A Long-term Extension Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease
VIVID-2
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
4 other identifiers
interventional
996
31 countries
319
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jun 2020
Longer than P75 for phase_3
319 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 15, 2020
CompletedFirst Posted
Study publicly available on registry
January 18, 2020
CompletedStudy Start
First participant enrolled
June 22, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 28, 2024
CompletedResults Posted
Study results publicly available
December 15, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2027
ExpectedDecember 15, 2025
November 1, 2025
4.4 years
January 15, 2020
November 27, 2025
November 27, 2025
Conditions
Outcome Measures
Primary Outcomes (2)
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.
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.
Week 52
Secondary Outcomes (5)
Percentage of Participants Achieving Alternate Endoscopic Remission at Week 52 (Participants Originating From AMAM Study)
Week 52
Percentage of Participants Achieving Clinical Response by Patient Reported Outcome (PRO) at Week 52 - (Participants Originating From AMAM Study)
Week 52
Fecal Calprotectin at Week 12 (Participants Originating From AMAM Study)
Week 12
C-Reactive Protein (CRP) at Week 12 (Participants Originating From AMAM Study)
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)
Baseline, Week 52
Study Arms (9)
AMAM Mirikizumab (Miri): Miri 300 mg SC
EXPERIMENTALParticipants 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.
AMAM Miri: Miri 900 mg IV Then 300 mg SC
EXPERIMENTALParticipants 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.
AMAM Placebo (PBO)/Miri: Miri 300 mg SC
EXPERIMENTALParticipants 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.
AMAM PBO/Miri: Miri 900 mg IV Then 300 mg SC
EXPERIMENTALParticipants 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.
AMAM Ustekinumab (Uste): Miri 300 mg SC
EXPERIMENTALParticipants 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.
AMAM Uste: Miri 900 mg IV Then 300 mg SC
EXPERIMENTALParticipants 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.
AMAM PBO: Miri 300 mg SC
EXPERIMENTALParticipants 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.
AMAM PBO: Miri 900 mg IV Then 300 mg SC
EXPERIMENTALParticipants 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.
All AMAG Participants: Miri 300 mg SC
EXPERIMENTALParticipants from Study AMAG who continued into Study AMAX received mirikizumab 300 mg SC Q4W for 52 weeks.
Interventions
Administered Q4W
Eligibility Criteria
You may qualify if:
- Participants must have completed study I6T-MC-AMAG (NCT02891226) or study I6T-MC-AMAM (NCT03926130)
- If female, participant must meet the contraception requirements
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (322)
Digestive Health Specialists
Dothan, Alabama, 36305, United States
Research Solutions of Arizona
Litchfield Park, Arizona, 85340, United States
Arizona Arthritis & Rheumatology Research, PLLC
Phoenix, Arizona, 85037, United States
Care Access - Gilroy
Gilroy, California, 95020, United States
Newport Huntington Medical Group
Huntington Beach, California, 92648, United States
California Medical Research Associates
Northridge, California, 91324, United States
Connecticut Clinical Research Institute
Bristol, Connecticut, 06010, United States
Gastroenterology Consultants of Clearwater
Clearwater, Florida, 33756, United States
Clinical Research of West Florida, Inc. (Clearwater)
Clearwater, Florida, 33765, United States
IHS Health Research
Kissimmee, Florida, 34741, United States
Ezy Medical Research
Miami, Florida, 33175, United States
Care Access - Orlando
Orlando, Florida, 32825, United States
Gastroenterology Associates of Pensacola, PA
Pensacola, Florida, 32503, United States
Precision Clinical Research
Sunrise, Florida, 33351, United States
USF Health
Tampa, Florida, 33612, United States
Alliance Clinical Research of Tampa
Tampa, Florida, 33615, United States
Digestive Healthcare of Georgia
Atlanta, Georgia, 30327, United States
Gastrointestinal Specialists of Georgia
Marietta, Georgia, 30060, United States
Grand Teton Research Group
Idaho Falls, Idaho, 83404, United States
Qualmedica Research, LLC
Evansville, Indiana, 47715, United States
Indiana University Health University Hospital
Indianapolis, Indiana, 46202, United States
Delta Research Partners
Monroe, Louisiana, 71201, United States
Capital Digestive Care - Chevy Chase
Chevy Chase, Maryland, 20815, United States
Woodholme Gastroenterology Associates - Glen Burnie
Glen Burnie, Maryland, 21061, United States
The Digestive Health Center of Michigan (DHCMI)
Chesterfield, Michigan, 48047, United States
Revive Research Institute, Inc.
