Crohn's DiseasePhase 3VIVID-2NCT04232553
A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease
A Phase 3 study testing Mirikizumab in people with Crohn's Disease, run by Eli Lilly and Company at 322 sites in 32 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Mirikizumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 996 participants
- Where
- 322 sitesin 32 countries
- Study dates
- 22 Jun 2020to Mar 2028
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants must have completed study I6T-MC-AMAG (NCT02891226) or study I6T-MC-AMAM (NCT03926130)
- If female, participant must meet the contraception requirements
Who cannot join
- Participants must not have developed a new condition, including cancer in the previous study (I6T-MC-AMAG or I6T-MC-AMAM) that would pose an unacceptable risk in the trial.
- Participants must not have any important infections including, but not limited to, hepatitis B, hepatitis C, HIV/AIDS, and active tuberculosis (TB) during either previous study.
- Note: Participants with a history of active TB with documentation of treatment by the Centers for Disease Control (CDC) and/or World Health Organization (WHO) criteria prior to the originator study are not excluded from the study.
- Participants must not have a known hypersensitivity to any component of mirikizumab or have experienced acute systemic hypersensitivity event with previous study drug administration in the originating study that precludes mirikizumab therapy.
- Participation must not be pregnant, lactating, or planning to become pregnant while enrolled in the study or 16 weeks after receiving the last dose of study drug.
Trial locations and contacts
322 sites in 32 countries.
322 sites in 32 countries
United States54 sites
Digestive Healthcare of Georgia
Atlanta, Georgia, 30327
First Surgical Hospital
Bellaire, Texas, 77401
Washington Gastroenterology - Bellevue
Bellevue, Washington, 98004
Connecticut Clinical Research Institute
Bristol, Connecticut, 06010
Clinical & Translational Research Center (CTRC)
Chapel Hill, North Carolina, 27599-7080
University of Virginia Health System
Charlottesville, Virginia, 22908
The Digestive Health Center of Michigan (DHCMI)
Chesterfield, Michigan, 48047
Capital Digestive Care - Chevy Chase
Chevy Chase, Maryland, 20815
Gastroenterology Consultants of Clearwater
Clearwater, Florida, 33756
Clinical Research of West Florida, Inc. (Clearwater)
Clearwater, Florida, 33765
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
Ohio Gastroenterology
Columbus, Ohio, 43202
Gastroenterology Center Of The Midsouth
Cordova, Tennessee, 38018
Digestive Health Specialists
Dothan, Alabama, 36305
Qualmedica Research, LLC
Evansville, Indiana, 47715
Revive Research Institute, Inc.
Farmington Hills, Michigan, 48334
Care Access - Gilroy
Gilroy, California, 95020
Woodholme Gastroenterology Associates - Glen Burnie
Glen Burnie, Maryland, 21061
Carolina Digestive Diseases and Endoscopy Center
Greenville, North Carolina, 27834
Ohio State University
Hilliard, Ohio, 43026
Baylor College of Medicine Medical Center
Houston, Texas, 77030
Newport Huntington Medical Group
Huntington Beach, California, 92648
Grand Teton Research Group
Idaho Falls, Idaho, 83404
Indiana University Health University Hospital
Indianapolis, Indiana, 46202
Care Access - Kinston
Kinston, North Carolina, 28501
IHS Health Research
Kissimmee, Florida, 34741
Care Access - Las Vegas
Las Vegas, Nevada, 89148
Research Solutions of Arizona
Litchfield Park, Arizona, 85340
West Texas Digestive Disease
Lubbock, Texas, 79424
Gastrointestinal Specialists of Georgia
Marietta, Georgia, 30060
Ezy Medical Research
Miami, Florida, 33175
Delta Research Partners
Monroe, Louisiana, 71201
California Medical Research Associates
Northridge, California, 91324
Care Access - Ogden
Ogden, Utah, 84403
The University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104-5008
Gastroenterology Associates of Orangeburg
Orangeburg, South Carolina, 29118
Care Access - Orlando
Orlando, Florida, 32825
Gastroenterology Associates of Pensacola, PA
Pensacola, Florida, 32503
Arizona Arthritis & Rheumatology Research, PLLC
Phoenix, Arizona, 85037
MNGI Digestive Health - Plymouth Endoscopy Center & Clinic
Plymouth, Minnesota, 55446
University Gastroenterology
Providence, Rhode Island, 02905
Clinical Research Partners, LLC
Richmond, Virginia, 23226
Care Access - Salt Lake City
Salt Lake City, Utah, 84124
Southern Star Research Institute
San Antonio, Texas, 78229
Virginia Mason Medical Center
Seattle, Washington, 98101
Washington University Medical School
St Louis, Missouri, 63110
Precision Clinical Research
Sunrise, Florida, 33351
