A Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease
VIVID-1
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo- and Active- Controlled, Treat-Through Study to Evaluate the Efficacy and Safety of Mirikizumab in Patients With Moderately to Severely Active Crohn's Disease
3 other identifiers
interventional
1,158
33 countries
569
Brief Summary
The reason for this study is to see if the study drug mirikizumab is safe and effective in participants with moderately to severely active Crohn's disease.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jul 2019
Typical duration for phase_3
569 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
April 23, 2019
CompletedFirst Posted
Study publicly available on registry
April 24, 2019
CompletedStudy Start
First participant enrolled
July 23, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 23, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
October 2, 2023
CompletedResults Posted
Study results publicly available
December 27, 2024
CompletedDecember 27, 2024
December 1, 2024
4.1 years
April 23, 2019
August 13, 2024
December 12, 2024
Conditions
Outcome Measures
Primary Outcomes (2)
Percentage of Adult Participants Achieving Clinical Response at Week 12 and Endoscopic Response at Week 52 (Placebo and Mirikizumab)
Clinical response by patient reported outcome (PRO) defined as ≥30% decrease in stool frequency (SF) and/or abdominal pain (AP) \& neither score worse than baseline. SF (number of liquid or very soft stools) as per Bristol Stool Scale Category 6 or 7 and AP (4-point scale: 0=none, 1=mild, 2=moderate, 3=severe). Endoscopic response defined as ≥50% reduction from baseline in total Simple Endoscopic Score for Crohn's Disease (SES-CD) score. SES-CD evaluates 4 variables assessed in 5 bowel segments, each scored from 0-3: presence \& size of ulcers (none=0; diameter 0.1-0.5 cm=1; 0.5-2 cm=2; \>2 cm=3); extent of ulcerated surface (none=0; \<10%=1; 10% to 30%=2; \>30%=3); extent of affected surface (none=0; \<50%=1; 50% to 75%=2; \>75%=3); presence \& type of narrowing (none=0; single, can be passed=1; multiple, can be passed=2; cannot be passed=3). Total is sum of all scores across all bowel segments. Scores range from 0 to 56, with higher scores indicating more severe disease.
Week 12 to Week 52
Percentage of Adult Participants Achieving Clinical Response at Week 12 and Clinical Remission at Week 52 (Placebo and Mirikizumab)
Clinical response by PRO defined as ≥ 30% decrease in SF and/or AP and neither score worse than baseline. SF (number of liquid or very soft stools) as per Bristol Stool Scale Category 6 or 7 and AP (4-point scale: 0=none, 1=mild, 2=moderate, 3=severe). Clinical remission defined as Crohn's Disease Activity Index (CDAI) total score \<150. The CDAI is an 8-item disease activity measure comprised of a composite of 3 patient-reported items: AP (4-point scale: 0=none, 1=mild, 2=moderate, 3=severe); SF (number of liquid or very soft stools) as per Bristol Stool Scale Category 6 or 7; and general well-being (0=generally well, 1=slightly under par, 2=poor, 3=very poor, 4=terrible), and 5 physician-reported/laboratory items (physical signs and a laboratory parameter \[hematocrit\]).. Total score range of 0 to 600 points.
Week 12 to Week 52
Secondary Outcomes (16)
Percentage of Adult Participants Achieving Endoscopic Response at Week 12 (Placebo and Mirikizumab)
Week 12
Percentage of Adult Participants Achieving Endoscopic Response at Week 52
Week 52
Percentage of Adult Participants Achieving Clinical Remission at Week 12 (Placebo and Mirikizumab)
Week 12
Percentage of Adult Participants Achieving Clinical Remission at Week 52
Week 52
Percentage of Adult Participants Achieving Endoscopic Remission at Week 12 (Placebo and Mirikizumab)
Week 12
- +11 more secondary outcomes
Study Arms (4)
Placebo
PLACEBO COMPARATORParticipants received Placebo intravenously (IV) or subcutaneously (SC) every 4 weeks (Q4W). Any participant in the placebo arm who was considered a non-responder at Week 12 received 900 mg Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W for the remainder of the study. Nonresponse is defined as failing to achieve at least a 30% decrease in stool frequency (SF) and/or abdominal pain (AP) and be no worse than baseline.
300 mg Mirikizumab
EXPERIMENTALParticipants received 900 milligrams (mg) Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W
90 mg Ustekinumab
ACTIVE COMPARATORParticipants received 6 mg/kg Ustekinumab IV for one dose, then 90 mg SC every 8 weeks (Q8W)
300 mg Mirikizumab (Adolescents)
EXPERIMENTALParticipants received open label 900 mg Mirikizumab IV for 3 doses, then 300 mg SC Q4W
Interventions
Administered IV
Eligibility Criteria
You may qualify if:
- Diagnosis of CD for at least 3 months prior to baseline
- Confirmed diagnosis of moderate to severe CD as assessed by SF, AP score, and SES-CD
- Demonstrated intolerance, loss of response or inadequate response to conventional or to biologic therapy for CD
- If female, subject must meet the contraception recommendations
You may not qualify if:
- Have a current diagnosis of ulcerative colitis, inflammatory bowel disease-unclassified (IBD-U) (formerly known as indeterminate colitis) or short bowel syndrome
- Have a stoma, ileoanal pouch or ostomy
- Have had a bowel resection within 6 months, or any kind of intra-abdominal or extra abdominal surgery within 3 months of baseline
- Have ever received any monoclonal antibodies binding IL-23
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (580)
University of Alabama-The Kirklin Clinic
Birmingham, Alabama, 35233, United States
Digestive Health Specialists
Dothan, Alabama, 36301, United States
Lakeview Clinical Research
Guntersville, Alabama, 35976, United States
Care Access Research - Tuscaloosa
Tuscaloosa, Alabama, 35406, United States
Research Solutions of Arizona
Litchfield Park, Arizona, 85340, United States
Central Arizona Medical Associates, PC
Mesa, Arizona, 85206, United States
Arizona Arthritis & Rheumatology Research, PLLC
Phoenix, Arizona, 85037, United States
Reliance Research
Scottsdale, Arizona, 85260, United States
Synexus Site Network
Tempe, Arizona, 85282, United States
inSite Digestive Health Care
Arcadia, California, 91006, United States
B G Clinical Research, Inc.
Encinitas, California, 92024, United States
Care Access - Gilroy
Gilroy, California, 95020, United States
Newport Huntington Med Grp
Huntington Beach, California, 92648, United States
Om Research, LLC
Lancaster, California, 93534, United States
GastroIntestinal Biosciences Clinical Trials
Los Angeles, California, 90067, United States
California Medical Research Associates
Northridge, California, 91324, United States
University of California Irvine
Orange, California, 92868, United States
inSite Digestive Health Care
Pasadena, California, 91105, United States
Care Access Research - San Jose
San Jose, California, 95124, United States
Wolverine Clinical Trials, LLC
Santa Ana, California, 92705, United States
Fomat Medical Research, Inc.
