A Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease (VIVID-1)

December 12, 2024 updated by: Eli Lilly and Company

A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active- Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients With Moderately to Severely Active Crohn's Disease

The reason for this study is to see if the study drug mirikizumab is safe and effective in participants with moderately to severely active Crohn's disease.

Study Overview

Status

Completed

Conditions

Crohn's Disease

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1158

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
- - Buenos Aires, Argentina, C1027AAP
    - Centro de Investigaciones Metabólicas (CINME)
- Buenos Aires
  - Caba, Buenos Aires, Argentina, 1111
    - DOM- Centro de Reumatologia
  - Caba, Buenos Aires, Argentina, C1128AAF
    - Mautalen Salud e Investigación
  - Caba, Buenos Aires, Argentina, C1431FWO
    - CEMIC- Servicio de Reumatología
  - Ciudadela, Buenos Aires, Argentina, 1702
    - Instituto Medico Elsa Perez SRL (IMEP)
- Ciudad Autónoma De Buenos Aire
  - Ciudad Autonoma de Buenos Aire, Ciudad Autónoma De Buenos Aire, Argentina, C1119ACN
    - CIPREC
- Tucumán
  - SAN M. DE Tucuman, Tucumán, Argentina, T4000AXL
    - Centro de Investigaciones Medicas Tucuman
Australia
- New South Wales
  - Concord, New South Wales, Australia, 2139
    - Concord Repatriation General Hospital
  - Darlinghurst, New South Wales, Australia, 2010
    - St. Vincents Hospital Sydney
  - Kingswood, New South Wales, Australia, 2747
    - Nepean Hospital
  - Liverpool, New South Wales, Australia, 2170
    - Liverpool Hospital
- Queensland
  - Herston, Queensland, Australia, 4029
    - Royal Brisbane and Women's Hospital
  - Maroochydore, Queensland, Australia, 4558
    - Coastal Digestive Health
  - North Mackay, Queensland, Australia, 4740
    - Coral Sea Clinical Research Institute
- Victoria
  - Camberwell, Victoria, Australia, 3124
    - Emeritus Research
  - Epping, Victoria, Australia, 3076
    - Northern Hospital
  - Parkville, Victoria, Australia, 3050
    - The Royal Melbourne Hospital
- Western Australia
  - Murdoch, Western Australia, Australia, 6150
    - Fiona Stanley Hospital
Austria
- - Innsbruck, Austria, 6020
    - Medizinische Universität Innsbruck
  - Salzburg, Austria, 5020
    - Universitätsklinikum Salzburg
  - Wien, Austria, 1060
    - Krankenhaus der Barmherzigen Schwestern Wien
  - Wien, Austria, 1090
    - AKH
Belgium
- - Brussel, Belgium, 1090
    - UZ Brussel
  - Kortrijk, Belgium, 8500
    - AZ Groeninge
  - Leuven, Belgium, 3000
    - Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
- Antwerpen
  - Bonheiden, Antwerpen, Belgium, 2820
    - Imelda General Hospital
- Brussel
  - Bruxelles, Brussel, Belgium, 1200
    - Cliniques Universitaires Saint-Luc
Brazil
- - Rio de Janeiro, Brazil, 22211-230
    - Hospital Gloria Dor
  - Sao Paulo, Brazil, 04543-001
    - Hepatogastro
  - Sao Paulo, Brazil, 01308-050
    - Hospital Sírio Libanês
  - São Paulo, Brazil, 01228-000
    - CPQuali Pesquisa Clínica
  - São Paulo, Brazil, 04543-000
    - Clinica Onco Star
- Bahia
  - Salvador, Bahia, Brazil, 41500-300
    - CLIAGEN - Clinica de Atenção em Gastroenterologia, Especialidades e Nutrição
- Ceara
  - Fortaleza, Ceara, Brazil, 60430-370
    - HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará
- Distrito Federal
  - Brasília, Distrito Federal, Brazil, 72145-450
    - Chronos Pesquisa Clinica
  - Brasília, Distrito Federal, Brazil, 70200-730
    - L2IP - Instituto de Pesquisas Clínicas Ltda.
- GO
  - Goiania, GO, Brazil, 74535-170
    - Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda
- MG
  - Belo Horizonte, MG, Brazil, 30110-934
    - Hospital Felicio Rocho
- Minas Gerais
  - Uberlandia, Minas Gerais, Brazil, 38411-186
    - Eurolatino Pesquisas Médicas Ltda.
- Parana
  - Curitiba, Parana, Brazil, 80230-130
    - Associacao Paranaense de Cultura - PUCPR
- Rio Grande Do Sul
  - Caxias do Sul, Rio Grande Do Sul, Brazil, 95070-560
    - Instituto de Pesquisa em Saúde - Fundação Universidade de Caxias do Sul
  - Porto Alegre, Rio Grande Do Sul, Brazil, 90430-001
    - Nucleo de Pesquisa Clínica do Rio Grande do Sul-NPCRS
  - Porto Alegre, Rio Grande Do Sul, Brazil, 90035-903
    - Hospital de Clinicas de Porto Alegre
  - Porto Alegre, Rio Grande Do Sul, Brazil, 90050-170
    - Irmandade da Santa Casa de Misericórdia de Porto Alegre
  - Porto Alegre, Rio Grande Do Sul, Brazil, 90160-093
    - Hospital Ernesto Dornelles
  - Porto Alegre, Rio Grande Do Sul, Brazil, 90560-030
    - Hospital Moinhos de Vento
- SP
  - Botucatu, SP, Brazil, 18618-687
    - Faculdade de Medicina de Botucatu
  - Santo Andre, SP, Brazil, 09060-870
    - Faculdade de Medicina do ABC
  - Sao Paulo, SP, Brazil, 04039-004
    - Instituto de Assistencia Medica ao Servidor Publico Estudo Estadual
- Sao Paulo
  - Campinas, Sao Paulo, Brazil, 13060-904
    - HMCP - Hospital e Maternidade Celso Pierro - PUC-Campinas
  - Santo Andre, Sao Paulo, Brazil, 09080-110
    - Pesquisare
- São Paulo
  - Santo Andre, São Paulo, Brazil, 09790790
    - Praxis Pesquisa Medica
  - São Bernardo do Campo, São Paulo, Brazil, 09715-090
    - CEMEC - Centro Multidisciplinar de Estudos Clinicos EPP Ltda
Canada
- Alberta
  - Edmonton, Alberta, Canada, T5R 1W2
    - Gastroenterology and internal medicine research institute
- British Columbia
  - New Westminster, British Columbia, Canada, V3L 3W4
    - Fraser Clinical Trials Inc
  - North Vancouver, British Columbia, Canada, V7L 4W8
    - The Medical Arts Health Research Group
  - Vancouver, British Columbia, Canada, V6Z 2K5
    - GI Research Institute
- Nova Scotia
  - Dartmouth, Nova Scotia, Canada, B2W 6L4
    - Milestone Clinical
  - Kentville, Nova Scotia, Canada, B4N 0A3
    - K&M Medical
- Ontario
  - London, Ontario, Canada, N6A 5A5
    - London Health Sciences Centre
  - London, Ontario, Canada, N6A 5W9
    - Victoria Hospital
  - Sudbury, Ontario, Canada, P3C 5K6
    - Viable Clinical Research
- Quebec
  - Montreal, Quebec, Canada, H1T 2M4
    - CIUSS-de-L'Est-de-l'île-de-Montréal-Hôpital
China
- - Xiamen, China, 361004
    - Zhongshan Hospital Xiamen University
- Anhui
  - Hefei, Anhui, China, 230001
    - Anhui Provincial Hospital
- Beijing
  - Beijing, Beijing, China, 100034
    - Peking University First Hospital
  - Beijing, Beijing, China, 100191
    - Peking University Third Hospital
- Chongqing
  - Chongqing, Chongqing, China, 400038
    - The First Hospital Affiliated to AMU (Southwest Hospital)
  - Chongqing, Chongqing, China, 400014
    - Chongqing General Hospital
  - Chongqing, Chongqing, China, 400037
    - The Affiliated 2nd Hosp. of Third Military Med. Univ. of PLA
- Fuzhou
  - Fujian, Fuzhou, China, 350005
    - The First Affiliated Hospital of Fujian Medical University
- Guangdong
  - Foshan, Guangdong, China, 528000
    - The First People's Hospital of Foshan
  - Guangzhou, Guangdong, China, 510120
    - Sun Yat-sen Memorial Hospital, Sun Yat-sen University
  - Guangzhou, Guangdong, China, 510080
    - First Affiliated Hospital of Sun Yat-sen University
  - Guangzhou, Guangdong, China, 510655
    - The Sixth Affiliated Hospital, Sun Yat-sen University
- Hainan
  - Haikou, Hainan, China, 570311
    - Hainan General Hospital
- Hubei
  - Wu Han, Hubei, China, 430030
    - Tongji Hosp Tongji Med Col Huazhong Univ of Sci & Tech
- Hunan
  - Changsha, Hunan, China, 410008
    - Xiangya Hospital Central South University
  - Changsha, Hunan, China, 410013
    - The Third Xiangya Hospital of Central South University
  - Changsha, Hunan, China, 410011
    - The Second Xiangya Hospital of Central South University
- Jiangsu
  - Changzhou, Jiangsu, China, 213003
    - The First People's Hospital of Changzhou
  - Changzhou, Jiangsu, China
    - Changzhou No.2 People's Hospital
  - Nanjing, Jiangsu, China, 210029
    - Jiangsu Province Hospital
  - Nanjing, Jiangsu, China, 210029
    - Jiangsu Province Hospital of Chinese Medicine
  - Suzhou, Jiangsu, China, 215004
    - The Second Affiliated Hospital of Soochow University
  - Suzhou, Jiangsu, China, 215066