Washington Gastroenterology - Tacoma
Tacoma, Washington, 98405
USF Health
Tampa, Florida, 33612
Alliance Clinical Research of Tampa
Tampa, Florida, 33615
Holy Name Medical Center
Teaneck, New Jersey, 07666
Tyler Research Institute
Tyler, Texas, 75701
North Shore Gastroenterology & Endoscopy Centers
Westlake, Ohio, 44145
Tidewater Physicians Multispecialty Group Clinical Research
Williamsburg, Virginia, 23188
China26 sites
Xiangya Hospital Central South University
Changsha, Hunan, 410008
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013
The First People's Hospital of Changzhou
Changzhou, Jiangsu, 213003
Changzhou No.2 People's Hospital
Changzhou, Jiangsu, 213004
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041
Chongqing General Hospital
Chongqing, Chongqing Municipality, 400014
The First People's Hospital of Foshan
Foshan, Guangdong, 528041
The First Affiliated Hospital Of Fujian Medical University
Fuzhou, 350005
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510655
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong
The First Affiliated Hospital, Zhejiang University
Hangzhou, Zhejiang, 310003
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, 310016
The Second Affiliated hospital of Zhejiang University school of medicine
Hangzhou, Zhejiang, 310052
Anhui Provincial Hospital
Hefei, Anhui, 230071
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650032
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006
Jiangsu Province Hospital of Chinese Medicine
Nanjing, Jiangsu, 210029
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110004
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215004
The Second Affiliated Hospital YuYing Childens Hospital of Wenzhou Medical university
Wenzhou, Zhejiang, 325000
Tongji Hospital Tongji Medical,Science & Technology
Wuhan, Hubei, 430030
Wuxi People's Hospital
Wuxi, Jiangsu, 214023
Zhongshan Hospital Affiliated to Xiamen University
Xiamen, Fujian, 350001
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, 212000
Japan26 sites
Institute of Science Tokyo Hospital
Bunkyo, Tokyo, 113-8519
Fukuoka University Chikushi Hospital
Chikushino-shi, Fukuoka, 818-0067
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
Chuo-ku, Sapporo-shi, Hokkaido, 060-0033
Fukuoka University Hospital
Fukuoka, Fukuoka, 814-0180
Matsuda Hospital
Hamamatsu, Shizuoka, 432-8061
National Hospital Organization Hirosaki General Medical Center
Hirosaki, Aomori, 036-8545
Kagoshima University Hospital
Kagoshima, Kagoshima-ken, 890-8520
Sameshima Hospital
Kagoshima, Kagoshima-ken, 892-0846
Ofuna Central Hospital
Kamakura, Kanagawa, 247-0056
Ibaraki Prefectural Central Hospital
Kasama, Ibaraki, 890-8520
Tsujinaka Hospital - Kashiwanoha
Kashiwa, Chiba, 277-0871
Kiryu Kosei General Hospital
Kiryū, Gunma, 376-0024
Kitakyushu Municipal Medical Center
Kitakyusyu-shi, Fukoka, 802-0077
Kumamoto University Hospital
Kumamoto, Kumamoto, 860-8556
University Hospital,Kyoto Prefectural University of Medicine
Kyoto, Kyoto, 602-8566
Kyorin University Hospital
Mitaka, Tokyo, 181-8611
Hyogo College of Medicine
Nishinomiya, Hyōgo, 663-8501
Okayama Saiseikai Outpatient Center Hospital
Okayama, Okayama-ken, 700-0013
Tokushukai Sapporo Tokushukai Hospital
Sapporo, Hokkaido, 004 0041
Sapporo Medical University Hospital
Sapporo, Hokkaido, 060-8543
Sapporo Higashi Tokushukai Hospital
Sapporo, Hokkaido, 065-0033
Takagi Clinic - Sendai
Sendai, Miyagi, 981-3213
Center Hospital of the National Center for Global Health and Medicine
Shinjyuku-ku, Tokyo, 162-8655
Tokyo Yamate Medical Center
Tokyo, Tokyo, 169-0073
Toyama Prefectural Central Hospital
Toyama, Toyama, 930-0975
Mie University Hospital
Tsu, Mie-ken, 514-8507
Poland24 sites
Nova Reuma Domyslawska i Rusilowicz Spolka Partnerska Lekarza Reumatologa i Fizjoterapeuty
Bialystok, Podlaskie Voivodeship, 15-707
Centrum Medyczne "Medis" Manermed
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-229
Synexus Polska Sp. z o.o. Oddzial w Czestochowie
Częstochowa, Silesian Voivodeship, 42-202
NZOZ TwojeZdrowie
Elblag, Warmian-Masurian Voivodeship, 82-300
Synexus Polska Gdansku
Gdansk, Pomeranian Voivodeship, 80-382
Synexus Polska Sp. z o.o. Oddzial w Gdyni
Gdynia, Pomeranian Voivodeship, 81-537
Synexus Polska - Katowicach
Katowice, Silesian Voivodeship, 40-588
Topolowa Medicenter
Krakow, Lesser Poland Voivodeship, 31-506
ZOZ Gastromed
Lublin, Lublin Voivodeship, 20-582
Synexus Polska Sp. z o.o. Oddzial w Poznaniu
Poznan, Greater Poland Voivodeship, 60-702
Private Practice - Dr. Korczowski Bartosz
Rzeszów, Podkarpackie Voivodeship, 35-302
Centrum Medyczne MEDYK
Rzeszów, Podkarpackie Voivodeship, 35-326
Endoskopia Sp. z.o.o.
