VIVID-2: A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease
Sponsor
Eli Lilly and Company (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04232553
Collaborator
(none)
778
357
2
82
2.2
0
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 3 |
Study Design
Study Type:
Interventional
Anticipated Enrollment
:
778 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
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
Actual Study Start Date
:
Jun 22, 2020
Anticipated Primary Completion Date
:
Jan 2, 2025
Anticipated Study Completion Date
:
Apr 22, 2027
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Mirikizumab SC Mirikizumab given subcutaneously (SC). |
Drug: Mirikizumab
Administered SC
Other Names:
|
| Experimental: Mirikizumab IV and SC Mirikizumab given intravenously (IV) and SC. |
Drug: Mirikizumab
Administered IV
Other Names:
Drug: Mirikizumab
Administered SC
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Percentage of Participants Achieving Endoscopic Response [Week 52]
Endoscopic response based on Simple Endoscopic Score for Crohn's Disease (SES-CD) total score
Secondary Outcome Measures
- Percentage of Participants Achieving Clinical Remission [Week 52]
Clinical remission by Patient Reported Outcome (PRO) based on stool frequency (SF) and abdominal pain (AP)
- Percentage of Participants Achieving Endoscopic Remission [Week 52]
Endoscopic remission based on SES-CD total score
- Percentage of Participants Achieving Clinical Response [Week 52]
Clinical response by PRO based on SF and AP
- Change from Baseline in C-Reactive Protein [Baseline, Week 12]
Change from baseline in c-reactive protein
- Change from Baseline in Fecal Calprotectin [Baseline, Week 12]
Change from baseline in fecal calprotectin
- Change from Baseline on the Inflammatory Bowel Disease Questionnaire (IBDQ) [Baseline to Week 52]
Change from baseline on the IBDQ
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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 developed adenomatous polyps during the originator study that have been removed prior to the start of this 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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Digestive Health Specialists | Dothan | Alabama | United States | 36301 |
| 2 | Research Solutions of Arizona | Litchfield Park | Arizona | United States | 85340 |
| 3 | Care Access - Gilroy | Gilroy | California | United States | 95020 |
| 4 | Newport Huntington Med Grp | Huntington Beach | California | United States | 92648 |
| 5 | California Medical Research Associates | Northridge | California | United States | 91324 |
| 6 | UCSF Medical Center at Mission Bay | San Francisco | California | United States | 94158 |
| 7 | Gastroenterology Consultants of Clearwater | Clearwater | Florida | United States | 33756 |
| 8 | Clinical Research of West Florida, Inc. (Clearwater) | Clearwater | Florida | United States | 33765 |
| 9 | Midland Florida Clinical Research Center, LLC | DeLand | Florida | United States | 32720 |
| 10 | C2 Research Center, LLC | Jacksonville | Florida | United States | 32204 |
| 11 | I.H.S. Health, LLC | Kissimmee | Florida | United States | 34741 |
| 12 | Wellness Clinical Research | Lehigh Acres | Florida | United States | 33936 |
| 13 | Ezy Medical Research | Miami | Florida | United States | 33175 |
| 14 | Center for Interventional Endoscopy | Orlando | Florida | United States | 32803 |
| 15 | Clintheory Healthcare | Orlando | Florida | United States | 32819 |
| 16 | Care Access Research - Orlando | Orlando | Florida | United States | 32825 |
| 17 | Gastroenterology Associates of Pensacola, PA | Pensacola | Florida | United States | 32503 |
| 18 | Synexus Clinical Research US, Inc. | Pinellas Park | Florida | United States | 33781 |
| 19 | Precision Clinical Research | Sunrise | Florida | United States | 33351 |
| 20 | University of South Florida | Tampa | Florida | United States | 33612 |
| 21 | Alliance Clinical Research, LLC | Tampa | Florida | United States | 33615 |
| 22 | Digestive Healthcare of Georgia | Atlanta | Georgia | United States | 30309 |
| 23 | Gastrointestinal Specialists of Georgia | Marietta | Georgia | United States | 30060 |