Farmington Hills, Michigan, 48334, United States
MNGI Digestive Health - Plymouth Endoscopy Center & Clinic
Plymouth, Minnesota, 55446, United States
Washington University Medical School
St Louis, Missouri, 63110, United States
Care Access - Las Vegas
Las Vegas, Nevada, 89148, United States
Holy Name Medical Center
Teaneck, New Jersey, 07666, United States
Clinical & Translational Research Center (CTRC)
Chapel Hill, North Carolina, 27599-7080, United States
Carolina Digestive Diseases and Endoscopy Center
Greenville, North Carolina, 27834, United States
Care Access - Kinston
Kinston, North Carolina, 28501, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Ohio Gastroenterology
Columbus, Ohio, 43202, United States
Ohio State University
Hilliard, Ohio, 43026, United States
North Shore Gastroenterology & Endoscopy Centers
Westlake, Ohio, 44145, United States
The University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104-5008, United States
University Gastroenterology
Providence, Rhode Island, 02905, United States
Gastroenterology Associates of Orangeburg
Orangeburg, South Carolina, 29118, United States
Gastroenterology Center Of The Midsouth
Cordova, Tennessee, 38018, United States
First Surgical Hospital
Bellaire, Texas, 77401, United States
Baylor College of Medicine Medical Center
Houston, Texas, 77030, United States
West Texas Digestive Disease
Lubbock, Texas, 79424, United States
Southern Star Research Institute
San Antonio, Texas, 78229, United States
Tyler Research Institute
Tyler, Texas, 75701, United States
Care Access - Ogden
Ogden, Utah, 84403, United States
Care Access - Salt Lake City
Salt Lake City, Utah, 84124, United States
University of Virginia Health System
Charlottesville, Virginia, 22908, United States
Clinical Research Partners, LLC
Richmond, Virginia, 23226, United States
Tidewater Physicians Multispecialty Group Clinical Research
Williamsburg, Virginia, 23188, United States
Washington Gastroenterology - Bellevue
Bellevue, Washington, 98004, United States
Virginia Mason Medical Center
Seattle, Washington, 98101, United States
Washington Gastroenterology - Tacoma
Tacoma, Washington, 98405, United States
DOM Centro de Reumatología
Buenos Aires, C1111, Argentina
Concord Repatriation General Hospital
Concord, New South Wales, 2139, Australia
St Vincent's Hospital
Sydney, New South Wales, 2010, Australia
Royal Brisbane and Women's Hospital
Brisbane, Queensland, 4029, Australia
Coastal Digestive Health
Maroochydore, Queensland, 4558, Australia
Royal Adelaide Hospital
Adelaide, South Australia, 5000, Australia
The Royal Melbourne Hospital
Parkville, Victoria, 3050, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, 6150, Australia
Medizinische Universitaet Innsbruck
Innsbruck, Tyrol, 6020, Austria
Universitaetsklinikum Allgemeines Krankenhaus Wien
Vienna, Vienna, 1090, Austria
Uniklinikum Salzburg
Salzburg, 5020, Austria
Imelda General Hospital
Bonheiden, Antwerpen, 2930, Belgium
Université Libre de Bruxelles - Hôpital Erasme
Brussels, Bruxelles-Capitale, Région de, 1070, Belgium
UZ Gent
Ghent, Oost-Vlaanderen, 9000, Belgium
UZ Leuven
Leuven, Vlaams-Brabant, 3000, Belgium
CLIAGEN Clínica de Atenção em Gastroenterologia, Especialidades e Nutrição
Salvador, Estado de Bahia, 41500-300, Brazil
L2IP - Instituto de Pesquisas Clínicas
Brasília, Federal District, 70200-730, Brazil
Chronos Pesquisa Clínica
Brasília, Federal District, 72145-450, Brazil
Hospital Felicio Rocho
Belo Horizonte, Minas Gerais, 30110-934, Brazil
Fundação Universidade de Caxias do Sul (FUCS)
Caxias do Sul, Rio Grande do Sul, 95070-560, Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
