseikai Outpatient Center Hospital
        • Principal Investigator:
          • Masao Yoshioka
      • Tokyo, Japan, 169-0073
        • Active, not recruiting
        • Tokyo Yamate Medical Center
      • Toyama, Japan, 930-0975
        • Recruiting
        • Toyama Prefectural Central Hospital
        • Principal Investigator:
          • Koichiro Matsuda
        • Contact:
          • Phone Number: 81120023812
    • Aomori
      • Hirosaki, Aomori, Japan, 036-8545
        • Recruiting
        • National Hospital Organization Hirosaki National Hospital
        • Principal Investigator:
          • Yoh Ishiguro
    • Chiba
      • Kashiwa, Chiba, Japan, 277-0871
        • Recruiting
        • Tsujinaka Hospital Kashiwanoha
        • Principal Investigator:
          • Ken Takeuchi
    • Fukoka
      • Kitakyusyu-shi, Fukoka, Japan, 802-0077
        • Active, not recruiting
        • Kitakyushu Municipal Medical Center
    • Fukuoka
      • Chikushino, Fukuoka, Japan, 818-0067
        • Active, not recruiting
        • Fukuoka University Chikushi Hospital
    • Gunma
      • Kiryu, Gunma, Japan, 376-0024
        • Recruiting
        • Kiryu Kosei General Hospital
        • Principal Investigator:
          • Tomohiro Iida
    • Hokkaido
      • Chuo-ku, Sapporo-shi, Hokkaido, Japan, 060-0033
        • Active, not recruiting
        • Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
      • Sapporo, Hokkaido, Japan, 060-8543
        • Recruiting
        • Sapporo Medical University Hospital
        • Contact:
          • Phone Number: 81116112111
        • Principal Investigator:
          • Keisuke Ishigami
      • Sapporo, Hokkaido, Japan, 065-0033
        • Active, not recruiting
        • Tokushukai Sapporo Higashi Tokushukai Hospital
      • Sapporo-shi, Hokkaido, Japan, 004 0041
        • Active, not recruiting
        • Tokushukai Sapporo Tokushukai Hospital
    • Hyogo
      • Nishinomiya, Hyogo, Japan, 663-8501
        • Recruiting
        • Hyogo College of Medicine
        • Principal Investigator:
          • Mikio Kawai
    • Ibaraki
      • Kasama, Ibaraki, Japan, 890-8520
        • Active, not recruiting
        • Ibaraki Prefectural Central Hospital
    • Kanagawa
      • Kamakura, Kanagawa, Japan, 247-0056
        • Active, not recruiting
        • Ofuna Central Hospital
    • Mie
      • Tsu, Mie, Japan, 514-8507
        • Recruiting
        • Mie University Hospital
        • Principal Investigator:
          • Noriyuki Horiki
        • Contact:
          • Phone Number: 81120023812
    • Miyagi
      • Sendai, Miyagi, Japan, 981-3213
        • Recruiting
        • Takagi Clinic - Sendai
        • Principal Investigator:
          • Sho Takagi
    • Shizuoka
      • Hamamatsu, Shizuoka, Japan, 432-8061
        • Recruiting
        • Matsuaikai Matsuda Hospital
        • Principal Investigator:
          • Kazuhiko Kawakami
        • Contact:
          • Phone Number: 81 534485121
    • Tokyo
      • Bunkyo, Tokyo, Japan, 113-8519
        • Recruiting
        • Tokyo Medical And Dental University Medical Hospital
        • Principal Investigator:
          • Toshimitsu Fujii
      • Shinjyuku-ku, Tokyo, Japan, 162-8655
        • Active, not recruiting
        • Center Hospital of the National Center for Global Health and Medicine
  • Korea, Republic of
    • Gyeonggi-do
      • Ansan-si, Gyeonggi-do, Korea, Republic of, 15355
        • Recruiting
        • Korea University Ansan Hospital
        • Principal Investigator:
          • Ja Seol Ja Koo
    • Kang-won-do
      • Wonju, Kang-won-do, Korea, Republic of, 26426
        • Recruiting
        • Yonsei University-Wonju Severance Christian Hospital
        • Principal Investigator:
          • Hyun Soo Kim
    • Korea
      • Seoul, Korea, Korea, Republic of, 06973
        • Recruiting
        • Chung-ang University Hospital
        • Principal Investigator:
          • Chang Hwan Choi
        • Contact:
          • Phone Number: 82262991518
    • Kyǒnggi-do
      • Guri-si, Kyǒnggi-do, Korea, Republic of, 11923
        • Recruiting
        • Hanyang University Guri Hospital
        • Principal Investigator:
          • Chang Soo Eun
      • Suwon-si, Kyǒnggi-do, Korea, Republic of, 16499
        • Recruiting
        • Ajou University Hospital
        • Principal Investigator:
          • Sung Jae Shin
    • Kyǒngsangbuk-do
      • Gyeongsan-si, Kyǒngsangbuk-do, Korea, Republic of, 42415
        • Recruiting
        • Yeungnam Univeristy Medical Center
        • Principal Investigator:
          • BYUNGIK JANG
    • Pusan-Kwangyǒkshi
      • Busan, Pusan-Kwangyǒkshi, Korea, Republic of, 49201
        • Recruiting
        • Dong-a University hospital
        • Principal Investigator:
          • Jonghun Lee
      • Haeundae-gu, Pusan-Kwangyǒkshi, Korea, Republic of, 48108
        • Recruiting
        • Inje University Haeundae Paik Hospital
        • Principal Investigator:
          • Tae Oh Kim
    • Seoul-teukbyeolsi [Seoul]
      • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 05505
        • Recruiting
        • Asan Medical Center
        • Principal Investigator:
          • Sang Hyoung Park
      • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 03181
        • Recruiting
        • Kangbuk Samsung Hospital
        • Principal Investigator:
          • Dong Il Park
      • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 02447
        • Recruiting
        • Kyung Hee University Hospital
        • Principal Investigator:
          • Hyo Jong Kim
      • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 6591
        • Recruiting
        • The Catholic Univ. of Korea Seoul St. Mary's Hospital
        • Principal Investigator:
          • Bo-In Lee
    • Taegu-Kwan
      • Deagu, Taegu-Kwan, Korea, Republic of, 41404
        • Recruiting
        • Kyungpook National University Chilgok Hospital
        • Principal Investigator:
          • Ben Kang
    • Taegu-Kwangyǒkshi
      • Daegu, Taegu-Kwangyǒkshi, Korea, Republic of, 42601
        • Recruiting
        • Keimyung University Dongsan Hospital
        • Principal Investigator:
          • Yoo Jin Lee
      • Jung-gu, Taegu-Kwangyǒkshi, Korea, Republic of, 41944
        • Recruiting
        • Kyungpook National University Hospital
        • Principal Investigator:
          • Eunsoo Kim
    • Taejǒn-Kwangyǒkshi
      • Daejeon, Taejǒn-Kwangyǒkshi, Korea, Republic of, 34943
        • Recruiting
        • The Catholic University of Korea, Daejeon St. Mary's Hospital
        • Principal Investigator:
          • Sang-Bum Kang
  • Latvia
    • Rīga
      • Riga, Rīga, Latvia, LV-1002
        • Recruiting
        • Pauls Stradins Clinical Univeristy Hospital
        • Contact:
          • Phone Number: 3717069509
        • Principal Investigator:
          • Juris Pokrotnieks
  • Lithuania
      • Kaunas, Lithuania, 50009
        • Completed
        • Hospital of Lithuanian University of Health Sciences Kaunas
  • Mexico
      • Chihuahua, Mexico, 31207
        • Recruiting
        • Scientia Investigacion Clinica S.C.
        • Principal Investigator:
          • Karina Ramirez
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 66460
        • Not yet recruiting
        • Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
        • Principal Investigator:
          • Carlos Alejandro Cortez Hernandez
      • Monterrey, Nuevo León, Mexico, 64000
        • Not yet recruiting
        • Christus Muguerza Hospital Sur
        • Principal Investigator:
          • RAFAEL CASTAÑEDA SEPULVEDA
    • San Luis Potosí
      • San Luis Potosi, San Luis Potosí, Mexico, 78213
        • Recruiting
        • Centro de Alta Especialidad en Reumatologia e Investigación del Potosi,S.C
        • Principal Investigator:
          • Jose Luis Vega Fonseca
  • Netherlands
    • Noord-Brabant
      • Tilburg, Noord-Brabant, Netherlands, 5022 GC
        • Active, not recruiting
        • Etz Elisabeth
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands, 1081 HV
        • Active, not recruiting
        • Amsterdam UMC, locatie AMC
  • Poland
    • Dolnośląskie
      • Wroclaw, Dolnośląskie, Poland, 50-381
        • Active, not recruiting
        • Synexus - Wroclaw
      • Wroclaw, Dolnośląskie, Poland, 50-449
        • Active, not recruiting
        • Melita Medical
      • Wroclaw, Dolnośląskie, Poland, 52-210
        • Active, not recruiting
        • Reumatop
      • Świdnica, Dolnośląskie, Poland, 58-100
        • Active, not recruiting
        • Dc-Med
    • Kujawsko-pomorskie
      • Bydgoszcz, Kujawsko-pomorskie, Poland, 85-168
        • Active, not recruiting
        • Szpital Uniwersytecki Nr 2 w Bydgoszczy, Klinika Reumatologii i Ukladowych Chorób Tkanki Lacznej
    • Lubelskie
      • Lublin, Lubelskie, Poland, 20-582
        • Active, not recruiting
        • ZOZ Gastromed
      • Zamosc, Lubelskie, Poland, 22-400
        • Active, not recruiting
        • ETG Zamosc
    • Mazowieckie
      • Warsaw, Mazowieckie, Poland, 04-746
        • Active, not recruiting
        • WIP Warsaw IBD Point Profesor Kierkus
      • Warszawa, Mazowieckie, Poland, 00-189
        • Active, not recruiting
        • Centrum Zdrowia MDM
    • Małopolskie
      • Krakow, Małopolskie, Poland, 31-506
        • Active, not recruiting
        • Topolowa Medicenter
      • Wadowice, Małopolskie, Poland, 34-100
        • Active, not recruiting
        • Nzoz Formed
    • Podkarpackie
      • Rzeszow, Podkarpackie, Poland, 35-302
        • Active, not recruiting
        • Private Practice - Dr. Korczowski Bartosz
      • Rzeszow, Podkarpackie, Poland, 35-326
        • Active, not recruiting
        • Centrum Medyczne Medyk
    • Podlaskie
      • Bialystok, Podlaskie, Poland, 15-707
        • Active, not recruiting
        • Nova Reuma Społka Partnerska
    • Pomorskie
      • Gdansk, Pomorskie, Poland, 80-382
        • Active, not recruiting
        • Synexus Polska Gdansku
      • Gdynia, Pomorskie, Poland, 81-537