Thousand Oaks, California, 91360, United States
Connecticut Gastroenterology
Manchester, Connecticut, 06040, United States
IMR of South Florida
Aventura, Florida, 33180, United States
Gastroenterology Consultants of Clearwater
Clearwater, Florida, 33756, United States
West Central Gastroenterology d/b/a Gastro Florida
Clearwater, Florida, 33761, United States
Inpatient Research Clinic
Hialeah, Florida, 33013, United States
Doral Medical Research
Hialeah, Florida, 33016, United States
C2 Research Center, LLC
Jacksonville, Florida, 32204, United States
I.H.S. Health, LLC
Kissimmee, Florida, 34741, United States
Central Florida Gastro Research
Kissimmee, Florida, 34744, United States
Florida Research Institute
Lakewood Rch, Florida, 34211, United States
Wellness Clinical Research
Lehigh Acres, Florida, 33936, United States
Columbus Clinical Services, LLC
Miami, Florida, 33125, United States
Infinite Clinical Research
Miami, Florida, 33133, United States
Nickalus Children's Hospital Research Institute
Miami, Florida, 33155, United States
Research Associates of South Florida, LLC
Miami, Florida, 33156, United States
SaludMax Medical Corp
Miami, Florida, 33165, United States
Ezy Medical Research
Miami, Florida, 33175, United States
Coral Research Clinic Corp
Miami, Florida, 33186, United States
Goji Group - Research Trials Group
Miami Lakes, Florida, 33016, United States
Wellness Clinical Research
Miami Lakes, Florida, 33016, United States
Center for Interventional Endoscopy
Orlando, Florida, 32803, United States
Endoscopic Research Inc
Orlando, Florida, 32803, United States
Orlando Health, Inc
Orlando, Florida, 32806, United States
Clintheory Healthcare
Orlando, Florida, 32819, United States
Care Access Research - Orlando
Orlando, Florida, 32825, United States
Digestive and Liver Center of Florida
Orlando, Florida, 32825, United States
Gastroenterology Associates of Pensacola, PA
Pensacola, Florida, 32503, United States
Synexus Clinical Research US, Inc.
Pinellas Park, Florida, 33781, United States
USPA Advance Concept Medical Research Group LLC.
South Miami, Florida, 33143, United States
Precision Clinical Research
Sunrise, Florida, 33351, United States
Advanced Research
Tamarac, Florida, 33321, United States
University of South Florida
Tampa, Florida, 33612, United States
Alliance Clinical Research, LLC
Tampa, Florida, 33615, United States
Grady Memorial Hospital
Atlanta, Georgia, 30303, United States
Digestive Healthcare of Georgia
Atlanta, Georgia, 30309, United States
Columbus Regional Research Institute
Columbus, Georgia, 31904, United States
Gastrointestinal Specialists of Georgia
Marietta, Georgia, 30060, United States
Grand Teton Research Group
Idaho Falls, Idaho, 83404, United States
Eagle Clinical Research
Chicago, Illinois, 60621, United States
Qualmedica Research, LLC
Evansville, Indiana, 47715, United States
Indiana University Health
Indianapolis, Indiana, 46202, United States
Care Access Research - Terre Haute
Terre Haute, Indiana, 47802, United States
University of Kansas Medical Center
Kansas City, Kansas, 66160, United States
Robley Rex VA Medical Center
Louisville, Kentucky, 40206, United States
CroNola LLC
Houma, Louisiana, 70360, United States
Delta Research Partners LLC
Monroe, Louisiana, 71201, United States
Nola Research Works, LLC
New Orleans, Louisiana, 70125, United States
Louisiana Clinical Research, LLC
Shreveport, Louisiana, 71105, United States
MGG Group, Inc.., Co., Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815, United States
Woodholme Gastroenterology Associates - Glen Burnie
Glen Burnie, Maryland, 21061, United States
Capital Digestive Care
Rockville, Maryland, 20850, United States
Tufts Medical Center
Boston, Massachusetts, 02111, United States
Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan, 48047, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Revive Research Institute
Farmington Hills, Michigan, 48334, United States
Infusion Associates
Grand Rapids, Michigan, 49525, United States
MNGI Digestive Health, P.A.
Plymouth, Minnesota, 55446, United States
Gastrointestinal Associates
Flowood, Mississippi, 39232, United States
University of Mississippi School of Medicine
Jackson, Mississippi, 39216-4500, United States
Southern Therapy and Advanced Research (STAR) LLC
Jackson, Mississippi, 39216, United States
Digestive Health Specialists
Tupelo, Mississippi, 38801, United States
BVL Research
Liberty, Missouri, 64068, United States
Advanced Biomedical Research of America - South Eastern Avenue
Las Vegas, Nevada, 89123, United States
Care Access - Las Vegas
Las Vegas, Nevada, 89148, United States
Lovelace Scientific Resources - Albuquerque
Albuquerque, New Mexico, 87108, United States
NYU Langone Long Island Clinical Research Associates
Lake Success, New York, 11042, United States
Care Access Research - Yonkers
Yonkers, New York, 10701, United States
Unc Hospitals
Chapel Hill, North Carolina, 27599, United States
Javara
Charlotte, North Carolina, 28210, United States
Medication Management
Greensboro, North Carolina, 27405, United States
Peters Medical Research
High Point, North Carolina, 27262, United States
Care Access Research-Kinston
Kinston, North Carolina, 28501, United States
Care Access Research-Lumberton
Lumberton, North Carolina, 28358, United States
Gastroenterology Associates of the Piedmont
Winston-Salem, North Carolina, 27103, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106, United States
Ohio State University Hospital
Columbus, Ohio, 43210, United States
Ohio Gastroenterology Group Inc.