| 24 | Grand Teton Research Group | Idaho Falls | Idaho | United States | 83404 |
| 25 | Qualmedica Research, LLC | Evansville | Indiana | United States | 47715 |
| 26 | Qualmedica Research, LLC | Evansville | Indiana | United States | 47715 |
| 27 | Indiana University Health | Indianapolis | Indiana | United States | 46202 |
| 28 | Robley Rex VA Medical Center | Louisville | Kentucky | United States | 40206 |
| 29 | Delta Research Partners LLC | Bastrop | Louisiana | United States | 71720 |
| 30 | Capital Digestive Care - Chevy Chase | Chevy Chase | Maryland | United States | 20815 |
| 31 | Woodholme Gastroenterology Associates - Glen Burnie | Glen Burnie | Maryland | United States | 21061 |
| 32 | Clinical Research Institute of Michigan, LLC | Chesterfield | Michigan | United States | 48047 |
| 33 | Revive Research Institute | Farmington Hills | Michigan | United States | 48334 |
| 34 | Robert Ferguson, MD PC | West Bloomfield | Michigan | United States | 48323 |
| 35 | MNGI Digestive Health - Plymouth Endoscopy Center & Clinic | Plymouth | Minnesota | United States | 55446 |
| 36 | BVL Research | Liberty | Missouri | United States | 64068 |
| 37 | Washington University Medical School | Saint Louis | Missouri | United States | 63110 |
| 38 | Care Access - Las Vegas | Las Vegas | Nevada | United States | 89148 |
| 39 | Holy Name Medical Center | Teaneck | New Jersey | United States | 07666 |
| 40 | University of North Carolina Center for Inflammatory Bowel Disease | Chapel Hill | North Carolina | United States | 27599 |
| 41 | Carolina Research | Greenville | North Carolina | United States | 27834 |
| 42 | Care Access Research-Kinston | Kinston | North Carolina | United States | 28501 |
| 43 | Care Access Research-Lumberton | Lumberton | North Carolina | United States | 28358 |
| 44 | University Hospitals Cleveland Medical Center | Cleveland | Ohio | United States | 44106 |
| 45 | Ohio Gastroenterology Group Inc. | Columbus | Ohio | United States | 43202 |
| 46 | Paramount Medical Research | Middleburg Heights | Ohio | United States | 44130 |
| 47 | Northshore Gastroenterology Research, LLC | Westlake | Ohio | United States | 44145 |
| 48 | University of Oklahoma Health Sciences Center | Oklahoma City | Oklahoma | United States | 73104 |
| 49 | Gastroenterology Associates of Orangeburg | Orangeburg | South Carolina | United States | 29118 |
| 50 | Gastro One | Germantown | Tennessee | United States | 38138 |
| 51 | First Surgical Hospital | Bellaire | Texas | United States | 77401 |
| 52 | Baylor College of Medicine Medical Center | Houston | Texas | United States | 77030 |
| 53 | Caprock Gastro Research, LLC | Lubbock | Texas | United States | 79424 |
| 54 | Southern Star Research Institute, LLC | San Antonio | Texas | United States | 78229 |
| 55 | Tyler Research Institute, LLC | Tyler | Texas | United States | 75701 |
| 56 | Care Access Research - Ogden | Ogden | Utah | United States | 84403 |
| 57 | Care Access Research LLC - Salt Lake City | Salt Lake City | Utah | United States | 84124 |
| 58 | Clinical Research Partners, LLC | Richmond | Virginia | United States | 23226 |
| 59 | Washington Gastroenterology, PLLC | Bellevue | Washington | United States | 98004 |
| 60 | Virginia Mason Medical Center | Seattle | Washington | United States | 98111 |
| 61 | Washington Gastroenterology, PLLC | Tacoma | Washington | United States | 98405 |
| 62 | DOM- Centro de Reumatologia | Caba | Buenos Aires | Argentina | 1111 |
| 63 | Mautalen Salud e Investigación | Buenos Aires | Ciudad Autónoma De Buenos Aire | Argentina | C1128AAF |
| 64 | Concord Repatriation General Hospital | Concord | New South Wales | Australia | 2139 |
| 65 | St. Vincents Hospital Sydney | Darlinghurst | New South Wales | Australia | 2010 |
| 66 | Royal Adelaide Hospital | Adelaide | South Australia | Australia | 5000 |
| 67 | The Royal Melbourne Hospital | Parkville | Victoria | Australia | 3050 |
| 68 | Fiona Stanley Hospital | Murdoch | Western Australia | Australia | 6150 |
| 69 | AKH - Gastroenterologie und Hepatologie - Interne Medizin III | Wien | Vienna | Austria | 1090 |
| 70 | Medizinische Universität Innsbruck | Innsbruck | Austria | 6020 | |