    - The First Affiliated Hospital of Soochow University
  - Wuxi, Jiangsu, China, 214023
    - Wuxi People's Hospital
  - Zhenjiang, Jiangsu, China, 212000
    - Affiliated Hospital of Jiangsu University
- Jiangxi
  - Nanchang, Jiangxi, China, 330006
    - The First Affiliated Hospital of Nanchang University
- Liaoning
  - Shenyang, Liaoning, China, 110001
    - The First Hospital of China Medical University
  - Shenyang, Liaoning, China, 110004
    - Shengjing Hospital of China Medical University
- Pudong District
  - Shanghai, Pudong District, China, 200120
    - Shanghai East Hospital
- Shanghai
  - Shanghai, Shanghai, China, 200032
    - Zhongshan Hospital, Fudan University
  - Shanghai, Shanghai, China, 200025
    - Shanghai Jiaotong University School of Medicine Ruijin Hospital
  - Shanghai, Shanghai, China
    - Shanghai 6th People's Hospital
- Sichuan
  - Cheng Du, Sichuan, China, 610041
    - West China Hospital of Sichuan University
- Tianjin
  - Tianjin, Tianjin, China, 300052
    - Tianjin Medical University General Hospital
- Yunnan
  - Kunming, Yunnan, China, 650034
    - The First People's Hospital of Yunnan Province
  - Kunming, Yunnan, China, 650032
    - First Affiliated Hospital of Kunming Medical University
- Zhejiang
  - Hangzhou, Zhejiang, China, 310009
    - The Second Affiliated Hospital of Zhejiang University School of Medicine
  - Hangzhou, Zhejiang, China, 310016
    - Sir Run Run Shaw Hospital
  - Hangzhou, Zhejiang, China, 310003
    - First Affiliated Hosp of College of Med, Zhejiang University
  - Wenzhou, Zhejiang, China, 310015
    - The Second Affiliated Hospital YuYing Childens Hospital of Wenzhou Medical university
Croatia
- - Osijek, Croatia, 31000
    - Clinical Medical Centre Osijek
  - Zagreb, Croatia, 10000
    - CHC Zagreb
Czechia
- - Brno, Czechia, 65691
    - Fakultni Nemocnice U svate Anny
  - Nachod, Czechia
    - Oblastni nemocnice Nachod-Endoskopicke centrum
  - Olomouc, Czechia, 77900
    - PreventaMed, s.r.o.
  - Ostrava - Muglinov, Czechia, 712 00
    - MUDr. Radka Koskova, s.r.o., Gastroenterologicka ambulance
  - Plzen, Czechia, 301 00
    - A-Shine, s.r.o.
  - Praha 5, Czechia, 150 00
    - AXON Clinical
  - Praha 8, Czechia, 18600
    - Mediendo, s.r.o.
  - Praha 9, Czechia, 19000
    - ISCARE Clinical Centre
- Brno-město
  - Brno, Brno-město, Czechia, 636 00
    - Vojenska nemocnice Brno
- Czech Republic
  - Usti nad Labem, Czech Republic, Czechia, 40113
    - Krajska zdravotni, a.s.-Masarykova nemocnice Usti nad Labem
- Hradec Králové
  - Hradec Kralove, Hradec Králové, Czechia, 500 12
    - Hepato-Gastroenterologie HK
- Olomoucký Kraj
  - Olomouc, Olomoucký Kraj, Czechia, 779 00
    - MUDr. Gregar, s.r.o.
- Prague
  - Praha 4, Prague, Czechia, 14021
    - Institut klinicke a experimentalni mediciny
- Praha 2
  - Prague, Praha 2, Czechia, 120 00
    - Synexus Czech
- Praha 4
  - Prague, Praha 4, Czechia, 14059
    - Thomayerova nemocnice
- Zlínský Kraj
  - Zlín, Zlínský Kraj, Czechia, 762 75
    - Nemocnice Tomase Bati ve Zline
Denmark
- - Aalborg, Denmark, 9100
    - Aalborg Hospital
- Midtjylland
  - Aarhus, Midtjylland, Denmark, 8200
    - Aarhus Universitetshospital, Skejby
France
- - Amiens, France, 80054
    - CHU Amiens Picardie Site Sud - Service d'Hepato-gastro-entérologie
  - Le Mans, France, 72000
    - Centre Hospitalier du Mans
  - Montpellier Cedex 5, France, 34295
    - CHRU de Montpellier-Hopital St Eloi
  - Paris, France, 75015
    - GH Necker - Enfants Malades
  - Pessac Cedex, France, 33604
    - CHU Bordeaux - Hôpital Haut-Lévêque
  - Poitiers Cedex, France, 86021
    - CHU de Poitiers- Service d'Hépato-gastro-entérologie,
  - Rouen cedex, France, 76036
    - CHU Charles Nicolle in Rouen
  - Saint Etienne Cedex 2, France, 42055
    - CHU St Etienne Hopital Nord
  - Vand?uvre-lès-Nancy, France, 54511
    - CHRU de Nancy
- Bas Rhin
  - Strasbourg Cedex, Bas Rhin, France, 67098
    - Hopital de Hautepierre - Service d'Hépatogastroentérolgie
- Cedex 12
  - Paris, Cedex 12, France, 75012
    - Hôpital Saint Antoine
- Paris
  - Clichy, Paris, France, 92110
    - Hôpital Beaujon
  - Le Kremlin-Bicêtre, Paris, France, 94270
    - Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre
- Rhone
  - Pierre Benite cedex, Rhone, France, 69495
    - Hospices Civils de Lyon - Centre Hospitalier Lyon Sud -
Germany
- - Berlin, Germany, 12200
    - Charité Campus Virchow-Klinikum
  - Berlin, Germany, 12627
    - Synexus Clinical Research GmbH
  - Düsseldorf, Germany, 40489
    - Florence-Nightingale-Krankenhaus
  - Hamburg, Germany, 20251
    - HaFCED - Hamburgisches Forschungsinstitut für chronisch entzündliche Darmerkrankungen
  - Mainz, Germany, 55122
    - Gastroenterologische Gemeinschaftspraxis Mainz
  - Uslar, Germany, 99734
    - Tumorzentrum Nordthüringen
- Baden-Württemberg
  - Pforzheim, Baden-Württemberg, Germany, 75179
    - Siloah St. Trudpert Klinikum-Zentrum für Innere Medizin
- Bayern
  - Würzburg, Bayern, Germany, 97080
    - Universitätsklinikum Würzburg A. ö. R.
- Hessen
  - Frankfurt am Main, Hessen, Germany, 60313
    - Synexus Clinical Research GmbH
  - Lauterbach, Hessen, Germany, 36341
    - Krankenhaus Eichhof
- Niedersachsen
  - Hannover, Niedersachsen, Germany, 30625
    - Medizinische Hochschule Hanover
- Nordrhein Westfalen
  - Bottrop, Nordrhein Westfalen, Germany, 46242
    - Knappschaftskrankenhaus Bottrop
- North Rhine-Westphalia
  - Essen, North Rhine-Westphalia, Germany, 45147
    - Universitaetsklinikum Essen
  - Neuss, North Rhine-Westphalia, Germany, 41462
    - Johanna Etienne Krankenhaus-Klinik für Allgemeine Innere Medizin
  - Wipperfurth, North Rhine-Westphalia, Germany, 51688
    - Gemeinschaftspraxis Jakobeit
- Rhineland-Palatinate
  - Ludwigshafen, Rhineland-Palatinate, Germany, 67067
    - St. Marienkrankenhaus-Medizinische Klinik I
- Saarland
  - Friedrichsthal, Saarland, Germany, 66299
    - Practice Dr.med. Denger and Dr.med. Pfitzner
- Sachsen Anhalt
  - Halle (Saale),, Sachsen Anhalt, Germany, 06108
    - Studiengesellschaft BSF Unternehmergesellschaft
- Saxony-Anhalt
  - Leipzig, Saxony-Anhalt, Germany, 04103
    - Synexus Clinical Research GmbH-Leipzig Research Centre
- Schleswig-Holstein
  - Kiel, Schleswig-Holstein, Germany, 24105
    - Universitätsklinikum Schleswig-Holstein
  - Oldenburg, Schleswig-Holstein, Germany, 23758
    - Red-Institut GmbH
Hungary
- - Budapest, Hungary, 1136
    - Pannónia Magánorvosi Centrum
  - Budapest, Hungary, 1036
    - Synexus Magyarorszag Kft.
  - Budapest, Hungary, 1033
    - Clinexpert SMO
  - Békéscsaba, Hungary, 5600
    - Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház
  - Gyöngyös, Hungary, 3200
    - Bugat Pal Korhaz
  - Miskolc, Hungary, 3526
    - Endomedix Diagnosztikai Központ - Miskolc
  - Szekszard, Hungary, 7100
    - CLINFAN Szolgáltató Kft
- Bekes
  - Gyula, Bekes, Hungary, 5700
    - Synexus Gyula
- Csongrad
  - Szeged, Csongrad, Hungary, 6725
    - SZTE AOK Belgyogyaszati Klinika
- EU
  - Balatonfüred, EU, Hungary, 8230
    - DRC Gyogyszervizsgalo Kozpont Kft.
- Komárom-Esztergom
  - Tatabánya, Komárom-Esztergom, Hungary, H-2800
    - Clinexpert Tatabánya Ltd.
India
- - Chandigarh, India, 160012
    - Postgraduate Institute of Medical Education & Research
  - New Delhi, India, 110075
    - Aakash Healthcare Super Speciality Hospital
  - Telangana, India, 500003
    - Gandhi Hospital
  - Telangana, India, 500003
    - Yashoda Super Speciality Hospital
- Delhi
  - New Delhi, Delhi, India, 110060
    - Sir Ganga Ram Hospital
  - New Delhi, Delhi, India, 110029
    - All India Institute of Medical Sciences
- Gujarat
  - Surat, Gujarat, India, 395009
    - Gujarat Hospital - Gastro and Vascular Centre
  - Vadodara, Gujarat, India, 390007
    - International Gastro Institute
- Maharashtra
  - Nagpur, Maharashtra, India, 440010
    - Midas Multispeciality Hospital Pvt.Ltd.
  - Pune, Maharashtra, India, 411001
    - Ruby Hall Clinic and Grant Medical Foundation
- Punjab
  - Ludhiana, Punjab, India, 141001
    - Dayanand Medical College and Hospital
- Rajasthan
  - Jaipur, Rajasthan, India, 302006
    - SR Kalla Memorial Gastro & General Hospital