Dublin, Ohio, 43016, United States
Northshore Gastroenterology Research, LLC
Westlake, Ohio, 44145, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Care Access Research LLC
Pottsville, Pennsylvania, 17901, United States
Care Access Research - Scranton
Scranton, Pennsylvania, 18508, United States
University Gastroenterology
Providence, Rhode Island, 02905, United States
Radiant Research
Anderson, South Carolina, 29621, United States
Strand GI
Myrtle Beach, South Carolina, 29572, United States
Gastroenterology Associates of Orangeburg
Orangeburg, South Carolina, 29118, United States
Gastro One
Germantown, Tennessee, 38138, United States
GIA Clinical Trials, LLC
Knoxville, Tennessee, 37909, United States
Amel Med LLC
Austin, Texas, 78750, United States
Baylor Scott & White Center for Inflammatory Bowel Diseases
Dallas, Texas, 75246, United States
Advanced Gastroenterology Associates
Decatur, Texas, 76234, United States
University of Texas Medical Branch at Galveston
Galveston, Texas, 77555, United States
Baylor College of Medicine
Houston, Texas, 77030, United States
University of Texas Health Services Center - Houston
Houston, Texas, 77030, United States
Biopharma Informatic, LLC
Houston, Texas, 77084, United States
Katy Gastro Health & Nutrition
Katy, Texas, 77494, United States
Caprock Gastro Research, LLC
Lubbock, Texas, 79424, United States
Biopharma Informatic, LLC
McAllen, Texas, 78503, United States
Digestive System Healthcare
Pasadena, Texas, 77505, United States
Sun Research Institute
San Antonio, Texas, 78215, United States
Southern Star Research Institute, LLC
San Antonio, Texas, 78229, United States
VIP Trials
San Antonio, Texas, 78230, United States
Tyler Research Institute, LLC
Tyler, Texas, 75701, United States
Care Access Research LLC - Salt Lake City
Ogden, Utah, 84403, United States
Velocity Clinical Research/Gut Whisperer
Riverton, Utah, 84065, United States
Kalo Clinical Research
Salt Lake City, Utah, 84102, United States
Care Access Research LLC - Salt Lake City
Salt Lake City, Utah, 84124, United States
University of Virginia Health System
Charlottesville, Virginia, 22908-0816, United States
Pediatrics Specialists of Virginia
Fairfax, Virginia, 22031, United States
Children's Specialty Group, PPLC
Norfolk, Virginia, 23507, United States
The Center for Gastrointestinal Health
Petersburg, Virginia, 23805, United States
Clinical Research Partners, LLC
Richmond, Virginia, 23226, United States
Carilion Clinic
Roanoke, Virginia, 24014, United States
Virginia Gastroenterology Institute
Suffolk, Virginia, 23434, United States
TPMG Clinical Research Williamsburg
Williamsburg, Virginia, 23188, United States
Washington Gastroenterology, PLLC
Bellevue, Washington, 98004, United States
Advanced Clinical Research-Spokane Gastroenterology
Spokane, Washington, 99202, United States
Washington Gastroenterology, PLLC
Tacoma, Washington, 98405, United States
Marshall Medical Center
Huntington, West Virginia, 25701, United States
Care Access Research - Wyoming
Casper, Wyoming, 82601, United States
DOM- Centro de Reumatologia
CABA, Buenos Aires, 1111, Argentina
Mautalen Salud e Investigación
CABA, Buenos Aires, C1128AAF, Argentina
CEMIC- Servicio de Reumatología
CABA, Buenos Aires, C1431FWO, Argentina
Instituto Medico Elsa Perez SRL (IMEP)
Ciudadela, Buenos Aires, 1702, Argentina
CIPREC
Ciudad Autonoma de Buenos Aire, Ciudad Autónoma de Buenos Aire, C1119ACN, Argentina
Centro de Investigaciones Médicas Tucuman
SAN M. de Tucuman, Tucumán Province, T4000AXL, Argentina
Centro de Investigaciones Metabólicas (CINME)
Buenos Aires, C1027AAP, Argentina
Concord Repatriation General Hospital
Concord, New South Wales, 2139, Australia
St. Vincents Hospital Sydney
Darlinghurst, New South Wales, 2010, Australia
Nepean Hospital
Kingswood, New South Wales, 2747, Australia
Liverpool Hospital
Liverpool, New South Wales, 2170, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, 4029, Australia
Coastal Digestive Health
Maroochydore, Queensland, 4558, Australia
Coral Sea Clinical Research Institute
North Mackay, Queensland, 4740, Australia
Emeritus Research
Camberwell, Victoria, 3124, Australia
Northern Hospital
Epping, Victoria, 3076, Australia
The Royal Melbourne Hospital
Parkville, Victoria, 3050, Australia
Fiona Stanley Hospital
Murdoch, Western Australia, 6150, Australia
Medizinische Universität Innsbruck
Innsbruck, 6020, Austria
Universitätsklinikum Salzburg
Salzburg, 5020, Austria
Krankenhaus der Barmherzigen Schwestern Wien
Vienna, 1060, Austria
AKH
Vienna, 1090, Austria
Imelda General Hospital
Bonheiden, Antwerpen, 2820, Belgium
Cliniques Universitaires Saint-Luc
Brussels, Brussels Capital, 1200, Belgium
UZ Brussel
Brussels, 1090, Belgium
AZ Groeninge
Kortrijk, 8500, Belgium
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
Leuven, 3000, Belgium
HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará
Fortaleza, Ceará, 60430-370, Brazil
Cliagen - Clinica de Atencao em Gastroenterologia, Especialidades e Nutricao
Salvador, Estado de Bahia, 41500-300, Brazil
L2IP - Instituto de Pesquisas Clinicas Ltda.
Brasília, Federal District, 70200-730, Brazil
Chronos Pesquisa Clínica
Brasília, Federal District, 72145-450, Brazil
Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda
Goiânia, Goiás, 74535-170, Brazil
Hospital Felício Rocho
Belo Horizonte, Minas Gerais, 30110-934, Brazil
Eurolatino Pesquisas Medicas Ltda.
Uberlândia, Minas Gerais, 38411-186, Brazil
Associacao Paranaense de Cultura - PUCPR
Curitiba, Paraná, 80230-130, Brazil
Instituto de Pesquisa em Saúde - Fundação Universidade de Caxias do Sul
Caxias do Sul, Rio Grande do Sul, 95070-560, Brazil
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-903, Brazil
Irmandade da Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90050-170, Brazil
Hospital Ernesto Dornelles
Porto Alegre, Rio Grande do Sul, 90160-093, Brazil
Nucleo de Pesquisa Clínica do Rio Grande do Sul-NPCRS
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 de Botucatu
Botucatu, São Paulo, 18618-687, Brazil
HMCP - Hospital e Maternidade Celso Pierro - PUC-Campinas
Campinas, São Paulo, 13060-904, Brazil
Faculdade de Medicina do ABC
Santo André, São Paulo, 09060-870, Brazil
Pesquisare
Santo André, São Paulo, 09080-110, Brazil
Praxis Pesquisa Medica
Santo André, São Paulo, 09790790, Brazil
CEMEC - Centro Multidisciplinar de Estudos Clinicos EPP Ltda
São Bernardo do Campo, São Paulo, 09715-090, Brazil
Instituto de Assistencia Medica ao Servidor Publico Estudo Estadual
São Paulo, São Paulo, 04039-004, Brazil
Hospital Gloria Dor
Rio de Janeiro, 22211-230, Brazil
CPQuali Pesquisa Clínica
São Paulo, 01228-000, Brazil
Hospital Sírio Libanês
São Paulo, 01308-050, Brazil
Clinica Onco Star
São Paulo, 04543-000, Brazil
Hepatogastro
São Paulo, 04543-001, Brazil
Gastroenterology and internal medicine research institute
Edmonton, Alberta, T5R 1W2, Canada
Fraser Clinical Trials Inc
New Westminster, British Columbia, V3L 3W4, Canada