| 71 | Universitätsklinikum Salzburg | Salzburg | Austria | 5020 | |
| 72 | Imelda General Hospital | Bonheiden | Antwerpen | Belgium | 2820 |
| 73 | Université Libre de Bruxelles - Hôpital Erasme | Brussel | Belgium | 1070 | |
| 74 | Universitair Ziekenhuis Gent | Gent | Belgium | 9000 | |
| 75 | Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg | Leuven | Belgium | 3000 | |
| 76 | Cliagen - Clinica de Atencao em Gastroenterologia, Especialidades e Nutricao | Salvador | Bahia | Brazil | 41500-300 |
| 77 | HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará | Fortaleza | Ceara | Brazil | 60430-370 |
| 78 | L2IP - Instituto de Pesquisas Clinicas Ltda. | Brasília | Distrito Federal | Brazil | 70200-730 |
| 79 | Chronos Pesquisa Clínica | Brasília | Distrito Federal | Brazil | 72145-450 |
| 80 | Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda | Goiania | GO | Brazil | 74535-170 |
| 81 | Hospital Felício Rocho | Belo Horizonte | Minas Gerais | Brazil | 30110-934 |
| 82 | Eurolatino Pesquisas Medicas Ltda. | Uberlandia | Minas Gerais | Brazil | 38411-186 |
| 83 | Associacao Paranaense de Cultura - PUCPR | Curitiba | Parana | Brazil | 80230-130 |
| 84 | Instituto de Pesquisa em Saúde - Fundação Universidade de Caxias do Sul | Caxias do Sul | Rio Grande Do Sul | Brazil | 95070-560 |
| 85 | Hospital de Clinicas de Porto Alegre | Porto Alegre | Rio Grande Do Sul | Brazil | 90035-903 |
| 86 | Santa Casa de Misericórdia de Porto Alegre | Porto Alegre | Rio Grande Do Sul | Brazil | 90050-170 |
| 87 | Hospital Ernesto Dornelles | Porto Alegre | Rio Grande Do Sul | Brazil | 90160-093 |
| 88 | Nucleo de Pesquisa Clínica do Rio Grande do Sul-NPCRS | Porto Alegre | Rio Grande Do Sul | Brazil | 90430-001 |
| 89 | Hospital Moinhos de Vento | Porto Alegre | Rio Grande Do Sul | Brazil | 90560-030 |
| 90 | HMCP - Hospital e Maternidade Celso Pierro - PUC-Campinas | Campinas | Sao Paulo | Brazil | 13060-904 |
| 91 | Pesquisare | Santo Andre | Sao Paulo | Brazil | 09080-110 |
| 92 | Praxis Pesquisa Medica | Santo André | Sao Paulo | Brazil | 09090-790 |
| 93 | Faculdade de Medicina do ABC | Santo Andre | SP | Brazil | 09060-870 |
| 94 | Instituto de Assistencia Medica ao Servidor Publico Estudo Estadual | Sao Paulo | SP | Brazil | 04039-004 |
| 95 | Upeclin - Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu - UNESP | Botucatu | São Paulo | Brazil | 18618-687 |
| 96 | CEMEC - Centro Multidisciplinar de Estudos Clinicos EPP Ltda | São Bernardo do Campo | São Paulo | Brazil | 09715-090 |
| 97 | Hospital Gloria Dor | Rio de Janeiro | Brazil | 22211-230 | |
| 98 | Hospital Sírio Libanês | Sao Paulo | Brazil | 01308-050 | |
| 99 | Hepatogastro | Sao Paulo | Brazil | 04543-001 | |
| 100 | CPQuali Pesquisa Clínica | São Paulo | Brazil | 01228-000 | |
| 101 | Clinica Onco Star | São Paulo | Brazil | 04543-000 | |
| 102 | Gastroenterology and internal medicine research institute | Edmonton | Alberta | Canada | T5R 1W2 |
| 103 | GI Research Institute | Vancouver | British Columbia | Canada | V6Z 2K5 |
| 104 | Victoria Hospital | London | Ontario | Canada | N6A 5W9 |
| 105 | Anhui Provincial Hospital | Hefei | Anhui | China | 230001 |
| 106 | Chongqing General Hospital | Chongqing | Chongqing | China | 400014 |
| 107 | The First Hospital Affiliated to AMU (Southwest Hospital) | Chongqing | Chongqing | China | 400038 |
| 108 | The First People's Hospital of Foshan | Foshan | Guangdong | China | 528000 |
| 109 | First affiliated Hospital of Sun Yat-Sen University | Guangzhou | Guangdong | China | 510080 |
| 110 | The Sixth Affiliated Hospital, Sun Yat-Sen University | Guangzhou | Guangdong | China | 510655 |
| 111 | Tongji Hosp Tongji Med Col Huazhong Univ of Sci & Tech | Wu Han | Hubei | China | 430030 |
| 112 | Xiangya Hospital, Central South University | Changsha | Hunan | China | 410008 |
| 113 | The Second Xiangya Hospital of Central South University | Changsha | Hunan | China | 410011 |
| 114 | The Third Xiangya Hospital of Central South University | Changsha | Hunan | China | 410013 |
| 115 | The First People's Hospital of Changzhou | Changzhou | Jiangsu | China | 213003 |