- Tamil Nadu
  - Chennai, Tamil Nadu, India, 600035
    - Apollo Speciality Hospital - Teynampet
- Telangana
  - Hyderabad, Telangana, India, 500032
    - Asian Institute of Gastroenterology
Israel
- - Beer Sheva, Israel, 8410101
    - Soroka Medical Center
  - Haifa, Israel, 31048
    - Bnai Zion Medical Center
  - Holon, Israel, 5822012
    - Edith Wolfson Medical Center
  - Jerusalem, Israel, 91031
    - Shaare Zedek Medical Center
  - Jerusalem, Israel, 9112001
    - Hadassah Medical Center
  - Nahariya, Israel, 22100
    - Galilee Medical Center Department of Internal Medicine A
  - Ramat Gan, Israel, 5262100
    - Chaim Sheba Medical Center
  - Rehovot, Israel, 7610001
    - Kaplan Medical Center
  - Zerifin, Israel, 70300
    - Assaf Harofeh Medical Center
Italy
- - Bari, Italy, 70124
    - Azienda Ospedaliera Policlinico Consorziale
  - Brescia, Italy, 25100
    - Università degli Studi c/o Spedali Civili
  - Cagliari, Italy, 09134
    - Azienda Ospedaliera Giuseppe Brotzu
  - Milano, Italy, 20157
    - Ospedale Luigi Sacco
  - Modena, Italy, 41124
    - Azienda Ospedaliera Universitaria Policlinico de Modena
  - Napoli, Italy, 80131
    - Azienda Ospedaliera Universitaria Federico II
  - Napoli, Italy, 80131
    - Azienda Ospedaliera Di Rilievo Nazionale A. Cardarelli
  - Reggio Emilia, Italy, 42123
    - Arcispedale Santa Maria Nuova
  - Roma, Italy, 00161
    - Polic.Umberto I -Univ. La Sapienza
  - Udine, Italy, 33100
    - Azienda Ospedaliera Santa Maria della Misericordia
- Bari
  - Castellana Grotte, Bari, Italy, 70013
    - Azienda Ospedaliera Saverio De Bellis
- Cagliari
  - Monserrato, Cagliari, Italy, 09042
    - Università di Cagliari - Presidio Policlinico Monserrato
- Catanzaro
  - Germaneto, Catanzaro, Italy, 88100
    - Azienda ospedaliero-universitaria Mater Domini
- Lazio
  - Roma, Lazio, Italy, 00168
    - Policlinico Gemelli - Università Cattolica del Sacro Cuore
- MI
  - Milano, MI, Italy, 20122
    - Istituto Mangiagalli
- Milan
  - San Donato Milanese, Milan, Italy, 20097
    - Ospedale Clinicizzato San Donato
- Milano
  - Rho, Milano, Italy, 20017
    - Presidio di Rho
  - Rozzano, Milano, Italy, 20089
    - Istituto Clinico Humanitas
Japan
- - Kagoshima, Japan, 892-0846
    - Sameshima Hospital
  - Kagoshima, Japan, 890-8520
    - Kagoshima University Hospital
  - Kumamoto, Japan, 860-8556
    - Kumamoto University Hospital
  - Kyoto, Japan, 602-8566
    - Kyoto Furitsu Medical University Hospital
  - Okayama, Japan, 700-8558
    - Okayama University Hospital
  - Okayama, Japan, 700-0013
    - Okayama Saiseikai General Hospital Outpatient Center
  - Saitama, Japan, 336-0963
    - Tokitokai Tokito Clinic
  - Toyama, Japan, 930-8550
    - Toyama Prefectural Central Hospital
  - Yamagata, Japan, 990-9585
    - Yamagata University Hospital
- Aichi
  - Nagoya, Aichi, Japan, 4570818
    - Kojunkai Daido Clinic
  - Toyoake, Aichi, Japan, 470-1192
    - Fujita Health University
- Aomori
  - Hirosaki, Aomori, Japan, 036-8545
    - National Hospital Organization Hirosaki General Medical Center
- Chiba
  - Kashiwa, Chiba, Japan, 277 0871
    - Tsujinaka Hospital
- Fukuoka
  - Chikushino, Fukuoka, Japan
    - Fukuoka University Chikushi Hospital
  - Fukuoka, Jonan-Ku, Fukuoka, Japan, 814-0180
    - Fukuoka University Hospital
- Fukushima
  - Koriyama, Fukushima, Japan, 963-8501
    - Hoshi General Hospital
- Gunma
  - Isesaki, Gunma, Japan, 372-0817
    - Isesakishimin Hospital
  - Kiryu, Gunma, Japan, 376 0024
    - Kiryu Kosei Hospital
  - Maebashi, Gunma, Japan, 371 0811
    - Maebashi Red Cross Hospital
- Hiroshima
  - Fukuyama, Hiroshima, Japan, 720-0825
    - National Hospital Organization Fukuyama Medical Center
- Hokkaido
  - Asahikawa, Hokkaido, Japan, 078-8510
    - Asahikawa Medical College Hospital
  - Chuo-ku, Sapporo-shi, Hokkaido, Japan, 060-0033
    - Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
  - Sapporo, Hokkaido, Japan
    - Sapporo Medical University Hospital
  - Sapporo, Hokkaido, Japan, 065-0033
    - Sapporo Higashi Tokushukai Hospital
  - Sapporo-shi, Hokkaido, Japan, 004 0041
    - Tokushukai Sapporo Tokushukai Hospital
- Hyogo
  - Nishinomiya, Hyogo, Japan, 663-8501
    - Hyogo College of Medicine
- Ibaraki
  - Kasama, Ibaraki, Japan, 890-8520
    - Ibaraki Prefectural Central Hospital
- Ishikawa
  - Kanazawa, Ishikawa, Japan, 920-8641
    - Kanazawa University Hospital
- Kagawa
  - Takamatsu, Kagawa, Japan, 760-8557
    - Kagawa Prefectural Central Hospital
- Kanagawa
  - Kamakura, Kanagawa, Japan, 247-0056
    - Ofuna Central Hospital
  - Sagamihara, Kanagawa, Japan, 252-0375
    - Kitasato University Hospital
  - Yokohama, Kanagawa, Japan, 220-0045
    - Matsushima Cinic
- Mie
  - Tsu, Mie, Japan, 514-8507
    - Mie University Hospital
- Miyagi
  - Sendai, Miyagi, Japan, 980-0021
    - IMS Meirikai Sendai General Hospital
  - Sendai, Miyagi, Japan, 981-3213
    - Takagi Clinic - Sendai
- Nagasaki
  - Nagasaki City, Nagasaki, Japan, 850-0842
    - Nagasaki Harbor Medical Center
- Osaka-Fu
  - Osaka-shi, Osaka-Fu, Japan, 530-0011
    - Infusion Clinic
- Saga
  - Saga-shi, Saga, Japan, 840 8571
    - Saga-Ken Medical Center Koseikan
- Shizuoka-Ken
  - Hamamatsu-shi, Shizuoka-Ken, Japan, 4328061
    - Matsuda Hospital
- Tochigi
  - Shimotsuke, Tochigi, Japan, 329-0498
    - Jichi Medical University Hospital
- Tokyo
  - Bunkyō, Tokyo, Japan, 113-8519
    - Tokyo Medical and Dental University Hospital
  - Koto-ku, Tokyo, Japan, 135 8577
    - Showa University Koto Toyosu Hospital
  - Shinjuku-ku, Tokyo, Japan, 169-0073
    - JHCO Tokyo Yamate Medical Center
  - Shinjuku-ku, Tokyo, Japan, 162-8655
    - National Center for Global Health and Medicine
- Tottori
  - Yonago, Tottori, Japan, 683-8504
    - Tottori University Hospital
Korea, Republic of
- - Busan, Korea, Republic of, 48108
    - Inje University Haeundae Paik Hospital
  - Busan, Korea, Republic of, 49201
    - Dong-A University Hospital
  - Daegu, Korea, Republic of, 42601
    - Keimyung University Dongsan Hospital
  - Daegu, Korea, Republic of, 41404
    - Kyungpook National University Medical Center Chilgok Hospital
  - Gangwon-do, Korea, Republic of, 26426
    - Yonsei University Wonju Severance Christian Hospital
  - Gyeonggi-do, Korea, Republic of, 15355
    - Korea University Ansan Hospital
  - Seoul, Korea, Republic of, 3080
    - Seoul National University Hospital
  - Seoul, Korea, Republic of, 06351
    - Samsung Medical Center
  - Seoul, Korea, Republic of, 03181
    - Kangbuk Samsung Hospital
  - Seoul, Korea, Republic of, 06973
    - Chungang University Hospital
- Gyeonggi-do
  - Suwon, Gyeonggi-do, Korea, Republic of, 16499
    - Ajou University Hospital
- Gyeonggido
  - Guri-si, Gyeonggido, Korea, Republic of, 11923
    - Hanyang University Guri Hospital
- Korea
  - Daegu, Korea, Korea, Republic of, 41944
    - Kyung Pook National University Hospital
  - Seoul, Korea, Korea, Republic of, 06591
    - Seoul St. Mary's Hospital
  - Seoul, Korea, Korea, Republic of, 02447
    - Kyung Hee University Hospital
  - Seoul, Korea, Korea, Republic of, 134727
    - Kyunghee University Hospital at Gangdong
- Kyǒngsangbuk-do
  - Gyeongsan-si, Kyǒngsangbuk-do, Korea, Republic of, 42415
    - Yeungnam Univeristy Medical Center
- Seoul, Korea
  - Seoul, Seoul, Korea, Korea, Republic of, 03080
    - Seoul National University Hospital
- Seoul-teukbyeolsi [Seoul]
  - Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 05505
    - Asan Medical Center
- Taejǒn-Kwangyǒkshi
  - Daejeon, Taejǒn-Kwangyǒkshi, Korea, Republic of, 34943
    - The Catholic University of Korea, Daejeon St. Mary's Hospital
Latvia
- Rīga
  - Riga, Rīga, Latvia, LV-1002
    - Pauls Stradins Clinical Univeristy Hospital
Lithuania
- - Kaunas, Lithuania, 50009
    - Hospital of Lithuanian University of Health Sciences Kaunas
Mexico
- - Chihuahua, Mexico, 31203
    - Scientia Investigacion Clinica S.C.
  - Durango, Mexico, 34000
    - Instituto de Investigaciones Clínicas para la Salud
  - San Luis Potosi, Mexico, 78213
    - Centro de Alta Especialidad Reumatologia Inv del Potosi SC
  - Veracruz, Mexico, 91900
    - Sociedad de Metabolismo y Corazon