        • Active, not recruiting
        • Synexus Polska Sp. z o.o. Oddział w Gdyni
      • Sopot, Pomorskie, Poland, 81-756
        • Active, not recruiting
        • Endoskopia Sp. z.o.o.
    • Silesian
      • Czestochowa, Silesian, Poland, 42-200
        • Active, not recruiting
        • Centrum Medyczne SYNEXUS
    • Warmińsko-mazurskie
      • Elblag, Warmińsko-mazurskie, Poland, 82-300
        • Active, not recruiting
        • NZOZ TwojeZdrowie
    • Wielkopolskie
      • Poznan, Wielkopolskie, Poland, 60-702
        • Active, not recruiting
        • Synexus Polska Sp. z o.o. Oddzial w Poznaniu
    • Zachodniopomorskie
      • Szczecin, Zachodniopomorskie, Poland, 71-685
        • Active, not recruiting
        • SONOMED Centrum Medyczne
      • Szczecin, Zachodniopomorskie, Poland, 71-434
        • Active, not recruiting
        • Twoja Przychodnia - Szczecinskie Centrum Medyczne
    • Śląskie
      • Katowice, Śląskie, Poland, 40-588
        • Active, not recruiting
        • Synexus Polska - Katowicach
      • Sosnowiec, Śląskie, Poland, 40-588
        • Active, not recruiting
        • Kiepury Clinic
  • Romania
      • Constanța, Romania, 900178
        • Active, not recruiting
        • Gastromed S.R.L.
    • București
      • Bucharest, București, Romania, 013812
        • Active, not recruiting
        • Spitalul de Oncologie Monza
      • Bucharest, București, Romania, 014142
        • Active, not recruiting
        • Delta Health Care
      • Bucuresti, București, Romania, 12015
        • Active, not recruiting
        • S.C. Centrul Medical Medicum SRL
      • Bucuresti, București, Romania, 20125
        • Completed
        • Spitalul Clinic Colentina
    • Timiș
      • Timisoara, Timiș, Romania, 300002
        • Active, not recruiting
        • S.C Centrul de Gastroenterologie Dr. Goldis S.R.L
  • Russian Federation
    • Altayskiy Kray
      • Barnaul, Altayskiy Kray, Russian Federation, 656038
        • Active, not recruiting
        • Poliklinika Agmu "Konsul'tativno-Diagnosticheskiy Tsentr"
    • Irkutskaya Oblast'
      • Irkutsk, Irkutskaya Oblast', Russian Federation, 664079
        • Active, not recruiting
        • Scientific Centre of Reconstructive and Restorative Surgery
    • Kareliya, Respublika
      • Petrozavodsk, Kareliya, Respublika, Russian Federation, 620109
        • Active, not recruiting
        • Karelia Republican Hospital V.A. Baranova
    • Kemerovskaya Oblast'
      • Kemerovo, Kemerovskaya Oblast', Russian Federation, 620109
        • Completed
        • Kemerovo Regional Clinical Hospital
    • Nizhegorodskaya Oblast'
      • Nizhny Novgorod, Nizhegorodskaya Oblast', Russian Federation, 603126
        • Active, not recruiting
        • Nizhny Novgorod Regional Hospital N.A. Semashko
    • Novosibirskaya Oblast'
      • Novosibirsk, Novosibirskaya Oblast', Russian Federation, 630117
        • Active, not recruiting
        • Research Institute of Physiology and Fundamental Medicine
      • Novosibirsk, Novosibirskaya Oblast', Russian Federation, 630005
        • Active, not recruiting
        • Medical Center SibNovoMed
    • Omskaya Oblast'
      • Omsk, Omskaya Oblast', Russian Federation, 644050
        • Completed
        • Clinic of Omsk State Medical University
    • Rostovskaya Oblast'
      • Rostov-on-Don, Rostovskaya Oblast', Russian Federation, 344091
        • Active, not recruiting
        • Rostov State Medical University
    • Samarskaya Oblast'
      • Samara, Samarskaya Oblast', Russian Federation, 443029
        • Completed
        • Private Healthcare Institution "Clinical Hospital "RZhD-Medicina" City Samara"
    • Sankt-Peterburg
      • Saint Petersburg, Sankt-Peterburg, Russian Federation, 196143
        • Active, not recruiting
        • Scientific research center ECO-security
      • Saint Petersburg, Sankt-Peterburg, Russian Federation, 194356
        • Active, not recruiting
        • Balt Med Clinic
      • Saint Petersburg, Sankt-Peterburg, Russian Federation, 197110
        • Active, not recruiting
        • Saint Petersburg State Budgetary Healthcare Institution City Clinical Hospital No.31
      • Saint Petersburg, Sankt-Peterburg, Russian Federation, 194354
        • Active, not recruiting
        • Reavita Med SPb
      • Saint-Petersburg, Sankt-Peterburg, Russian Federation, 197022
        • Active, not recruiting
        • First Pavlov State Medical University of Saint Petersburg
    • Sverdlovskaya Oblast'
      • Ekaterinburg, Sverdlovskaya Oblast', Russian Federation, 620109
        • Active, not recruiting
        • MO New Hospital
  • Serbia
    • Beograd
      • Belgrade, Beograd, Serbia, 11000
        • Recruiting
        • Clinical Hospital Center Zvezdara
        • Principal Investigator:
          • Petar Svorcan
      • Belgrade, Beograd, Serbia, 11080
        • Recruiting
        • Clinical Center Bezanijska Kosa
        • Principal Investigator:
          • Slobodanka Crevar Marinovic
    • Vojvodina
      • Zrenjanin, Vojvodina, Serbia, 23000