The Medical Arts Health Research Group
North Vancouver, British Columbia, V7L 4W8, Canada
GI Research Institute
Vancouver, British Columbia, V6Z 2K5, Canada
Milestone Clinical
Dartmouth, Nova Scotia, B2W 6L4, Canada
K&M Medical
Kentville, Nova Scotia, B4N 0A3, Canada
Viable Clinical Research
Greater Sudbury, Ontario, P3C 5K6, Canada
London Health Sciences Centre
London, Ontario, N6A 5A5, Canada
Victoria Hospital
London, Ontario, N6A 5W9, Canada
CIUSS-de-L'Est-de-l'île-de-Montréal-Hôpital
Montreal, Quebec, H1T 2M4, Canada
Anhui Provincial Hospital
Hefei, Anhui, 230001, China
Peking University First Hospital
Beijing, Beijing Municipality, 100034, China
Peking University Third Hospital
Beijing, Beijing Municipality, 100191, China
Chongqing General Hospital
Chongqing, Chongqing Municipality, 400014, China
The Affiliated 2nd Hosp. of Third Military Med. Univ. of PLA
Chongqing, Chongqing Municipality, 400037, China
The First Hospital Affiliated to AMU (Southwest Hospital)
Chongqing, Chongqing Municipality, 400038, China
The First Affiliated Hospital of Fujian Medical University
Fujian, Fuzhou, 350005, China
The First People's Hospital of Foshan
Foshan, Guangdong, 528000, China
First affiliated Hospital of Sun Yat-Sen University
Guangzhou, Guangdong, 510080, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510120, China
The Sixth Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510655, China
Hainan General Hospital
Haikou, Hainan, 570311, China
Tongji Hosp Tongji Med Col Huazhong Univ of Sci & Tech
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, China
Jiangsu Province Hospital of Chinese Medicine
Nanjing, Jiangsu, 210029, China
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029, China
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215004, China
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, 215066, 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
The First Hospital of China Medical University
Shenyang, Liaoning, 110001, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110004, China
Shanghai East Hospital
Shanghai, Pudong District, 200120, China
Shanghai Jiaotong University School of Medicine Ruijin Hospital
Shanghai, Shanghai Municipality, 200025, China
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032, China
Shanghai 6th people's hospital
Shanghai, Shanghai Municipality, China
West China Hospital of Sichuan University
Chengdu, Sichuan, 610041, China
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, 300052, China
First Affiliated Hospital of Kunming Medical University
Kunming, Yunnan, 650032, China
The First People's Hospital of Yunnan Province
Kunming, Yunnan, 650034, China
First Affiliated Hosp of College of Med, Zhejiang University
Hangzhou, Zhejiang, 310003, China
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009, China
Sir Run Run Shaw Hospital
Hangzhou, Zhejiang, 310016, China
The Second Affiliated Hospital YuYing Childens Hospital of Wenzhou Medical university
Wenzhou, Zhejiang, 310015, China
Zhongshan Hospital Xiamen University
Xiamen, 361004, China
Clinical Medical Centre Osijek
Osijek, 31000, Croatia
CHC Zagreb
Zagreb, 10000, Croatia
Vojenská Nemocnice Brno
Brno, Brno-město, 636 00, Czechia
Krajska zdravotni, a.s.-Masarykova nemocnice Usti nad Labem
Ústí nad Labem, Czech Republic, 40113, Czechia
Hepato-Gastroenterologie HK
Hradec Králové, Hradec Králové, 500 12, Czechia
MUDr. Gregar, s.r.o.
Olomouc, Olomoucký kraj, 779 00, Czechia
Institut Klinicke a Experimentalni Mediciny
Prague, Prague, 14021, Czechia
Synexus Czech
Prague, Praha 2, 120 00, Czechia
Thomayerova nemocnice
Prague, Praha 4, 14059, Czechia
Nemocnice Tomase Bati ve Zline
Zlín, Zlín, 762 75, Czechia
Fakultni Nemocnice U svate Anny
Brno, 65691, Czechia
Oblastni nemocnice Nachod-Endoskopicke centrum
Náchod, Czechia
PreventaMed, s.r.o.
Olomouc, 77900, Czechia
MUDr. Radka Koskova, s.r.o., Gastroenterologicka ambulance
Ostrava - Muglinov, 712 00, Czechia
A-Shine, s.r.o.
Pilsen, 301 00, Czechia
AXON Clinical
Prague, 150 00, Czechia
Mediendo, s.r.o.
Prague, 18600, Czechia
ISCARE Clinical Centre
Prague, 19000, Czechia
Aarhus Universitetshospital, Skejby
Aarhus, Central Jutland, 8200, Denmark
Aalborg Hospital
Aalborg, 9100, Denmark
Hopital de Hautepierre - Service d'Hépatogastroentérolgie
Strasbourg, Bas Rhin, 67098, France
Hôpital Saint Antoine
Paris, Cedex 12, 75012, France
Hôpital Beaujon
Clichy, Paris, 92110, France
Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre
Le Kremlin-Bicêtre, Paris, 94270, France
Hospices Civils de Lyon - Centre Hospitalier Lyon Sud -
Pierre-Bénite, Rhone, 69495, France
CHU Amiens Picardie Site Sud - Service d'Hepato-gastro-entérologie
Amiens, 80054, France
Centre Hospitalier du Mans
Le Mans, 72000, France
CHRU de Montpellier-Hopital St Eloi
Montpellier, 34295, France
GH Necker - Enfants Malades
Paris, 75015, France
CHU Bordeaux - Hôpital Haut-Lévêque
Pessac, 33604, France
CHU de Poitiers- Service d'Hépato-gastro-entérologie,
Poitiers, 86021, France
CHU Charles Nicolle in Rouen
Rouen, 76036, France
CHU St Etienne Hopital Nord
Saint-Etienne, 42055, France
CHRU de Nancy
Vand?uvre-lès-Nancy, 54511, France
Siloah St. Trudpert Klinikum-Zentrum für Innere Medizin
Pforzheim, Baden-Wurttemberg, 75179, Germany
Universitätsklinikum Würzburg A. ö. R.
Würzburg, Bavaria, 97080, Germany
Synexus Clinical Research GmbH
Frankfurt am Main, Hesse, 60313, Germany
Krankenhaus Eichhof
Lauterbach, Hesse, 36341, Germany
Medizinische Hochschule Hanover
Hanover, Lower Saxony, 30625, Germany
Knappschaftskrankenhaus Bottrop
Bottrop, North Rhine-Westphalia, 46242, Germany
Universitaetsklinikum Essen
Essen, North Rhine-Westphalia, 45147, Germany
Johanna Etienne Krankenhaus-Klinik für Allgemeine Innere Medizin
Neuss, North Rhine-Westphalia, 41462, Germany
Gemeinschaftspraxis Jakobeit
Wipperfürth, North Rhine-Westphalia, 51688, Germany
St. Marienkrankenhaus-Medizinische Klinik I
Ludwigshafen am Rhein, Rhineland-Palatinate, 67067, Germany
Practice Dr.med. Denger and Dr.med. Pfitzner
Friedrichsthal, Saarland, 66299, Germany
Studiengesellschaft BSF Unternehmergesellschaft
Halle, Saxony-Anhalt, 06108, Germany
Synexus Clinical Research GmbH-Leipzig Research Centre
Leipzig, Saxony-Anhalt, 04103, Germany
Universitätsklinikum Schleswig-Holstein
Kiel, Schleswig-Holstein, 24105, Germany
RED-Institut GmbH
Oldenburg in Holstein, Schleswig-Holstein, 23758, Germany
Charité Campus Virchow-Klinikum
Berlin, 12200, Germany
Synexus Clinical Research GmbH
Berlin, 12627, Germany
Florence-Nightingale-Krankenhaus
Düsseldorf, 40489, Germany
HaFCED - Hamburgisches Forschungsinstitut für chronisch entzündliche Darmerkrankungen
Hamburg, 20251, Germany
Gastroenterologische Gemeinschaftspraxis Mainz
Mainz, 55122, Germany
Tumorzentrum Nordthüringen
Uslar, 99734, Germany
Synexus Gyula
Gyula, Bekes County, 5700, Hungary
SZTE AOK Belgyogyaszati Klinika
Szeged, Csongrád megye, 6725, Hungary
DRC Gyogyszervizsgalo Kozpont Kft.