| 116 | Changzhou No.2 People's Hospital | Changzhou | Jiangsu | China | |
| 117 | Jiangsu Province Hospital of Chinese Medicine | Nanjing | Jiangsu | China | 210029 |
| 118 | The Second Affiliated Hospital of Soochow University | Suzhou | Jiangsu | China | 215004 |
| 119 | Wuxi People's Hospital | Wuxi | Jiangsu | China | 214023 |
| 120 | Affiliated Hospital of Jiangsu University | Zhenjiang | Jiangsu | China | 212000 |
| 121 | The First Affiliated Hospital of Nanchang University | Nanchang | Jiangxi | China | 330006 |
| 122 | Shanghai Jiaotong University School of Medicine Ruijin Hospital | Shanghai | Shanghai | China | 200025 |
| 123 | West China Hospital of Sichuan University | Chengdu | Sichuan | China | 610041 |
| 124 | The First People's Hospital of Yunnan Province | Kunming | Yunnan | China | 650034 |
| 125 | First Affiliated Hosp of College of Med, Zhejiang University | Hangzhou | Zhejiang | China | 310003 |
| 126 | Sir Run Run Shaw Hospital | Hangzhou | Zhejiang | China | 310016 |
| 127 | The Second Affiliated Hospital YuYing Childens Hospital of Wenzhou Medical university | Wenzhou | Zhejiang | China | 310015 |
| 128 | The Second Affiliated Hospital of Zhejiang University School of Medicine | Hangzhou | China | 310009 | |
| 129 | Zhongshan Hospital Xiamen University | Xiamen | China | 361004 | |
| 130 | CHC Zagreb | Zagreb | Croatia | 10000 | |
| 131 | Vojenská Nemocnice Brno | Brno | Brno-město | Czechia | 636 00 |
| 132 | Hepato-Gastroenterologie HK | Hradec Kralove | Hradec Králové | Czechia | 500 12 |
| 133 | MUDr. Gregar, s.r.o. | Olomouc | Olomoucký Kraj | Czechia | 779 00 |
| 134 | Synexus Czech | Prague | Praha 2 | Czechia | 120 00 |
| 135 | MEDIENDO | Prague | Praha 8 | Czechia | 186 00 |
| 136 | Nemocnice Tomase Bati ve Zline | Zlín | Zlínský Kraj | Czechia | 762 75 |
| 137 | Fakultni Nemocnice u sv. Anny v Brne | Brno | Czechia | 65691 | |
| 138 | Oblastni nemocnice Nachod-Endoskopicke centrum | Nachod | Czechia | ||
| 139 | PreventaMed, s.r.o. | Olomouc | Czechia | 779 00 | |
| 140 | A-Shine | Plzen | Czechia | 31200 | |
| 141 | Thomayerova nemocnice | Praha 4 - Krc | Czechia | 140 59 | |
| 142 | AXON Clinical | Praha 5 | Czechia | 150 00 | |
| 143 | Fakultni Nemocnice v Motole | Praha 5 | Czechia | 150 06 | |
| 144 | Masarykova Nemocnice V Usti Nad Labem | Usti nad Labem | Ústí Nad Labem | Czechia | 40113 |
| 145 | Aarhus Universitetshospital, Skejby | Aarhus | Midtjylland | Denmark | 8200 |
| 146 | Aalborg Universitets hospital | Aalborg | Denmark | 9000 | |
| 147 | CHRU de Montpellier-Hopital St Eloi | Montpellier Cedex 5 | France | 34295 | |
| 148 | Siloah St. Trudpert Klinikum-Zentrum für Innere Medizin | Pforzheim | Baden-Württemberg | Germany | 75179 |
| 149 | Universitätsklinikum Würzburg A. ö. R. | Würzburg | Bayern | Germany | 97080 |
| 150 | Synexus Clinical Research GmbH | Frankfurt am Main | Hessen | Germany | 60313 |
| 151 | Medizinische Hochschule Hanover | Hannover | Niedersachsen | Germany | 30625 |
| 152 | Knappschaftskrankenhaus Bottrop | Bottrop | Nordrhein Westfalen | Germany | 46242 |
| 153 | Gemeinschaftspraxis Jakobeit | Wipperfurth | North Rhine-Westphalia | Germany | 51688 |
| 154 | Synexus Clinical Research GmbH | Leipzig | Sachsen | Germany | 04103 |
| 155 | Universitätsklinikum Schleswig-Holstein | Kiel | Schleswig-Holstein | Germany | 24105 |
| 156 | RED-Institut GmbH | Oldenburg | Schleswig-Holstein | Germany | 23758 |
| 157 | Studiengesellschaft BSF Unternehmergesellschaft | Halle (Saale), | Germany | 06108 | |
| 158 | Tumorzentrum Nordthüringen | Uslar | Germany | 99734 | |
| 159 | Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház | Bekescsaba | Bekes | Hungary | 5600 |
| 160 | Synexus Gyula | Gyula | Bekes | Hungary | 5700 |
| 161 | DRC Gyogyszervizsgalo Kozpont Kft. | Balatonfüred | EU | Hungary | 8230 |
| 162 | Clinexpert Tatabánya Ltd. | Tatabánya | Komárom-Esztergom | Hungary | H-2800 |
| 163 | Jávorszky Ödön Kórház | Vác | Pest | Hungary | 2600 |
| 164 | Clinexpert SMO | Budapest | Hungary | 1033 | |
| 165 | Synexus Magyarorszag Kft. | Budapest | Hungary | 1036 | |
| 166 | Pannonia Maganorvosi Centrum | Budapest | Hungary | 1136 | |
| 167 | Bugát Pál Kórház | Gyöngyös | Hungary | 3200 | |