- Distrito Federal
  - Ciudad de México, Distrito Federal, Mexico, 03100
    - Health Pharma Professional Research S.A. de C.V:
  - México City, Distrito Federal, Mexico, 03310
    - Grupo Medico Camino Sc
- JA
  - Guadalajara, JA, Mexico, 44670
    - PanAmerican Clinical Research S.A.de C.V. Guadalajara
- Nuevo Leon
  - Monterrey, Nuevo Leon, Mexico, 64460
    - Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
- Queretaro
  - Santiago de Queretaro, Queretaro, Mexico, 76226
    - Panamerican Clinical Research Mexico S.A. de C.V.
Netherlands
- - Uden, Netherlands, 5406 PT
    - Bernhoven Uden
- North Brabant
  - Tilburg, North Brabant, Netherlands, 5022 GC
    - ETZ Elisabeth Tilburg
Poland
- - Bydgoszcz, Poland, 85-168
    - Szpital Uniwersytecki Nr 2 im. dr J. Biziela w Bydgoszczy
  - Elblag, Poland, 82-300
    - NZOZ "Twoje Zdrowie EL" Sp. z o.o.
  - Knurow, Poland, 44-190
    - Indywidualna Specjalistyczna Praktyka Lekarska
  - Lodz, Poland, 90-127
    - Synexus Polska Oddział w Lodzi
  - Szczecin, Poland, 71-434
    - Twoja Przychodnia - Szczecinskie Centrum Medyczne
  - Warszawa, Poland, 00-728
    - WIP Warsaw IBD Point Profesor Kierkuś
  - Zamosc, Poland, 22-400
    - ETG Zamosc
- Dolnośląskie
  - Karwiany, Dolnośląskie, Poland, 52-200
    - MED-ROZ
  - Wroclaw, Dolnośląskie, Poland, 50-449
    - Melita Medical
- Lower Silesian
  - Swidnica, Lower Silesian, Poland, 58-100
    - Dc-Med. Sp. z o.o.
  - Wroclaw, Lower Silesian, Poland, 50-381
    - M. Sklodowskiej-Curie 12
- Lubelskie
  - Lublin, Lubelskie, Poland, 20-582
    - ZOZ Gastromed
- Mazowieckie
  - Warsaw, 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
- Podkarpackie
  - Rzeszow, Podkarpackie, Poland, 35-302
    - Private Practice - Dr. Korczowski Bartosz
- Podlaskie
  - Bialystok, Podlaskie, Poland, 15-707
    - Nova Reuma Społka Partnerska
- Pomorskie
  - Gdansk, Pomorskie, Poland, 80-382
    - Synexus Polska Gdansku
  - Gdynia, Pomorskie, Poland, 81-537
    - Synexus Polska Sp. z o.o. Oddzial w Gdyni
  - Sopot, Pomorskie, Poland, 81-756
    - Endoskopia Sp. z.o.o.
- Silesian
  - Sosnowiec, Silesian, Poland, 41-200
    - Kiepury Clinic
- Subcarpathian
  - Rzeszow, Subcarpathian, Poland, 35-326
    - Centrum Medyczne Medyk
- West Pomeranian
  - Szczecin, West Pomeranian, Poland, 71-685
    - Sonomed Sp. z o.o.
- Wielkopolskie
  - Poznan, Wielkopolskie, Poland, 60-702
    - Synexus Polska Sp. z o.o. Oddzial w Poznaniu
- Woj Mazowieckie
  - Warszawa, Woj Mazowieckie, Poland, 04-730
    - Instytut Pomnik-Centrum Zdrowia Dziecka
- Śląskie
  - Czestochowa, Śląskie, Poland, 42-202
    - Centrum Medyczne Synexus
  - Katowice, Śląskie, Poland, 40040
    - Synexus Polska - Katowicach
Puerto Rico
- - Caguas, Puerto Rico, 00726-4980
    - Caguas Gastroenterology and Hepatology Center, LLC
  - Rio Piedras, Puerto Rico, 00935
    - Pan American Center for Oncology Trials
  - San Juan, Puerto Rico, 00909
    - Latin Clinical Trial Center
  - Vega Baja, Puerto Rico, 00694
    - Wellness clinical Research Vega Baja
Romania
- - Bucuresti, Romania, 010719
    - SC Med Life SA
  - Bucuresti, Romania, 022328
    - Institutul Clinic Fundeni
  - Bucuresti, Romania, 012015
    - S.C. Centrul Medical Medicum SRL
  - Bucuresti, Romania, 21155
    - Spitalul Clinic Colentina
  - Bucuresti, Romania, 30463
    - CCBR Clinical Research
  - Bucuresti, Romania, 011464
    - Spitalul Clinic CF 2 Bucuresti
  - București, Romania, 050098
    - Spitalul Universitar de Urgenta Bucuresti
  - Constanta, Romania, 900168
    - Gastromed S.R.L.
  - Constanta, Romania, 900591
    - Affidea Medical Research Center
  - Targu Mures, Romania, 540103
    - Spitalul Clinic Judetean Targu Mures
  - Timisoara, Romania, 300645
    - S.C. Materna Care S.R.L.
- Bihor
  - Oradea, Bihor, Romania, 410450
    - Spitalul Pelican
- București
  - Bucureti, București, Romania, 014461
    - Spitalul Euroclinic
- Cluj
  - Cluj-Napoca, Cluj, Romania, 400132
    - Sc Tvm Med Serv
Russian Federation
- - Barnaul, Russian Federation, 656043
    - Multidisciplinary Medical Clinic "Anthurium"
  - Chelyabinsk, Russian Federation, 454048
    - LLC Evimed
  - Cherepovets, Russian Federation, 162600
    - Medical and Sanitary Division of Severstal
  - Ekaterinburg, Russian Federation, 620109
    - LLC MA New Hospital
  - Kaliningrad, Russian Federation, 236035
    - Clinical Trials Center of Medical Institute
  - Kazan, Russian Federation, 420029
    - Kazan State Medical University
  - Kemerovo, Russian Federation, 650066
    - SIH Kemerovo Regional Clinical Hosptial
  - Moscow, Russian Federation, 123423
    - State Scientific Centre of Coloproctology
  - Moscow, Russian Federation, 123022
    - LLC ?Medsanchast No 14?
  - Novosibirsk, Russian Federation, 630005
    - LLC "Medicine Center SibNovoMed"
  - Omsk, Russian Federation, 644050
    - The University Clinic of OSMU
  - Saint Petersburg, Russian Federation, 195257
    - Saint-Petersburg City Hospital of Saint Elizabeth
  - 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, 198328
    - SPb SBIH "City Polyclinic # 106"
  - Samara, Russian Federation, 443029
    - NonState Healthcare Institution Central Clinical Hospital
  - St-Petersburg, Russian Federation, 197022
    - Academician I.P. Pavlov First St-Petersburg State Medical University
- 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
- Moskva
  - Moscow, Moskva, Russian Federation, 105554
    - Olla-Med
- Nizhegorodskaya Oblast'
  - Nizhny Novgorod, Nizhegorodskaya Oblast', Russian Federation, 603126
    - Nizhny Novgorod Regional Hospital N.A. Semashko
- Novosibirskaya Oblast'
  - Novosibirsk, Novosibirskaya Oblast', Russian Federation, 630007
    - Novosibirski Gastrocenter
- Rostovskaya Oblast'
  - Rostov-on-Don, Rostovskaya Oblast', Russian Federation, 344091
    - Rostov State Medical University
- Sankt-Peterburg
  - Saint Petersburg, Sankt-Peterburg, Russian Federation, 196143
    - Scientific research center ECO-security
  - Saint Petersburg, Sankt-Peterburg, Russian Federation, 194354
    - LLC Medical Center Reavita Med SPb
Serbia
- - Belgrade, Serbia, 11000
    - Clinical Center " Dr Dragisa Misovic Dedinje"
  - Kragujevac, Serbia, 34000
    - Clinical Center Kragujevac Gastroenterohepatology Clinic
- Beograd
  - Belgrade, Beograd, Serbia, 11000
    - Clinical Hospital Center Zvezdara
  - Zemun, Beograd, Serbia, 11080
    - Zemun Medical Centre
- NAP
  - Belgrade, NAP, Serbia, 11080
    - University Medical Center "Bezanijska kosa"
- Nišavski Okrug
  - Nis, Nišavski Okrug, Serbia, 18000
    - Clinical Center Nis
- Vojvodina
  - Sremska Mitrovica, Vojvodina, Serbia, 22000
    - Sremska Mitrovica Health Centre
  - Zrenjanin, Vojvodina, Serbia, 23000
    - General Hospital "Djordje Joanovic"
Slovakia
- - Banska Bystrica, Slovakia, 97517
    - FNsP FDRoosevelta Banska Bystrica
  - Bratislava, Slovakia, 811 09
    - CLINIQ, s.r.o
  - Nove Zamky, Slovakia, 94002
    - Gastromedic
  - Presov, Slovakia, 08001
    - Gastro LM s.r.o.
- Prešovský Kraj
  - Prešov, Prešovský Kraj, Slovakia, 080 01
    - Gastro
  - Vranov N. Toplou, Prešovský Kraj, Slovakia, 093 01
    - Endomed, s.r.o.
Spain
- - Alicante, Spain, 3004
    - Instituto de Ciencias Médicas
  - Barcelona, Spain, 8022
    - Centro Medico Teknon - DIGESTIVO
  - Cordoba, Spain, 14004
    - Hospital Reina Sofia
  - 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
  - Madrid, Spain, 28006
    - Hospital La Princesa
  - Santa Cruz de Tenerife, Spain, 38010
    - Hospital Universitario Nuestra Señora de la Candelaria
- A Coruña [La Coruña]
  - Santiago de Compostela, A Coruña [La Coruña], Spain, 15702
    - Clínica Gaias - Santiago
- Asturias
  - Oviedo, Asturias, Spain, 33011
    - Hospital Universitario Central de Asturias
- Barcelona
  - Girona, Barcelona, Spain, 17007
    - Hospital Universitari de Girona Dr. Josep Trueta
- Navarra
  - Pamplona, Navarra, Spain, 31008
    - Complejo Hospitalario de Navarra NAVARRABIOMED UNIDAD EC
Switzerland
- - Bern, Switzerland, 3010
    - Inselspital Bern
  - Bern, Switzerland, CH-3012
    - Gastroenterologische Praxis Balsiger, Seibold & Partner
- Sankt Gallen