        • Recruiting
        • General Hospital "Djordje Joanovic"
        • Principal Investigator:
          • Tatjana Latinovic Radakovic
  • Slovakia
    • Banskobystrický Kraj
      • Banska Bystrica, Banskobystrický Kraj, Slovakia, 97517
        • Recruiting
        • Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica
        • Principal Investigator:
          • Jozef Balaz
    • Bratislavs
      • Bratislava, Bratislavs, Slovakia, 811 09
        • Recruiting
        • Cliniq s.r.o.
        • Principal Investigator:
          • Tibor Hlavaty
    • Nitriansky Kraj
      • Nové Zámky, Nitriansky Kraj, Slovakia, 940 81
        • Recruiting
        • Gastromedic
        • Principal Investigator:
          • Iveta Kalisova
    • Prešovský Kraj
      • Presov, Prešovský Kraj, Slovakia, 080 01
        • Recruiting
        • Gastro LM
        • Principal Investigator:
          • Lubomir Mihalkanin
      • Vranov N. Toplou, Prešovský Kraj, Slovakia, 093 01
        • Recruiting
        • Endomed, s.r.o.
        • Principal Investigator:
          • Miroslav Fedurco
  • Switzerland
      • Berne, Switzerland, 3010
        • Recruiting
        • Inselspital Bern
        • Principal Investigator:
          • Benjamin Misselwitz
    • Berne
      • Bern, Berne, Switzerland, 3012
        • Recruiting
        • Gastroenterologische Praxis Balsiger, Seibold & Partner
        • Contact:
          • Phone Number: 41313023234
        • Principal Investigator:
          • Frank Seibold
  • Turkey
      • Ankara, Turkey, 06230
        • Recruiting
        • Ankara City Hospital
        • Principal Investigator:
          • Yasemin Ozin
      • Ankara, Turkey, 6560
        • Recruiting
        • Gazi University Health Research and Application Center Gazi Hospital Pediatric Hematology BD
        • Principal Investigator:
          • Tarkan Karakan
      • Ankara, Turkey, 6230
        • Recruiting
        • Hacettepe Universitesi
        • Principal Investigator:
          • Cem SIMSEK
      • Antalya, Turkey, 7100
        • Recruiting
        • Antalya Egitim ve Arastırma Hastanesi
        • Principal Investigator:
          • ayhan cekin
      • Bursa, Turkey, 16059
        • Recruiting
        • Uludag Universitesi
        • Principal Investigator:
          • Murat KIYICI
      • Edirne, Turkey, 22030
        • Recruiting
        • Trakya University
        • Contact:
          • Phone Number: 902842357641
        • Principal Investigator:
          • Hüseyin Ahmet Tezel
      • Hatay, Turkey, 31001
        • Recruiting
        • Mustafa Kemal Universitesi
        • Principal Investigator:
          • Mehmet Demir
      • Istanbul, Turkey, 34724
        • Recruiting
        • Medicana Kadiköy Hastanesi
        • Principal Investigator:
          • Hakan Demirci
      • Istanbul, Turkey, 34734
        • Recruiting
        • Acbadem Kozyatagi Hospital
        • Principal Investigator:
          • Can GONEN
      • Mersin, Turkey, 33343
        • Recruiting
        • Mersin University
        • Principal Investigator:
          • Engin Altintas
    • Balçova
      • Izmir, Balçova, Turkey, 35100
        • Recruiting
        • Dokuz Eylul Universitesi Hastanesi
        • Principal Investigator:
          • Goksel Bengi
    • Eskişehir
      • Eskisehir, Eskişehir, Turkey, 26480
        • Recruiting
        • Eskisehir Osmangazi University
        • Principal Investigator:
          • Tuncer Temel
    • İstanbul
      • Istanbul- Fatih, İstanbul, Turkey, 34098
        • Recruiting
        • Istanbul Universitesi Cerrahpasa
        • Principal Investigator:
          • Yusuf Erzin
  • Ukraine
      • Chernivtsi, Ukraine, 58000
        • Recruiting
        • Chernivtsi Regional Clinical Hospital
        • Principal Investigator:
          • Oleksandr Ivanovich Fediv
      • Kyiv, Ukraine, 03049
        • Recruiting
        • Kyiv Railway Clinical Hospital No.2 of Branch Health Center of the Public Joint Stock Company Ukrainian Railway
        • Principal Investigator:
          • Olga Kyrychenko
      • Kyiv, Ukraine, 04050
        • Recruiting
        • Medical Center of Limited Liability Company "Medical Center "Consilium Medical"
        • Principal Investigator:
          • Oksana Gerasymenko
      • Kyiv, Ukraine, 02091
        • Recruiting
        • Medical Center Ok!Clinic+
        • Principal Investigator:
          • Nataliia Tsarynna
      • Kyiv, Ukraine, 04106
        • Recruiting
        • Kiev Regional Clinical Hospital No. 1
        • Principal Investigator:
          • Svitlana Danyliuk
      • Kyiv, Ukraine, 04078
        • Recruiting
        • Kyiv Regional Clinical Hospital
        • Principal Investigator:
          • Tetiana Lohdanidi
    • Dnipropetrovska Oblast
      • Dnipro, Dnipropetrovska Oblast, Ukraine, 49038
        • Recruiting
        • Medical Center Family Medicine Clinic
        • Principal Investigator:
          • Yana Shapovalova
    • Ivano-Frankivska Oblast