Balatonfüred, EU, 8230, Hungary
Clinexpert Tatabánya Ltd.
Tatabánya, Komárom-Esztergom, H-2800, Hungary
Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház
Békéscsaba, 5600, Hungary
Clinexpert SMO
Budapest, 1033, Hungary
Synexus Magyarorszag Kft.
Budapest, 1036, Hungary
Pannonia Maganorvosi Centrum
Budapest, 1136, Hungary
Bugát Pál Kórház
Gyöngyös, 3200, Hungary
Endomedix Diagnosztikai Központ - Miskolc
Miskolc, 3526, Hungary
CLINFAN Szolgáltató Kft
Szekszárd, 7100, Hungary
Gujarat Hospital - Gastro and Vascular Centre
Surat, Gujarat, 395009, India
International Gastro Institute
Vadodara, Gujarat, 390007, India
Midas Multispeciality Hospital Pvt.Ltd.
Nagpur, Maharashtra, 440010, India
Ruby Hall Clinic and Grant Medical Foundation
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, 302006, India
Apollo Speciality Hospital - Teynampet
Chennai, Tamil Nadu, 600035, India
Asian Institute of Gastroenterology
Hyderabad, Telangana, 500032, India
Postgraduate Institute of Medical Education & Research
Chandigarh, 160012, India
Aakash Healthcare Super Speciality Hospital
New Delhi, 110075, India
Gandhi Hospital
Telangana, 500003, India
Yashoda Super Speciality Hospital
Telangana, 500003, India
Soroka Medical Center
Beersheba, 8410101, Israel
Bnai Zion Medical Center
Haifa, 31048, Israel
Edith Wolfson Medical Center
Holon, 5822012, Israel
Shaare Zedek Medical Center
Jerusalem, 91031, Israel
Hadassah Medical Center
Jerusalem, 9112001, Israel
Galilee Medical Center Department of Internal Medicine A
Nahariya, 22100, Israel
Chaim Sheba Medical Center
Ramat Gan, 5262100, Israel
Kaplan Medical Center
Rehovot, 7610001, Israel
Assaf Harofeh Medical Center
Ẕerifin, 70300, Israel
Azienda Ospedaliera Saverio De Bellis
Castellana Grotte, Bari, 70013, Italy
Università di Cagliari - Presidio Policlinico Monserrato
Monserrato, Cagliari, 09042, Italy
Azienda ospedaliero-universitaria Mater Domini
Germaneto, Catanzaro, 88100, Italy
Policlinico Gemelli - Università Cattolica del Sacro Cuore
Rome, Lazio, 00168, Italy
Presidio di Rho
Rho, Milano, 20017, Italy
Istituto Clinico Humanitas
Rozzano, Milano, 20089, Italy
Ospedale Clinicizzato San Donato
San Donato Milanese, Milan, 20097, Italy
Istituto Mangiagalli
Milan, MI, 20122, Italy
Azienda Ospedaliera Policlinico Consorziale
Bari, 70124, Italy
Università degli Studi c/o Spedali Civili
Brescia, 25100, Italy
Azienda Ospedaliera Giuseppe Brotzu
Cagliari, 09134, Italy
Ospedale Luigi Sacco
Milan, 20157, Italy
Azienda Ospedaliera Universitaria Policlinico de Modena
Modena, 41124, Italy
Azienda Ospedaliera Di Rilievo Nazionale A. Cardarelli
Napoli, 80131, Italy
Azienda Ospedaliera Universitaria Federico II
Napoli, 80131, Italy
Arcispedale Santa Maria Nuova
Reggio Emilia, 42123, Italy
Polic.Umberto I -Univ. La Sapienza
Roma, 00161, Italy
Azienda Ospedaliera Santa Maria Della Misericordia
Udine, 33100, Italy
Kojunkai Daido Clinic
Nagoya, Aichi-ken, 4570818, Japan
Fujita Health University
Toyoake, Aichi-ken, 470-1192, Japan
National Hospital Organization Hirosaki General Medical Center
Hirosaki, Aomori, 036-8545, Japan
Tsujinaka Hospital
Kashiwa, Chiba, 277 0871, Japan
Fukuoka University Chikushi Hospital
Chikushino-shi, Fukuoka, Japan
Fukuoka University Hospital
Fukuoka, Jonan-Ku, Fukuoka, 814-0180, Japan
Hoshi General Hospital
Kōriyama, Fukushima, 963-8501, Japan
Isesakishimin Hospital
Isesaki, Gunma, 372-0817, Japan
Kiryu Kosei Hospital
Kiryū, Gunma, 376 0024, Japan
Maebashi Red Cross Hospital
Maebashi, Gunma, 371 0811, Japan
National Hospital Organization Fukuyama Medical Center
Fukuyama, Hiroshima, 720-0825, Japan
Asahikawa Medical College Hospital
Asahikawa, Hokkaido, 078-8510, 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 Higashi Tokushukai Hospital
Sapporo, Hokkaido, 065-0033, Japan
Sapporo Medical University Hospital
Sapporo, Hokkaido, Japan
Hyogo College of Medicine
Nishinomiya, Hyōgo, 663-8501, Japan
Ibaraki Prefectural Central Hospital
Kasama, Ibaraki, 890-8520, Japan
Kanazawa University Hospital
Kanazawa, Ishikawa-ken, 920-8641, Japan
Kagawa Prefectural Central Hospital
Takamatsu, Kagawa-ken, 760-8557, Japan
Ofuna Central Hospital
Kamakura, Kanagawa, 247-0056, Japan
Kitasato University Hospital
Sagamihara, Kanagawa, 252-0375, Japan
Matsushima Cinic
Yokohama, Kanagawa, 220-0045, Japan
Mie University Hospital
Tsu, Mie-ken, 514-8507, Japan
IMS Meirikai Sendai General Hospital
Sendai, Miyagi, 980-0021, Japan
Takagi Clinic - Sendai
Sendai, Miyagi, 981-3213, Japan
Nagasaki Harbor Medical Center
Nagasaki, Nagasaki, 850-0842, Japan
Infusion Clinic
Osaka, Osaka, 530-0011, Japan
Saga-Ken Medical Center Koseikan
Saga, Saga-ken, 840 8571, Japan
Matsuda Hospital
Hamamatsu, Shizuoka, 4328061, Japan
Jichi Medical University Hospital
Shimotsuke, Tochigi, 329-0498, Japan
Tokyo Medical and Dental University Hospital
Bunkyō, Tokyo, 113-8519, Japan
Showa University Koto Toyosu Hospital
Koto-ku, Tokyo, 135 8577, Japan
National Center for Global Health and Medicine
Shinjuku-ku, Tokyo, 162-8655, Japan
JHCO Tokyo Yamate Medical Center
Shinjuku-ku, Tokyo, 169-0073, Japan
Tottori University Hospital
Yonago, Tottori, 683-8504, Japan
Kagoshima University Hospital
Kagoshima, 890-8520, Japan
Sameshima Hospital
Kagoshima, 892-0846, Japan
Kumamoto University Hospital
Kumamoto, 860-8556, Japan
Kyoto Furitsu Medical University Hospital
Kyoto, 602-8566, Japan
Okayama Saiseikai General Hospital Outpatient Center
Okayama, 700-0013, Japan
Okayama University Hospital
Okayama, 700-8558, Japan
Tokitokai Tokito Clinic
Saitama, 336-0963, Japan
Toyama Prefectural Central Hospital
Toyama, 930-8550, Japan
Yamagata University Hospital
Yamagata, 990-9585, Japan
Pauls Stradins Clinical Univeristy Hospital
Riga, Rīga, LV-1002, Latvia
Hospital of Lithuanian University of Health Sciences Kaunas
Kaunas, 50009, Lithuania
PanAmerican Clinical Research S.A.de C.V. Guadalajara
Guadalajara, JA, 44670, Mexico
Health Pharma Professional Research S.A. de C.V:
Mexico City, Mexico City, 03100, Mexico
Grupo Medico Camino Sc
Mexico City, Mexico City, 03310, Mexico
Hospital Universitario "Dr. Jose Eleuterio Gonzalez"
Monterrey, Nuevo León, 64460, Mexico
PanAmerican Clinical Research Mexico S.A. de C.V.