Sopot, Pomeranian Voivodeship, 81-756
Kiepury Clinic
Sosnowiec, Silesian Voivodeship, 40-588
Dc-Med
Swidnica, Lower Silesian Voivodeship, 58-100
Twoja Przychodnia - Szczecinskie Centrum Medyczne
Szczecin, West Pomeranian Voivodeship, 71-434
SONOMED Centrum Medyczne
Szczecin, West Pomeranian Voivodeship, 71-685
NZOZ Formed
Wadowice, Lesser Poland Voivodeship, 34-100
Centrum Zdrowia MDM
Warsaw, Masovian Voivodeship, 00-189
WIP Warsaw IBD Point Profesor Kierkus
Warsaw, Masovian Voivodeship, 04-501
Melita Medical
Wroclaw, Lower Silesian Voivodeship, 50-449
Reumatop
Wroclaw, Lower Silesian Voivodeship, 52-210
Synexus - Wroclaw
Wroclaw, Lower Silesian Voivodeship, 58-100
ETG Zamość
Zamość, Lublin Voivodeship, 22-400
Ukraine19 sites
Chernivtsi Regional Clinical Hospital
Chernivtsi, 58000
Medical Center Family Medicine Clinic
Dnipro, Dnipropetrovsk Oblast, 49038
Communal non-profit enterprise "Regional clinical hospital of Ivano-Frankivsk Regional Council"
Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76008
City Clinical Hospital No. 2
Kharkiv, Kharkiv Oblast, 61037
Medical Center Ok!Clinic+
Kyiv, Kyiv Oblast, 02091
Medical Center of Limited Liability Company "Medical Center "Consilium Medical"
Kyiv, Kyiv Oblast, 04050
Municipal non-profit enterprise of Kyiv Regional Council "Kyiv Regional Center for Rehabilitation Medicine"
Kyiv, Kyiv Oblast, 04078
Municipal Nonprofit Enterprise of Kyiv Region Council "Kyiv Regional Clinical Hospital"
Kyiv, Kyiv Oblast, 04106
Medbud Clinic
Kyiv, Kyivska Oblast, 03037
Kyiv Railway Clinical Hospital No.2 of Branch Health Center of the Public Joint Stock Company Ukrainian Ra -T
Kyiv, 03049
University Hospital branch of Danylo Halytsky Lviv National Medical University (UH DHLNMU)
Lviv, Lviv Oblast, 79000
Municipal non-profit enterprise'Odesa Regional Clinical Hospital'of Odesa Regional Council
Odesa, Odesa Oblast, 65025
Transcarpathian Regional Hospital im.Andriya Novak
Uzhhorod, Zakarpattia Oblast, 88018
City Clinical Hospital #1, Vinnitsya National Medical University
Vinnytsia, Vinnytsia Oblast, 21000
Medical Clinical Investigational Center of Medical Center Health Clinic
Vinnytsia, Vinnytsia Oblast, 21009
Municipal Nonprofit Enterprise "Vinnytsia Regional Clinical Hospital n.a. M. I. Pyrohov of Vinnytsia Regio -T
Vinnytsia, Vinnytsia Oblast, 21018
VNMU
Vinnytsia, Vinnytsia Oblast, 21018
Communal Non-profit Enterprise "City Hospital #6" of Zaporizhzhia City Council
Zaporizhia, Zaporizhzhia Oblast, 69035
Diacenter
Zaporizhzhya, Zaporizhzhia Oblast, 69076
Russia18 sites
Poliklinika Agmu "Konsul'tativno-Diagnosticheskiy Tsentr"
Barnaul, Altayskiy Kray, 656038
Scientific Centre of Reconstructive and Restorative Surgery
Irkutsk, Irkutsk Oblast, 664079
SIH Kemerovo Regional Clinical Hosptial
Kemerovo, Kemerovo Oblast, 620109
Olla-Med
Moscow, Moscow, 105554
Nizhny Novgorod Regional Hospital N.A. Semashko
Nizhny Novgorod, Nizhny Novgorod Oblast, 603126
LLC "Medicine Center SibNovoMed"
Novosibirsk, Novosibirsk Oblast, 630005
Research Institute of Physiology and Fundamental Medicine
Novosibirsk, Novosibirsk Oblast, 630117
Clinic of Omsk State Medical University
Omsk, Omsk Oblast, 644050
Karelia Republican Hospital V.A. Baranova
Petrozavodsk, Kareliya, Respublika, 620109
Rostov State Medical University
Rostov-on-Don, Rostov Oblast, 344091
LLC Medical Center Reavita Med SPb