  - St. Gallen, Sankt Gallen, Switzerland, 9007
    - Cantonal Hospital St.Gallen
Turkey
- - Ankara, Turkey, 06800
    - Ankara City Hospital
  - Ankara, Turkey, 06100
    - Hacettepe University Faculty of Medicine
  - Ankara, Turkey
    - Gazi university faculty of medicine
  - Bursa, Turkey, 16059
    - Uludag Universitesi
  - Edirne, Turkey, 22030
    - Trakya University
  - Eskisehir, Turkey, 26040
    - Eskisehir Osmangazi University Gastroenterology
  - Gaziantep, Turkey, 27310
    - Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi
  - Hatay, Turkey, 31040
    - Mustafa Kemal Universitesi Tayfur Ata Sokmen Tip Fakultesi
  - Istanbul, Turkey, 34098
    - Istanbul Universitesi-Cerrahpasa Cerrahpasa Tip Fakultesi Yerleskesi
  - Istanbul, Turkey, 34340
    - Marmara University Pendik Research and Training Hospital
  - Istanbul, Turkey, 34724
    - Medicana Kadiköy Hastanesi
  - Istanbul, Turkey
    - Fulya Acıbadem
  - Izmir, Turkey, 35340
    - Dokuz Eylul Universitesi
  - Izmit, Turkey, 41380
    - Kocaeli University Medical Faculty Hospital
  - Kayseri, Turkey, 38039
    - Erciyes University Hospital
  - Konya, Turkey, 42080
    - Konya Necmettin Erbakan Gastroenterology
  - Malatya, Turkey, 44280
    - İnönü Üniversitesi Turgut Özal Tıp Merkezi
- Antalya
  - Kocaeli, Antalya, Turkey, 7100
    - Antalya Egitim ve Arastırma Hastanesi
- Istanbul
  - Kadıkoy, Istanbul, Turkey, 34734
    - Acibadem Universitesi - Acibadem Kozyatagi Hastanesi
- Mersin
  - Yenişehir, Mersin, Turkey, 33343
    - Mersin University Medical Faculty
Ukraine
- - Chernivtsi, Ukraine, 58002
    - RCI Chernivtsi Regional Clinical Hospital
  - Dnipro, Ukraine, 49038
    - Medical Center of Limited Liability Company Medical Center Clinic of Family Medicine
  - Ivano-Frankivsk, Ukraine, 76018
    - Ivano-Frankivsk State Medical University
  - Kharkiv, Ukraine, 61058
    - Kharkiv Regional Council Regional Clinical Hospital
  - Kyiv, Ukraine, 02091
    - International Institute of Clinical Trials LLC
  - 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"
  - Kyiv, Ukraine, 03037
    - LLC Medbud-Clinic Medical Center
  - Kyiv, Ukraine, 01030
    - Medical Centre of Ukrainian German Antiulcer Gastroenterology Centre BYK-KYIV
  - Kyiv, Ukraine, 03049
    - Kyiv Railway Clinical Hospital No.2 of Branch Health Center of the Public Joint Stock Company Ukrainian Railway
  - Odesa, Ukraine, 65117
    - Communal Enterprise "Odesa Regional Clinical Hospital"
  - Uzhgorod, Ukraine, 88000
    - A. Novak Transcarpathian Regional Clinical Hospital
  - Vinnitsa, Ukraine, 21009
    - Medical Center "Health Clinic" LLC
  - 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
  - Vinnytsya, Ukraine, 21018
    - Vinnytsya Regional Clinical Hospital
  - Zaporizhzhia, Ukraine, 69076
    - Diacenter LLC
  - Zaporizhzhia, Ukraine, 69000
    - Zaporozhye City Clinical Hospital #6
- Kharkivska Oblast
  - Kharkiv, Kharkivska Oblast, Ukraine, 61037
    - City Clinical Hospital No. 2
- Kyiv
  - Kiev, Kyiv, Ukraine, 4050
    - Medical Center of Limited Liability Company "Medical Center "Consilium Medical"
- Lvivska Oblast
  - Lviv, Lvivska Oblast, Ukraine, 79000
    - Lviv Railway Clinical Hospital
  - Lviv, Lvivska Oblast, Ukraine, 79000
    - Lviv Regional Endocrinology Dispensary
United Kingdom
- - Doncaster, United Kingdom, DN2 5LT
    - Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust
  - Edinburgh, United Kingdom, EH16 4TJ
    - Paediatric Clinical Research Facility Royal Hospital for Children and Young People
  - Hexham, United Kingdom, NE46 1QJ
    - Synexus North East Clinical Research Centre
- Cambridgeshire
  - Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
    - Addenbrookes Hospital
- England
  - London, England, United Kingdom, E11 1NR
    - Whipps Cross University Hospital
- Greater Manchester
  - Manchester, Greater Manchester, United Kingdom, M15 6SE
    - Synexus Manchester Clinical Research Centre
- London
  - Fulham, London, United Kingdom, SW10 9NH
    - Chelsea and Westminster Hospital
- South Glamorgan
  - Cardiff, South Glamorgan, United Kingdom, CF15 9SS
    - Synexus Wales Clinical Research Centre
- Wstmid
  - Birmingham, Wstmid, United Kingdom, B15 2SQ
    - Synexus Midlands Clinical Research Center
United States
- Alabama
  - Birmingham, Alabama, United States, 35233
    - University of Alabama-The Kirklin Clinic
  - Dothan, Alabama, United States, 36301
    - Digestive Health Specialists
  - Guntersville, Alabama, United States, 35976
    - Lakeview Clinical Research
  - Tuscaloosa, Alabama, United States, 35406
    - Care Access Research - Tuscaloosa
- Arizona
  - Litchfield Park, Arizona, United States, 85340
    - Research Solutions of Arizona
  - Mesa, Arizona, United States, 85206
    - Central Arizona Medical Associates, PC
  - Phoenix, Arizona, United States, 85037
    - Arizona Arthritis & Rheumatology Research, PLLC
  - Scottsdale, Arizona, United States, 85260
    - Reliance Research
  - Tempe, Arizona, United States, 85282
    - Synexus Site Network
- California
  - Arcadia, California, United States, 91006
    - InSite Digestive Health Care
  - Encinitas, California, United States, 92024
    - B G Clinical Research, Inc.
  - Gilroy, California, United States, 95020
    - Care Access - Gilroy
  - Huntington Beach, California, United States, 92648
    - Newport Huntington Med Grp
  - Lancaster, California, United States, 93534
    - Om Research, LLC
  - Los Angeles, California, United States, 90067
    - GastroIntestinal Biosciences Clinical Trials
  - Northridge, California, United States, 91324
    - California Medical Research Associates
  - Orange, California, United States, 92868
    - University of California Irvine
  - Pasadena, California, United States, 91105
    - InSite Digestive Health Care
  - San Jose, California, United States, 95124
    - Care Access Research - San Jose
  - Santa Ana, California, United States, 92705
    - Wolverine Clinical Trials, Llc
  - Thousand Oaks, California, United States, 91360
    - Fomat Medical Research, Inc.
- Connecticut
  - Manchester, Connecticut, United States, 06040
    - Connecticut Gastroenterology
- Florida
  - Aventura, Florida, United States, 33180
    - IMR of South Florida
  - Clearwater, Florida, United States, 33756
    - Gastroenterology Consultants of Clearwater
  - Clearwater, Florida, United States, 33761
    - West Central Gastroenterology d/b/a Gastro Florida
  - Hialeah, Florida, United States, 33013
    - Inpatient Research Clinic
  - Hialeah, Florida, United States, 33016
    - Doral Medical Research
  - Jacksonville, Florida, United States, 32204
    - C2 Research Center, LLC
  - Kissimmee, Florida, United States, 34741
    - I.H.S. Health, LLC
  - Kissimmee, Florida, United States, 34744
    - Central Florida Gastro Research
  - Lakewood Ranch, Florida, United States, 34211
    - Florida Research Institute
  - Lehigh Acres, Florida, United States, 33936
    - Wellness Clinical Research
  - Miami, Florida, United States, 33156
    - Research Associates of South Florida, LLC
  - Miami, Florida, United States, 33133
    - Infinite Clinical Research
  - Miami, Florida, United States, 33186
    - Coral Research Clinic Corp
  - Miami, Florida, United States, 33175
    - Ezy Medical Research
  - Miami, Florida, United States, 33125
    - Columbus Clinical Services, LLC
  - Miami, Florida, United States, 33155
    - Nickalus Children's Hospital Research Institute
  - Miami, Florida, United States, 33165
    - SaludMax Medical Corp
  - Miami Lakes, Florida, United States, 33016
    - Wellness Clinical Research
  - Miami Lakes, Florida, United States, 33016
    - Goji Group - Research Trials Group
  - Orlando, Florida, United States, 32806
    - Orlando Health, Inc
  - Orlando, Florida, United States, 32803
    - Center for Interventional Endoscopy
  - Orlando, Florida, United States, 32803
    - Endoscopic Research Inc
  - Orlando, Florida, United States, 32819
    - Clintheory Healthcare
  - Orlando, Florida, United States, 32825
    - Care Access Research - Orlando
  - Orlando, Florida, United States, 32825
    - Digestive and Liver Center of Florida