Núcleo de Pesquisa Clínica do Rio Grande do Sul
Porto Alegre, Rio Grande do Sul, 90430-001, Brazil
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, 90560-030, Brazil
Faculdade de Medicina da UNESP
Botucatu, São Paulo, 18618-686, Brazil
Centro de Pesquisa Sao Lucas
Campinas, São Paulo, 13034-685, Brazil
Pesquisare Saude
Santo André, São Paulo, 09080-110, Brazil
Praxis Pesquisa Medica
Santo André, São Paulo, 09790790, Brazil
Centro Multidisciplinar de Estudos Clinicos
São Bernardo do Campo, São Paulo, 09715-090, Brazil
Hospital Sírio Libanês
São Paulo, São Paulo, 01308-060, Brazil
CPQuali Pesquisa Clínica
São Paulo, 01228-000, Brazil
Instituto de Assistência Médica ao Servidor Público Estadual - IAMSPE/HSPE-FMO Conhecer Centro de Oncolog -T
São Paulo, 04038-034, Brazil
Clínica Hepatogastro JK
São Paulo, 04543-011, Brazil
Gastroenterology and internal medicine research institute
Edmonton, Alberta, T5R 1W2, Canada
GIRI GI Research Institute - Vancouver
Vancouver, British Columbia, V5Z 2K5, Canada
Private Practice - Dr. Bruce Musgrave
Kentville, Nova Scotia, B4N 0A3, Canada
Victoria Hospital
London, Ontario, N6A 4G5, Canada
Private Practice - Dr. Stephane M. Gauthier
North Bay, Ontario, P1B 2H3, Canada
Anhui Provincial Hospital
Hefei, Anhui, 230071, China
Chongqing General Hospital
Chongqing, Chongqing Municipality, 400014, China
Zhongshan Hospital Affiliated to Xiamen University
Xiamen, Fujian, 350001, China
The First People's Hospital of Foshan
Foshan, Guangdong, 528041, China
The Sixth Affiliated Hospital of Sun Yat-sen University
Guangzhou, Guangdong, 510655, China
The First Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
Tongji Hospital Tongji Medical,Science & Technology
Wuhan, Hubei, 430030, China
Xiangya Hospital Central South University
Changsha, Hunan, 410008, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011, China
The Third Xiangya Hospital of Central South University
Changsha, Hunan, 410013, China
The First People's Hospital of Changzhou
Changzhou, Jiangsu, 213003, China
Changzhou No.2 People's Hospital
Changzhou, Jiangsu, 213004, China
Jiangsu Province Hospital of Chinese Medicine
Nanjing, Jiangsu, 210029, China
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215004, China
Wuxi People's Hospital
Wuxi, Jiangsu, 214023, China
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, 212000, China
The First Affiliated Hospital of Nanchang University
Nanchang, Jiangxi, 330006, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110004, China
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, China
West China Hospital, Sichuan University
Chengdu, Sichuan, 610041, China
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650032, China
The First Affiliated Hospital, Zhejiang University
Hangzhou, Zhejiang, 310003, China
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, 310016, China
The Second Affiliated hospital of Zhejiang University school of medicine
Hangzhou, Zhejiang, 310052, China
The Second Affiliated Hospital YuYing Childens Hospital of Wenzhou Medical university
Wenzhou, Zhejiang, 325000, China
The First Affiliated Hospital Of Fujian Medical University
Fuzhou, 350005, China
Klinički bolnički centar Zagreb
Zagreb, City of Zagreb, 10000, Croatia
Klinički bolnički centar Osijek
Osijek, 31000, Croatia
Vojenská Nemocnice Brno
Brno, Brno-město, 636 00, Czechia
Fakultni Nemocnice u sv. Anny v Brne
Brno, Brno-město, 656 91, Czechia
Hepato-Gastroenterologie HK
Hradec Králové, Hradec Králové, 500 12, Czechia
Oblastni nemocnice Nachod
Náchod, Náchod, 547 69, Czechia
MUDr. Gregar, s.r.o.