| 168 | Endomedix Diagnosztikai Központ - Miskolc | Miskolc | Hungary | 3526 | |
| 169 | CLINFAN Szolgáltató Kft | Szekszard | Hungary | 7100 | |
| 170 | Gandhi Hospital | Secunderabad | Andhra Pradesh | India | 500003 |
| 171 | All India Institute of Medical Sciences | New Delhi | Delhi | India | 110029 |
| 172 | Sir Ganga Ram Hospital | New Delhi | Delhi | India | 110060 |
| 173 | Gujarat Hospital - Gastro and Vascular Centre | Surat | Gujarat | India | 395009 |
| 174 | Midas Multispeciality Hospital Pvt.Ltd. | Nagpur | Maharashtra | India | 440010 |
| 175 | Ruby Hall Clinic and Grant Medical Foundation | Pune | Maharashtra | India | 411001 |
| 176 | Dayanand Medical College and Hospital | Ludhiana | Punjab | India | 141001 |
| 177 | SR Kalla Memorial Gastro & General Hospital | Jaipur | Rajasthan | India | 302001 |
| 178 | Apollo Speciality Hospital - Teynampet | Chennai | Tamil Nadu | India | 600018 |
| 179 | Postgraduate Institute of Medical Education & Research | Chandigarh | India | 160012 | |
| 180 | Yashoda Super Speciality Hospital | Telangana | India | 500003 | |
| 181 | Sheba Medical Center | Ramat Gan | HaMerkaz | Israel | 5262100 |
| 182 | Soroka Medical Center | Beer Sheva | Israel | 8410101 | |
| 183 | Bnai Zion Medical Center | Haifa | Israel | 3339419 | |
| 184 | Shaare Zedek Medical Center | Jerusalem | Israel | 91031 | |
| 185 | Galilee Medical Center Department of Internal Medicine A | Nahariya | Israel | 22100 | |
| 186 | Kaplan Medical Center | Rehovot | Israel | 7610001 | |
| 187 | Assaf Harofeh Medical Center | Zerifin | Israel | 70300 | |
| 188 | Università di Cagliari - Presidio Policlinico Monserrato | Monserrato | Cagliari | Italy | 09042 |
| 189 | Ospedale Di Circolo | Rho | Milano | Italy | 20017 |
| 190 | Istituto Clinico Humanitas | Rozzano | Milano | Italy | 20089 |
| 191 | Ospedale Clinicizzato San Donato | San Donato Milanese | Milano | Italy | 20097 |
| 192 | Istituto Mangiagalli | Milano | MI | Italy | 20122 |
| 193 | Policlinico Mater Domini | Catanzaro | Italy | 88100 | |
| 194 | Policlinico di Modena | Modena | Italy | 41124 | |
| 195 | Policlinico Gemelli - Università Cattolica del Sacro Cuore | Roma | Italy | ||
| 196 | National Hospital Organization Hirosaki General Medical Center | Hirosaki-shi | Aomori | Japan | 036 8545 |
| 197 | Kitakyushu Municipal Medical Center | Kitakyusyu-shi | Fukoka | Japan | 802-0077 |
| 198 | Fukuoka University Chikushi Hospital | Chikushino | Fukuoka | Japan | |
| 199 | Fukuoka University Hospital | Fukuoka, Jonan-Ku | Fukuoka | Japan | 814-0180 |
| 200 | Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital | Chuo-ku, Sapporo-shi | Hokkaido | Japan | 060-0033 |
| 201 | Tokushukai Sapporo Tokushukai Hospital | Sapporo-shi | Hokkaido | Japan | 004 0041 |
| 202 | Hyogo College of Medicine | Nishinomiya | Hyogo | Japan | 663-8501 |
| 203 | Ibaraki Prefectural Central Hospital | Kasama | Ibaraki | Japan | 309 1793 |
| 204 | Ofuna Central Hospital | Kamakura | Kanagawa | Japan | 247-0056 |
| 205 | Mie University Hospital | Tsu | Mie | Japan | 514-8507 |
| 206 | Takagi Clinic - Sendai | Sendai | Miyagi | Japan | 981-3213 |
| 207 | Center Hospital of the National Center for Global Health and Medicine | Shinjuku-ku | Tokyo-To | Japan | 162 8655 |
| 208 | Tokyo Medical and Dental University Hospital | Bunkyō | Tokyo | Japan | 113-8519 |
| 209 | Kyorin University Hospital | Mitaka | Tokyo | Japan | 181-8611 |
| 210 | JHCO Tokyo Yamate Medical Center | Shinjuku-ku | Tokyo | Japan | 169-0073 |
| 211 | Kagoshima University Hospital | Kagoshima | Japan | 890-8520 | |
| 212 | Sameshima Hospital | Kagoshima | Japan | 892-0846 | |
| 213 | Kumamoto University Hospital | Kumamoto | Japan | 860-8556 | |
| 214 | Toyama Prefectural Central Hospital | Toyama | Japan | 930-8550 | |
| 215 | Ajou University Hospital | Suwon-si | Gyeonggi-do | Korea, Republic of | 443380 |
| 216 | Kyung Pook National University Hospital | Daegu | Korea | Korea, Republic of | 41944 |
| 217 | Kyung Hee University Hospital | Seoul | Korea | Korea, Republic of | 02447 |
| 218 | Asan Medical Center | Seoul | Korea | Korea, Republic of | 05505 |