  - Pensacola, Florida, United States, 32503
    - Gastroenterology Associates of Pensacola, PA
  - Pinellas Park, Florida, United States, 33781
    - Synexus Clinical Research US, Inc.
  - South Miami, Florida, United States, 33143
    - USPA Advance Concept Medical Research Group LLC.
  - Sunrise, Florida, United States, 33351
    - Precision Clinical Research
  - Tamarac, Florida, United States, 33321
    - Advanced Research
  - Tampa, Florida, United States, 33612
    - University of South Florida
  - Tampa, Florida, United States, 33615
    - Alliance Clinical Research, LLC
- Georgia
  - Atlanta, Georgia, United States, 30303
    - Grady Memorial Hospital
  - Atlanta, Georgia, United States, 30309
    - Digestive Healthcare of Georgia
  - Columbus, Georgia, United States, 31904
    - Columbus Regional Research Institute
  - Marietta, Georgia, United States, 30060
    - Gastrointestinal Specialists of Georgia
- Idaho
  - Idaho Falls, Idaho, United States, 83404
    - Grand Teton Research Group
- Illinois
  - Chicago, Illinois, United States, 60621
    - Eagle Clinical Research
- Indiana
  - Evansville, Indiana, United States, 47715
    - Qualmedica Research, LLC
  - Indianapolis, Indiana, United States, 46202
    - Indiana University Health
  - Terre Haute, Indiana, United States, 47802
    - Care Access Research - Terre Haute
- Kansas
  - Kansas City, Kansas, United States, 66160
    - University of Kansas Medical Center
- Kentucky
  - Louisville, Kentucky, United States, 40206
    - Robley Rex VA Medical Center
- Louisiana
  - Houma, Louisiana, United States, 70360
    - CroNola LLC
  - Monroe, Louisiana, United States, 71201
    - Delta Research Partners LLC
  - New Orleans, Louisiana, United States, 70125
    - Nola Research Works, LLC
  - Shreveport, Louisiana, United States, 71105
    - Louisiana Clinical Research, LLC
- Maryland
  - Chevy Chase, Maryland, United States, 20815
    - MGG Group, Inc.., Co., Chevy Chase Clinical Research
  - Glen Burnie, Maryland, United States, 21061
    - Woodholme Gastroenterology Associates - Glen Burnie
  - Rockville, Maryland, United States, 20850
    - Capital Digestive Care
- Massachusetts
  - Boston, Massachusetts, United States, 02111
    - Tufts Medical Center
- Michigan
  - Chesterfield, Michigan, United States, 48047
    - Clinical Research Institute of Michigan, LLC
  - Detroit, Michigan, United States, 48202
    - Henry Ford Health System
  - Farmington Hills, Michigan, United States, 48334
    - Revive Research Institute
  - Grand Rapids, Michigan, United States, 49525
    - Infusion Associates
- Minnesota
  - Plymouth, Minnesota, United States, 55446
    - MNGI Digestive Health, P.A.
- Mississippi
  - Flowood, Mississippi, United States, 39232
    - Gastrointestinal Associates
  - Jackson, Mississippi, United States, 39216-4500
    - University of Mississippi School of Medicine
  - Jackson, Mississippi, United States, 39216
    - Southern Therapy and Advanced Research (STAR) LLC
  - Tupelo, Mississippi, United States, 38801
    - Digestive Health Specialists
- Missouri
  - Liberty, Missouri, United States, 64068
    - BVL Research
- Nevada
  - Las Vegas, Nevada, United States, 89123
    - Advanced Biomedical Research of America - South Eastern Avenue
  - Las Vegas, Nevada, United States, 89148
    - Care Access - Las Vegas
- New Mexico
  - Albuquerque, New Mexico, United States, 87108
    - Lovelace Scientific Resources - Albuquerque
- New York
  - Lake Success, New York, United States, 11042
    - NYU Langone Long Island Clinical Research Associates
  - Yonkers, New York, United States, 10701
    - Care Access Research - Yonkers
- North Carolina
  - Chapel Hill, North Carolina, United States, 27599
    - UNC Hospitals
  - Charlotte, North Carolina, United States, 28210
    - Javara
  - Greensboro, North Carolina, United States, 27405
    - Medication Management
  - High Point, North Carolina, United States, 27262
    - Peters Medical Research
  - Kinston, North Carolina, United States, 28501
    - Care Access Research-Kinston
  - Lumberton, North Carolina, United States, 28358
    - Care Access Research-Lumberton
  - Winston-Salem, North Carolina, United States, 27103
    - Gastroenterology Associates of the Piedmont
- Ohio
  - Cleveland, Ohio, United States, 44106
    - University Hospitals Cleveland Medical Center
  - Columbus, Ohio, United States, 43210
    - Ohio State University Hospital
  - Dublin, Ohio, United States, 43016
    - Ohio Gastroenterology Group Inc.
  - Westlake, Ohio, United States, 44145
    - NorthShore Gastroenterology Research, LLC
- Oklahoma
  - Oklahoma City, Oklahoma, United States, 73104
    - University of Oklahoma Health Sciences Center
- Pennsylvania
  - Pottsville, Pennsylvania, United States, 17901
    - Care Access Research LLC
  - Scranton, Pennsylvania, United States, 18508
    - Care Access Research - Scranton
- Rhode Island
  - Providence, Rhode Island, United States, 02905
    - University Gastroenterology
- South Carolina
  - Anderson, South Carolina, United States, 29621
    - Radiant Research
  - Myrtle Beach, South Carolina, United States, 29572
    - Strand GI
  - Orangeburg, South Carolina, United States, 29118
    - Gastroenterology Associates of Orangeburg
- Tennessee
  - Germantown, Tennessee, United States, 38138
    - Gastro One
  - Knoxville, Tennessee, United States, 37909
    - GIA Clinical Trials, LLC
- Texas
  - Austin, Texas, United States, 78750
    - Amel Med LLC
  - Dallas, Texas, United States, 75246
    - Baylor Scott & White Center for Inflammatory Bowel Diseases
  - Decatur, Texas, United States, 76234
    - Advanced Gastroenterology Associates
  - Galveston, Texas, United States, 77555
    - University of Texas Medical Branch at Galveston
  - Houston, Texas, United States, 77030
    - Baylor College of Medicine
  - Houston, Texas, United States, 77084
    - Biopharma Informatic, LLC
  - Houston, Texas, United States, 77030
    - University of Texas Health Services Center - Houston
  - Katy, Texas, United States, 77494
    - Katy Gastro Health & Nutrition
  - Lubbock, Texas, United States, 79424
    - Caprock Gastro Research, LLC
  - McAllen, Texas, United States, 78503
    - Biopharma Informatic, LLC
  - Pasadena, Texas, United States, 77505
    - Digestive System Healthcare
  - San Antonio, Texas, United States, 78229
    - Southern Star Research Institute, LLC
  - San Antonio, Texas, United States, 78215
    - Sun Research Institute
  - San Antonio, Texas, United States, 78230
    - VIP Trials
  - Tyler, Texas, United States, 75701
    - Tyler Research Institute, LLC
- Utah
  - Ogden, Utah, United States, 84403
    - Care Access Research LLC - Salt Lake City
  - Riverton, Utah, United States, 84065
    - Velocity Clinical Research/Gut Whisperer
  - Salt Lake City, Utah, United States, 84124
    - Care Access Research LLC - Salt Lake City
  - Salt Lake City, Utah, United States, 84102
    - Kalo Clinical Research
- Virginia
  - Charlottesville, Virginia, United States, 22908-0816
    - University of Virginia Health System
  - Fairfax, Virginia, United States, 22031
    - Pediatrics Specialists of Virginia
  - Norfolk, Virginia, United States, 23507
    - Children's Specialty Group, PPLC
  - Petersburg, Virginia, United States, 23805
    - The Center for Gastrointestinal Health
  - Richmond, Virginia, United States, 23226
    - Clinical Research Partners, LLC
  - Roanoke, Virginia, United States, 24014
    - Carilion Clinic
  - Suffolk, Virginia, United States, 23434
    - Virginia Gastroenterology Institute
  - Williamsburg, Virginia, United States, 23188
    - TPMG Clinical Research Williamsburg
- Washington
  - Bellevue, Washington, United States, 98004
    - Washington Gastroenterology, PLLC
  - Spokane, Washington, United States, 99202
    - Advanced Clinical Research-Spokane Gastroenterology
  - Tacoma, Washington, United States, 98405
    - Washington Gastroenterology, PLLC
- West Virginia
  - Huntington, West Virginia, United States, 25701
    - Marshall Medical Center
- Wyoming
  - Casper, Wyoming, United States, 82601
    - Care Access Research - Wyoming