      • Ivano-Frankivsk, Ivano-Frankivska Oblast, Ukraine, 76008
        • Recruiting
        • Communal non-profit enterprise "Regional clinical hospital of Ivano-Frankivsk Regional Council"
        • Principal Investigator:
          • Vira Vyshyvanyuk
    • Kharkivska Oblast
      • Kharkiv, Kharkivska Oblast, Ukraine, 61037
        • Completed
        • City Clinical Hospital No. 2
    • Kyivska Oblast
      • Kyiv, Kyivska Oblast, Ukraine, 03037
        • Recruiting
        • Medbud Clinic
        • Principal Investigator:
          • Dmytro Donets
    • Lvivska Oblast
      • Lviv, Lvivska Oblast, Ukraine, 79000
        • Recruiting
        • Lviv Railway Clinical Hospital
        • Principal Investigator:
          • Olha Ivanishyn
    • Odeska Oblast
      • Odesa, Odeska Oblast, Ukraine, 65025
        • Recruiting
        • Municipal non-profit enterprise'Odesa Regional Clinical Hospital'of Odesa Regional Council
        • Principal Investigator:
          • Andriy Yurkiv
    • Vinnytska Oblast
      • Vinnytsia, Vinnytska Oblast, Ukraine, 21009
        • Recruiting
        • Medical Clinical Investigational Center of Medical Center Health Clinic
        • Principal Investigator:
          • Oleksandr Golovchenko
      • Vinnytsya, Vinnytska Oblast, Ukraine, 21018
        • Recruiting
        • VNMU
        • Principal Investigator:
          • Sergii Shevchuk
      • Vinnytsya, Vinnytska Oblast, Ukraine, 21000
        • Recruiting
        • City Clinical Hospital #1, Vinnitsya National Medical University
        • Principal Investigator:
          • Valerii Ivanov
    • Zakarpatska Oblast
      • Uzhgorod, Zakarpatska Oblast, Ukraine, 88018
        • Recruiting
        • Transcarpathian Regional Hospital im.Andriya Novak
        • Principal Investigator:
          • Yaroslava Rishko
    • Zaporizka Oblast
      • Zaporizhia, Zaporizka Oblast, Ukraine, 69035
        • Recruiting
        • Communal Non-profit Enterprise "City Hospital #6" of Zaporizhzhia City Council
        • Principal Investigator:
          • Oleksandr Oliinyk
      • Zaporizhzhia, Zaporizka Oblast, Ukraine, 69076
        • Recruiting
        • Diacenter
        • Contact:
          • Phone Number: 380612965685
        • Principal Investigator:
          • Yevgen Poplyonkin
  • United Kingdom
      • Cardiff, United Kingdom, CF15 9SS
        • Active, not recruiting
        • Synexus Wales Clinical Research Centre
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom, CB2 2QQ
        • Active, not recruiting
        • Addenbrooke's Hospital
    • England
      • London, England, United Kingdom, E11 1NR
        • Active, not recruiting
        • Barts Health Nhs Trust - Whipps Cross University Hospital
  • United States
    • Alabama
      • Dothan, Alabama, United States, 36305
        • Active, not recruiting
        • Digestive Health Specialists
    • Arizona
      • Litchfield Park, Arizona, United States, 85340
        • Active, not recruiting
        • Research Solutions of Arizona
      • Phoenix, Arizona, United States, 85037
        • Active, not recruiting
        • Arizona Arthritis & Rheumatology Associates
    • California
      • Gilroy, California, United States, 95020
        • Active, not recruiting
        • Care Access - Gilroy
      • Huntington Beach, California, United States, 92648
        • Active, not recruiting
        • Christine Thai, MD
      • Northridge, California, United States, 91324
        • Active, not recruiting
        • California Medical Research Associates
    • Connecticut
      • Bristol, Connecticut, United States, 06010
        • Active, not recruiting
        • Connecticut Clinical Research Institute
    • Florida
      • Clearwater, Florida, United States, 33765
        • Active, not recruiting
        • Clinical Research of West Florida, Inc. (Clearwater)
      • Kissimmee, Florida, United States, 34741
        • Active, not recruiting
        • IHS Health Research
      • Miami, Florida, United States, 33175
        • Active, not recruiting
        • Ezy Medical Research
      • Orlando, Florida, United States, 32825
        • Completed
        • Care Access - Orlando
      • Pensacola, Florida, United States, 32503
        • Completed
        • Gastroenterology Associates of Pensacola, PA
      • Sunrise, Florida, United States, 33351
        • Active, not recruiting
        • Precision Clinical Research
      • Tampa, Florida, United States, 33615
        • Active, not recruiting
        • Alliance Clinical Research of Tampa
      • Tampa, Florida, United States, 33612
        • Active, not recruiting
        • USF Health
    • Georgia
      • Atlanta, Georgia, United States, 30327
        • Active, not recruiting
        • Digestive Healthcare of Georgia
      • Marietta, Georgia, United States, 30060
        • Active, not recruiting
        • Gastrointestinal Specialists of Georgia
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Active, not recruiting
        • Grand Teton Research Group