Saint Petersburg, Sankt-Peterburg, 194354
Balt Med Clinic
Saint Petersburg, Sankt-Peterburg, 194356
Saint-Petersburg City Hospital of Saint Elizabeth
Saint Petersburg, Sankt-Peterburg, 195257
Scientific research center ECO-security
Saint Petersburg, Sankt-Peterburg, 196143
First Pavlov State Medical University of Saint Petersburg
Saint Petersburg, Sankt-Peterburg, 197022
Saint Petersburg State Budgetary Healthcare Institution City Clinical Hospital No.31
Saint Petersburg, Sankt-Peterburg, 197110
NonState Healthcare Institution Central Clinical Hospital
Samara, Samara Oblast, 443029
LLC MA New Hospital
Yekaterinburg, Sverdlovsk Oblast, 620109
Brazil17 sites
Hospital Felicio Rocho
Belo Horizonte, Minas Gerais, 30110-934
Faculdade de Medicina da UNESP
Botucatu, São Paulo, 18618-686
L2IP - Instituto de Pesquisas Clínicas
Brasília, Federal District, 70200-730
Chronos Pesquisa Clínica
Brasília, Federal District, 72145-450
Centro de Pesquisa Sao Lucas
Campinas, São Paulo, 13034-685
Fundação Universidade de Caxias do Sul (FUCS)
Caxias do Sul, Rio Grande do Sul, 95070-560
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903
Núcleo de Pesquisa Clínica do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90430-001
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, 90560-030
CLIAGEN Clínica de Atenção em Gastroenterologia, Especialidades e Nutrição
Salvador, Estado de Bahia, 41500-300
Pesquisare Saude
Santo André, São Paulo, 09080-110
Praxis Pesquisa Medica
Santo André, São Paulo, 09790790
Centro Multidisciplinar de Estudos Clinicos
São Bernardo do Campo, São Paulo, 09715-090
CPQuali Pesquisa Clínica
São Paulo, São Paulo, 01228-000
Hospital Sírio Libanês
São Paulo, São Paulo, 01308-060
Instituto de Assistência Médica ao Servidor Público Estadual - IAMSPE/HSPE-FMO Conhecer Centro de Oncolog -T
São Paulo, São Paulo, 04038-034
Clínica Hepatogastro JK
São Paulo, São Paulo, 04543-011
South Korea16 sites
Korea University Ansan Hospital
Ansan-si, Kyǒnggi-do, 15355
Dong-A University Hospital
Busan, Pusan-Kwangyǒkshi, 49201
Keimyung University Dongsan Hospital
Daegu, Taegu-Kwangyǒkshi, 42601
The Catholic University of Korea, Daejeon St. Mary's Hospital
Daejeon, Taejǒn-Kwangyǒkshi, 34943
Kyungpook National University Chilgok Hospital
Deagu, Taegu-Kwangyǒkshi, 41404
Chungang University Hospital
Dongjak-gu, Seoul-teukbyeolsi [Seoul], 6973
Hanyang University Guri Hospital
Guri-si, Kyǒnggi-do, 11923
Yeungnam Univeristy Medical Center
Gyeongsan-si, Kyǒngsangbuk-do, 42415
Inje University Haeundae Paik Hospital
Haeundae-gu, Pusan-Kwangyǒkshi, 48108
Kyungpook National University Hospital
Junggu, Taegu-Kwangyǒkshi, 41944
Kyung Hee University Hospital
Seoul, Seoul-teukbyeolsi [Seoul], 02447
Asan Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], 05505
Kangbuk Samsung Hospital
Seoul, Seoul-teukbyeolsi [Seoul], 3181
The Catholic Univ. of Korea Seoul St. Mary's Hospital
Seoul, Seoul-teukbyeolsi [Seoul], 6591
Ajou University Hospital
Suwon, Kyǒnggi-do, 16499
Yonsei University-Wonju Severance Christian Hospital
Wŏnju, Kang-won-do, 26426
Czechia15 sites
Vojenská Nemocnice Brno
Brno, Brno-město, 636 00
Fakultni Nemocnice u sv. Anny v Brne
Brno, Brno-město, 656 91
Hepato-Gastroenterologie HK
Hradec Králové, Hradec Králové, 500 12
Oblastni nemocnice Nachod
Náchod, Náchod, 547 69
MUDr. Gregar, s.r.o.
Olomouc, Olomouc Region, 779 00
PreventaMed
Olomouc, Olomouc, 779 00
MUDr. Radka Koskova, s.r.o.
Ostrava, Ostrava město, 712 00
Synexus Czech
Prague, Praha 2, 120 00
Institut Klinicke a Experimentalni Mediciny
Prague, Praha 4, 140 21
Fakultni Thomayerova nemocnice
Prague, Praha 4, 14059
AXON Clinical
Prague, Praha 5, 150 00
Fakultni nemocnice Motol
Prague, Praha 5, 150 06
ISCARE klinické centrum
Prague, Praha 9, 19000
Masarykova Nemocnice V Usti Nad Labem
Ústí nad Labem, Ústí Nad Labem, 40113
Nemocnice Tomase Bati ve Zline
Zlín, Zlín, 762 75
Turkey (Türkiye)14 sites
Ankara City Hospital
Ankara, Ankara, 06230
Hacettepe Universite Hastaneleri
Ankara, Ankara, 6230
Gazi University Health Research and Application Center Gazi Hospital
Ankara, Ankara, 6560
Mustafa Kemal Universitesi
Antakya, Hatay, 31001
Antalya Egitim ve Arastırma Hastanesi
Antalya, Antalya, 7100
Dokuz Eylül Üniversitesi
Balçova, İzmir, 35340
Uludag Universitesi
Bursa, Bursa, 16059
Trakya University
Edirne, Edirne, 22030
Eskisehir Osmangazi University
Eskişehir, Eskişehir, 26480
Medicana Kadiköy Hastanesi
Istanbul, Istanbul, 34724
Acbadem Kozyatagi Hospital
Istanbul, Istanbul, 34734
Istanbul Universitesi Cerrahpasa
Istanbul- Fatih, Istanbul, 34098
Kocaeli University Medical Faculty Hospital
İzmit, Kocaeli, 41380
Mersin University
Mersin, Mersin, 33343
Germany12 sites
Knappschaftskrankenhaus Bottrop
Bottrop, North Rhine-Westphalia, 52074
Synexus Clinical Research GmbH
Frankfurt am Main, Hesse, 60313
Studiengesellschaft BSF Unternehmergesellschaft
Halle, Saxony-Anhalt, 06108
Medizinische Hochschule Hannover
Hanover, Lower Saxony, 30625
Allgemeine Innere Medizin I
Kiel, Schleswig-Holstein, 24105
Siteworks GmbH - Lauterbach
Lauterbach, Hesse, 36341
Synexus Leipzig Clinical Research Centre
Leipzig, Saxony, 4103
Tumorzentrum Nordthüringen Medizinisches Versorgungszentrum
Nordhausen, Thuringia, 99734
RED-Institut GmbH
Oldenburg in Holstein, Schleswig-Holstein, 23758
Siloah St. Trudpert Klinikum
Pforzheim, Baden-Wurttemberg, 75179
Gemeinschaftspraxis Jakobeit
Wipperfürth, North Rhine-Westphalia, 51688
Universitaetsklinikum Wuerzburg
Würzburg, Bavaria, 97080
Hungary10 sites
DRC Gyógyszervizsgáló Központ
Balatonfüred, Veszprém megye, 8230
Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház
Békéscsaba, Békéscsaba, 5600
Clinexpert Kft.
Budapest, Budapest, 1033
SYNEXUS Magyarország Kft. Eü.
Budapest, Budapest, 1036
Pannónia Magánorvosi Centrum
Budapest, Budapest
Bugát Pál Kórház
Gyöngyös, Heves County
Synexus Magyarország Kft
Gyula, Bekes County, 5700
CLINFAN Szolgáltató Kft
Szekszárd, Tolna County, 7100
Szent Borbala Korhaz
Tatabánya, Komárom-Esztergom, 2800
Jávorszky Ödön Kórház
Vác, Pest County, 2600
India8 sites
Postgraduate Institute of Medical Education & Research
Chandigarh, Chandigarh, 160012
Apollo Speciality Hospital - Teynampet
Chennai, Tamil Nadu, 600035
SR Kalla Memorial Gastro & General Hospital
Jaipur, Rajasthan, 302001
Dayanand Medical College and Hospital
Ludhiana, Punjab, 141001
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, 110029
Sir Ganga Ram Hospital
New Delhi, National Capital Territory of Delhi, 110060
Grant Medical Foundation - Ruby Hall Clinic
Pune, Maharashtra, 411001
Gujarat Hospital - Gastro & Vascular Centre
Surat, Gujarat, 395009
Australia7 sites
Royal Adelaide Hospital
Adelaide, South Australia, 5000
Royal Brisbane and Women's Hospital
Brisbane, Queensland, 4029
Concord Repatriation General Hospital
Concord, New South Wales, 2139
Coastal Digestive Health
Maroochydore, Queensland, 4558
Fiona Stanley Hospital
Murdoch, Western Australia, 6150
The Royal Melbourne Hospital
Parkville, Victoria, 3050
St Vincent's Hospital
Sydney, New South Wales, 2010
Israel6 sites
Soroka Medical Center
Beersheba, Southern District, 8410101
Shaare Zedek Medical Center
Jerusalem, Jerusalem, 9778419
Galilee Medical Center
Nahariya, Northern District, 2210001
Sheba Medical Center
Ramat Gan, Central District, 5262100
Kaplan Medical Center
Rehovot, Central District, 7610001
Yitzhak Shamir Medical Center
Ẕerifin, Central District, 70300
Romania6 sites
Spitalul de Oncologie Monza
Bucharest, Bucharest, 013812
Delta Health Care
Bucharest, Bucharest, 014142
S.C. Centrul Medical Medicum SRL
Bucharest, Bucharest, 12015
Spitalul Clinic Colentina
Bucharest, Bucharest, 20125
Gastromed S.R.L.
Constanța, Constanța County, 900178
S.C Centrul de Gastroenterologie Dr. Goldis S.R.L
Timișoara, Timiș County, 300002
Canada5 sites
Gastroenterology and internal medicine research institute
Edmonton, Alberta, T5R 1W2
Private Practice - Dr. Bruce Musgrave
Kentville, Nova Scotia, B4N 0A3
Victoria Hospital
London, Ontario, N6A 4G5
Private Practice - Dr. Stephane M. Gauthier
North Bay, Ontario, P1B 2H3
GIRI GI Research Institute - Vancouver
Vancouver, British Columbia, V5Z 2K5
Slovakia5 sites
Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica
Banská Bystrica, Banská Bystrica Region, 97517
Cliniq s.r.o.
Bratislava, Bratislava Region, 81109
Gastromedic
Nové Zámky, Nitra Region, 940 81
Gastro LM
Prešov, Presov, 080 01
Endomed, s.r.o.
Vranov N. Toplou, Presov, 093 01
Belgium4 sites
Imelda General Hospital
Bonheiden, Antwerpen, 2930
Université Libre de Bruxelles - Hôpital Erasme
Brussels, Bruxelles-Capitale, Région de, 1070
UZ Gent
Ghent, Oost-Vlaanderen, 9000
UZ Leuven
Leuven, Vlaams-Brabant, 3000
Mexico4 sites
Scientia Investigacion Clinica S.C.
Chihuahua City, Chihuahua, 31207
Christus Muguerza Hospital Sur
Monterrey, Nuevo León, 64000
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, Nuevo León, 66460
Centro de Alta Especialidad en Reumatologia e Investigación del Potosi,S.C
San Luis Potosí City, San Luis Potosí, 78213
Austria3 sites
Medizinische Universitaet Innsbruck
Innsbruck, Tyrol, 6020
Uniklinikum Salzburg
Salzburg, State of Salzburg, 5020
Universitaetsklinikum Allgemeines Krankenhaus Wien
Vienna, State of Vienna, 1090
France3 sites
Chu Saint Eloi
Montpellier, Languedoc-Roussillon, 34295
Centre Hospitalier Universitaire de Poitiers
Poitiers, Vienne, 86021
Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54511
Italy3 sites
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, Lombardy, 20122
IRCCS Policlinico San Donato
Milan, Milano, 20097
Ospedale Di Circolo
Rho, Milano, 20017
Serbia3 sites
Clinical Hospital Center Zvezdara
Belgrade, Beograd, 11000
University Medical Center "Bezanijska kosa"
Belgrade, Beograd, 11080
General Hospital "Djordje Joanovic"
Zrenjanin, Vojvodina, 23000
Switzerland3 sites
Inselspital Bern
Bern, Canton of Bern, 3010
Gastroenterologische Praxis Balsiger, Seibold & Partner
Bern, Canton of Bern, 3012
Cantonal Hospital St.Gallen
Sankt Gallen, Canton of St. Gallen, 9007
United Kingdom3 sites
Addenbrooke's Hospital
Cambridge, Cambridgeshire, CB2 2QQ
Synexus Wales Clinical Research Centre
Cardiff, CF15 9SS
Whipps Cross University Hospital
London, England, E11 1NR
Croatia2 sites
Klinički bolnički centar Osijek
Osijek, 31000
Klinički bolnički centar Zagreb
Zagreb, City of Zagreb, 10000
Netherlands2 sites
Amsterdam UMC, locatie VUmc
Amsterdam, North Holland, 1081 HZ
Elisabeth-TweeSteden Ziekenhuis
Tilburg, North Brabant, 5022 GC
Argentina1 site
DOM Centro de Reumatología
Buenos Aires, Buenos Aires F.D., C1111
Denmark1 site
Gastroenterologische Praxis Balsiger, Seibold & Partner
Aalborg, North Denmark, 9000
Lithuania1 site
Hospital of Lithuanian University of Health Sciences Kaunas
Kaunas, Kaunas County, 50009
About this study
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
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.
- Conditions
- Crohn's Disease
- Being tested
- Mirikizumab
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MirikizumabDrug
Also called LY3074828
Administered Q4W
| Study group | Role | What they receive |
|---|---|---|
| AMAM Mirikizumab (Miri): Miri 300 mg SC | Experimental | Participants assigned to mirikizumab in Study AMAM who achieved Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 300 milligrams (mg) subcutaneously (SC) every 4 weeks (Q4W) for 52 weeks. Receives: Drug: Mirikizumab |
| AMAM Miri: Miri 900 mg IV Then 300 mg SC | Experimental | Participants assigned to mirikizumab in Study AMAM who did not achieve Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 900 mg intravenously (IV) Q4W for 3 doses, followed by mirikizumab 300 mg SC Q4W for 52 weeks. Receives: Drug: Mirikizumab |
| AMAM Placebo (PBO)/Miri: Miri 300 mg SC | Experimental | Participants assigned to placebo in Study AMAM who switched from placebo to mirikizumab at week 12 and achieved Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 300 mg SC Q4W for 52 weeks. Receives: Drug: Mirikizumab |
| AMAM PBO/Miri: Miri 900 mg IV Then 300 mg SC | Experimental | Participants assigned to placebo in Study AMAM who switched from placebo to mirikizumab at week 12 and did not achieve Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 900 mg IV Q4W for 3 doses, followed by mirikizumab 300 mg SC Q4W for 52 weeks. Receives: Drug: Mirikizumab |
| AMAM Ustekinumab (Uste): Miri 300 mg SC | Experimental | Participants assigned to ustekinumab in Study AMAM who achieved Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 300 mg SC Q4W for 52 weeks. Receives: Drug: Mirikizumab |
| AMAM Uste: Miri 900 mg IV Then 300 mg SC | Experimental | Participants assigned to ustekinumab in Study AMAM who did not achieve Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 900 mg IV Q4W for 3 doses, followed by mirikizumab 300 mg SC Q4W for 52 weeks. Receives: Drug: Mirikizumab |
| AMAM PBO: Miri 300 mg SC | Experimental | Participants assigned to placebo in Study AMAM who achieved Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 300 mg SC Q4W for 52 weeks. Receives: Drug: Mirikizumab |
| AMAM PBO: Miri 900 mg IV Then 300 mg SC | Experimental | Participants assigned to placebo in Study AMAM who did not achieve Endoscopic Response at Week 52 of AMAM continued into Study AMAX and received mirikizumab 900 mg IV Q4W for 3 doses, followed by mirikizumab 300 mg SC Q4W for 52 weeks. Receives: Drug: Mirikizumab |
| All AMAG Participants: Miri 300 mg SC | Experimental | Participants from Study AMAG who continued into Study AMAX received mirikizumab 300 mg SC Q4W for 52 weeks. Receives: Drug: Mirikizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving Endoscopic Response at Week 52 (Participants Originating From AMAM Study)
Endoscopic Response defined as ≥50% reduction from AMAM study baseline in Simple Endoscopic Score for Crohn's Disease (SES-CD) total score. The SES-CD evaluates 4 endoscopic variables (presence/size of ulcers, extent of ulcerated surface, extent of affected surface, and presence/severity of stenosis) across 5 ileocolonic bowel segments (ileum, right colon, transverse colon, left colon, and rectum), with each of the 4 variables scored from 0 (best) to 3 (worst) per segment, resulting in 20 individual assessments. Total SES-CD score is the sum of all 20 individual assessment scores across all the bowel segments. Scores range from 0 to 56, with higher scores indicating more severe disease.
Measured: Week 52
Percentage of Participants Achieving Clinical Remission at Week 52 (Participants Originating From AMAM Study)
Clinical remission was defined as a Crohn's Disease Activity Index (CDAI) total score < (less than) 150. The CDAI measures the severity of active disease using 8 disease variables: stool frequency, severity of abdominal pain, degree of general well-being, presence or absence of extra-intestinal manifestations, presence or absence of fistula, use or non-use of antidiarrheal agents, presence or absence of an abdominal mass, hematocrit, and body weight. Each variable is assigned a specific weight/multiplier, and the weighted values are summed to produce a CDAI total score. CDAI total scores can range from 0 to 600, with higher scores indicating more severe disease.
Measured: Week 52
Secondary outcomes (5)
Percentage of Participants Achieving Alternate Endoscopic Remission at Week 52 (Participants Originating From AMAM Study)
Alternate endoscopic remission is defined as SES-CD Total Score ≤4 with at least a 2-point reduction from the AMAM study baseline and no subscore >1. The SES-CD evaluates 4 endoscopic variables (presence/size of ulcers, extent of ulcerated surface, extent of affected surface, and presence/severity of stenosis) across 5 ileocolonic bowel segments (ileum, right colon, transverse colon, left colon, and rectum), with each of the 4 variables scored from 0 (best) to 3 (worst) per segment, resulting in 20 individual assessments. Total SES-CD score is the sum of all 20 individual assessment scores across all the bowel segments. Scores range from 0 to 56, with higher scores indicating more severe disease. No subscore >1 is defined as no individual assessment score >1 across all 20 individual assessments.
Measured: Week 52
Percentage of Participants Achieving Clinical Response by Patient Reported Outcome (PRO) at Week 52 - (Participants Originating From AMAM Study)
Clinical response by Patient Reported Outcome (PRO) was defined as a ≥30% decrease from baseline in stool frequency (SF) and/or abdominal pain (AP) score, with neither symptom worsening from baseline. SF was measured as the number of liquid or very soft stools per day. AP was scored daily on a 4-point scale: 0 = none, 1 = mild, 2 = moderate, and 3 = severe.
Measured: Week 52
Fecal Calprotectin at Week 12 (Participants Originating From AMAM Study)
Fecal calprotectin is an indicator of inflammation in the intestines with higher levels indicative of higher levels of inflammation.
Measured: Week 12
C-Reactive Protein (CRP) at Week 12 (Participants Originating From AMAM Study)
C-Reactive Protein is a biomarker of systemic inflammation measured in the blood, with elevated levels indicating increased inflammatory activity in the body.
Measured: Week 12
Change From Baseline in Health Related Quality of Life at Week 52 : Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score (Participants Originating From AMAM Study)
The Inflammatory Bowel Disease Questionnaire (IBDQ) is a 32-item participant completed questionnaire that measures 4 aspects of patients' lives: symptoms directly related to the primary bowel disturbance (10 items), systemic symptoms (5 items), emotional function (12 items), and social function(5 items). 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. Total scores range from 32 to 224; a higher score indicates a better quality of life.
Measured: Baseline, Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start22 Jun 2020
- Primary completion28 Nov 2024
- Study completionMar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 996 participants (actual)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04232553
- Sponsor's protocol ID
- 16628
- Other IDs
- I6T-MC-AMAX, 2022-502841-91-00, 2019-002687-27, 2019
- Acronym
- VIVID-2
- Status last verified
- Nov 2025
- First submitted
- 15 Jan 2020
- Last updated
- 11 Aug 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Sands BE, Barnes EL, D'Haens G, Hisamatsu T, Regueiro M, Kelly CR, Laharie D, Hozak RR, Yu G, Gandhi R A, Lopes MU, Durand F, Protic M, Moses RE, Vermeire S. Mirikizumab Long-Term Efficacy and Safety in Patients With Crohn's Disease: Results From the VIVID-2 Open-Label Extension Trial. Clin Gastroenterol Hepatol. 2026 Sep;24(9):2512-2523. doi: 10.1016/j.cgh.2026.01.049. Epub 2026 Mar 5.
PubMed 41794217