| 219 | Korea University Ansan Hospital | Ansan-si | Kyǒnggi-do | Korea, Republic of | 15355 |
| 220 | Yeungnam Univeristy Medical Center | Gyeongsan-si | Kyǒngsangbuk-do | Korea, Republic of | 42415 |
| 221 | Dong-A University Hospital | Busan | Pusan-Kwangyǒkshi | Korea, Republic of | 49201 |
| 222 | The Catholic Univ. of Korea Seoul St. Mary's Hospital | Seoul | Teukbyeolsi [Seoul] | Korea, Republic of | 06591 |
| 223 | Inje University Haeundae Paik Hospital | Busan | Korea, Republic of | 48108 | |
| 224 | Kyungpook National University Medical Center Chilgok Hospital | Daegu | Korea, Republic of | 41404 | |
| 225 | Keimyung University Dongsan Hospital | Daegu | Korea, Republic of | 42601 | |
| 226 | The Catholic University of Korea, Daejeon St. Mary's Hospital | Daejeon | Korea, Republic of | 35301 | |
| 227 | Yonsei University Wonju Severance Christian Hospital | Gangwon-do | Korea, Republic of | 26426 | |
| 228 | Kangbuk Samsung Hospital | Seoul | Korea, Republic of | 03181 | |
| 229 | Chungang University Hospital | Seoul | Korea, Republic of | 06973 | |
| 230 | Pauls Stradins Clinical Univeristy Hospital | Riga | Rīga | Latvia | LV-1002 |
| 231 | Hospital of Lithuanian University of Health Sciences Kaunas | Kaunas | Lithuania | 50009 | |
| 232 | Grupo Medico Camino Sc | Mexico City | Distrito Federal | Mexico | 03310 |
| 233 | Health Pharma Professional Research S.A. de C.V: | Mexico City | Federal District | Mexico | 03100 |
| 234 | PanAmerican Clinical Research S.A.de C.V. Guadalajara | Guadalajara | Jalisco | Mexico | 44690 |
| 235 | Christus Muguerza Hospital Sur | Monterrey | Nuevo León | Mexico | 64000 |
| 236 | Hospital Universitario "Dr. Jose Eleuterio Gonzalez" Depto Gastroenterología | Monterrey | Nuevo León | Mexico | 64460 |
| 237 | PanAmerican Clinical Research Mexico S.A. de C.V. | Santiago de Queretaro | Queretaro | Mexico | 76226 |
| 238 | Centro de Alta Especialidad en Reumatologia e Investigación del Potosi,S.C | San Luis Potosi | San Luis Potosí | Mexico | 78213 |
| 239 | Scientia Investigacion Clinica S.C. | Chihuahua | Mexico | 31203 | |
| 240 | Instituto de Investigaciones Clínicas para la Salud | Durango | Mexico | 34000 | |
| 241 | Unidad de Atención Médica e Investigación en Salud (UNAMIS) | Merida | Mexico | 97000 | |
| 242 | ETZ Elisabeth Tilburg | Tilburg | North Brabant | Netherlands | 5022 GC |
| 243 | Amsterdam UMC, locatie AMC | Amsterdam | Netherlands | 1105 AZ | |
| 244 | MED-ROZ | Karwiany | Dolnośląskie | Poland | 52-200 |
| 245 | Melita Medical | Wroclaw | Dolnośląskie | Poland | 50-449 |
| 246 | ZOZ Gastromed | Lublin | Lubelskie | Poland | 20-582 |
| 247 | Topolowa Medicenter | Krakow | Małopolskie | Poland | 31-506 |
| 248 | NZOZ Formed | Wadowice | Małopolskie | Poland | 34-100 |
| 249 | Private Practice - Dr. Korczowski Bartosz | Rzeszow | Podkarpackie | Poland | 35-302 |
| 250 | Centrum Medyczne MEDYK | Rzeszow | Podkarpackie | Poland | 35-326 |
| 251 | Nova Reuma Społka Partnerska | Bialystok | Podlaskie | Poland | 15-707 |
| 252 | Synexus Polska Gdansku | Gdansk | Pomorskie | Poland | 80-382 |
| 253 | Synexus Polska Sp. z o.o. Oddzial w Gdyni | Gdynia | Pomorskie | Poland | 81-537 |
| 254 | Endoskopia Sp. z.o.o. | Sopot | Pomorskie | Poland | 81-756 |
| 255 | Kiepury Clinic | Sosnowiec | Silesian | Poland | 41-200 |
| 256 | Synexus Polska Sp. z o.o. Oddzial w Poznaniu | Poznan | Wielkopolskie | Poland | 60-702 |
| 257 | SONOMED Centrum Medyczne | Szczecin | Zachodniopomorskie | Poland | 71-685 |
| 258 | Szpital Uniwersytecki Nr 2 im. dr J. Biziela w Bydgoszczy | Bydgoszcz | Poland | 85-168 | |
| 259 | Twoja Przychodnia - Szczecinskie Centrum Medyczne | Szczecin | Poland | 71-434 | |
| 260 | WIP Warsaw IBD Point Profesor Kierkus | Warszawa | Poland | 00-728 | |
| 261 | Centrum Zdrowia MDM | Warszawa | Poland | 00635 | |
| 262 | Synexus Polska Sp. z o.o. Oddzial we Wroclawiu | Wroclaw | Poland | 50-381 | |
| 263 | ETG Zamość | Zamosc | Poland | 22-400 | |
| 264 | Centrum Medyczne SYNEXUS | Czestochowa | Śląskie | Poland | 42-202 |
| 265 | Synexus Polska - Katowicach | Katowice | Śląskie | Poland | 40040 |
| 266 | SC Pelican SRL | Oradea | Bihor | Romania | 410469 |