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

15 years to 80 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

Description

Inclusion Criteria:

Diagnosis of CD for at least 3 months prior to baseline
Confirmed diagnosis of moderate to severe CD as assessed by SF, AP score, and SES-CD
Demonstrated intolerance, loss of response or inadequate response to conventional or to biologic therapy for CD
If female, subject must meet the contraception recommendations

Exclusion Criteria:

Have a current diagnosis of ulcerative colitis, inflammatory bowel disease-unclassified (IBD-U) (formerly known as indeterminate colitis) or short bowel syndrome
Currently have or are suspected to have an abscess. Recent cutaneous and perianal abscesses are not exclusionary if drained, adequately treated and resolved at least 3 weeks prior to baseline or 8 weeks prior to baseline for intra-abdominal abscesses, provided that there is no anticipated need for any further surgery
Have a stoma, ileoanal pouch or ostomy
Have had a bowel resection within 6 months, or any kind of intra-abdominal or extra abdominal surgery within 3 months of baseline
Have ever received any monoclonal antibodies binding IL-23

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: Triple

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo Participants received Placebo intravenously (IV) or subcutaneously (SC) every 4 weeks (Q4W). Any participant in the placebo arm who was considered a non-responder at Week 12 received 900 mg Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W for the remainder of the study. Nonresponse is defined as failing to achieve at least a 30% decrease in stool frequency (SF) and/or abdominal pain (AP) and be no worse than baseline.	Drug: Placebo Administered SC Drug: Placebo Administered IV
Experimental: 300 mg Mirikizumab Participants received 900 milligrams (mg) Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W	Drug: Mirikizumab Administered SC Other Names: LY3074828 Drug: Mirikizumab Administered IV Other Names: LY3074828
Active Comparator: 90 mg Ustekinumab Participants received 6 mg/kg Ustekinumab IV for one dose, then 90 mg SC every 8 weeks (Q8W)	Drug: Ustekinumab Administered SC Drug: Ustekinumab Administered IV
Experimental: 300 mg Mirikizumab (Adolescents) Participants received open label 900 mg Mirikizumab IV for 3 doses, then 300 mg SC Q4W	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 Adult Participants Achieving Clinical Response at Week 12 and Endoscopic Response at Week 52 (Placebo and Mirikizumab) Time Frame: Week 12 to Week 52	Clinical response by patient reported outcome (PRO) defined as ≥30% decrease in stool frequency (SF) and/or abdominal pain (AP) & neither score worse than baseline. SF (number of liquid or very soft stools) as per Bristol Stool Scale Category 6 or 7 and AP (4-point scale: 0=none, 1=mild, 2=moderate, 3=severe). Endoscopic response defined as ≥50% reduction from baseline in total Simple Endoscopic Score for Crohn's Disease (SES-CD) score. SES-CD evaluates 4 variables assessed in 5 bowel segments, each scored from 0-3: presence & size of ulcers (none=0; diameter 0.1-0.5 cm=1; 0.5-2 cm=2; >2 cm=3); extent of ulcerated surface (none=0; <10%=1; 10% to 30%=2; >30%=3); extent of affected surface (none=0; <50%=1; 50% to 75%=2; >75%=3); presence & type of narrowing (none=0; single, can be passed=1; multiple, can be passed=2; cannot be passed=3). Total is sum of all scores across all bowel segments. Scores range from 0 to 56, with higher scores indicating more severe disease.	Week 12 to Week 52
Percentage of Adult Participants Achieving Clinical Response at Week 12 and Clinical Remission at Week 52 (Placebo and Mirikizumab) Time Frame: Week 12 to Week 52	Clinical response by PRO defined as ≥ 30% decrease in SF and/or AP and neither score worse than baseline. SF (number of liquid or very soft stools) as per Bristol Stool Scale Category 6 or 7 and AP (4-point scale: 0=none, 1=mild, 2=moderate, 3=severe). Clinical remission defined as Crohn's Disease Activity Index (CDAI) total score <150. The CDAI is an 8-item disease activity measure comprised of a composite of 3 patient-reported items: AP (4-point scale: 0=none, 1=mild, 2=moderate, 3=severe); SF (number of liquid or very soft stools) as per Bristol Stool Scale Category 6 or 7; and general well-being (0=generally well, 1=slightly under par, 2=poor, 3=very poor, 4=terrible), and 5 physician-reported/laboratory items (physical signs and a laboratory parameter [hematocrit]).. Total score range of 0 to 600 points.	Week 12 to Week 52