    • Indiana
      • Evansville, Indiana, United States, 47715
        • Completed
        • Qualmedica Research, LLC
      • Indianapolis, Indiana, United States, 46202
        • Active, not recruiting
        • Indiana University Health University Hospital
    • Kentucky
      • Louisville, Kentucky, United States, 40206
        • Not yet recruiting
        • Robley Rex VA Medical Center
        • Principal Investigator:
          • Gerald Dryden
    • Louisiana
      • Monroe, Louisiana, United States, 71201
        • Active, not recruiting
        • Delta Research Partners
    • Maryland
      • Chevy Chase, Maryland, United States, 20815
        • Active, not recruiting
        • Capital Digestive Care - Chevy Chase
      • Glen Burnie, Maryland, United States, 21061
        • Active, not recruiting
        • Woodholme Gastroenterology Associates - Glen Burnie
    • Michigan
      • Chesterfield, Michigan, United States, 48047
        • Active, not recruiting
        • The Digestive Health Center of Michigan (DHCMI)
      • Farmington Hills, Michigan, United States, 48334
        • Active, not recruiting
        • Revive Research Institute, Inc.
    • Minnesota
      • Plymouth, Minnesota, United States, 55446
        • Active, not recruiting
        • MNGI Digestive Health - Plymouth Endoscopy Center & Clinic
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Active, not recruiting
        • Washington University Medical School
    • Nevada
      • Las Vegas, Nevada, United States, 89148
        • Recruiting
        • Care Access - Las Vegas
        • Principal Investigator:
          • Christian Stone
    • New Jersey
      • Teaneck, New Jersey, United States, 07666
        • Active, not recruiting
        • Holy Name Medical Center
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599-7080
        • Completed
        • Clinical & Translational Research Center (CTRC)
      • Greenville, North Carolina, United States, 27834
        • Active, not recruiting
        • Carolina Digestive Diseases and Endoscopy Center
      • Kinston, North Carolina, United States, 28501
        • Active, not recruiting
        • Care Access - Kinston
      • Lumberton, North Carolina, United States, 28358
        • Not yet recruiting
        • Care Access Research-Lumberton
        • Principal Investigator:
          • Kwadwo Agyei-Gyamfi
    • Ohio
      • Cleveland, Ohio, United States, 44106
        • Active, not recruiting
        • University Hospitals Cleveland Medical Center
      • Columbus, Ohio, United States, 43202
        • Active, not recruiting
        • Ohio Gastroenterology
      • Hilliard, Ohio, United States, 43026
        • Active, not recruiting
        • Ohio State University
      • Westlake, Ohio, United States, 44145
        • Active, not recruiting
        • North Shore Gastroenterology & Endoscopy Centers
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104-5008
        • Active, not recruiting
        • The University of Oklahoma Health Sciences Center
    • Rhode Island
      • Providence, Rhode Island, United States, 02905
        • Active, not recruiting
        • University Gastroenterology
    • South Carolina
      • Orangeburg, South Carolina, United States, 29118
        • Active, not recruiting
        • Gastroenterology Associates of Orangeburg
    • Tennessee
      • Cordova, Tennessee, United States, 38018
        • Active, not recruiting
        • Gastroenterology Center Of The Midsouth
    • Texas
      • Bellaire, Texas, United States, 77401
        • Completed
        • First Surgical Hospital
      • Houston, Texas, United States, 77030
        • Active, not recruiting
        • Baylor College of Medicine Medical Center
      • Lubbock, Texas, United States, 79424
        • Active, not recruiting
        • West Texas Digestive Disease
      • San Antonio, Texas, United States, 78229
        • Active, not recruiting
        • Southern Star Research Institute
      • Tyler, Texas, United States, 75701
        • Active, not recruiting
        • Digestive Health Specialists of Tyler
    • Utah
      • Ogden, Utah, United States, 84403
        • Active, not recruiting
        • Care Access - Ogden
      • Salt Lake City, Utah, United States, 84124
        • Active, not recruiting
        • Care Access - Salt Lake City
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Active, not recruiting
        • University of Virginia Health System
      • Williamsburg, Virginia, United States, 23188
        • Active, not recruiting
        • Tidewater Physicians Multispecialty Group Clinical Research
    • Washington
      • Bellevue, Washington, United States, 98004
        • Active, not recruiting
        • Washington Gastroenterology - Bellevue
      • Seattle, Washington, United States, 98111
        • Active, not recruiting
        • Virginia Mason Medical Center
      • Tacoma, Washington, United States, 98405
        • Active, not recruiting
        • Washington Gastroenterology - Tacoma