| 267 | Spitalul Euroclinic | Bucureti | București | Romania | 014461 |
| 268 | Sc Tvm Med Serv | Cluj-Napoca | Cluj | Romania | 400132 |
| 269 | SC Med Life SA | Bucuresti | Romania | 010719 | |
| 270 | Spitalul Clinic CF 2 Bucuresti | Bucuresti | Romania | 011464 | |
| 271 | S.C. Centrul Medical Medicum SRL | Bucuresti | Romania | 012015 | |
| 272 | Institutul Clinic Fundeni | Bucuresti | Romania | 022328 | |
| 273 | CCBR Clinical Research | Bucuresti | Romania | 30463 | |
| 274 | Spital Clinic Colentina | Bucuresti | Romania | ||
| 275 | Spitalul Universitar de Urgență București | București | Romania | 050098 | |
| 276 | Gastromed S.R.L. | Constanta | Romania | 900168 | |
| 277 | Affidea Medical Research Center | Constanta | Romania | 900591 | |
| 278 | Spitalul Clinic Judetean Targu Mures | Targu Mures | Romania | 540103 | |
| 279 | S.C Centrul de Gastroenterologie Dr. Goldis S.R.L | Timisoara | Romania | 300002 | |
| 280 | S.C. Materna Care S.R.L. | Timisoara | Romania | 300645 | |
| 281 | Scientific Centre of Reconstructive and Restorative Surgery | Irkutsk | Irkutskaya Oblast' | Russian Federation | 664079 |
| 282 | Karelia Republican Hospital V.A. Baranova | Petrozavodsk | Kareliya, Respublika | Russian Federation | 185019 |
| 283 | Olla-Med | Moscow | Moskva | Russian Federation | 105554 |
| 284 | Nizhny Novgorod Regional Hospital N.A. Semashko | Nizhny Novgorod | Nizhegorodskaya Oblast' | Russian Federation | 603126 |
| 285 | Novosibirski Gastrocenter | Novosibirsk | Novosibirskaya Oblast' | Russian Federation | 630007 |
| 286 | Clinic of Omsk State Medical University | Omsk | Omskaya Oblast' | Russian Federation | 644050 |
| 287 | Rostov State Medical University | Rostov-on-Don | Rostovskaya Oblast' | Russian Federation | 344091 |
| 288 | LLC Medical Center Reavita Med SPb | Saint Petersburg | Sankt-Peterburg | Russian Federation | 194354 |
| 289 | Scientific research center ECO-security | Saint Petersburg | Sankt-Peterburg | Russian Federation | 196143 |
| 290 | LLC Multidisciplinary Medical Clinic Anthurium | Barnaul | Russian Federation | 656043 | |
| 291 | LLC MA New Hospital | Ekaterinburg | Russian Federation | 620109 | |
| 292 | SIH Kemerovo Regional Clinical Hosptial | Kemerovo | Russian Federation | 650066 | |
| 293 | LLC "Medicine Center SibNovoMed" | Novosibirsk | Russian Federation | 630005 | |
| 294 | Saint-Petersburg City Hospital of Saint Elizabeth | Saint Petersburg | Russian Federation | 195257 | |
| 295 | Saint Petersburg State Medical University n.a. Pavlov I.P. | Saint Petersburg | Russian Federation | 197022 | |
| 296 | SBIH City Clinical Hospital #31 | Saint-Petersburg | Russian Federation | 197110 | |
| 297 | NonState Healthcare Institution Central Clinical Hospital | Samara | Russian Federation | 443029 | |
| 298 | GOU VPO St-Petersburg SMA n/a Mechnikov Fed. Agen of Health | St. Petersburg | Russian Federation | 195067 | |
| 299 | Clinical Hospital Center Zvezdara | Belgrade | Beograd | Serbia | 11000 |
| 300 | University Medical Center "Bezanijska kosa" | Belgrade | NAP | Serbia | 11080 |
| 301 | General Hospital "Djordje Joanovic" | Zrenjanin | Vojvodina | Serbia | 23000 |
| 302 | Gastro | Prešov | Prešovský Kraj | Slovakia | 080 01 |
| 303 | FNsP FDRoosevelta Banska Bystrica | Banska Bystrica | Slovakia | 97517 | |
| 304 | CLINIQ, s.r.o | Bratislava | Slovakia | 811 09 | |
| 305 | Univerzitna nemocnica Bratislava | Bratislava | Slovakia | 81107 | |
| 306 | ENDOMED s.r.o. | Kosice | Slovakia | 04013 | |
| 307 | Gastromedic | Nove Zamky | Slovakia | 94002 | |
| 308 | Gastro LM s.r.o. | Presov | Slovakia | 08001 | |
| 309 | Instituto de Ciencias Médicas | Alicante | Spain | 03004 | |
| 310 | Hospital Universitario La Paz | Madrid | Spain | 28046 | |
| 311 | Cantonal Hospital St.Gallen | St. Gallen | Sankt Gallen | Switzerland | 9007 |
| 312 | Inselspital Bern | Bern | Switzerland | 3010 | |
| 313 | Gastroenterologische Praxis Balsiger, Seibold & Partner | Bern | Switzerland | 3012 | |
| 314 | Antalya Egitim ve Arastırma Hastanesi | Kocaeli | Antalya | Turkey | 7100 |
| 315 | Kocaeli University Medical Faculty Hospital | Izmit | Kocaeli | Turkey | 41380 |
| 316 | Mersin University Medical Faculty | Yenişehir | Mersin | Turkey | 33110 |