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Adult Participants Achieving Endoscopic Response at Week 12 (Placebo and Mirikizumab) Time Frame: Week 12	Endoscopic Response defined as ≥50% reduction from baseline in SES-CD total score. SES-CD evaluates 4 variables assessed in 5 bowel segments, each scored from 0-3: presence & size of ulcers (none = 0; diameter 0.1-0.5 cm = 1; 0.5-2 cm = 2; >2 cm = 3); extent of ulcerated surface (none = 0; <10% = 1; 10% to 30% = 2; >30% = 3); extent of affected surface (none = 0; <50% = 1; 50% to 75% = 2; >75% = 3); presence & type of narrowing (none = 0; single, can be passed = 1; multiple, can be passed = 2; cannot be passed = 3). Total is sum of all scores across all bowel segments. Scores range from 0 to 56, with higher scores indicating more severe disease.	Week 12
Percentage of Adult Participants Achieving Endoscopic Response at Week 52 Time Frame: Week 52	Endoscopic Response defined as ≥50% reduction from baseline in SES-CD total score. SES-CD evaluates 4 variables assessed in 5 bowel segments, each scored from 0-3: presence & size of ulcers (none = 0; diameter 0.1-0.5 cm = 1; 0.5-2 cm = 2; >2 cm = 3); extent of ulcerated surface (none = 0; <10% = 1; 10% to 30% = 2; >30% = 3); extent of affected surface (none = 0; <50% = 1; 50% to 75% = 2; >75% = 3); presence & type of narrowing (none = 0; single, can be passed = 1; multiple, can be passed = 2; cannot be passed = 3). Total is sum of all scores across all bowel segments. Scores range from 0 to 56, with higher scores indicating more severe disease.	Week 52
Percentage of Adult Participants Achieving Clinical Remission at Week 12 (Placebo and Mirikizumab) Time Frame: Week 12	Clinical remission defined as CDAI total score <150. The CDAI is an 8- item disease activity measure comprised of a composite of 3 patient-reported items: AP (4-point scale: 0=none, 1=mild, 2=moderate, 3=severe); SF (number of liquid or very soft stools) as per Bristol Stool Scale Category 6 or 7; and general well-being (0=generally well, 1=slightly under par, 2=poor, 3=very poor, 4=terrible), and 5 physician-reported/laboratory items (physical signs and a laboratory parameter [hematocrit]). Total score range of 0 to 600 points.	Week 12
Percentage of Adult Participants Achieving Clinical Remission at Week 52 Time Frame: Week 52	Clinical remission defined as CDAI total score <150. The CDAI is an 8- item disease activity measure comprised of a composite of 3 patient-reported items: AP (4-point scale: 0=none, 1=mild, 2=moderate, 3=severe); SF (number of liquid or very soft stools) as per Bristol Stool Scale Category 6 or 7; and general well-being (0=generally well, 1=slightly under par, 2=poor, 3=very poor, 4=terrible), and 5 physician-reported/laboratory items (physical signs and a laboratory parameter [hematocrit]). Total score range of 0 to 600 points.	Week 52
Percentage of Adult Participants Achieving Endoscopic Remission at Week 12 (Placebo and Mirikizumab) Time Frame: Week 12	Endoscopic remission is defined as SES-CD Total Score ≤4 and at least a 2-point reduction from baseline and no subscore >1. SES-CD evaluates 4 endoscopic variables in 5 bowel segments and each of the 20 individual variables is scored from 0-3: presence & size of ulcers (none = 0; diameter 0.1-0.5 cm = 1; 0.5-2 cm = 2; >2 cm = 3); extent of ulcerated surface (none = 0; <10% = 1; 10% to 30% = 2; >30% = 3); extent of affected surface (none = 0; <50% = 1; 50% to 75% = 2; >75% = 3); presence & type of narrowing (none = 0; single, can be passed = 1; multiple, can be passed = 2; cannot be passed =3). Total is sum of all scores across all bowel segments. Scores range from 0 to 56, with higher scores indicating more severe disease. No subscore >1 is defined as no segmental subscore (sum of the 4 individual variable scores for each of the 5 bowel segments) >1.	Week 12
Change From Baseline in Urgency Numeric Rating Scale (NRS) at Week 12 in Adult Participants (Placebo and Mirikizumab) Time Frame: Baseline, Week 12	The Urgency NRS is a single patient-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).	Baseline, Week 12
Change From Baseline in Urgency NRS at Week 52 in Adult Participants (Placebo and Mirikizumab) Time Frame: Baseline, Week 52	The Urgency NRS is a single patient-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).	Baseline, Week 52
Percentage of Adult Participants Achieving Clinical Response at Week 12 and Clinical Remission by PRO at Week 52 (Placebo and Mirikizumab) Time Frame: Week 12 to Week 52	Clinical Response by PRO defined as ≥30% decrease in SF and/or AP & neither score worse than baseline. SF (number of liquid or very soft stools) as per Bristol Stool Scale Category 6 or 7 and AP (4-point scale: 0=none, 1=mild, 2=moderate, 3=severe). Clinical Remission by PRO defined as SF≤3 and not worse than baseline (as per Bristol Stool Scale Category 6 or 7) and AP ≤1 and no worse than baseline.	Week 12 to Week 52
Percentage of Adult Participants Achieving Clinical Response at Week 12 and Endoscopic Remission at Week 52 (Placebo and Mirikizumab) Time Frame: Week 12 to Week 52	Clinical Response by PRO defined as ≥30% decrease in SF and/or AP & neither score worse than baseline. SF (number of liquid or very soft stools) per Bristol Stool Scale Category 6 or 7 & AP (4-point scale:0=none,1=mild,2=moderate,3=severe). Endoscopic remission=SES-CD Total Score ≤4 & at least 2-point reduction from baseline & no subscore >1.SES-CD evaluates 4 endoscopic variables in 5 bowel segments & each of 20 individual variables scored 0-3: presence & size of ulcers (none=0;diameter 0.1-0.5 cm=1;0.5-2 cm=2;>2 cm=3);extent of ulcerated surface (none=0;<10%=1;10% to 30%=2;>30%=3);extent of affected surface (none=0;<50%=1;50% to 75%=2;>75%=3);presence & type of narrowing (none=0;single,can be passed=1;multiple,can be passed=2;cannot be passed=3). Total is sum of all scores across all bowel segments. Scores range from 0 to 56;higher scores indicating more severe disease. No subscore >1=no segmental subscore (sum of the 4 individual variable scores for each of the 5 bowel segments) >1	Week 12 to Week 52
Percentage of Adult Participants Achieving Clinical Response at Week 12 and Corticosteroid-free Clinical Remission at Week 52 (Placebo and Mirikizumab) Time Frame: Week 12 to Week 52	Clinical response by PRO defined as ≥30% decrease in SF and/or AP and neither score worse than baseline. SF (number of liquid or very soft stools) as per Bristol Stool Scale Category 6 or 7 and AP (4-point scale: 0=none, 1=mild, 2=moderate, 3=severe). Clinical remission defined as CDAI total score <150. The CDAI is an 8- item disease activity measure comprised of a composite of 3 patient-reported items: AP (4-point scale: 0=none, 1=mild, 2=moderate, 3=severe); SF (number of liquid or very soft stools) as per Bristol Stool Scale Category 6 or 7; and general well-being (0=generally well, 1=slightly under par, 2=poor, 3=very poor, 4=terrible), and 5 physician-reported/laboratory items (physical signs and a laboratory parameter [hematocrit]). Total score range of 0 to 600 points. Corticosteroid-free clinical remission by CDAI is defined as achieving clinical remission by CDAI at Week 52 and being corticosteroid free from Week 40 to Week 52.	Week 12 to Week 52
Change From Baseline in C-Reactive Protein (CRP) at Week 52 in Adult Participants (Placebo and Mirikizumab) Time Frame: Baseline, Week 52	Change from baseline in CRP	Baseline, Week 52
Change From Baseline in Fecal Calprotectin at Week 52 in Adult Participants (Placebo and Mirikizumab) Time Frame: Baseline, Week 52	Change from baseline in Fecal Calprotectin	Baseline, Week 52
Percentage of Adult Participants Achieving Clinical Response at Week 12 and Resolution of Baseline Extraintestinal Manifestations (EIMs) at Week 52 (Placebo and Mirikizumab) Time Frame: Week 12 to Week 52	Clinical response by PRO defined as ≥30% decrease in SF and/or AP and neither score worse than baseline. SF (number of liquid or very soft stools) as per Bristol Stool Scale Category 6 or 7 and AP (4-point scale: 0=none, 1=mild, 2=moderate, 3=severe).	Week 12 to Week 52
Percentage of Adult Participants Achieving Clinical Response at Week 12 and ≥50% Reduction in Number of Draining Cutaneous Fistulae at Week 52 in Participants With Draining Cutaneous Fistulae at Baseline (Placebo and Mirikizumab) Time Frame: Week 12 to Week 52	Clinical response by PRO defined as ≥ 30% decrease in SF and/or AP and neither score worse than baseline. SF (number of liquid or very soft stools) as per Bristol Stool Scale Category 6 or 7 and AP (4-point scale: 0=none, 1=mild, 2=moderate, 3=severe).	Week 12 to Week 52
Change From Baseline in Health Related Quality of Life at Week 52 in Adult Participants: Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score (Placebo and Mirikizumab) Time Frame: Baseline, Week 52	The IBDQ is a 32-item patient completed questionnaire that measures 4 aspects of patients' lives: symptoms directly related to the primary bowel disturbance, systemic symptoms, emotional function, and social function. Responses are graded on a 7-point Likert scale in which 7 denotes "not a problem at all" and 1 denotes "a very severe problem." IBDQ total score is calculated as the sum of all questions. Scores range from 32 to 224; a higher score indicates a better quality of life.	Baseline, Week 52
Adult Population Pharmacokinetics (PopPK): Area Under the Concentration Time Curve (AUC) of Mirikizumab Time Frame: 900 mg Mirikizumab: Week 4: Predose; Week 4, Day 1: Postdose; Week 8, 12: Predose 300 mg Mirikizumab: Week 16, 24, 36: Predose; Week 52	PopPK: AUC of Mirikizumab	900 mg Mirikizumab: Week 4: Predose; Week 4, Day 1: Postdose; Week 8, 12: Predose 300 mg Mirikizumab: Week 16, 24, 36: Predose; 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

A Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease

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)

July 23, 2019

Primary Completion (Actual)

August 23, 2023

Study Completion (Actual)

October 2, 2023

Study Registration Dates

First Submitted

April 23, 2019

First Submitted That Met QC Criteria

April 23, 2019

First Posted (Actual)

April 24, 2019

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

December 12, 2024

Last Verified

December 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

16590
I6T-MC-AMAM (Other Identifier: Eli Lilly and Company)
2018-004614-18 (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

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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Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Publications and helpful links

Helpful Links

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

IPD Sharing Time Frame

IPD Sharing Access Criteria

IPD Sharing Supporting Information Type

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

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