Querétaro City, Querétaro, 76226, Mexico
Scientia Investigacion Clinica S.C.
Chihuahua City, 31203, Mexico
Instituto de Investigaciones Clínicas para la Salud
Durango, 34000, Mexico
Centro de Alta Especialidad Reumatologia Inv del Potosi SC
San Luis Potosí City, 78213, Mexico
Sociedad de Metabolismo y Corazon
Veracruz, 91900, Mexico
ETZ Elisabeth Tilburg
Tilburg, North Brabant, 5022 GC, Netherlands
Bernhoven Uden
Uden, 5406 PT, Netherlands
Synexus Polska Sp. z o.o. Oddzial w Poznaniu
Poznan, Greater Poland Voivodeship, 60-702, Poland
Topolowa Medicenter
Krakow, Lesser Poland Voivodeship, 31-506, Poland
Medicenter Nowy Targ
Nowy Targ, Lesser Poland Voivodeship, 34-400, Poland
NZOZ Formed
Wadowice, Lesser Poland Voivodeship, 34-100, Poland
MED-ROZ
Karwiany, Lower Silesian Voivodeship, 52-200, Poland
Dc-Med. Sp. z o.o.
Swidnica, Lower Silesian Voivodeship, 58-100, Poland
M. Sklodowskiej-Curie 12
Wroclaw, Lower Silesian Voivodeship, 50-381, Poland
Melita Medical
Wroclaw, Lower Silesian Voivodeship, 50-449, Poland
ZOZ Gastromed
Lublin, Lublin Voivodeship, 20-582, Poland
NZOZ Vivamed
Warsaw, Masovian Voivodeship, 03-580, Poland
Private Practice - Dr. Korczowski Bartosz
Rzeszów, Podkarpackie Voivodeship, 35-302, Poland
Nova Reuma Społka Partnerska
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
Centrum Medyczne SYNEXUS
Częstochowa, Silesian Voivodeship, 42-202, Poland
Synexus Polska - Katowicach
Katowice, Silesian Voivodeship, 40040, Poland
Kiepury Clinic
Sosnowiec, Silesian, 41-200, Poland
Centrum Medyczne Medyk
Rzeszów, Subcarpathian, 35-326, Poland
Sonomed Sp. z o.o.
Szczecin, West Pomeranian Voivodeship, 71-685, Poland
Instytut Pomnik-Centrum Zdrowia Dziecka
Warsaw, Woj Mazowieckie, 04-730, Poland
Szpital Uniwersytecki Nr 2 im. dr J. Biziela w Bydgoszczy
Bydgoszcz, 85-168, Poland
NZOZ "Twoje Zdrowie EL" Sp. z o.o.
Elblag, 82-300, Poland
Indywidualna Specjalistyczna Praktyka Lekarska
Knurów, 44-190, Poland
Synexus Polska Oddział w Lodzi
Lodz, 90-127, Poland
Twoja Przychodnia - Szczecinskie Centrum Medyczne
Szczecin, 71-434, Poland
WIP Warsaw IBD Point Profesor Kierkus
Warsaw, 00-728, Poland
ETG Zamość
Zamość, 22-400, Poland
Caguas Gastroenterology and Hepatology Center, LLC
Caguas, 00726-4980, Puerto Rico
Pan American Center for Oncology Trials
Rio Piedras, 00935, Puerto Rico
Latin Clinical Trial Center
San Juan, 00909, Puerto Rico
Wellness clinical Research Vega Baja
Vega Baja, 00694, Puerto Rico
Spitalul Pelican
Oradea, Bihor County, 410450, Romania
Spitalul Euroclinic
Bucureti, București, 014461, Romania
Sc Tvm Med Serv
Cluj-Napoca, Cluj, 400132, Romania
SC Med Life SA
Bucharest, 010719, Romania
Spitalul Clinic CF 2 Bucuresti
Bucharest, 011464, Romania
S.C. Centrul Medical Medicum SRL
Bucharest, 012015, Romania
Institutul Clinic Fundeni
Bucharest, 022328, Romania
Spitalul Universitar de Urgență București
Bucharest, 050098, Romania
Spitalul Clinic Colentina
Bucharest, 21155, Romania
CCBR Clinical Research
Bucharest, 30463, Romania
Gastromed S.R.L.
Constanța, 900168, Romania
Affidea Medical Research Center
Constanța, 900591, Romania
Spitalul Clinic Judetean Targu Mures
Târgu Mureş, 540103, Romania
S.C. Materna Care S.R.L.
Timișoara, 300645, Romania
Scientific Centre of Reconstructive and Restorative Surgery
Irkutsk, Irkutsk Oblast, 664079, Russia
Karelia Republican Hospital V.A. Baranova
Petrozavodsk, Kareliya, Respublika, 185019, Russia
Olla-Med
Moscow, Moscow, 105554, Russia
Nizhny Novgorod Regional Hospital N.A. Semashko
Nizhny Novgorod, Nizhny Novgorod Oblast, 603126, Russia
Novosibirski Gastrocenter
Novosibirsk, Novosibirsk Oblast, 630007, Russia
Rostov State Medical University
Rostov-on-Don, Rostov Oblast, 344091, Russia
LLC Medical Center Reavita Med SPb
Saint Petersburg, Sankt-Peterburg, 194354, Russia
Scientific research center ECO-security
Saint Petersburg, Sankt-Peterburg, 196143, Russia
Multidisciplinary Medical Clinic "Anthurium"
Barnaul, 656043, Russia
LLC Evimed
Chelyabinsk, 454048, Russia
Medical and Sanitary Division of Severstal
Cherepovets, 162600, Russia
Clinical Trials Center of Medical Institute
Kaliningrad, 236035, Russia
Kazan State Medical University
Kazan', 420029, Russia
SIH Kemerovo Regional Clinical Hosptial
Kemerovo, 650066, Russia
LLC ?Medsanchast No 14?