Olomouc, Olomoucký kraj, 779 00, Czechia
MUDr. Radka Koskova, s.r.o.
Ostrava, Ostrava Město, 712 00, Czechia
Synexus Czech
Prague, Praha 2, 120 00, Czechia
Institut Klinicke a Experimentalni Mediciny
Prague, Praha 4, 140 21, Czechia
Fakultni Thomayerova nemocnice
Prague, Praha 4, 14059, Czechia
AXON Clinical
Prague, Praha 5, 150 00, Czechia
Fakultni nemocnice Motol
Prague, Praha 5, 150 06, Czechia
ISCARE klinické centrum
Prague, Praha 9, 19000, Czechia
Nemocnice Tomase Bati ve Zline
Zlín, Zlín, 762 75, Czechia
PreventaMed
Olomouc, 779 00, Czechia
Masarykova Nemocnice V Usti Nad Labem
Ústí nad Labem, Ústí Nad Labem, 40113, Czechia
Gastroenterologische Praxis Balsiger, Seibold & Partner
Aalborg, North Denmark, 9000, Denmark
Chu Saint Eloi
Montpellier, Languedoc-Roussillon, 34295, France
Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54511, France
Centre Hospitalier Universitaire de Poitiers
Poitiers, Vienne, 86021, France
Siloah St. Trudpert Klinikum
Pforzheim, Baden-Wurttemberg, 75179, Germany
Universitaetsklinikum Wuerzburg
Würzburg, Bavaria, 97080, Germany
Synexus Clinical Research GmbH
Frankfurt am Main, Hesse, 60313, Germany
Siteworks GmbH - Lauterbach
Lauterbach, Hesse, 36341, Germany
Medizinische Hochschule Hannover
Hanover, Lower Saxony, 30625, Germany
Knappschaftskrankenhaus Bottrop
Bottrop, North Rhine-Westphalia, 52074, Germany
Gemeinschaftspraxis Jakobeit
Wipperfürth, North Rhine-Westphalia, 51688, Germany
Synexus Leipzig Clinical Research Centre
Leipzig, Saxony, 4103, Germany
Studiengesellschaft BSF Unternehmergesellschaft
Halle, Saxony-Anhalt, 06108, Germany
Allgemeine Innere Medizin I
Kiel, Schleswig-Holstein, 24105, Germany
RED-Institut GmbH
Oldenburg in Holstein, Schleswig-Holstein, 23758, Germany
Tumorzentrum Nordthüringen Medizinisches Versorgungszentrum
Nordhausen, Thuringia, 99734, Germany
Synexus Magyarország Kft
Gyula, Bekes County, 5700, Hungary
Bugát Pál Kórház
Gyöngyös, Heves County, Hungary
Szent Borbala Korhaz
Tatabánya, Komárom-Esztergom, 2800, Hungary
Jávorszky Ödön Kórház
Vác, Pest County, 2600, Hungary
CLINFAN Szolgáltató Kft
Szekszárd, Tolna County, 7100, Hungary
DRC Gyógyszervizsgáló Központ
Balatonfüred, Veszprém megye, 8230, Hungary
Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház
Békéscsaba, 5600, Hungary
Clinexpert Kft.
Budapest, 1033, Hungary
SYNEXUS Magyarország Kft. Eü.