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Participants must have completed study I6T-MC-AMAG (NCT02891226) or study I6T-MC-AMAM (NCT03926130)
  • If female, participant must meet the contraception requirements

Exclusion Criteria:

  • Participants must not have developed a new condition, including cancer in the previous study (I6T-MC-AMAG or I6T-MC-AMAM) that would pose an unacceptable risk in the trial.
  • Participants must not have any important infections including, but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during either previous study.

Note: Participants with a history of active TB with documentation of treatment by the Centers for Disease Control (CDC) and/or World Health Organization (WHO) criteria prior to the originator study are not excluded from the study.

  • Participants must not have a known hypersensitivity to any component of mirikizumab or have experienced acute systemic hypersensitivity event with previous study drug administration in the originating study that precludes mirikizumab therapy.
  • Participation must not be pregnant, lactating, or planning to become pregnant while enrolled in the study or 16 weeks after receiving the last dose of study drug.

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: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mirikizumab SC
Mirikizumab given subcutaneously (SC).
Drug: Mirikizumab
Administered SC
Other Names:
  • LY3074828
Drug: Mirikizumab
Administered IV
Other Names:
  • LY3074828
Experimental: Mirikizumab IV and SC
Mirikizumab given intravenously (IV) and SC.
Drug: Mirikizumab
Administered SC
Other Names:
  • LY3074828
Drug: Mirikizumab
Administered IV
Other Names:
  • LY3074828

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving Endoscopic Response
Time Frame: Week 52
Endoscopic response based on Simple Endoscopic Score for Crohn's Disease (SES-CD) total score
Week 52
Percentage of Participants Achieving Clinical Remission
Time Frame: Week 52
Clinical remission based on Crohn's Disease Activity Index (CDAI)
Week 52

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Achieving Endoscopic Remission
Time Frame: Week 52
Endoscopic remission based on SES-CD total score
Week 52
Percentage of Participants Achieving Clinical Response
Time Frame: Week 52
Clinical response by patient-reported outcomes (PRO) based on stool frequency (SF) and abdominal pain (AP)
Week 52
Change from Baseline in C-Reactive Protein
Time Frame: Baseline, Week 12
Change from baseline in c-reactive protein
Baseline, Week 12
Change from Baseline in Fecal Calprotectin
Time Frame: Baseline, Week 12
Change from baseline in fecal calprotectin
Baseline, Week 12
Change from Baseline on the Inflammatory Bowel Disease Questionnaire (IBDQ)
Time Frame: Baseline to Week 52
Change from baseline on the IBDQ
Baseline to Week 52

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 22, 2020

Primary Completion (Estimated)

January 2, 2025

Study Completion (Estimated)

December 20, 2026

Study Registration Dates

First Submitted

January 15, 2020

First Submitted That Met QC Criteria

January 15, 2020

First Posted (Actual)

January 18, 2020

Study Record Updates

Last Update Posted (Actual)

April 17, 2024

Last Update Submitted That Met QC Criteria

April 16, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 16628
  • I6T-MC-AMAX (Other Identifier: Eli Lilly and Company)
  • 2019-002687-27 (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 European Union (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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