Moscow, 123022, Russia
State Scientific Centre of Coloproctology
Moscow, 123423, Russia
LLC "Medicine Center SibNovoMed"
Novosibirsk, 630005, Russia
The University Clinic of OSMU
Omsk, 644050, Russia
Pokrovskaya Municipal Hospital
Saint Petersburg, 195067, Russia
Saint-Petersburg City Hospital of Saint Elizabeth
Saint Petersburg, 195257, Russia
Academician I.P. Pavlov First St-Petersburg State Medical University
Saint Petersburg, 197022, Russia
LLC Gastroenterology Centre Expert
Saint Petersburg, 197110, Russia
SBIH City Clinical Hospital #31
Saint Petersburg, 197110, Russia
SPb SBIH "City Polyclinic # 106"
Saint Petersburg, 198328, Russia
NonState Healthcare Institution Central Clinical Hospital
Samara, 443029, Russia
LLC MA New Hospital
Yekaterinburg, 620109, Russia
Clinical Hospital Center Zvezdara
Belgrade, Beograd, 11000, Serbia
Zemun Medical Centre
Zemun, Beograd, 11080, Serbia
University Medical Center "Bezanijska kosa"
Belgrade, NAP, 11080, Serbia
Clinical Center Nis
Niš, Nišavski Okrug, 18000, Serbia
Sremska Mitrovica Health Centre
Sremska Mitrovica, Vojvodina, 22000, Serbia
General Hospital "Djordje Joanovic"
Zrenjanin, Vojvodina, 23000, Serbia
Clinical Center " Dr Dragisa Misovic Dedinje"
Belgrade, 11000, Serbia
Clinical Center Kragujevac Gastroenterohepatology Clinic
Kragujevac, 34000, Serbia
Gastro
Prešov, Presov, 080 01, Slovakia
Endomed, s.r.o.
Vranov N. Toplou, Presov, 093 01, Slovakia
FNsP FDRoosevelta Banska Bystrica
Banská Bystrica, 97517, Slovakia
CLINIQ, s.r.o
Bratislava, 811 09, Slovakia
Gastromedic
Nové Zámky, 94002, Slovakia
Gastro LM s.r.o.
Prešov, 08001, Slovakia
Yonsei University Wonju Severance Christian Hospital
Gangwon-do, Gangwon-do, 26426, South Korea
Ajou University Hospital
Suwon, Gyeonggi-do, 16499, South Korea
Hanyang University Guri Hospital
Guri-si, Gyeonggido, 11923, South Korea
Kyung Pook National University Hospital
Daegu, Korea, 41944, South Korea
Kyung Hee University Hospital
Seoul, Korea, 02447, South Korea
Seoul St. Mary's Hospital
Seoul, Korea, 06591, South Korea
Kyunghee University Hospital at Gangdong
Seoul, Korea, 134727, South Korea
Yeungnam Univeristy Medical Center
Gyeongsan-si, Kyǒngsangbuk-do, 42415, South Korea
Seoul National University Hospital
Seoul, Seoul, Korea, 03080, South Korea
Asan Medical Center
Seoul, Seoul-teukbyeolsi [Seoul], 05505, South Korea
The Catholic University of Korea, Daejeon St. Mary's Hospital
Daejeon, Taejǒn-Kwangyǒkshi, 34943, South Korea
Inje University Haeundae Paik Hospital
Busan, 48108, South Korea
Dong-A University Hospital
Busan, 49201, South Korea
Kyungpook National University Medical Center Chilgok Hospital
Daegu, 41404, South Korea
Keimyung University Dongsan Hospital
Daegu, 42601, South Korea
Korea University Ansan Hospital
Gyeonggi-do, 15355, South Korea
Kangbuk Samsung Hospital
Seoul, 03181, South Korea
Samsung Medical Center
Seoul, 06351, South Korea
Chungang University Hospital
Seoul, 06973, South Korea
Seoul National University Hospital
Seoul, 3080, South Korea
Clínica Gaias - Santiago
Santiago de Compostela, A Coruña [La Coruña], 15702, Spain
Hospital Universitari de Girona Dr. Josep Trueta
Girona, Barcelona, 17007, Spain
Complejo Hospitalario de Navarra NAVARRABIOMED UNIDAD EC
Pamplona, Navarre, 31008, Spain
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, 33011, Spain
Complexo Hospitalario Universitario A Coruña, CHUAC
A Coruña, 15006, Spain
Instituto de Ciencias Médicas
Alicante, 3004, Spain
Centro Medico Teknon - DIGESTIVO
Barcelona, 8022, Spain
Hospital Reina Sofia
Córdoba, 14004, Spain
Hospital De Gran Canaria Dr. Negrin
Las Palmas de Gran Canaria, 35010, Spain
Hospital La Princesa
Madrid, 28006, Spain
Hospital Universitario La Paz
Madrid, 28046, Spain
Hospital Universitario Nuestra Señora de la Candelaria
Santa Cruz de Tenerife, 38010, Spain
Cantonal Hospital St.Gallen
Sankt Gallen, Canton of St. Gallen, 9007, Switzerland
Inselspital Bern
Bern, 3010, Switzerland
Gastroenterologische Praxis Balsiger, Seibold & Partner
Bern, CH-3012, Switzerland
Antalya Egitim ve Arastırma Hastanesi
Kocaeli, Antalya, 7100, Turkey (Türkiye)
Acibadem Universitesi - Acibadem Kozyatagi Hastanesi
Kadıköy, Istanbul, 34734, Turkey (Türkiye)
Mersin University Medical Faculty
Yenişehir, Mersin, 33343, Turkey (Türkiye)
Hacettepe University Faculty of Medicine
Ankara, 06100, Turkey (Türkiye)
Ankara City Hospital
Ankara, 06800, Turkey (Türkiye)
Gazi University Faculty of Medicine
Ankara, Turkey (Türkiye)
Uludag Universitesi
Bursa, 16059, Turkey (Türkiye)
Trakya University
Edirne, 22030, Turkey (Türkiye)
Eskisehir Osmangazi University Gastroenterology
Eskişehir, 26040, Turkey (Türkiye)
Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi
Gaziantep, 27310, Turkey (Türkiye)
Mustafa Kemal Universitesi Tayfur Ata Sokmen Tip Fakultesi
Hatay, 31040, Turkey (Türkiye)
Istanbul Universitesi-Cerrahpasa Cerrahpasa Tip Fakultesi Yerleskesi
Istanbul, 34098, Turkey (Türkiye)
Marmara University Pendik Research and Training Hospital
Istanbul, 34340, Turkey (Türkiye)
Medicana Kadiköy Hastanesi
Istanbul, 34724, Turkey (Türkiye)
Fulya Acıbadem
Istanbul, Turkey (Türkiye)
Dokuz Eylül Üniversitesi
Izmir, 35340, Turkey (Türkiye)
Kocaeli University Medical Faculty Hospital
İzmit, 41380, Turkey (Türkiye)
Erciyes University Hospital
Kayseri, 38039, Turkey (Türkiye)
Konya Necmettin Erbakan Gastroenterology
Konya, 42080, Turkey (Türkiye)
Inonu Universitesi Turgut Ozal Tıp Merkezi
Malatya, 44280, Turkey (Türkiye)
City Clinical Hospital No. 2
Kharkiv, Kharkivs’ka Oblast’, 61037, Ukraine
Medical Center of Limited Liability Company "Medical Center "Consilium Medical"
Kiev, Kyiv Oblast, 4050, Ukraine
Lviv Railway Clinical Hospital
Lviv, Lviv Oblast, 79000, Ukraine
Lviv Regional Endocrinology Dispensary
Lviv, Lviv Oblast, 79000, Ukraine
RCI Chernivtsi Regional Clinical Hospital
Chernivtsi, 58002, Ukraine
Medical Center of Limited Liability Company Medical Center Clinic of Family Medicine
Dnipro, 49038, Ukraine
Ivano-Frankivsk State Medical University
Ivano-Frankivsk, 76018, Ukraine
Kharkiv Regional Council Regional Clinical Hospital
Kharkiv, 61058, Ukraine
Medical Centre of Ukrainian German Antiulcer Gastroenterology Centre BYK-KYIV
Kyiv, 01030, Ukraine
International Institute of Clinical Trials LLC
Kyiv, 02091, Ukraine
LLC Medbud-Clinic Medical Center
Kyiv, 03037, Ukraine
Kyiv Railway Clinical Hospital No.2 of Branch Health Center of the Public Joint Stock Company Ukrainian Railway
Kyiv, 03049, Ukraine
Communal institution of the Kyiv Regional Council "Kyiv Regional Clinical Oncology Dispensary"
Kyiv, 04078, Ukraine
Communal institution of the Kyiv Regional Council "Kyiv Regional Clinical Oncology Dispensary"
Kyiv, 04107, Ukraine
Communal Enterprise "Odesa Regional Clinical Hospital"
Odesa, 65117, Ukraine
A. Novak Transcarpathian Regional Clinical Hospital
Uzhhorod, 88000, Ukraine
Medical Center "Health Clinic" LLC
Vinnitsa, 21009, Ukraine
Vinnytsia RCH of Veterans of War Dept of Therapy#1 Vinnytsia M.I.Pyrogov NMU
Vinnytsia, 21005, Ukraine
Vinnytsya Regional Clinical Hospital
Vinnytsia, 21018, Ukraine
CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM
Vinnytsia, 21029, Ukraine
Zaporozhye City Clinical Hospital #6
Zaporizhzhia, 69000, Ukraine
Diacenter LLC
Zaporizhzhia, 69076, Ukraine
Addenbrookes Hospital
Cambridge, Cambridgeshire, CB2 0QQ, United Kingdom
Whipps Cross University Hospital
London, England, E11 1NR, United Kingdom
Synexus Manchester Clinical Research Centre
Manchester, Greater Manchester, M15 6SE, United Kingdom
Chelsea and Westminster Hospital
Fulham, London, SW10 9NH, United Kingdom
Synexus Wales Clinical Research Centre
Cardiff, South Glamorgan, CF15 9SS, United Kingdom
Synexus Midlands Clinical Research Center
Birmingham, Wstmid, B15 2SQ, United Kingdom
Doncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust
Doncaster, DN2 5LT, United Kingdom
Paediatric Clinical Research Facility Royal Hospital for Children and Young People
Edinburgh, EH16 4TJ, United Kingdom
Synexus North East Clinical Research Centre
Hexham, NE46 1QJ, United Kingdom
Related Publications (7)
Jairath V, D'Haens G, Sands BE, Travis S, Chaparro M, Peyrin-Biroulet L, Chen MH, Dubinsky M, Ferrante M, Schreiber S, McGinnis K, Vadhariya A, Appelmans S, Lin Z, Yu G, Protic M, Moses R, Ghosh S. Bowel Urgency in Crohn's Disease: Effects of Mirikizumab in a Randomized Controlled Phase 3 Study. Clin Gastroenterol Hepatol. 2025 Jul 14:S1542-3565(25)00581-6. doi: 10.1016/j.cgh.2025.07.003. Online ahead of print.
PMID: 40669578DERIVEDRegueiro M, Fischer M, Bossuyt P, Protic M, Traxler K, Yu G, Zang H, Vadhariya A, Hisamatsu T, Juillerat P, Armuzzi A, Gisbert JP, Walsh A. Impact of mirikizumab treatment on fatigue in patients with moderately to severely active Crohn's disease: results from the phase 3 VIVID-1 study. J Crohns Colitis. 2025 Jul 3;19(7):jjaf100. doi: 10.1093/ecco-jcc/jjaf100.
PMID: 40491246DERIVEDLee SD, Vermeire S, Ungaro R, Vadhariya A, Durand F, Morris N, Yu G, Fisher DA, Traxler K, Long M. Mirikizumab Improves Quality of Life and Work Productivity in Patients with Moderately to Severely Active Crohn's Disease: Results from the Phase 3 VIVID-1 Study. Am J Gastroenterol. 2025 Mar 13;120(8):1809-1819. doi: 10.14309/ajg.0000000000003410.
PMID: 40079470DERIVEDLewis JD, Vadhariya A, Su S, Zhou X, Durand F, Kawata AK, Stassek L, Clucas C, Schreiber S. A patient-reported outcome measure comprising the stool frequency and abdominal pain items from the Crohn's Disease Activity Index: psychometric evaluation in adults with Crohn's disease. J Patient Rep Outcomes. 2025 Feb 17;9(1):19. doi: 10.1186/s41687-025-00851-y.
PMID: 39962027DERIVEDDubinsky M, Vadhariya A, Su S, Zhou X, Durand F, Clucas C, Stassek L, Kawata AK, Travis S. The Urgency Numeric Rating Scale: Psychometric Evaluation in Adults with Crohn's Disease. Adv Ther. 2025 Feb;42(2):1044-1060. doi: 10.1007/s12325-024-03081-8. Epub 2024 Dec 18.
PMID: 39692838DERIVEDFerrante M, D'Haens G, Jairath V, Danese S, Chen M, Ghosh S, Hisamatsu T, Kierkus J, Siegmund B, Bragg SM, Crandall W, Durand F, Hon E, Lin Z, Lopes MU, Morris N, Protic M, Carlier H, Sands BE; VIVID Study Group. Efficacy and safety of mirikizumab in patients with moderately-to-severely active Crohn's disease: a phase 3, multicentre, randomised, double-blind, placebo-controlled and active-controlled, treat-through study. Lancet. 2024 Dec 14;404(10470):2423-2436. doi: 10.1016/S0140-6736(24)01762-8. Epub 2024 Nov 21.
PMID: 39581202DERIVEDRegueiro M, Su S, Vadhariya A, Zhou X, Durand F, Stassek L, Kawata AK, Clucas C, Jairath V. Psychometric evaluation of the Functional Assessment of chronic illness therapy-fatigue (FACIT-Fatigue) in adults with moderately to severely active Crohn's disease. Qual Life Res. 2025 Feb;34(2):509-521. doi: 10.1007/s11136-024-03829-3. Epub 2024 Nov 13.
PMID: 39537976DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
After enrolling 6 participants, sponsor elected to stop enrollment of adolescents in study AMAM and enroll pediatric participants in a separate, pediatric study. The 6 enrolled participants were allowed to continue treatment and finish the study.
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
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 23, 2019
First Posted
April 24, 2019
Study Start
July 23, 2019
Primary Completion
August 23, 2023
Study Completion
October 2, 2023
Last Updated
December 27, 2024
Results First Posted
December 27, 2024
Record last verified: 2024-12
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.