Budapest, 1036, Hungary
Pannónia Magánorvosi Centrum
Budapest, Hungary
Gujarat Hospital - Gastro & Vascular Centre
Surat, Gujarat, 395009, India
Grant Medical Foundation - Ruby Hall Clinic
Pune, Maharashtra, 411001, India
All India Institute of Medical Sciences
New Delhi, National Capital Territory of Delhi, 110029, India
Sir Ganga Ram Hospital
New Delhi, National Capital Territory of Delhi, 110060, India
Dayanand Medical College and Hospital
Ludhiana, Punjab, 141001, India
SR Kalla Memorial Gastro & General Hospital
Jaipur, Rajasthan, 302001, India
Apollo Speciality Hospital - Teynampet
Chennai, Tamil Nadu, 600035, India
Postgraduate Institute of Medical Education & Research
Chandigarh, 160012, India
Sheba Medical Center
Ramat Gan, Central District, 5262100, Israel
Kaplan Medical Center
Rehovot, Central District, 7610001, Israel
Yitzhak Shamir Medical Center
Ẕerifin, Central District, 70300, Israel
Shaare Zedek Medical Center
Jerusalem, Jerusalem, 9778419, Israel
Galilee Medical Center
Nahariya, Northern District, 2210001, Israel
Soroka Medical Center
Beersheba, Southern District, 8410101, Israel
Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico
Milan, Lombardy, 20122, Italy
IRCCS Policlinico San Donato
Milan, Milano, 20097, Italy
Ospedale Di Circolo
Rho, Milano, 20017, Italy
National Hospital Organization Hirosaki General Medical Center
Hirosaki, Aomori, 036-8545, Japan
Tsujinaka Hospital - Kashiwanoha
Kashiwa, Chiba, 277-0871, Japan
Kitakyushu Municipal Medical Center
Kitakyusyu-shi, Fukoka, 802-0077, Japan
Fukuoka University Chikushi Hospital
Chikushino-shi, Fukuoka, 818-0067, Japan
Kiryu Kosei General Hospital
Kiryū, Gunma, 376-0024, Japan
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
Chuo-ku, Sapporo-shi, Hokkaido, 060-0033, Japan
Tokushukai Sapporo Tokushukai Hospital
Sapporo, Hokkaido, 004 0041, Japan
Sapporo Medical University Hospital
Sapporo, Hokkaido, 060-8543, Japan
Sapporo Higashi Tokushukai Hospital
Sapporo, Hokkaido, 065-0033, Japan
Hyogo College of Medicine
Nishinomiya, Hyōgo, 663-8501, Japan
Ibaraki Prefectural Central Hospital
Kasama, Ibaraki, 890-8520, Japan
Ofuna Central Hospital
Kamakura, Kanagawa, 247-0056, Japan
Mie University Hospital
Tsu, Mie-ken, 514-8507, Japan
Takagi Clinic - Sendai
Sendai, Miyagi, 981-3213, Japan
Matsuda Hospital
Hamamatsu, Shizuoka, 432-8061, Japan
Institute of Science Tokyo Hospital
Bunkyo, Tokyo, 113-8519, Japan
Kyorin University Hospital
Mitaka, Tokyo, 181-8611, Japan
Center Hospital of the National Center for Global Health and Medicine
Shinjyuku-ku, Tokyo, 162-8655, Japan
Fukuoka University Hospital
Fukuoka, 814-0180, Japan
Kagoshima University Hospital
Kagoshima, 890-8520, Japan
Sameshima Hospital
Kagoshima, 892-0846, Japan
Kumamoto University Hospital
Kumamoto, 860-8556, Japan
University Hospital,Kyoto Prefectural University of Medicine
Kyoto, 602-8566, Japan
Okayama Saiseikai Outpatient Center Hospital
Okayama, 700-0013, Japan
Tokyo Yamate Medical Center
Tokyo, 169-0073, Japan
Toyama Prefectural Central Hospital
Toyama, 930-0975, Japan
Pauls Stradins Clinical Univeristy Hospital
Riga, Rīga, LV-1002, Latvia
Hospital of Lithuanian University of Health Sciences Kaunas
Kaunas, 50009, Lithuania
Christus Muguerza Hospital Sur
Monterrey, Nuevo León, 64000, Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, Nuevo León, 66460, Mexico
Centro de Alta Especialidad en Reumatologia e Investigación del Potosi,S.C
San Luis Potosí City, San Luis Potosí, 78213, Mexico
Scientia Investigacion Clinica S.C.
Chihuahua City, 31207, Mexico
Elisabeth-TweeSteden Ziekenhuis
Tilburg, North Brabant, 5022 GC, Netherlands
Amsterdam UMC, locatie VUmc
Amsterdam, North Holland, 1081 HZ, Netherlands
Synexus Polska Sp. z o.o. Oddzial w Poznaniu
Poznan, Greater Poland Voivodeship, 60-702, Poland
Centrum Medyczne "Medis" Manermed
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-229, Poland
Topolowa Medicenter
Krakow, Lesser Poland Voivodeship, 31-506, Poland
NZOZ Formed
Wadowice, Lesser Poland Voivodeship, 34-100, Poland
Dc-Med
Swidnica, Lower Silesian Voivodeship, 58-100, Poland
Melita Medical
Wroclaw, Lower Silesian Voivodeship, 50-449, Poland
Reumatop
Wroclaw, Lower Silesian Voivodeship, 52-210, Poland
Synexus - Wroclaw
Wroclaw, Lower Silesian Voivodeship, 58-100, Poland
ZOZ Gastromed
Lublin, Lublin Voivodeship, 20-582, Poland
ETG Zamość
Zamość, Lublin Voivodeship, 22-400, Poland
Centrum Zdrowia MDM
Warsaw, Masovian Voivodeship, 00-189, Poland
WIP Warsaw IBD Point Profesor Kierkus
Warsaw, Masovian Voivodeship, 04-501, Poland
Private Practice - Dr. Korczowski Bartosz
Rzeszów, Podkarpackie Voivodeship, 35-302, Poland
Centrum Medyczne MEDYK
Rzeszów, Podkarpackie Voivodeship, 35-326, Poland
Nova Reuma Domyslawska i Rusilowicz Spolka Partnerska Lekarza Reumatologa i Fizjoterapeuty
Bialystok, Podlaskie Voivodeship, 15-707, Poland
Synexus Polska Gdansku
Gdansk, Pomeranian Voivodeship, 80-382, Poland
Synexus Polska Sp. z o.o. Oddzial w Gdyni
Gdynia, Pomeranian Voivodeship, 81-537, Poland
Endoskopia Sp. z.o.o.
Sopot, Pomeranian Voivodeship, 81-756, Poland
Synexus Polska Sp. z o.o. Oddzial w Czestochowie
Częstochowa, Silesian Voivodeship, 42-202, Poland
Synexus Polska - Katowicach
Katowice, Silesian Voivodeship, 40-588, Poland
Kiepury Clinic
Sosnowiec, Silesian Voivodeship, 40-588, Poland
NZOZ TwojeZdrowie
Elblag, Warmian-Masurian Voivodeship, 82-300, Poland
Twoja Przychodnia - Szczecinskie Centrum Medyczne
Szczecin, West Pomeranian Voivodeship, 71-434, Poland
SONOMED Centrum Medyczne
Szczecin, West Pomeranian Voivodeship, 71-685, Poland
Spitalul de Oncologie Monza
Bucharest, București, 013812, Romania
Delta Health Care
Bucharest, București, 014142, Romania
S.C. Centrul Medical Medicum SRL
Bucharest, București, 12015, Romania
Spitalul Clinic Colentina
Bucharest, București, 20125, Romania
S.C Centrul de Gastroenterologie Dr. Goldis S.R.L
Timișoara, Timiș County, 300002, Romania
Gastromed S.R.L.
Constanța, 900178, Romania
Poliklinika Agmu "Konsul'tativno-Diagnosticheskiy Tsentr"
Barnaul, Altayskiy Kray, 656038, Russia
Scientific Centre of Reconstructive and Restorative Surgery
Irkutsk, Irkutsk Oblast, 664079, Russia
Karelia Republican Hospital V.A. Baranova
Petrozavodsk, Kareliya, Respublika, 620109, Russia
SIH Kemerovo Regional Clinical Hosptial
Kemerovo, Kemerovo Oblast, 620109, Russia
Olla-Med
Moscow, Moscow, 105554, Russia
Nizhny Novgorod Regional Hospital N.A. Semashko
Nizhny Novgorod, Nizhny Novgorod Oblast, 603126, Russia
LLC "Medicine Center SibNovoMed"
Novosibirsk, Novosibirsk Oblast, 630005, Russia
Research Institute of Physiology and Fundamental Medicine
Novosibirsk, Novosibirsk Oblast, 630117, Russia
Clinic of Omsk State Medical University
Omsk, Omsk Oblast, 644050, Russia
Rostov State Medical University
Rostov-on-Don, Rostov Oblast, 344091, Russia
NonState Healthcare Institution Central Clinical Hospital
Samara, Samara Oblast, 443029, Russia
LLC Medical Center Reavita Med SPb
Saint Petersburg, Sankt-Peterburg, 194354, Russia
Balt Med Clinic
Saint Petersburg, Sankt-Peterburg, 194356, Russia
Saint-Petersburg City Hospital of Saint Elizabeth
Saint Petersburg, Sankt-Peterburg, 195257, Russia
Scientific research center ECO-security
Saint Petersburg, Sankt-Peterburg, 196143, Russia
First Pavlov State Medical University of Saint Petersburg
Saint Petersburg, Sankt-Peterburg, 197022, Russia
Saint Petersburg State Budgetary Healthcare Institution City Clinical Hospital No.31
Saint Petersburg, Sankt-Peterburg, 197110, Russia
LLC MA New Hospital
Yekaterinburg, Sverdlovsk Oblast, 620109, Russia
Clinical Hospital Center Zvezdara
Belgrade, Beograd, 11000, Serbia
University Medical Center "Bezanijska kosa"
Belgrade, Beograd, 11080, Serbia
General Hospital "Djordje Joanovic"
Zrenjanin, Vojvodina, 23000, Serbia
Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica
Banská Bystrica, Banská Bystrica Region, 97517, Slovakia
Cliniq s.r.o.
Bratislava, Bratislava Region, 81109, Slovakia
Gastromedic
Nové Zámky, Nitra Region, 940 81, Slovakia
Gastro LM
Prešov, Presov, 080 01, Slovakia
Endomed, s.r.o.
Vranov N. Toplou, Presov, 093 01, Slovakia
Yonsei University-Wonju Severance Christian Hospital
Wŏnju, Kang-won-do, 26426, South Korea
Korea University Ansan Hospital
Ansan-si, Kyǒnggi-do, 15355, South Korea
Hanyang University Guri Hospital
Guri-si, Kyǒnggi-do, 11923, South Korea
Ajou University Hospital
Suwon, Kyǒnggi-do, 16499, South Korea
Yeungnam Univeristy Medical Center
Gyeongsan-si, Kyǒngsangbuk-do, 42415, South Korea
Dong-A University Hospital
Busan, Pusan-Kwangyǒkshi, 49201, South Korea
Inje University Haeundae Paik Hospital
Haeundae-gu, Pusan-Kwangyǒkshi, 48108, South Korea
Chungang University Hospital
Dongjak-gu, Seoul-teukbyeolsi [Seoul], 6973, South Korea
Kyung Hee University Hospital
Seoul, Seoul-teukbyeolsi [Seoul], 02447, South Korea
Asan Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], 05505, South Korea
Kangbuk Samsung Hospital
Seoul, Seoul-teukbyeolsi [Seoul], 3181, South Korea
The Catholic Univ. of Korea Seoul St. Mary's Hospital
Seoul, Seoul-teukbyeolsi [Seoul], 6591, South Korea
Keimyung University Dongsan Hospital
Daegu, Taegu-Kwangyǒkshi, 42601, South Korea
Kyungpook National University Chilgok Hospital
Deagu, Taegu-Kwangyǒkshi, 41404, South Korea
Kyungpook National University Hospital
Junggu, Taegu-Kwangyǒkshi, 41944, South Korea
The Catholic University of Korea, Daejeon St. Mary's Hospital
Daejeon, Taejǒn-Kwangyǒkshi, 34943, South Korea
Gastroenterologische Praxis Balsiger, Seibold & Partner
Bern, Canton of Bern, 3012, Switzerland
Cantonal Hospital St.Gallen
Sankt Gallen, Canton of St. Gallen, 9007, Switzerland
Inselspital Bern
Bern, 3010, Switzerland
Eskisehir Osmangazi University
Eskişehir, Eskişehir, 26480, Turkey (Türkiye)
Istanbul Universitesi Cerrahpasa
Istanbul- Fatih, Istanbul, 34098, Turkey (Türkiye)
Dokuz Eylül Üniversitesi
Balçova, İzmir, 35340, Turkey (Türkiye)
Kocaeli University Medical Faculty Hospital
İzmit, Kocaeli, 41380, Turkey (Türkiye)
Ankara City Hospital
Ankara, 06230, Turkey (Türkiye)
Hacettepe Universite Hastaneleri
Ankara, 6230, Turkey (Türkiye)
Gazi University Health Research and Application Center Gazi Hospital
Ankara, 6560, Turkey (Türkiye)
Antalya Egitim ve Arastırma Hastanesi
Antalya, 7100, Turkey (Türkiye)
Uludag Universitesi
Bursa, 16059, Turkey (Türkiye)
Trakya University
Edirne, 22030, Turkey (Türkiye)
Mustafa Kemal Universitesi
Hatay, 31001, Turkey (Türkiye)
Medicana Kadiköy Hastanesi
Istanbul, 34724, Turkey (Türkiye)
Acbadem Kozyatagi Hospital
Istanbul, 34734, Turkey (Türkiye)
Mersin University
Mersin, 33343, Turkey (Türkiye)
Medical Center Family Medicine Clinic
Dnipro, Dnipropetrovsk Oblast, 49038, Ukraine
Communal non-profit enterprise "Regional clinical hospital of Ivano-Frankivsk Regional Council"
Ivano-Frankivsk, Ivano-Frankivsk Oblast, 76008, Ukraine
City Clinical Hospital No. 2
Kharkiv, Kharkivs’ka Oblast’, 61037, Ukraine
Medbud Clinic
Kyiv, Kyivska Oblast, 03037, Ukraine
University Hospital branch of Danylo Halytsky Lviv National Medical University (UH DHLNMU)
Lviv, Lviv Oblast, 79000, Ukraine
Municipal non-profit enterprise'Odesa Regional Clinical Hospital'of Odesa Regional Council
Odesa, Odesa Oblast, 65025, Ukraine
City Clinical Hospital #1, Vinnitsya National Medical University
Vinnytsia, Vinnytsia Oblast, 21000, Ukraine
Medical Clinical Investigational Center of Medical Center Health Clinic
Vinnytsia, Vinnytsia Oblast, 21009, Ukraine
Municipal Nonprofit Enterprise "Vinnytsia Regional Clinical Hospital n.a. M. I. Pyrohov of Vinnytsia Regio -T
Vinnytsia, Vinnytsia Oblast, 21018, Ukraine
VNMU
Vinnytsia, Vinnytsia Oblast, 21018, Ukraine
Transcarpathian Regional Hospital im.Andriya Novak
Uzhhorod, Zakarpattia Oblast, 88018, Ukraine
Communal Non-profit Enterprise "City Hospital #6" of Zaporizhzhia City Council
Zaporizhia, Zaporizhzhia Oblast, 69035, Ukraine
Diacenter
Zaporizhzhia, Zaporizhzhia Oblast, 69076, Ukraine
Chernivtsi Regional Clinical Hospital
Chernivtsi, 58000, Ukraine
Medical Center Ok!Clinic+
Kyiv, 02091, Ukraine
Kyiv Railway Clinical Hospital No.2 of Branch Health Center of the Public Joint Stock Company Ukrainian Ra -T
Kyiv, 03049, Ukraine
Medical Center of Limited Liability Company "Medical Center "Consilium Medical"
Kyiv, 04050, Ukraine
Municipal non-profit enterprise of Kyiv Regional Council "Kyiv Regional Center for Rehabilitation Medicine"
Kyiv, 04078, Ukraine
Municipal Nonprofit Enterprise of Kyiv Region Council "Kyiv Regional Clinical Hospital"
Kyiv, 04106, Ukraine
Addenbrooke's Hospital
Cambridge, Cambridgeshire, CB2 2QQ, United Kingdom
Whipps Cross University Hospital
London, England, E11 1NR, United Kingdom
Synexus Wales Clinical Research Centre
Cardiff, CF15 9SS, United Kingdom
Related Publications (1)
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 Mar 5:S1542-3565(26)00155-2. doi: 10.1016/j.cgh.2026.01.049. Online ahead of print.
PMID: 41794217DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chief Medical Officer
- Organization
- Eli Lilly and Company
Study Officials
- 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
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 15, 2020
First Posted
January 18, 2020
Study Start
June 22, 2020
Primary Completion
November 28, 2024
Study Completion (Estimated)
April 1, 2027
Last Updated
December 15, 2025
Results First Posted
December 15, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
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.