| 317 | Hacettepe University Faculty of Medicine | Ankara | Turkey | 06100 | |
| 318 | Ankara City Hospital | Ankara | Turkey | 1604 | |
| 319 | Gazi University Faculty of Medicine | Ankara | Turkey | 6500 | |
| 320 | Uludag Universitesi | Bursa | Turkey | 16059 | |
| 321 | Trakya University | Edirne | Turkey | 22030 | |
| 322 | Eskisehir Osmangazi University Gastroenterology | Eskisehir | Turkey | 26040 | |
| 323 | Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi | Gaziantep | Turkey | 27310 | |
| 324 | Hatay Namik Kemal University Hospital Gastroenterology | Hatay | Turkey | 31060 | |
| 325 | Istanbul Universitesi-Cerrahpasa Cerrahpasa Tip Fakultesi Yerleskesi | Istanbul | Turkey | 34098 | |
| 326 | Acibadem Kozyatagi Hospital | Istanbul | Turkey | 34668 | |
| 327 | Marmara University Pendik Research and Training Hospital | İstanbul | Turkey | 34899 | |
| 328 | Medical Park Pendik Hospital | Istanbul | Turkey | 34899 | |
| 329 | Fulya Acıbadem | Istanbul | Turkey | ||
| 330 | Dokuz Eylül Üniversitesi | Izmir | Turkey | ||
| 331 | Erciyes University Hospital | Kayseri | Turkey | 38039 | |
| 332 | Konya Necmettin Erbakan Gastroenterology | Konya | Turkey | 42080 | |
| 333 | Inonu Universitesi Turgut Ozal Tıp Merkezi | Malatya | Turkey | 44280 | |
| 334 | Communal non-profit enterprise "Regional clinical hospital of Ivano-Frankivsk Regional Council" | Ivano-Frankivsk | Ivano-Frankivska Oblast | Ukraine | 76008 |
| 335 | City Clinical Hospital No. 2 | Kharkiv | Kharkivska Oblast | Ukraine | 61037 |
| 336 | Lviv Railway Clinical Hospital | Lviv | Lvivska Oblast | Ukraine | 79000 |
| 337 | Diaservis - Medical and Diagnostic Center | Zaporizhia | Zaporizka Oblast | Ukraine | 69076 |
| 338 | Chernivtsi Regional Clinical Hospital | Chernivtsi | Ukraine | 58000 | |
| 339 | Medical Center of Limited Liability Company Medical Center Clinic of Family Medicine | Dnipro | Ukraine | 49038 | |
| 340 | Kharkiv Regional Council Regional Clinical Hospital | Kharkiv | Ukraine | 61058 | |
| 341 | Medical Center Ok!Clinic of Intl Inst of Clinical Trials LLC | Kyiv | Ukraine | 02091 | |
| 342 | LLC Medbud-Clinic Medical Center | Kyiv | Ukraine | 03037 | |
| 343 | Kyiv Railway Clinical Hospital No.2 of Branch Health Center of the Public Joint Stock Company Ukrainian Railway | Kyiv | Ukraine | 03049 | |
| 344 | Medical Center of Limited Liability Company "Medical Center "Consilium Medical" | Kyiv | Ukraine | 04050 | |
| 345 | Communal institution of the Kyiv Regional Council "Kyiv Regional Clinical Oncology Dispensary" | Kyiv | Ukraine | 04078 | |
| 346 | Communal institution of the Kyiv Regional Council "Kyiv Regional Clinical Oncology Dispensary" | Kyiv | Ukraine | 04107 | |
| 347 | Communal Enterprise "Odesa Regional Clinical Hospital" | Odesa | Ukraine | 65000 | |
| 348 | A. Novak Transcarpathian Regional Clinical Hospital | Uzhgorod | Ukraine | 88018 | |
| 349 | Vinnytsia RCH of Veterans of War Dept of Therapy#1 Vinnytsia M.I.Pyrogov NMU | Vinnytsia | Ukraine | 21005 | |
| 350 | MCIC MC LLC Health Clinic | Vinnytsia | Ukraine | 21009 | |
| 351 | Ukrayins'kyy Derzhavnyy Naukovo-Doslidnyy Instytut Rebilitatsiyi Invalidiv | Vinnytsia | Ukraine | 21029 | |
| 352 | M.I. Pyrogov Regional Clinical Hospital | Vinnytsya | Ukraine | 21018 | |
| 353 | Diacenter LLC | Zaporizhzhia | Ukraine | 69076 | |
| 354 | Addenbrookes Hospital | Cambridge | Cambridgeshire | United Kingdom | CB2 2QQ |
| 355 | Synexus Wales Clinical Research Centre | Cardiff | Cardiff [Caerdydd Gb-crd] | United Kingdom | CF15 9SS |
| 356 | Whipps Cross University Hospital | London | Surrey | United Kingdom | E11 1NR |
| 357 | Synexus North East Clinical Research Centre | Hexham | United Kingdom | NE46 1QJ |
Sponsors and Collaborators
- 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
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Eli Lilly and Company
ClinicalTrials.gov Identifier:
NCT04232553
Other Study ID Numbers:
- 16628
- I6T-MC-AMAX
- 2019-002687-27
First Posted:
Jan 18, 2020
Last Update Posted:
Aug 19, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
Yes
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms: