A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease (VIVID-2)
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04232553 |
Recruitment Status :
Recruiting
First Posted : January 18, 2020
Last Update Posted : March 4, 2021
|
Sponsor:
Eli Lilly and Company
Information provided by (Responsible Party):
Eli Lilly and Company
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
---|---|---|
Crohn's Disease | Drug: Mirikizumab | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated 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 : | June 22, 2020 |
Estimated Primary Completion Date : | June 15, 2024 |
Estimated Study Completion Date : | June 15, 2024 |
Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics:
Crohn disease
MedlinePlus related topics:
Crohn's Disease
Arm | Intervention/treatment |
---|---|
Experimental: Mirikizumab SC
Mirikizumab given subcutaneously (SC).
|
Drug: Mirikizumab
Administered SC
Other Name: LY3074828 |
Experimental: Mirikizumab IV and SC
Mirikizumab given intravenously (IV) and SC.
|
Drug: Mirikizumab
Administered IV
Other Name: LY3074828 Drug: Mirikizumab Administered SC
Other Name: LY3074828 |
Primary Outcome Measures :
- Percentage of Participants Achieving Endoscopic Response [ Time Frame: Week 52 ]Endoscopic response based on Simple Endoscopic Score for Crohn's Disease (SES-CD) total score
Secondary Outcome Measures :
- Percentage of Participants Achieving Clinical Remission [ Time Frame: Week 52 ]Clinical remission by Patient Reported Outcome (PRO) based on stool frequency (SF) and abdominal pain (AP)
- Percentage of Participants Achieving Endoscopic Remission [ Time Frame: Week 52 ]Endoscopic remission based on SES-CD total score
- Percentage of Participants Achieving Clinical Response [ Time Frame: Week 52 ]Clinical response by PRO based on SF and AP
- Change from Baseline in C-Reactive Protein [ Time Frame: Baseline, Week 12 ]Change from baseline in c-reactive protein
- Change from Baseline in Fecal Calprotectin [ Time Frame: Baseline, Week 12 ]Change from baseline in fecal calprotectin
- Change from Baseline on the Inflammatory Bowel Disease Questionnaire (IBDQ) [ Time Frame: Baseline to Week 52 ]Change from baseline on the IBDQ
Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Criteria
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)
- 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
- Participants may not have received surgery for Crohn's disease in the originator study or are likely to require surgery for treatment of Crohn's disease during the study
- Participants must not have developed adenomatous polyps during the originator study that have not been removed prior to the start of this study
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04232553
Contacts
Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or | 1-317-615-4559 | clinicaltrials.gov@lilly.com |
Locations


United States, California | |
California Medical Research Group | Not yet recruiting |
Northridge, California, United States, 91324 | |
Contact 818-349-1979 | |
Principal Investigator: Calin Arimie | |
UCSF Medical Center at Mission Bay | Not yet recruiting |
San Francisco, California, United States, 94158 | |
Contact 415-514-2069 | |
Principal Investigator: Sofia G Verstraete | |
United States, Florida | |
Gastro Florida | Not yet recruiting |
Clearwater, Florida, United States, 33756 | |
Contact 727-443-7700 | |
Principal Investigator: Michael Weiss | |
Clinical Research of West Florida | Recruiting |
Clearwater, Florida, United States, 33765 | |
Contact 7274660078 | |
Principal Investigator: Leonard Jay Dunn | |
Midland Florida Clinical Research Center, LLC | Not yet recruiting |
DeLand, Florida, United States, 32720 | |
Contact 386-228-0661 | |
Principal Investigator: Godson Oguchi | |
C2 Research Center, LLC | Not yet recruiting |
Jacksonville, Florida, United States, 32204 | |
Contact 32142223031001 | |
Principal Investigator: Samir Habashi | |
SIH Research, LLC | Not yet recruiting |
Kissimmee, Florida, United States, 34741 | |
Contact 407-932-1977 | |
Principal Investigator: Syed Lateef | |
Wellness Clinical Research | Recruiting |
Lehigh Acres, Florida, United States, 33936 | |
Contact 239-368-7310 | |
Principal Investigator: Edgardo Castillo | |
Center for Interventional Endoscopy | Not yet recruiting |
Orlando, Florida, United States, 32804 | |
Contact 407-303-2570 | |
Principal Investigator: Udayakumar Navaneethan | |
Clintheory Healthcare | Not yet recruiting |
Orlando, Florida, United States, 32819 | |
Contact 407-698-3424 | |
Principal Investigator: Souheil Moussly | |
Care Access Research - Orlando | Not yet recruiting |
Orlando, Florida, United States, 32825 | |
Contact 321-300-2821 | |
Principal Investigator: Keith Moore | |
Gastroenterology Associates of Pensacola, PA | Not yet recruiting |
Pensacola, Florida, United States, 32503 | |
Contact 850-436-4563 | |
Principal Investigator: Frederic Newman | |
Synexus Clinical Research - St. Petersburg | Not yet recruiting |
Pinellas Park, Florida, United States, 33781 | |
Contact 727-544-6367 | |
Principal Investigator: Linda Murray | |
Precision Clinical Research | Not yet recruiting |
Sunrise, Florida, United States, 33351 | |
Contact 954-915-9991 | |
Principal Investigator: Jeffrey Schneider | |
University of South Florida | Not yet recruiting |
Tampa, Florida, United States, 33612 | |
Contact 813-396-2373 | |
Principal Investigator: Renee Marchioni Beery | |
Alliance Clinical Research, LLC | Not yet recruiting |
Tampa, Florida, United States, 33615 | |
Contact 813-515-5400 | |
Principal Investigator: Israel Crespo | |
United States, Georgia | |
Digestive Healthcare of Georgia | Recruiting |
Atlanta, Georgia, United States, 30309 | |
Contact 404-355-3200 | |
Principal Investigator: Michael R Galambos | |
United States, Idaho | |
Grand Teton Research Group, PLLC | Not yet recruiting |
Idaho Falls, Idaho, United States, 83404 | |
Contact 208-528-4256 | |
Principal Investigator: Todd Williams | |
United States, Indiana | |
Qualmedica Research, LLC | Not yet recruiting |
Evansville, Indiana, United States, 47715 | |
Contact 812-604-0088 | |
Principal Investigator: Gregory McCord | |
Qualmedica Research, LLC | Recruiting |
Evansville, Indiana, United States, 47715 | |
Contact 812-604-0088 | |
Principal Investigator: Gregory McCord | |
Indiana University Health | Recruiting |
Indianapolis, Indiana, United States, 46202 | |
Contact 317-948-9212 | |
Principal Investigator: Monika Fischer | |
United States, Kentucky | |
Robley Rex VAMC | Not yet recruiting |
Louisville, Kentucky, United States, 40206 | |
Contact 502287400053026 | |
Principal Investigator: Gerald W Dryden | |
United States, Louisiana | |
Delta Research Partners LLC | Recruiting |
Bastrop, Louisiana, United States, 71720 | |
Contact 318-283-2177 | |
Principal Investigator: Bal Raj Bhandari | |
United States, Michigan | |
Clinical Research Institute of Michigan, LLC | Not yet recruiting |
Chesterfield, Michigan, United States, 48047 | |
Contact 586-598-3329 | |
Principal Investigator: Ronald P Fogel | |
Robert Ferguson, MD PC | Not yet recruiting |
West Bloomfield, Michigan, United States, 48323 | |
Contact 248-682-1720 | |
Principal Investigator: Robert Ferguson | |
United States, Minnesota | |
Minnesota Gastroenterology, P.A. | Recruiting |
Plymouth, Minnesota, United States, 55446 | |
Contact 612-870-5595 | |
Principal Investigator: Daniel M Van Handel | |
United States, Missouri | |
Washington University Medical School | Recruiting |
Saint Louis, Missouri, United States, 63110 | |
Contact 314-273-0301 | |
Principal Investigator: Richard Rood | |
United States, New Jersey | |
Holy Name Medical Center | Recruiting |
Teaneck, New Jersey, United States, 07666 | |
Contact 201-541-6312 | |
Principal Investigator: Mitchell Spinnell | |
United States, North Carolina | |
University of North Carolina Center for Inflammatory Bowel Disease | Recruiting |
Chapel Hill, North Carolina, United States, 27599 | |
Contact 919-843-3873 | |
Principal Investigator: Animesh Jain | |
Carolina Research | Recruiting |
Greenville, North Carolina, United States, 27834 | |
Contact 252-758-8181 | |
Principal Investigator: Phillip J Goldstein | |
United States, Ohio | |
University Hospitals Cleveland Medical Center | Recruiting |
Cleveland, Ohio, United States, 44106 | |
Contact 216-844-1995 | |
Principal Investigator: Jeffry A Katz | |
Paramount Medical Research | Not yet recruiting |
Middleburg Heights, Ohio, United States, 44130 | |
Contact 440-826-0742 | |
Principal Investigator: Isam A Diab | |
United States, Oklahoma | |
University of Oklahoma Health Sciences Center | Recruiting |
Oklahoma City, Oklahoma, United States, 73104 | |
Contact 405-271-5428 | |
Principal Investigator: Hussein Bitar | |
United States, Tennessee | |
Gastro One | Recruiting |
Germantown, Tennessee, United States, 38138 | |
Contact 901-309-6035 | |
Principal Investigator: Ziad H Younes | |
United States, Texas | |
HD Research | Recruiting |
Bellaire, Texas, United States, 77401 | |
Contact 832-748-1074 | |
Principal Investigator: Jignesh Shah | |
Southern Star Research Institute, LLC | Recruiting |
San Antonio, Texas, United States, 78229 | |
Contact 210-581-2812 | |
Principal Investigator: Jeff S Bullock | |
United States, Utah | |
Care Access Research LLC - Salt Lake City | Recruiting |
Salt Lake City, Utah, United States, 84124 | |
Contact 385-474-6935 | |
Principal Investigator: Peder J Pedersen | |
United States, Washington | |
Virginia Mason Medical Center | Recruiting |
Seattle, Washington, United States, 98111 | |
Contact 206-223-2319 | |
Principal Investigator: Michael V Chiorean | |
Argentina | |
DOM- Centro de Reumatologia | Recruiting |
Caba, Buenos Aires, Argentina, 1111 | |
Contact 541121203180 | |
Principal Investigator: Fernanda Dorado | |
Instituto Medico Elsa Perez SRL (IMEP) | Not yet recruiting |
Ciudadela, Buenos Aires, Argentina, 1702 | |
Contact 541146538023 | |
Principal Investigator: Sandra Covanti | |
Australia, New South Wales | |
Concord Repatriation General Hospital | Not yet recruiting |
Concord, New South Wales, Australia, 2139 | |
Contact 61297676111 | |
Principal Investigator: Rupert Leong | |
Australia, South Australia | |
Royal Adelaide Hospital | Recruiting |
Adelaide, South Australia, Australia, 5000 | |
Contact 61870742200 | |
Principal Investigator: Abdul Shaikh | |
Austria | |
AKH - Gastroenterologie und Hepatologie - Interne Medizin III | Not yet recruiting |
Wien, Vienna, Austria, 1090 | |
Contact 43014040047440 | |
Principal Investigator: Walter Reinisch | |
Medizinische Universität Innsbruck | Recruiting |
Innsbruck, Austria, 6020 | |
Contact 0043 512 5040 | |
Principal Investigator: Robert Koch | |
Universitätsklinikum Salzburg | Recruiting |
Salzburg, Austria, 5020 | |
Contact 4357255 25402 | |
Principal Investigator: Sonja Gassner | |
Krankenhaus der Barmherzigen Schwestern | Not yet recruiting |
Wien, Austria, 1060 | |
Contact 43 1 599 88 2119 | |
Principal Investigator: Franz Pfeffel | |
Belgium | |
Université Libre de Bruxelles - Hôpital Erasme | Recruiting |
Brussel, Belgium, 1070 | |
Contact 003225553712 | |
Principal Investigator: Denis Franchimont | |
Universitair Ziekenhuis Gent | Recruiting |
Gent, Belgium, 9000 | |
Contact (329) 332-4984 | |
Principal Investigator: Triana Lobaton Ortega | |
Brazil | |
Cliagen - Clinica de Atencao em Gastroenterologia, Especialidades e Nutricao | Not yet recruiting |
Salvador, Bahia, Brazil, 41500-300 | |
Contact 55713396383 | |
Principal Investigator: Genoile Santana Silva | |
HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará | Not yet recruiting |
Fortaleza, Ceara, Brazil, 60430-370 | |
Contact 558533668444 | |
Principal Investigator: Lucia Campelo Braga | |
L2IP - Instituto de Pesquisas Clinicas Ltda. | Not yet recruiting |
Brasília, Distrito Federal, Brazil, 70200-730 | |
Contact 5561981508274 | |
Principal Investigator: Luciana Teixeira de Campos | |
Chronos Pesquisa Clínica | Not yet recruiting |
Brasília, Distrito Federal, Brazil, 72145-450 | |
Contact 556134454305 | |
Principal Investigator: Cintia Mendes Clemente | |
Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda | Not yet recruiting |
Goiania, GO, Brazil, 74535-170 | |
Contact 556232337236 | |
Principal Investigator: Mauro Bafutto | |
Hospital Felício Rocho | Not yet recruiting |
Belo Horizonte, Minas Gerais, Brazil, 30110-934 | |
Contact 553135147195 | |
Principal Investigator: Carolina de Paula Guimaraes Baia | |
Eurolatino Pesquisas Medicas Ltda. | Not yet recruiting |
Uberlandia, Minas Gerais, Brazil, 38411-186 | |
Contact 553432355207 | |
Principal Investigator: Valeria Ferreira de Almeida Borges | |
Associacao Paranaense de Cultura - PUCPR | Not yet recruiting |
Curitiba, Parana, Brazil, 80230-130 | |
Contact 554132430033 | |
Principal Investigator: Paulo Gustavo Kotze | |
IPCEM Inst. Pesquisa Clinica para Estudos Multicêntricos | Not yet recruiting |
Caxias do Sul, Rio Grande Do Sul, Brazil, 95070560 | |
Contact 555430393165 | |
Principal Investigator: Jonathan Soldera | |
Santa Casa de Misericórdia de Porto Alegre | Not yet recruiting |
Porto Alegre, Rio Grande Do Sul, Brazil, 90050-170 | |
Contact 555132148143 | |
Principal Investigator: Daniel Azambuja | |
Hospital Ernesto Dornelles | Not yet recruiting |
Porto Alegre, Rio Grande Do Sul, Brazil, 90160-093 | |
Contact 555132178555 | |
Principal Investigator: Felipe Mazzoleni | |
Nucleo de Pesquisa Clínica do Rio Grande do Sul-NPCRS | Not yet recruiting |
Porto Alegre, Rio Grande Do Sul, Brazil, 90430-001 | |
Contact 555133336031 | |
Principal Investigator: Julio Cesar Razera | |
Hospital Moinhos de Vento - Instituto de Educação e Pesquisa | Not yet recruiting |
Porto Alegre, Rio Grande Do Sul, Brazil, 90560-030 | |
Contact 555133123296 | |
Principal Investigator: Jonathas Stifft | |
Loema Instituto de Pesquisa Clinica e Consultores Ltda | Not yet recruiting |
Campinas, Sao Paulo, Brazil, 13010-001 | |
Contact 551932353575 | |
Principal Investigator: Raquel Coris Arrelaro | |
HMCP - Hospital e Maternidade Celso Pierro - PUC-Campinas | Not yet recruiting |
Campinas, Sao Paulo, Brazil, 13060-904 | |
Contact 551933438526 | |
Principal Investigator: Joaquim Simões Neto | |
Pesquisare | Not yet recruiting |
Santo Andre, Sao Paulo, Brazil, 09080-110 | |
Contact 551144273339 | |
Principal Investigator: Alexander de Sa Rolim | |
Praxis Pesquisa Medica | Not yet recruiting |
Santo André, Sao Paulo, Brazil, 09090-790 | |
Contact 551127598377 | |
Principal Investigator: Fabio L Maximiano | |
Faculdade de Medicina do ABC | Not yet recruiting |
Santo Andre, SP, Brazil, 09060-870 | |
Contact 551149935459 | |
Principal Investigator: Wilson Catapani | |
Instituto de Assistencia Medica ao Servidor Publico Estudo Estadual | Not yet recruiting |
Sao Paulo, SP, Brazil, 04039-004 | |
Contact 551150840931 | |
Principal Investigator: Debora Dourado Poli | |
Upeclin - Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu - UNESP | Not yet recruiting |
Botucatu, São Paulo, Brazil, 18618-687 | |
Contact 551438801171 | |
Principal Investigator: Ligia Yukie Sassaki | |
CEMEC - Centro Multidisciplinar de Estudos Clinicos EPP Ltda | Not yet recruiting |
São Bernardo do Campo, São Paulo, Brazil, 09715-090 | |
Contact 551144688183 | |
Principal Investigator: Sandra Di Felice Boratto | |
Hospital Sirio-Libanes | Not yet recruiting |
Sao Paulo, Brazil, 01308-050 | |
Contact 551132141414 | |
Principal Investigator: Marcelo Rodrigues Borba | |
Hepatogastro | Not yet recruiting |
Sao Paulo, Brazil, 04543-001 | |
Principal Investigator: Rodrigo Andrey Rocco | |
CPQuali Pesquisa Clínica | Not yet recruiting |
São Paulo, Brazil, 01228-000 | |
Contact 551127766801 | |
Principal Investigator: Alexandre de Sousa Carlos | |
Canada, Ontario | |
Victoria Hospital | Not yet recruiting |
London, Ontario, Canada, N6A 5W9 | |
Contact 5196675977 | |
Principal Investigator: Terry Ponich | |
Czechia | |
Vojenska nemocnice Brno | Not yet recruiting |
Brno, Czechia, 636 00 | |
Contact 420973445520 | |
Principal Investigator: David Stepek | |
Fakultni nemocnice u sv. Anny v Brne | Not yet recruiting |
Brno, Czechia, 65691 | |
Contact 420543182644 | |
Principal Investigator: Jan Ulbrych | |
Hepato-gastroenterologie HK, s.r.o. | Not yet recruiting |
Hradec Kralove, Czechia, 50012 | |
Contact 420495218475 | |
Principal Investigator: Miroslava Volfova | |
Gregar s.r.o. | Recruiting |
Olomouc, Czechia, 779 00 | |
Contact 420585428910 | |
Principal Investigator: Jan Gregar | |
PreventaMed, s.r.o. | Recruiting |
Olomouc, Czechia, 779 00 | |
Contact 420602708148 | |
Principal Investigator: Jiri Pumprla | |
A-Shine s.r.o. | Not yet recruiting |
Plzen, Czechia, 31200 | |
Contact 420777242101 | |
Principal Investigator: Lubos Janu | |
Thomayerova nemocnice | Recruiting |
Praha 4 - Krc, Czechia, 140 59 | |
Principal Investigator: Pavel Kohout | |
Fakultni Nemocnice v Motole | Recruiting |
Praha 5, Czechia, 150 06 | |
Contact 420224433076 | |
Principal Investigator: Radan Keil | |
Mediendo s.r.o. | Not yet recruiting |
Praha 8 - Karlin, Czechia, 18600 | |
Contact 420273139861 | |
Principal Investigator: Stepan Suchanek | |
Krajska nemocnice T. Bati a.s. | Recruiting |
Zlin, Czechia, 76275 | |
Contact 420577552213 | |
Principal Investigator: Vladimir Kojecky | |
Germany | |
Siloah St. Trudpert Klinikum-Zentrum für Innere Medizin | Not yet recruiting |
Pforzheim, Baden-Württemberg, Germany, 75179 | |
Contact 4972314983701 | |
Principal Investigator: Oliver Bachmann | |
Synexus Clinical Research GmbH | Not yet recruiting |
Frankfurt am Main, Hessen, Germany, 60313 | |
Contact 4969697125 | |
Principal Investigator: Christel Contzen | |
Medizinische Hochschule Hanover | Not yet recruiting |
Hannover, Niedersachsen, Germany, 30625 | |
Contact 00495115329427 | |
Principal Investigator: Ursula Seidler | |
Magen-Darm-Zentrum Remscheid | Not yet recruiting |
Remscheid, North Rhine-Westphalia, Germany, 42859 | |
Contact 004921918901050 | |
Principal Investigator: Eric Jörgensen | |
Practice Dr.med. Denger and Dr.med. Pfitzner | Not yet recruiting |
Friedrichsthal, Saarland, Germany, 66299 | |
Contact 49689798190 | |
Principal Investigator: Thomas Pfitzner | |
Studiengesellschaft BSF Unternehmergesellschaft haftungsbeschraenkt | Not yet recruiting |
Halle (Saale),, Sachsen Anhalt, Germany, 06108 | |
Contact 0049 345 299 760 | |
Principal Investigator: Lars Fechner | |
Synexus Clinical Research GmbH | Not yet recruiting |
Leipzig, Sachsen, Germany, 04103 | |
Contact 0049341213159 | |
Principal Investigator: Gunter Glas | |
Universität Leipzig - Universitätsklinikum | Not yet recruiting |
Leipzig, Sachsen, Germany, 04103 | |
Contact 00493419712200 | |
Principal Investigator: Martin Hecker | |
Charité Campus Virchow-Klinikum | Not yet recruiting |
Berlin, Germany, 12200 | |
Contact 004930450 514358 | |
Principal Investigator: Britta Siegmund | |
Synexus Clinical Research GmbH | Not yet recruiting |
Berlin, Germany, 12627 | |
Contact 0049305844500 | |
Principal Investigator: Ozan Dursun | |
Hungary | |
Dr. Rethy Pal Korhaz es Rendelointezet | Recruiting |
Bekescsaba, Bekes, Hungary, 5600 | |
Contact 36309159350 | |
Principal Investigator: Marta Varga | |
Synexus Gyula | Not yet recruiting |
Gyula, Bekes, Hungary, 5700 | |
Principal Investigator: Laszlo Szalai | |
DRC Gyogyszervizsgalo Rendelointezet Kft | Recruiting |
Balatonfüred, EU, Hungary, 8230 | |
Contact 36 87 481 616 | |
Principal Investigator: Katalin Bezzegh | |
Clinexpert Tatabánya Ltd. | Recruiting |
Tatabánya, Komarom-Esztergom, Hungary, H-2800 | |
Contact 36 30 957 8269 | |
Principal Investigator: Andras Kafony | |
Clinexpert SMO | Recruiting |
Budapest, Hungary, 1033 | |
Contact 36703622417 | |
Principal Investigator: Zsanett Heringh | |
Synexus Magyarorszag Kft. | Not yet recruiting |
Budapest, Hungary, 1036 | |
Contact 3614367330 | |
Principal Investigator: Ferenc Izbeki | |
Pannonia Maganorvosi Centrum | Not yet recruiting |
Budapest, Hungary, 1136 | |
Contact 36304202991 | |
Principal Investigator: Robert Schnabel | |
Bugat Pal Korhaz | Recruiting |
Gyongyos, Hungary, 3200 | |
Contact 36703916537 | |
Principal Investigator: Gyula Horvat | |
Endomedix Diagnosztikai Kozpont | Recruiting |
Miskolc, Hungary, 3525 | |
Contact 36302912183 | |
Principal Investigator: Tunde Kristof | |
Karolina Korhaz-Rendelointezet | Not yet recruiting |
Mosonmagyarovar, Hungary, 9200 | |
Principal Investigator: Gyula Pecsi | |
SZTE AOK Belgyogyaszati Klinika | Recruiting |
Szeged, Hungary, 6720 | |
Contact 3662545185 | |
Principal Investigator: Zoltan Szepes | |
Clinfan Szolgaltato Kft. | Recruiting |
Szekszard, Hungary, 7100 | |
Contact 36302777114 | |
Principal Investigator: Agnes Salamon | |
Javorszky Odon Hospital | Recruiting |
Vac, Hungary, 2600 | |
Contact 3627620620 | |
Principal Investigator: Tibor Szaloki | |
Israel | |
Soroka Medical Center | Not yet recruiting |
Beer Sheva, Israel, 8410101 | |
Contact 972507413471 | |
Principal Investigator: Arik Segal | |
Bnai Zion Medical Center | Not yet recruiting |
Haifa, Israel, 3339419 | |
Contact 97248359281543090 | |
Principal Investigator: Tova Rainis | |
Shaare Zedek Medical Center | Not yet recruiting |
Jerusalem, Israel, 91031 | |
Contact 972-2-6666064 | |
Principal Investigator: Eran Goldin | |
Galilee Medical Center Department of Internal Medicine A | Recruiting |
Nahariya, Israel, 22100 | |
Contact 972-4-9107748 | |
Principal Investigator: Assy Nimer | |
Kaplan Medical Center | Not yet recruiting |
Rehovot, Israel, 7610001 | |
Contact 972-8-9441587 | |
Principal Investigator: Ehud Melzer | |
Assaf Harofeh Medical Center | Not yet recruiting |
Zerifin, Israel, 70300 | |
Contact (972) 89779722 | |
Principal Investigator: Haim Shirin | |
Italy | |
Ospedale di Rho | Not yet recruiting |
Rho, Milano, Italy, 20017 | |
Contact 393479030959 | |
Principal Investigator: Simone Saibeni | |
Istituto Clinico Humanitas | Not yet recruiting |
Rozzano, Milano, Italy, 20089 | |
Contact 390282245555 | |
Principal Investigator: Silvio Danese | |
Policlinico Mater Domini | Not yet recruiting |
Catanzaro, Italy, 88100 | |
Contact 3909613647113 | |
Principal Investigator: Francesco Luzza | |
Policlinico di Modena | Not yet recruiting |
Modena, Italy, 41124 | |
Contact 00390594223109 | |
Principal Investigator: Erica Villa | |
Japan | |
Kitakyushu Municipal Medical Center | Recruiting |
Kitakyusyu-shi, Fukoka, Japan, 802-0077 | |
Contact 81120023812 | |
Principal Investigator: Hirotada Akiho | |
Fukuoka University Chikushi Hospital | Recruiting |
Chikushino-shi, Fukuoka-Ken, Japan, 818 8502 | |
Contact 81120023812 | |
Principal Investigator: Takashi Hisabe | |
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital | Recruiting |
Chuo-ku, Sapporo-shi, Hokkaido, Japan, 060-0033 | |
Contact +81120023812 | |
Principal Investigator: Satoshi Motoya | |
Tokushukai Sapporo Tokushukai Hospital | Recruiting |
Sapporo-shi, Hokkaido, Japan, 004 0041 | |
Contact 81120023812 | |
Principal Investigator: Toshifumi Ashida | |
Ibaraki Prefectural Central Hp | Recruiting |
Kasama, Ibaraki, Japan, 309 1793 | |
Contact 81120023812 | |
Principal Investigator: Mitsuhide Goto | |
Sameshima Hospital | Recruiting |
Kagoshima-shi, Kagoshima, Japan, 892-0846 | |
Contact 81120023812 | |
Principal Investigator: Nobuaki Nishimata | |
Gokeikai Ofuna Chuo Hospital | Recruiting |
Kamakura-shi, Kanagawa, Japan, 247-0056 | |
Contact +81120023812 | |
Principal Investigator: Yutaka Endo | |
Takagi Clinic | Recruiting |
Sendai-shi, Miyagi-Ken, Japan, 981 3213 | |
Contact +81120023812 | |
Principal Investigator: Sho Takagi | |
Tokyo Medical And Dental University Medical Hospital | Recruiting |
Bunkyō, Tokyo, Japan, 113-8519 | |
Contact 81120023812 | |
Principal Investigator: Toshimitsu Fujii | |
Kyorin University Hospital | Recruiting |
Mitaka, Tokyo, Japan, 181-8611 | |
Contact 81120023812 | |
Principal Investigator: Tadakazu Hisamatsu | |
JHCO Tokyo Yamate Medical Center | Recruiting |
Shinjuku-ku, Tokyo, Japan, 169-0073 | |
Contact 81120023812 | |
Principal Investigator: Naoki Yoshimura | |
Toyama Prefectural Central Hospital | Recruiting |
Toyama-Shi, Toyama, Japan, 930-8550 | |
Contact 81120023812 | |
Principal Investigator: Koichiro Matsuda | |
Fukuoka University Hospital | Recruiting |
Fukuoka, Japan, 814-0180 | |
Contact 81120023812 | |
Principal Investigator: Fumihito Hirai | |
Korea, Republic of | |
Ajou University Hospital | Not yet recruiting |
Suwon-si, Gyeonggi-do, Korea, Republic of, 443380 | |
Contact 82312195149 | |
Principal Investigator: Sung Jae Shin | |
Yeungnam Univeristy Medical Center | Recruiting |
Daegu, Korea, Korea, Republic of, 42415 | |
Contact 82536203831 | |
Principal Investigator: Byung Ik Jang | |
Kyung Hee University Hospital | Not yet recruiting |
Seoul, Korea, Korea, Republic of, 02447 | |
Contact 8229588147 | |
Principal Investigator: Hyo-Jong Kim | |
Asan Medical Center | Recruiting |
Seoul, Korea, Korea, Republic of, 05505 | |
Contact 820230105768 | |
Principal Investigator: Sang Hyoung Park | |
Inje University Haeundae Paik Hospital | Not yet recruiting |
Busan, Korea, Republic of, 48108 | |
Contact 821093302333 | |
Principal Investigator: Tae-oh Kim | |
Kangbuk Samsung Hosp | Recruiting |
Seoul, Korea, Republic of, 03181 | |
Contact 82220018555 | |
Principal Investigator: Dong II Park | |
Netherlands | |
ETZ Elisabeth Tilburg | Recruiting |
Tilburg, North Brabant, Netherlands, 5022 GC | |
Contact 31 135398466 | |
Principal Investigator: Robert Laheij | |
Academisch Medisch Centrum | Recruiting |
Amsterdam, Netherlands, 1105 AZ | |
Contact 31205669124 | |
Principal Investigator: Geert R.A.M. D'Haens | |
Poland | |
Szpital Uniwersytecki Nr 2 w Bydgoszczy, Klinika Reumatologii i Ukladowych Chorob Tkanki Lacznej | Recruiting |
Bydgoszcz, Poland, 85-168 | |
Contact 48601667497 | |
Principal Investigator: Maria Klopocka | |
GASTROMED Zakład Opieki Zdrowotnej | Recruiting |
Lublin, Poland, 20-582 | |
Contact 48814758800 | |
Principal Investigator: Wit Danilkiewicz | |
Korczowski Bartosz, Gabinet Lekarski | Recruiting |
Rzeszow, Poland, 35-302 | |
Contact 48178664145 | |
Principal Investigator: Bartosz Korczowski | |
Twoja Przychodnia-Szczecinskie Centrum Medyczne | Recruiting |
Szczecin, Poland, 71-434 | |
Contact 0048 91 433 29 19 | |
Principal Investigator: Beata Gawdis-Wojnarska | |
Nzoz Formed | Recruiting |
Wadowice, Poland, 34-100 | |
Contact 48338233255 | |
Principal Investigator: Beata Mroziak | |
WIP Warsaw IBD Point Profesor Kierkus | Recruiting |
Warszawa, Poland, 00-728 | |
Contact 48 228157384 | |
Principal Investigator: Jaroslaw Kierkus | |
Centrum Zdrowia Matki, Dziecka i Młodzieży (CZMDM) Przychodnie | Recruiting |
Warszawa, Poland, 00635 | |
Contact 48 22 815 73 82 | |
Principal Investigator: Michal Lawinski | |
Melita Medical Sp. Z O. O. | Recruiting |
Wroclaw, Poland, 50-449 | |
Contact 48661302302 | |
Principal Investigator: Jaroslaw Leszczyszyn | |
ETG Zamosc | Recruiting |
Zamosc, Poland, 22-400 | |
Contact 48223702134 | |
Principal Investigator: Katarzyna Wojcik | |
Romania | |
SC Pelican SRL | Not yet recruiting |
Oradea, Bihor, Romania, 410469 | |
Contact 40259422077 | |
Principal Investigator: Alin-Horea Suta | |
Sc Tvm Med Serv | Recruiting |
Cluj-Napoca, Cluj, Romania, 400132 | |
Contact 40264598465 | |
Principal Investigator: Alina Tantau | |
Arensia Exploratory Medicine Colentina Clinical Hospital | Not yet recruiting |
Bucharest, Romania, 020125 | |
Contact 1140722588451 | |
Principal Investigator: Radu B Mateescu | |
SC Med Life SA | Recruiting |
Bucuresti, Romania, 010719 | |
Contact 40212094030 | |
Principal Investigator: Ion-Eugeniu Craciun | |
S.C. Centrul Medical Medicum SRL | Not yet recruiting |
Bucuresti, Romania, 012015 | |
Contact +40726732764 | |
Principal Investigator: Theodor-Alexandru Voiosu | |
Institutul Clinic Fundeni | Recruiting |
Bucuresti, Romania, 022328 | |
Contact 40722300252 | |
Principal Investigator: George Stancu | |
Centrul Medical Unirea SRL | Not yet recruiting |
Bucuresti, Romania, 040055 | |
Contact 040745086735 | |
Principal Investigator: Camelia Chioncel | |
CCBR Clinical Research | Recruiting |
Bucuresti, Romania, 30463 | |
Contact 40745123327 | |
Principal Investigator: Daniela Bartos | |
S.C Centrul de Gastroenterologie Dr. Goldis S.R.L | Recruiting |
Timisoara, Romania, 300002 | |
Contact 40722410712 | |
Principal Investigator: Adrian Goldis | |
Russian Federation | |
LLC Multidisciplinary Medical Clinic Anthurium | Recruiting |
Barnaul, Russian Federation, 656043 | |
Contact 73852441030 | |
Principal Investigator: Galina Chumakova | |
LLC MA New Hospital | Not yet recruiting |
Ekaterinburg, Russian Federation, 620109 | |
Contact 79122465255 | |
Principal Investigator: Elina Petrova | |
Irkutsk State Medical Academy of Continuing Education | Recruiting |
Irkutsk, Russian Federation, 664049 | |
Contact 79501328180 | |
Principal Investigator: Olga Fedorishina | |
LLC Olla-Med | Not yet recruiting |
Moscow, Russian Federation, 105554 | |
Contact 74951059905 | |
Principal Investigator: Pavel Makarchuk | |
Nizhegorodskiy Regional Clinical Hospital N.A.Semashko | Recruiting |
Nizhniy Novgorod, Russian Federation, 603126 | |
Contact 789601472598 | |
Principal Investigator: Olga Alexeeva | |
LLC "Medicine Center SibNovoMed" | Recruiting |
Novosibirsk, Russian Federation, 630005 | |
Contact 79139426182 | |
Principal Investigator: Marina Osipenko | |
Saint-Petersburg City Hospital of Saint Elizabeth | Not yet recruiting |
Saint Petersburg, Russian Federation, 195257 | |
Principal Investigator: Anatoly Pershko | |
Saint Petersburg State Medical University n.a. Pavlov I.P. | Recruiting |
Saint Petersburg, Russian Federation, 197022 | |
Contact 78122345451 | |
Principal Investigator: Vasiliy Trofimov | |
SBIH City Clinical Hospital #31 | Not yet recruiting |
Saint-Petersburg, Russian Federation, 197110 | |
Contact 79112935646 | |
Principal Investigator: Oksana Shchukina | |
NonState Healthcare Institution Central Clinical Hospital | Recruiting |
Samara, Russian Federation, 443029 | |
Contact 79179514686 | |
Principal Investigator: Pavel Andreev | |
LLC Scientific Research Centre EKO-Bezopasnost | Not yet recruiting |
St. Petersburg, Russian Federation, 196143 | |
Contact 78123250305 | |
Principal Investigator: Konstantin Zakharov | |
Slovakia | |
FNsP FDRoosevelta Banska Bystrica | Not yet recruiting |
Banska Bystrica, Slovakia, 97517 | |
Principal Investigator: Jozef Balaz | |
ENDOMED s.r.o. | Recruiting |
Kosice, Slovakia, 04013 | |
Principal Investigator: Miroslav Fedurco | |
Gastromedic | Not yet recruiting |
Nove Zamky, Slovakia, 94002 | |
Contact 421356423284 | |
Principal Investigator: Iveta Kalisova | |
Gastro LM s.r.o. | Not yet recruiting |
Presov, Slovakia, 08001 | |
Contact 421905794001 | |
Principal Investigator: Lubomir Mihalkanin | |
Spain | |
Instituto de Ciencias Médicas | Recruiting |
Alicante, Spain, 03004 | |
Contact +34966592350 | |
Principal Investigator: Luis De Teresa Parreno | |
Turkey | |
Antalya Training and Research Hospital | Recruiting |
Muratpasa, Antayla, Turkey, 7100 | |
Contact 902422494400 | |
Principal Investigator: Ayhan Hilmi Cekin | |
Kocaeli University Medical Faculty Hospital | Not yet recruiting |
Izmit, Kocaeli, Turkey, 41380 | |
Contact 905323252996 | |
Principal Investigator: Sadettin Hulagu | |
Mersin University Medical Faculty | Not yet recruiting |
Yenişehir, Mersin, Turkey, 33110 | |
Contact 905053682634 | |
Principal Investigator: Engin Altintas | |
Hacettepe University Faculty of Medicine | Recruiting |
Ankara, Turkey, 06100 | |
Contact 0090 312 442 37 15 | |
Principal Investigator: Halis Simsek | |
Gazi University Faculty of Medicine | Recruiting |
Ankara, Turkey, 6500 | |
Contact 90 5053192257 | |
Principal Investigator: Tarkan Karakan | |
Uludag University Medical Faculty | Not yet recruiting |
Bursa, Turkey, 16059 | |
Contact 0090224 442 85 64 | |
Principal Investigator: Murat Kiyici | |
Trakya University | Recruiting |
Edirne, Turkey, 22030 | |
Contact 00902842357641 | |
Principal Investigator: Ahmet Tezel | |
Gaziantep University Medical Faculty | Not yet recruiting |
Gaziantep, Turkey, 27310 | |
Contact 00905052760075 | |
Principal Investigator: Bugra Tolga Konduk | |
Acibadem Fulya Hospital | Not yet recruiting |
Istanbuk, Turkey, 34349 | |
Contact 9005322523728 | |
Principal Investigator: Hulya Hamzaoglu | |
Acibadem Kozyatagi Hospital | Not yet recruiting |
Istanbul, Turkey, 34668 | |
Contact 902165714444 | |
Principal Investigator: Can Gonen | |
Marmara University Pendik Research and Training Hospital | Not yet recruiting |
İstanbul, Turkey, 34899 | |
Contact 0090216 625 45 45 | |
Principal Investigator: Ozlen Atug | |
Dokuz Eylul University Hospital | Not yet recruiting |
Izmir, Turkey | |
Contact 90 232 - 4123716 - 3716 | |
Principal Investigator: Hale Akpinar | |
Erciyes University Hospital | Not yet recruiting |
Kayseri, Turkey, 38039 | |
Contact 00903522076666 | |
Principal Investigator: Kadri Guven | |
Ukraine | |
Medical Center of Limited Liability Company Medical Center Clinic of Family Medicine | Not yet recruiting |
Dnipro, Ukraine, 49038 | |
Contact 380562310310 | |
Principal Investigator: Yana Shapovalova | |
CHI Prof.O.O.Shalimov Kharkiv City Clinical Hospital #2 | Recruiting |
Kharkiv, Ukraine, 61037 | |
Contact 380674416147 | |
Principal Investigator: Oleksii Datsenko | |
Kharkiv Regional Council Regional Clinical Hospital | Not yet recruiting |
Kharkiv, Ukraine, 61058 | |
Contact 380504022938 | |
Principal Investigator: Maryna Zinchenko | |
Medical Center Ok!Clinic of Intl Inst of Clinical Trials LLC | Recruiting |
Kyiv, Ukraine, 02091 | |
Contact 380674028636 | |
Principal Investigator: Nataliia Tsarynna | |
Communal institution of the Kyiv Regional Council "Kyiv Regional Clinical Oncology Dispensary" | Not yet recruiting |
Kyiv, Ukraine, 04078 | |
Contact 38 0953497886 | |
Principal Investigator: Tetiana Lohdanidi | |
Lviv Clinical Hospital at Railway Transport of Division Healthcare Center PJSC Ukrainian Railway Sta | Not yet recruiting |
Lviv, Ukraine, 79007 | |
Contact 06 32380055 | |
Principal Investigator: Olha Ivanishyn | |
Communal Enterprise "Odesa Regional Clinical Hospital" | Recruiting |
Odesa, Ukraine, 65000 | |
Contact 380487500115 | |
Principal Investigator: Andriy Yurkiv | |
A. Novak Transcarpathian Regional Clinical Hospital | Recruiting |
Uzhgorod, Ukraine, 88018 | |
Contact 380312228645 | |
Principal Investigator: Yaroslava Rishko | |
Vinnytsia RCH of Veterans of War Dept of Therapy#1 Vinnytsia M.I.Pyrogov NMU | Recruiting |
Vinnytsia, Ukraine, 21005 | |
Contact 380432550794 | |
Principal Investigator: Valerii Ivanov | |
MCIC MC LLC Health Clinic | Not yet recruiting |
Vinnytsia, Ukraine, 21009 | |
Contact 380432538157 | |
Principal Investigator: Oleksandr Golovchenko | |
SRI of Invalid Rehabil.,Educ.Scient.Med.Complex | Recruiting |
Vinnytsia, Ukraine, 21029 | |
Contact 380432511269 | |
Principal Investigator: Sergii Shevchuk | |
Diacenter LLC | Recruiting |
Zaporizhzhia, Ukraine, 69076 | |
Contact 380 612 965 685 | |
Principal Investigator: Yevgen Poplyonkin |
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 |
Additional Information:
Responsible Party: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT04232553 |
Other Study ID Numbers: |
16628 I6T-MC-AMAX ( Other Identifier: Eli Lilly and Company ) 2019-002687-27 ( EudraCT Number ) |
First Posted: | January 18, 2020 Key Record Dates |
Last Update Posted: | March 4, 2021 |
Last Verified: | March 1, 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
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. |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Clinical Study Report (CSR) |
Time Frame: | Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting. |
Access Criteria: | A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement. |
URL: | https://vivli.org/ |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
Crohn Disease Inflammatory Bowel Diseases Gastroenteritis |
Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases |