A Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease

Recruitment Status
COMPLETED - HAS RESULTS
(See Contacts and Locations)Verified November 2024 by Eli Lilly and Company
Sponsor
Eli Lilly and Company
Information Provided by (Responsible Party)
Eli Lilly and Company
Clinicaltrials.gov Identifier
NCT03926130
Other Study ID Numbers:
16590
First Submitted
April 22, 2019
First Posted
April 23, 2019
Results First Posted
August 12, 2024
Last Update Posted
December 26, 2024
Last Verified
November 2024

ClinicalTrials.gov processed this data on December 2024. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Crohn's Disease
Drug: PlaceboDrug: MirikizumabDrug: UstekinumabDrug: Mirikizumab

Study Design

Study TypeInterventional
Actual Enrollment1158 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingTriple
Primary PurposeTreatment
Official TitleA 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
Study Start DateJuly 22, 2019
Actual Primary Completion DateAugust 22, 2023
Actual Study Completion DateOctober 1, 2023

Groups and Cohorts

Group/CohortIntervention/Treatment
Placebo
Participants 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.
Drug: Placebo
Administered IV
300 mg Mirikizumab
Participants received 900 milligrams (mg) Mirikizumab IV Q4W for 3 doses, then 300 mg SC Q4W
Drug: Mirikizumab
Administered IV
90 mg Ustekinumab
Participants received 6 mg/kg Ustekinumab IV for one dose, then 90 mg SC every 8 weeks (Q8W)
Drug: Ustekinumab
Administered IV
300 mg Mirikizumab (Adolescents)
Participants received open label 900 mg Mirikizumab IV for 3 doses, then 300 mg SC Q4W
Drug: Mirikizumab
Administered IV

Outcome Measures

Primary Outcome Measures
  1. 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.
  2. 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.
Secondary Outcome Measures
  1. Percentage of Adult Participants Achieving Endoscopic Response at Week 12 (Placebo and Mirikizumab)
    Endoscopic Response defined as ≥50% reduction from baseline in SES-CD total 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.
  2. Percentage of Adult Participants Achieving Endoscopic Response at Week 52
    Endoscopic Response defined as ≥50% reduction from baseline in SES-CD total 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.
  3. Percentage of Adult Participants Achieving Clinical Remission at Week 12 (Placebo and Mirikizumab)
    Clinical remission defined as 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.
  4. Percentage of Adult Participants Achieving Clinical Remission at Week 52
    Clinical remission defined as 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.
  5. Percentage of Adult Participants Achieving Endoscopic Remission at Week 12 (Placebo and Mirikizumab)
    Endoscopic remission is defined as SES-CD Total Score ≤4 and at least a 2-point reduction from baseline and no subscore \>1. SES-CD evaluates 4 endoscopic variables in 5 bowel segments and each of the 20 individual variables is 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. No subscore \>1 is defined as no segmental subscore (sum of the 4 individual variable scores for each of the 5 bowel segments) \>1.
  6. Change From Baseline in Urgency Numeric Rating Scale (NRS) at Week 12 in Adult Participants (Placebo and Mirikizumab)
    The Urgency NRS is a single patient-reported item that measures the severity for the urgency (sudden or immediate need) to have a bowel movement in the past 24 hours using an 11-point NRS ranging from 0 (no urgency) to 10 (worst possible urgency).
  7. Change From Baseline in Urgency NRS at Week 52 in Adult Participants (Placebo and Mirikizumab)
    The Urgency NRS is a single patient-reported item that measures the severity for the urgency (sudden or immediate need) to have a bowel movement in the past 24 hours using an 11-point NRS ranging from 0 (no urgency) to 10 (worst possible urgency).
  8. Percentage of Adult Participants Achieving Clinical Response at Week 12 and Clinical Remission by PRO at Week 52 (Placebo and Mirikizumab)
    Clinical Response by PRO defined as ≥30% decrease in SF and/or 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). Clinical Remission by PRO defined as SF≤3 and not worse than baseline (as per Bristol Stool Scale Category 6 or 7) and AP ≤1 and no worse than baseline.
  9. Percentage of Adult Participants Achieving Clinical Response at Week 12 and Endoscopic Remission at Week 52 (Placebo and Mirikizumab)
    Clinical Response by PRO defined as ≥30% decrease in SF and/or AP \& neither score worse than baseline. SF (number of liquid or very soft stools) per Bristol Stool Scale Category 6 or 7 \& AP (4-point scale:0=none,1=mild,2=moderate,3=severe). Endoscopic remission=SES-CD Total Score ≤4 \& at least 2-point reduction from baseline \& no subscore \>1.SES-CD evaluates 4 endoscopic variables in 5 bowel segments \& each of 20 individual variables scored 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;higher scores indicating more severe disease. No subscore \>1=no segmental subscore (sum of the 4 individual variable scores for each of the 5 bowel segments) \>1
  10. Percentage of Adult Participants Achieving Clinical Response at Week 12 and Corticosteroid-free 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 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. Corticosteroid-free clinical remission by CDAI is defined as achieving clinical remission by CDAI at Week 52 and being corticosteroid free from Week 40 to Week 52.
  11. Change From Baseline in C-Reactive Protein (CRP) at Week 52 in Adult Participants (Placebo and Mirikizumab)
    Change from baseline in CRP
  12. Change From Baseline in Fecal Calprotectin at Week 52 in Adult Participants (Placebo and Mirikizumab)
    Change from baseline in Fecal Calprotectin
  13. Percentage of Adult Participants Achieving Clinical Response at Week 12 and Resolution of Baseline Extraintestinal Manifestations (EIMs) 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).
  14. Percentage of Adult Participants Achieving Clinical Response at Week 12 and ≥50% Reduction in Number of Draining Cutaneous Fistulae at Week 52 in Participants With Draining Cutaneous Fistulae at Baseline (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).
  15. Change From Baseline in Health Related Quality of Life at Week 52 in Adult Participants: Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score (Placebo and Mirikizumab)
    The IBDQ is a 32-item patient completed questionnaire that measures 4 aspects of patients' lives: symptoms directly related to the primary bowel disturbance, systemic symptoms, emotional function, and social function. 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. Scores range from 32 to 224; a higher score indicates a better quality of life.
  16. Adult Population Pharmacokinetics (PopPK): Area Under the Concentration Time Curve (AUC) of Mirikizumab
    PopPK: AUC of Mirikizumab

Eligibility Criteria

Ages Eligible for Study(Child, Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
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
Exclusion Criteria
Have a current diagnosis of ulcerative colitis, inflammatory bowel disease-unclassified (IBD-U) (formerly known as indeterminate colitis) or short bowel syndrome
Currently have or are suspected to have an abscess. Recent cutaneous and perianal abscesses are not exclusionary if drained, adequately treated and resolved at least 3 weeks prior to baseline or 8 weeks prior to baseline for intra-abdominal abscesses, provided that there is no anticipated need for any further surgery
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

Contacts and Locations

Sponsors and CollaboratorsEli Lilly and Company
Locations
University of Alabama-The Kirklin Clinic | Birmingham Alabama, United States, 35233Digestive Health Specialists | Dothan Alabama, United States, 36301Lakeview Clinical Research | Guntersville Alabama, United States, 35976Care Access Research - Tuscaloosa | Tuscaloosa Alabama, United States, 35406Research Solutions of Arizona | Litchfield Park Arizona, United States, 85340Central Arizona Medical Associates, PC | Mesa Arizona, United States, 85206Arizona Arthritis & Rheumatology Research, PLLC | Phoenix Arizona, United States, 85037Reliance Research | Scottsdale Arizona, United States, 85260Synexus Site Network | Tempe Arizona, United States, 85282inSite Digestive Health Care | Arcadia California, United States, 91006B G Clinical Research, Inc. | Encinitas California, United States, 92024Care Access - Gilroy | Gilroy California, United States, 95020Newport Huntington Med Grp | Huntington Beach California, United States, 92648Om Research, LLC | Lancaster California, United States, 93534GastroIntestinal Biosciences Clinical Trials | Los Angeles California, United States, 90067California Medical Research Associates | Northridge California, United States, 91324University of California Irvine | Orange California, United States, 92868inSite Digestive Health Care | Pasadena California, United States, 91105Care Access Research - San Jose | San Jose California, United States, 95124Wolverine Clinical Trials, LLC | Santa Ana California, United States, 92705Fomat Medical Research, Inc. | Thousand Oaks California, United States, 91360Connecticut Gastroenterology | Manchester Connecticut, United States, 06040IMR of South Florida | Aventura Florida, United States, 33180Gastroenterology Consultants of Clearwater | Clearwater Florida, United States, 33756West Central Gastroenterology d/b/a Gastro Florida | Clearwater Florida, United States, 33761Inpatient Research Clinic | Hialeah Florida, United States, 33013Doral Medical Research | Hialeah Florida, United States, 33016C2 Research Center, LLC | Jacksonville Florida, United States, 32204I.H.S. Health, LLC | Kissimmee Florida, United States, 34741Central Florida Gastro Research | Kissimmee Florida, United States, 34744Florida Research Institute | Lakewood Rch Florida, United States, 34211Wellness Clinical Research | Lehigh Acres Florida, United States, 33936Columbus Clinical Services, LLC | Miami Florida, United States, 33125Infinite Clinical Research | Miami Florida, United States, 33133Nickalus Children's Hospital Research Institute | Miami Florida, United States, 33155Research Associates of South Florida, LLC | Miami Florida, United States, 33156SaludMax Medical Corp | Miami Florida, United States, 33165Ezy Medical Research | Miami Florida, United States, 33175Coral Research Clinic Corp | Miami Florida, United States, 33186Goji Group - Research Trials Group | Miami Lakes Florida, United States, 33016Wellness Clinical Research | Miami Lakes Florida, United States, 33016Center for Interventional Endoscopy | Orlando Florida, United States, 32803Endoscopic Research Inc | Orlando Florida, United States, 32803Orlando Health, Inc | Orlando Florida, United States, 32806Clintheory Healthcare | Orlando Florida, United States, 32819Care Access Research - Orlando | Orlando Florida, United States, 32825Digestive and Liver Center of Florida | Orlando Florida, United States, 32825Gastroenterology Associates of Pensacola, PA | Pensacola Florida, United States, 32503Synexus Clinical Research US, Inc. | Pinellas Park Florida, United States, 33781USPA Advance Concept Medical Research Group LLC. | South Miami Florida, United States, 33143Precision Clinical Research | Sunrise Florida, United States, 33351Advanced Research | Tamarac Florida, United States, 33321University of South Florida | Tampa Florida, United States, 33612Alliance Clinical Research, LLC | Tampa Florida, United States, 33615Grady Memorial Hospital | Atlanta Georgia, United States, 30303Digestive Healthcare of Georgia | Atlanta Georgia, United States, 30309Columbus Regional Research Institute | Columbus Georgia, United States, 31904Gastrointestinal Specialists of Georgia | Marietta Georgia, United States, 30060Grand Teton Research Group | Idaho Falls Idaho, United States, 83404Eagle Clinical Research | Chicago Illinois, United States, 60621Qualmedica Research, LLC | Evansville Indiana, United States, 47715Indiana University Health | Indianapolis Indiana, United States, 46202Care Access Research - Terre Haute | Terre Haute Indiana, United States, 47802University of Kansas Medical Center | Kansas City Kansas, United States, 66160Robley Rex VA Medical Center | Louisville Kentucky, United States, 40206CroNola LLC | Houma Louisiana, United States, 70360Delta Research Partners LLC | Monroe Louisiana, United States, 71201Nola Research Works, LLC | New Orleans Louisiana, United States, 70125Louisiana Clinical Research, LLC | Shreveport Louisiana, United States, 71105MGG Group, Inc.., Co., Chevy Chase Clinical Research | Chevy Chase Maryland, United States, 20815Woodholme Gastroenterology Associates - Glen Burnie | Glen Burnie Maryland, United States, 21061Capital Digestive Care | Rockville Maryland, United States, 20850Tufts Medical Center | Boston Massachusetts, United States, 02111Clinical Research Institute of Michigan, LLC | Chesterfield Michigan, United States, 48047Henry Ford Health System | Detroit Michigan, United States, 48202Revive Research Institute | Farmington Hills Michigan, United States, 48334Infusion Associates | Grand Rapids Michigan, United States, 49525MNGI Digestive Health, P.A. | Plymouth Minnesota, United States, 55446Gastrointestinal Associates | Flowood Mississippi, United States, 39232University of Mississippi School of Medicine | Jackson Mississippi, United States, 39216-4500Southern Therapy and Advanced Research (STAR) LLC | Jackson Mississippi, United States, 39216Digestive Health Specialists | Tupelo Mississippi, United States, 38801BVL Research | Liberty Missouri, United States, 64068Advanced Biomedical Research of America - South Eastern Avenue | Las Vegas Nevada, United States, 89123Care Access - Las Vegas | Las Vegas Nevada, United States, 89148Lovelace Scientific Resources - Albuquerque | Albuquerque New Mexico, United States, 87108NYU Langone Long Island Clinical Research Associates | Lake Success New York, United States, 11042Care Access Research - Yonkers | Yonkers New York, United States, 10701Unc Hospitals | Chapel Hill North Carolina, United States, 27599Javara | Charlotte North Carolina, United States, 28210Medication Management | Greensboro North Carolina, United States, 27405Peters Medical Research | High Point North Carolina, United States, 27262Care Access Research-Kinston | Kinston North Carolina, United States, 28501Care Access Research-Lumberton | Lumberton North Carolina, United States, 28358Gastroenterology Associates of the Piedmont | Winston-Salem North Carolina, United States, 27103University Hospitals Cleveland Medical Center | Cleveland Ohio, United States, 44106Ohio State University Hospital | Columbus Ohio, United States, 43210Ohio Gastroenterology Group Inc. | Dublin Ohio, United States, 43016Northshore Gastroenterology Research, LLC | Westlake Ohio, United States, 44145University of Oklahoma Health Sciences Center | Oklahoma City Oklahoma, United States, 73104Care Access Research LLC | Pottsville Pennsylvania, United States, 17901Care Access Research - Scranton | Scranton Pennsylvania, United States, 18508University Gastroenterology | Providence Rhode Island, United States, 02905Radiant Research | Anderson South Carolina, United States, 29621Strand GI | Myrtle Beach South Carolina, United States, 29572Gastroenterology Associates of Orangeburg | Orangeburg South Carolina, United States, 29118Gastro One | Germantown Tennessee, United States, 38138GIA Clinical Trials, LLC | Knoxville Tennessee, United States, 37909Amel Med LLC | Austin Texas, United States, 78750Baylor Scott & White Center for Inflammatory Bowel Diseases | Dallas Texas, United States, 75246Advanced Gastroenterology Associates | Decatur Texas, United States, 76234University of Texas Medical Branch at Galveston | Galveston Texas, United States, 77555Baylor College of Medicine | Houston Texas, United States, 77030University of Texas Health Services Center - Houston | Houston Texas, United States, 77030Biopharma Informatic, LLC | Houston Texas, United States, 77084Katy Gastro Health & Nutrition | Katy Texas, United States, 77494Caprock Gastro Research, LLC | Lubbock Texas, United States, 79424Biopharma Informatic, LLC | McAllen Texas, United States, 78503Digestive System Healthcare | Pasadena Texas, United States, 77505Sun Research Institute | San Antonio Texas, United States, 78215Southern Star Research Institute, LLC | San Antonio Texas, United States, 78229VIP Trials | San Antonio Texas, United States, 78230Tyler Research Institute, LLC | Tyler Texas, United States, 75701Care Access Research LLC - Salt Lake City | Ogden Utah, United States, 84403Velocity Clinical Research/Gut Whisperer | Riverton Utah, United States, 84065Kalo Clinical Research | Salt Lake City Utah, United States, 84102Care Access Research LLC - Salt Lake City | Salt Lake City Utah, United States, 84124University of Virginia Health System | Charlottesville Virginia, United States, 22908-0816Pediatrics Specialists of Virginia | Fairfax Virginia, United States, 22031Children's Specialty Group, PPLC | Norfolk Virginia, United States, 23507The Center for Gastrointestinal Health | Petersburg Virginia, United States, 23805Clinical Research Partners, LLC | Richmond Virginia, United States, 23226Carilion Clinic | Roanoke Virginia, United States, 24014Virginia Gastroenterology Institute | Suffolk Virginia, United States, 23434TPMG Clinical Research Williamsburg | Williamsburg Virginia, United States, 23188Washington Gastroenterology, PLLC | Bellevue Washington, United States, 98004Advanced Clinical Research-Spokane Gastroenterology | Spokane Washington, United States, 99202Washington Gastroenterology, PLLC | Tacoma Washington, United States, 98405Marshall Medical Center | Huntington West Virginia, United States, 25701Care Access Research - Wyoming | Casper Wyoming, United States, 82601DOM- Centro de Reumatologia | CABA Buenos Aires, Argentina, 1111Mautalen Salud e Investigación | CABA Buenos Aires, Argentina, C1128AAFCEMIC- Servicio de Reumatología | CABA Buenos Aires, Argentina, C1431FWOInstituto Medico Elsa Perez SRL (IMEP) | Ciudadela Buenos Aires, Argentina, 1702CIPREC | Ciudad Autonoma de Buenos Aire Ciudad Autónoma de Buenos Aire, Argentina, C1119ACNCentro de Investigaciones Médicas Tucuman | SAN M. de Tucuman Tucumán Province, Argentina, T4000AXLCentro de Investigaciones Metabólicas (CINME) | Buenos Aires , Argentina, C1027AAPConcord Repatriation General Hospital | Concord New South Wales, Australia, 2139St. Vincents Hospital Sydney | Darlinghurst New South Wales, Australia, 2010Nepean Hospital | Kingswood New South Wales, Australia, 2747Liverpool Hospital | Liverpool New South Wales, Australia, 2170Royal Brisbane and Women's Hospital | Herston Queensland, Australia, 4029Coastal Digestive Health | Maroochydore Queensland, Australia, 4558Coral Sea Clinical Research Institute | North Mackay Queensland, Australia, 4740Emeritus Research | Camberwell Victoria, Australia, 3124Northern Hospital | Epping Victoria, Australia, 3076The Royal Melbourne Hospital | Parkville Victoria, Australia, 3050Fiona Stanley Hospital | Murdoch Western Australia, Australia, 6150Medizinische Universität Innsbruck | Innsbruck , Austria, 6020Universitätsklinikum Salzburg | Salzburg , Austria, 5020Krankenhaus der Barmherzigen Schwestern Wien | Vienna , Austria, 1060AKH | Vienna , Austria, 1090Imelda General Hospital | Bonheiden Antwerpen, Belgium, 2820Cliniques Universitaires Saint-Luc | Brussels Brussels Capital, Belgium, 1200UZ Brussel | Brussels , Belgium, 1090AZ Groeninge | Kortrijk , Belgium, 8500Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg | Leuven , Belgium, 3000HUWC - UFC - Hospital Universitário Walter Cantídio - Universidade Federal do Ceará | Fortaleza Ceará, Brazil, 60430-370Cliagen - Clinica de Atencao em Gastroenterologia, Especialidades e Nutricao | Salvador Estado de Bahia, Brazil, 41500-300L2IP - Instituto de Pesquisas Clinicas Ltda. | Brasília Federal District, Brazil, 70200-730Chronos Pesquisa Clínica | Brasília Federal District, Brazil, 72145-450Instituto Goiano de Gastroenterologia e Endoscopia Digestiva Ltda | Goiânia Goiás, Brazil, 74535-170Hospital Felício Rocho | Belo Horizonte Minas Gerais, Brazil, 30110-934Eurolatino Pesquisas Medicas Ltda. | Uberlândia Minas Gerais, Brazil, 38411-186Associacao Paranaense de Cultura - PUCPR | Curitiba Paraná, Brazil, 80230-130Instituto de Pesquisa em Saúde - Fundação Universidade de Caxias do Sul | Caxias do Sul Rio Grande do Sul, Brazil, 95070-560Hospital de Clínicas de Porto Alegre | Porto Alegre Rio Grande do Sul, Brazil, 90035-903Irmandade da Santa Casa de Misericórdia de Porto Alegre | Porto Alegre Rio Grande do Sul, Brazil, 90050-170Hospital Ernesto Dornelles | Porto Alegre Rio Grande do Sul, Brazil, 90160-093Nucleo de Pesquisa Clínica do Rio Grande do Sul-NPCRS | Porto Alegre Rio Grande do Sul, Brazil, 90430-001Hospital Moinhos de Vento | Porto Alegre Rio Grande do Sul, Brazil, 90560-030Faculdade de Medicina de Botucatu | Botucatu São Paulo, Brazil, 18618-687HMCP - Hospital e Maternidade Celso Pierro - PUC-Campinas | Campinas São Paulo, Brazil, 13060-904Faculdade de Medicina do ABC | Santo André São Paulo, Brazil, 09060-870Pesquisare | Santo André São Paulo, Brazil, 09080-110Praxis Pesquisa Medica | Santo André São Paulo, Brazil, 09790790CEMEC - Centro Multidisciplinar de Estudos Clinicos EPP Ltda | São Bernardo do Campo São Paulo, Brazil, 09715-090Instituto de Assistencia Medica ao Servidor Publico Estudo Estadual | São Paulo São Paulo, Brazil, 04039-004Hospital Gloria Dor | Rio de Janeiro , Brazil, 22211-230CPQuali Pesquisa Clínica | São Paulo , Brazil, 01228-000Hospital Sírio Libanês | São Paulo , Brazil, 01308-050Clinica Onco Star | São Paulo , Brazil, 04543-000Hepatogastro | São Paulo , Brazil, 04543-001Gastroenterology and internal medicine research institute | Edmonton Alberta, Canada, T5R 1W2Fraser Clinical Trials Inc | New Westminster British Columbia, Canada, V3L 3W4The Medical Arts Health Research Group | North Vancouver British Columbia, Canada, V7L 4W8GI Research Institute | Vancouver British Columbia, Canada, V6Z 2K5Milestone Clinical | Dartmouth Nova Scotia, Canada, B2W 6L4K&M Medical | Kentville Nova Scotia, Canada, B4N 0A3Viable Clinical Research | Greater Sudbury Ontario, Canada, P3C 5K6London Health Sciences Centre | London Ontario, Canada, N6A 5A5Victoria Hospital | London Ontario, Canada, N6A 5W9CIUSS-de-L'Est-de-l'île-de-Montréal-Hôpital | Montreal Quebec, Canada, H1T 2M4Anhui Provincial Hospital | Hefei Anhui, China, 230001Peking University First Hospital | Beijing Beijing Municipality, China, 100034Peking University Third Hospital | Beijing Beijing Municipality, China, 100191Chongqing General Hospital | Chongqing Chongqing Municipality, China, 400014The Affiliated 2nd Hosp. of Third Military Med. Univ. of PLA | Chongqing Chongqing Municipality, China, 400037The First Hospital Affiliated to AMU (Southwest Hospital) | Chongqing Chongqing Municipality, China, 400038The First Affiliated Hospital of Fujian Medical University | Fujian Fuzhou, China, 350005The First People's Hospital of Foshan | Foshan Guangdong, China, 528000First affiliated Hospital of Sun Yat-Sen University | Guangzhou Guangdong, China, 510080Sun Yat-sen Memorial Hospital, Sun Yat-sen University | Guangzhou Guangdong, China, 510120The Sixth Affiliated Hospital, Sun Yat-Sen University | Guangzhou Guangdong, China, 510655Hainan General Hospital | Haikou Hainan, China, 570311Tongji Hosp Tongji Med Col Huazhong Univ of Sci & Tech | Wuhan Hubei, China, 430030Xiangya Hospital Central South University | Changsha Hunan, China, 410008The Second Xiangya Hospital of Central South University | Changsha Hunan, China, 410011The Third Xiangya Hospital of Central South University | Changsha Hunan, China, 410013The First People's Hospital of Changzhou | Changzhou Jiangsu, China, 213003Changzhou No.2 People's Hospital | Changzhou Jiangsu, China, Jiangsu Province Hospital of Chinese Medicine | Nanjing Jiangsu, China, 210029Jiangsu Province Hospital | Nanjing Jiangsu, China, 210029The Second Affiliated Hospital of Soochow University | Suzhou Jiangsu, China, 215004The First Affiliated Hospital of Soochow University | Suzhou Jiangsu, China, 215066Wuxi People's Hospital | Wuxi Jiangsu, China, 214023Affiliated Hospital of Jiangsu University | Zhenjiang Jiangsu, China, 212000The First Affiliated Hospital of Nanchang University | Nanchang Jiangxi, China, 330006The First Hospital of China Medical University | Shenyang Liaoning, China, 110001Shengjing Hospital of China Medical University | Shenyang Liaoning, China, 110004Shanghai East Hospital | Shanghai Pudong District, China, 200120Shanghai Jiaotong University School of Medicine Ruijin Hospital | Shanghai Shanghai Municipality, China, 200025Zhongshan Hospital, Fudan University | Shanghai Shanghai Municipality, China, 200032Shanghai 6th people's hospital | Shanghai Shanghai Municipality, China, West China Hospital of Sichuan University | Chengdu Sichuan, China, 610041Tianjin Medical University General Hospital | Tianjin Tianjin Municipality, China, 300052First Affiliated Hospital of Kunming Medical University | Kunming Yunnan, China, 650032The First People's Hospital of Yunnan Province | Kunming Yunnan, China, 650034First Affiliated Hosp of College of Med, Zhejiang University | Hangzhou Zhejiang, China, 310003The Second Affiliated Hospital of Zhejiang University School of Medicine | Hangzhou Zhejiang, China, 310009Sir Run Run Shaw Hospital | Hangzhou Zhejiang, China, 310016The Second Affiliated Hospital YuYing Childens Hospital of Wenzhou Medical university | Wenzhou Zhejiang, China, 310015Zhongshan Hospital Xiamen University | Xiamen , China, 361004Clinical Medical Centre Osijek | Osijek , Croatia, 31000CHC Zagreb | Zagreb , Croatia, 10000Vojenská Nemocnice Brno | Brno Brno-město, Czechia, 636 00Krajska zdravotni, a.s.-Masarykova nemocnice Usti nad Labem | Ústí nad Labem Czech Republic, Czechia, 40113Hepato-Gastroenterologie HK | Hradec Králové Hradec Králové, Czechia, 500 12MUDr. Gregar, s.r.o. | Olomouc Olomouc Region, Czechia, 779 00Institut Klinicke a Experimentalni Mediciny | Prague Prague, Czechia, 14021Synexus Czech | Prague Praha 2, Czechia, 120 00Thomayerova nemocnice | Prague Praha 4, Czechia, 14059Nemocnice Tomase Bati ve Zline | Zlín Zlín, Czechia, 762 75Fakultni Nemocnice U svate Anny | Brno , Czechia, 65691Oblastni nemocnice Nachod-Endoskopicke centrum | Náchod , Czechia, PreventaMed, s.r.o. | Olomouc , Czechia, 77900MUDr. Radka Koskova, s.r.o., Gastroenterologicka ambulance | Ostrava - Muglinov , Czechia, 712 00A-Shine, s.r.o. | Pilsen , Czechia, 301 00AXON Clinical | Prague , Czechia, 150 00Mediendo, s.r.o. | Prague , Czechia, 18600ISCARE Clinical Centre | Prague , Czechia, 19000Aarhus Universitetshospital, Skejby | Aarhus Central Jutland, Denmark, 8200Aalborg Hospital | Aalborg , Denmark, 9100Hopital de Hautepierre - Service d'Hépatogastroentérolgie | Strasbourg Bas Rhin, France, 67098Hôpital Saint Antoine | Paris Cedex 12, France, 75012Hôpital Beaujon | Clichy Paris, France, 92110Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre | Le Kremlin-Bicêtre Paris, France, 94270Hospices Civils de Lyon - Centre Hospitalier Lyon Sud - | Pierre-Bénite Rhone, France, 69495CHU Amiens Picardie Site Sud - Service d'Hepato-gastro-entérologie | Amiens , France, 80054Centre Hospitalier du Mans | Le Mans , France, 72000CHRU de Montpellier-Hopital St Eloi | Montpellier , France, 34295GH Necker - Enfants Malades | Paris , France, 75015CHU Bordeaux - Hôpital Haut-Lévêque | Pessac , France, 33604CHU de Poitiers- Service d'Hépato-gastro-entérologie, | Poitiers , France, 86021CHU Charles Nicolle in Rouen | Rouen , France, 76036CHU St Etienne Hopital Nord | Saint-Etienne , France, 42055CHRU de Nancy | Vand?uvre-lès-Nancy , France, 54511Siloah St. Trudpert Klinikum-Zentrum für Innere Medizin | Pforzheim Baden-Wurttemberg, Germany, 75179Universitätsklinikum Würzburg A. ö. R. | Würzburg Bavaria, Germany, 97080Synexus Clinical Research GmbH | Frankfurt am Main Hesse, Germany, 60313Krankenhaus Eichhof | Lauterbach Hesse, Germany, 36341Medizinische Hochschule Hanover | Hanover Lower Saxony, Germany, 30625Knappschaftskrankenhaus Bottrop | Bottrop North Rhine-Westphalia, Germany, 46242Universitaetsklinikum Essen | Essen North Rhine-Westphalia, Germany, 45147Johanna Etienne Krankenhaus-Klinik für Allgemeine Innere Medizin | Neuss North Rhine-Westphalia, Germany, 41462Gemeinschaftspraxis Jakobeit | Wipperfürth North Rhine-Westphalia, Germany, 51688St. Marienkrankenhaus-Medizinische Klinik I | Ludwigshafen am Rhein Rhineland-Palatinate, Germany, 67067Practice Dr.med. Denger and Dr.med. Pfitzner | Friedrichsthal Saarland, Germany, 66299Studiengesellschaft BSF Unternehmergesellschaft | Halle Saxony-Anhalt, Germany, 06108Synexus Clinical Research GmbH-Leipzig Research Centre | Leipzig Saxony-Anhalt, Germany, 04103Universitätsklinikum Schleswig-Holstein | Kiel Schleswig-Holstein, Germany, 24105RED-Institut GmbH | Oldenburg in Holstein Schleswig-Holstein, Germany, 23758Charité Campus Virchow-Klinikum | Berlin , Germany, 12200Synexus Clinical Research GmbH | Berlin , Germany, 12627Florence-Nightingale-Krankenhaus | Düsseldorf , Germany, 40489HaFCED - Hamburgisches Forschungsinstitut für chronisch entzündliche Darmerkrankungen | Hamburg , Germany, 20251Gastroenterologische Gemeinschaftspraxis Mainz | Mainz , Germany, 55122Tumorzentrum Nordthüringen | Uslar , Germany, 99734Synexus Gyula | Gyula Bekes County, Hungary, 5700SZTE AOK Belgyogyaszati Klinika | Szeged Csongrád megye, Hungary, 6725DRC Gyogyszervizsgalo Kozpont Kft. | Balatonfüred EU, Hungary, 8230Clinexpert Tatabánya Ltd. | Tatabánya Komárom-Esztergom, Hungary, H-2800Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház | Békéscsaba , Hungary, 5600Clinexpert SMO | Budapest , Hungary, 1033Synexus Magyarorszag Kft. | Budapest , Hungary, 1036Pannonia Maganorvosi Centrum | Budapest , Hungary, 1136Bugát Pál Kórház | Gyöngyös , Hungary, 3200Endomedix Diagnosztikai Központ - Miskolc | Miskolc , Hungary, 3526CLINFAN Szolgáltató Kft | Szekszárd , Hungary, 7100Gujarat Hospital - Gastro and Vascular Centre | Surat Gujarat, India, 395009International Gastro Institute | Vadodara Gujarat, India, 390007Midas Multispeciality Hospital Pvt.Ltd. | Nagpur Maharashtra, India, 440010Ruby Hall Clinic and Grant Medical Foundation | Pune Maharashtra, India, 411001All India Institute of Medical Sciences | New Delhi National Capital Territory of Delhi, India, 110029Sir Ganga Ram Hospital | New Delhi National Capital Territory of Delhi, India, 110060Dayanand Medical College and Hospital | Ludhiana Punjab, India, 141001SR Kalla Memorial Gastro & General Hospital | Jaipur Rajasthan, India, 302006Apollo Speciality Hospital - Teynampet | Chennai Tamil Nadu, India, 600035Asian Institute of Gastroenterology | Hyderabad Telangana, India, 500032Postgraduate Institute of Medical Education & Research | Chandigarh , India, 160012Aakash Healthcare Super Speciality Hospital | New Delhi , India, 110075Gandhi Hospital | Telangana , India, 500003Yashoda Super Speciality Hospital | Telangana , India, 500003Soroka Medical Center | Beersheba , Israel, 8410101Bnai Zion Medical Center | Haifa , Israel, 31048Edith Wolfson Medical Center | Holon , Israel, 5822012Shaare Zedek Medical Center | Jerusalem , Israel, 91031Hadassah Medical Center | Jerusalem , Israel, 9112001Galilee Medical Center Department of Internal Medicine A | Nahariya , Israel, 22100Chaim Sheba Medical Center | Ramat Gan , Israel, 5262100Kaplan Medical Center | Rehovot , Israel, 7610001Assaf Harofeh Medical Center | Ẕerifin , Israel, 70300Azienda Ospedaliera Saverio De Bellis | Castellana Grotte Bari, Italy, 70013Università di Cagliari - Presidio Policlinico Monserrato | Monserrato Cagliari, Italy, 09042Azienda ospedaliero-universitaria Mater Domini | Germaneto Catanzaro, Italy, 88100Policlinico Gemelli - Università Cattolica del Sacro Cuore | Rome Lazio, Italy, 00168Presidio di Rho | Rho Milano, Italy, 20017Istituto Clinico Humanitas | Rozzano Milano, Italy, 20089Ospedale Clinicizzato San Donato | San Donato Milanese Milan, Italy, 20097Istituto Mangiagalli | Milan MI, Italy, 20122Azienda Ospedaliera Policlinico Consorziale | Bari , Italy, 70124Università degli Studi c/o Spedali Civili | Brescia , Italy, 25100Azienda Ospedaliera Giuseppe Brotzu | Cagliari , Italy, 09134Ospedale Luigi Sacco | Milan , Italy, 20157Azienda Ospedaliera Universitaria Policlinico de Modena | Modena , Italy, 41124Azienda Ospedaliera Di Rilievo Nazionale A. Cardarelli | Naples , Italy, 80131Azienda Ospedaliera Universitaria Federico II | Naples , Italy, 80131Arcispedale Santa Maria Nuova | Reggio Emilia , Italy, 42123Polic.Umberto I -Univ. La Sapienza | Roma , Italy, 00161Azienda Ospedaliera Santa Maria Della Misericordia | Udine , Italy, 33100Kojunkai Daido Clinic | Nagoya Aichi-ken, Japan, 4570818Fujita Health University | Toyoake Aichi-ken, Japan, 470-1192National Hospital Organization Hirosaki General Medical Center | Hirosaki Aomori, Japan, 036-8545Tsujinaka Hospital | Kashiwa Chiba, Japan, 277 0871Fukuoka University Chikushi Hospital | Chikushino-shi Fukuoka, Japan, Fukuoka University Hospital | Fukuoka, Jonan-Ku Fukuoka, Japan, 814-0180Hoshi General Hospital | Kōriyama Fukushima, Japan, 963-8501Isesakishimin Hospital | Isesaki Gunma, Japan, 372-0817Kiryu Kosei Hospital | Kiryū Gunma, Japan, 376 0024Maebashi Red Cross Hospital | Maebashi Gunma, Japan, 371 0811National Hospital Organization Fukuyama Medical Center | Fukuyama Hiroshima, Japan, 720-0825Asahikawa Medical College Hospital | Asahikawa Hokkaido, Japan, 078-8510Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital | Chuo-ku, Sapporo-shi Hokkaido, Japan, 060-0033Tokushukai Sapporo Tokushukai Hospital | Sapporo Hokkaido, Japan, 004 0041Sapporo Higashi Tokushukai Hospital | Sapporo Hokkaido, Japan, 065-0033Sapporo Medical University Hospital | Sapporo Hokkaido, Japan, Hyogo College of Medicine | Nishinomiya Hyōgo, Japan, 663-8501Ibaraki Prefectural Central Hospital | Kasama Ibaraki, Japan, 890-8520Kanazawa University Hospital | Kanazawa Ishikawa-ken, Japan, 920-8641Kagawa Prefectural Central Hospital | Takamatsu Kagawa-ken, Japan, 760-8557Ofuna Central Hospital | Kamakura Kanagawa, Japan, 247-0056Kitasato University Hospital | Sagamihara Kanagawa, Japan, 252-0375Matsushima Cinic | Yokohama Kanagawa, Japan, 220-0045Mie University Hospital | Tsu Mie-ken, Japan, 514-8507IMS Meirikai Sendai General Hospital | Sendai Miyagi, Japan, 980-0021Takagi Clinic - Sendai | Sendai Miyagi, Japan, 981-3213Nagasaki Harbor Medical Center | Nagasaki Nagasaki, Japan, 850-0842Infusion Clinic | Osaka Osaka, Japan, 530-0011Saga-Ken Medical Center Koseikan | Saga Saga-ken, Japan, 840 8571Matsuda Hospital | Hamamatsu Shizuoka, Japan, 4328061Jichi Medical University Hospital | Shimotsuke Tochigi, Japan, 329-0498Tokyo Medical and Dental University Hospital | Bunkyō Tokyo, Japan, 113-8519Showa University Koto Toyosu Hospital | Koto-ku Tokyo, Japan, 135 8577National Center for Global Health and Medicine | Shinjuku-ku Tokyo, Japan, 162-8655JHCO Tokyo Yamate Medical Center | Shinjuku-ku Tokyo, Japan, 169-0073Tottori University Hospital | Yonago Tottori, Japan, 683-8504Kagoshima University Hospital | Kagoshima , Japan, 890-8520Sameshima Hospital | Kagoshima , Japan, 892-0846Kumamoto University Hospital | Kumamoto , Japan, 860-8556Kyoto Furitsu Medical University Hospital | Kyoto , Japan, 602-8566Okayama Saiseikai General Hospital Outpatient Center | Okayama , Japan, 700-0013Okayama University Hospital | Okayama , Japan, 700-8558Tokitokai Tokito Clinic | Saitama , Japan, 336-0963Toyama Prefectural Central Hospital | Toyama , Japan, 930-8550Yamagata University Hospital | Yamagata , Japan, 990-9585Pauls Stradins Clinical Univeristy Hospital | Riga Riga, Latvia, LV-1002Hospital of Lithuanian University of Health Sciences Kaunas | Kaunas , Lithuania, 50009PanAmerican Clinical Research S.A.de C.V. Guadalajara | Guadalajara JA, Mexico, 44670Health Pharma Professional Research S.A. de C.V: | Mexico City Mexico City, Mexico, 03100Grupo Medico Camino Sc | Mexico City Mexico City, Mexico, 03310Hospital Universitario "Dr. Jose Eleuterio Gonzalez" | Monterrey Nuevo León, Mexico, 64460PanAmerican Clinical Research Mexico S.A. de C.V. | Querétaro City Querétaro, Mexico, 76226Scientia Investigacion Clinica S.C. | Chihuahua City , Mexico, 31203Instituto de Investigaciones Clínicas para la Salud | Durango , Mexico, 34000Centro de Alta Especialidad Reumatologia Inv del Potosi SC | San Luis Potosí City , Mexico, 78213Sociedad de Metabolismo y Corazon | Veracruz , Mexico, 91900ETZ Elisabeth Tilburg | Tilburg North Brabant, Netherlands, 5022 GCBernhoven Uden | Uden , Netherlands, 5406 PTSynexus Polska Sp. z o.o. Oddzial w Poznaniu | Poznan Greater Poland Voivodeship, Poland, 60-702Topolowa Medicenter | Krakow Lesser Poland Voivodeship, Poland, 31-506Medicenter Nowy Targ | Nowy Targ Lesser Poland Voivodeship, Poland, 34-400NZOZ Formed | Wadowice Lesser Poland Voivodeship, Poland, 34-100MED-ROZ | Karwiany Lower Silesian Voivodeship, Poland, 52-200Dc-Med. Sp. z o.o. | Swidnica Lower Silesian Voivodeship, Poland, 58-100M. Sklodowskiej-Curie 12 | Wroclaw Lower Silesian Voivodeship, Poland, 50-381Melita Medical | Wroclaw Lower Silesian Voivodeship, Poland, 50-449ZOZ Gastromed | Lublin Lublin Voivodeship, Poland, 20-582NZOZ Vivamed | Warsaw Masovian Voivodeship, Poland, 03-580Private Practice - Dr. Korczowski Bartosz | Rzeszów Podkarpackie Voivodeship, Poland, 35-302Nova Reuma Społka Partnerska | Bialystok Podlaskie Voivodeship, Poland, 15-707Synexus Polska Gdansku | Gdansk Pomeranian Voivodeship, Poland, 80-382Synexus Polska Sp. z o.o. Oddzial w Gdyni | Gdynia Pomeranian Voivodeship, Poland, 81-537Endoskopia Sp. z.o.o. | Sopot Pomeranian Voivodeship, Poland, 81-756Centrum Medyczne SYNEXUS | Częstochowa Silesian Voivodeship, Poland, 42-202Synexus Polska - Katowicach | Katowice Silesian Voivodeship, Poland, 40040Kiepury Clinic | Sosnowiec Silesian, Poland, 41-200Centrum Medyczne Medyk | Rzeszów Subcarpathian, Poland, 35-326Sonomed Sp. z o.o. | Szczecin West Pomeranian Voivodeship, Poland, 71-685Instytut Pomnik-Centrum Zdrowia Dziecka | Warsaw Woj Mazowieckie, Poland, 04-730Szpital Uniwersytecki Nr 2 im. dr J. Biziela w Bydgoszczy | Bydgoszcz , Poland, 85-168NZOZ "Twoje Zdrowie EL" Sp. z o.o. | Elblag , Poland, 82-300Indywidualna Specjalistyczna Praktyka Lekarska | Knurów , Poland, 44-190Synexus Polska Oddział w Lodzi | Lodz , Poland, 90-127Twoja Przychodnia - Szczecinskie Centrum Medyczne | Szczecin , Poland, 71-434WIP Warsaw IBD Point Profesor Kierkus | Warsaw , Poland, 00-728ETG Zamość | Zamość , Poland, 22-400Caguas Gastroenterology and Hepatology Center, LLC | Caguas , Puerto Rico, 00726-4980Pan American Center for Oncology Trials | Rio Piedras , Puerto Rico, 00935Latin Clinical Trial Center | San Juan , Puerto Rico, 00909Wellness clinical Research Vega Baja | Vega Baja , Puerto Rico, 00694Spitalul Pelican | Oradea Bihor County, Romania, 410450Spitalul Euroclinic | Bucureti Bucharest, Romania, 014461Sc Tvm Med Serv | Cluj-Napoca Cluj, Romania, 400132SC Med Life SA | Bucharest , Romania, 010719Spitalul Clinic CF 2 Bucuresti | Bucharest , Romania, 011464S.C. Centrul Medical Medicum SRL | Bucharest , Romania, 012015Institutul Clinic Fundeni | Bucharest , Romania, 022328Spitalul Universitar de Urgență București | Bucharest , Romania, 050098Spitalul Clinic Colentina | Bucharest , Romania, 21155CCBR Clinical Research | Bucharest , Romania, 30463Gastromed S.R.L. | Constanța , Romania, 900168Affidea Medical Research Center | Constanța , Romania, 900591Spitalul Clinic Judetean Targu Mures | Târgu Mureş , Romania, 540103S.C. Materna Care S.R.L. | Timișoara , Romania, 300645Scientific Centre of Reconstructive and Restorative Surgery | Irkutsk Irkutsk Oblast, Russia, 664079Karelia Republican Hospital V.A. Baranova | Petrozavodsk Kareliya, Respublika, Russia, 185019Olla-Med | Moscow Moscow, Russia, 105554Nizhny Novgorod Regional Hospital N.A. Semashko | Nizhny Novgorod Nizhny Novgorod Oblast, Russia, 603126Novosibirski Gastrocenter | Novosibirsk Novosibirsk Oblast, Russia, 630007Rostov State Medical University | Rostov-on-Don Rostov Oblast, Russia, 344091LLC Medical Center Reavita Med SPb | Saint Petersburg Sankt-Peterburg, Russia, 194354Scientific research center ECO-security | Saint Petersburg Sankt-Peterburg, Russia, 196143Multidisciplinary Medical Clinic "Anthurium" | Barnaul , Russia, 656043LLC Evimed | Chelyabinsk , Russia, 454048Medical and Sanitary Division of Severstal | Cherepovets , Russia, 162600Clinical Trials Center of Medical Institute | Kaliningrad , Russia, 236035Kazan State Medical University | Kazan' , Russia, 420029SIH Kemerovo Regional Clinical Hosptial | Kemerovo , Russia, 650066LLC ?Medsanchast No 14? | Moscow , Russia, 123022State Scientific Centre of Coloproctology | Moscow , Russia, 123423LLC "Medicine Center SibNovoMed" | Novosibirsk , Russia, 630005The University Clinic of OSMU | Omsk , Russia, 644050Pokrovskaya Municipal Hospital | Saint Petersburg , Russia, 195067Saint-Petersburg City Hospital of Saint Elizabeth | Saint Petersburg , Russia, 195257Academician I.P. Pavlov First St-Petersburg State Medical University | Saint Petersburg , Russia, 197022LLC Gastroenterology Centre Expert | Saint Petersburg , Russia, 197110SBIH City Clinical Hospital #31 | Saint Petersburg , Russia, 197110SPb SBIH "City Polyclinic # 106" | Saint Petersburg , Russia, 198328NonState Healthcare Institution Central Clinical Hospital | Samara , Russia, 443029LLC MA New Hospital | Yekaterinburg , Russia, 620109Clinical Hospital Center Zvezdara | Belgrade Beograd, Serbia, 11000Zemun Medical Centre | Zemun Beograd, Serbia, 11080University Medical Center "Bezanijska kosa" | Belgrade NAP, Serbia, 11080Clinical Center Nis | Niš Nišavski Okrug, Serbia, 18000Sremska Mitrovica Health Centre | Sremska Mitrovica Vojvodina, Serbia, 22000General Hospital "Djordje Joanovic" | Zrenjanin Vojvodina, Serbia, 23000Clinical Center " Dr Dragisa Misovic Dedinje" | Belgrade , Serbia, 11000Clinical Center Kragujevac Gastroenterohepatology Clinic | Kragujevac , Serbia, 34000Gastro | Prešov Presov, Slovakia, 080 01Endomed, s.r.o. | Vranov N. Toplou Presov, Slovakia, 093 01FNsP FDRoosevelta Banska Bystrica | Banská Bystrica , Slovakia, 97517CLINIQ, s.r.o | Bratislava , Slovakia, 811 09Gastromedic | Nové Zámky , Slovakia, 94002Gastro LM s.r.o. | Prešov , Slovakia, 08001Yonsei University Wonju Severance Christian Hospital | Gangwon-do Gangwon-do, South Korea, 26426Ajou University Hospital | Suwon Gyeonggi-do, South Korea, 16499Hanyang University Guri Hospital | Guri-si Gyeonggido, South Korea, 11923Kyung Pook National University Hospital | Daegu Korea, South Korea, 41944Kyung Hee University Hospital | Seoul Korea, South Korea, 02447Seoul St. Mary's Hospital | Seoul Korea, South Korea, 06591Kyunghee University Hospital at Gangdong | Seoul Korea, South Korea, 134727Yeungnam Univeristy Medical Center | Gyeongsan-si Kyǒngsangbuk-do, South Korea, 42415Seoul National University Hospital | Seoul Seoul, Korea, South Korea, 03080Asan Medical Center | Seoul Seoul-teukbyeolsi [Seoul], South Korea, 05505The Catholic University of Korea, Daejeon St. Mary's Hospital | Daejeon Taejǒn-Kwangyǒkshi, South Korea, 34943Inje University Haeundae Paik Hospital | Busan , South Korea, 48108Dong-A University Hospital | Busan , South Korea, 49201Kyungpook National University Medical Center Chilgok Hospital | Daegu , South Korea, 41404Keimyung University Dongsan Hospital | Daegu , South Korea, 42601Korea University Ansan Hospital | Gyeonggi-do , South Korea, 15355Kangbuk Samsung Hospital | Seoul , South Korea, 03181Samsung Medical Center | Seoul , South Korea, 06351Chungang University Hospital | Seoul , South Korea, 06973Seoul National University Hospital | Seoul , South Korea, 3080Clínica Gaias - Santiago | Santiago de Compostela A Coruña [La Coruña], Spain, 15702Hospital Universitari de Girona Dr. Josep Trueta | Girona Barcelona, Spain, 17007Complejo Hospitalario de Navarra NAVARRABIOMED UNIDAD EC | Pamplona Navarre, Spain, 31008Hospital Universitario Central de Asturias | Oviedo Principality of Asturias, Spain, 33011Complexo Hospitalario Universitario A Coruña, CHUAC | A Coruña , Spain, 15006Instituto de Ciencias Médicas | Alicante , Spain, 3004Centro Medico Teknon - DIGESTIVO | Barcelona , Spain, 8022Hospital Reina Sofia | Córdoba , Spain, 14004Hospital De Gran Canaria Dr. Negrin | Las Palmas de Gran Canaria , Spain, 35010Hospital La Princesa | Madrid , Spain, 28006Hospital Universitario La Paz | Madrid , Spain, 28046Hospital Universitario Nuestra Señora de la Candelaria | Santa Cruz de Tenerife , Spain, 38010Cantonal Hospital St.Gallen | Sankt Gallen Canton of St. Gallen, Switzerland, 9007Inselspital Bern | Bern , Switzerland, 3010Gastroenterologische Praxis Balsiger, Seibold & Partner | Bern , Switzerland, CH-3012Antalya Egitim ve Arastırma Hastanesi | Kocaeli Antalya, Turkey (Türkiye), 7100Acibadem Universitesi - Acibadem Kozyatagi Hastanesi | Kadıköy Istanbul, Turkey (Türkiye), 34734Mersin University Medical Faculty | Yenişehir Mersin, Turkey (Türkiye), 33343Hacettepe University Faculty of Medicine | Ankara , Turkey (Türkiye), 06100Ankara City Hospital | Ankara , Turkey (Türkiye), 06800Gazi University Faculty of Medicine | Ankara , Turkey (Türkiye), Uludag Universitesi | Bursa , Turkey (Türkiye), 16059Trakya University | Edirne , Turkey (Türkiye), 22030Eskisehir Osmangazi University Gastroenterology | Eskişehir , Turkey (Türkiye), 26040Gaziantep Universitesi Sahinbey Arastirma ve Uygulama Hastanesi | Gaziantep , Turkey (Türkiye), 27310Mustafa Kemal Universitesi Tayfur Ata Sokmen Tip Fakultesi | Hatay , Turkey (Türkiye), 31040Istanbul Universitesi-Cerrahpasa Cerrahpasa Tip Fakultesi Yerleskesi | Istanbul , Turkey (Türkiye), 34098Marmara University Pendik Research and Training Hospital | Istanbul , Turkey (Türkiye), 34340Medicana Kadiköy Hastanesi | Istanbul , Turkey (Türkiye), 34724Fulya Acıbadem | Istanbul , Turkey (Türkiye), Dokuz Eylül Üniversitesi | Izmir , Turkey (Türkiye), 35340Kocaeli University Medical Faculty Hospital | İzmit , Turkey (Türkiye), 41380Erciyes University Hospital | Kayseri , Turkey (Türkiye), 38039Konya Necmettin Erbakan Gastroenterology | Konya , Turkey (Türkiye), 42080Inonu Universitesi Turgut Ozal Tıp Merkezi | Malatya , Turkey (Türkiye), 44280City Clinical Hospital No. 2 | Kharkiv Kharkiv Oblast, Ukraine, 61037Medical Center of Limited Liability Company "Medical Center "Consilium Medical" | Kiev Kyiv Oblast, Ukraine, 4050Lviv Railway Clinical Hospital | Lviv Lviv Oblast, Ukraine, 79000Lviv Regional Endocrinology Dispensary | Lviv Lviv Oblast, Ukraine, 79000RCI Chernivtsi Regional Clinical Hospital | Chernivtsi , Ukraine, 58002Medical Center of Limited Liability Company Medical Center Clinic of Family Medicine | Dnipro , Ukraine, 49038Ivano-Frankivsk State Medical University | Ivano-Frankivsk , Ukraine, 76018Kharkiv Regional Council Regional Clinical Hospital | Kharkiv , Ukraine, 61058Medical Centre of Ukrainian German Antiulcer Gastroenterology Centre BYK-KYIV | Kyiv , Ukraine, 01030International Institute of Clinical Trials LLC | Kyiv , Ukraine, 02091LLC Medbud-Clinic Medical Center | Kyiv , Ukraine, 03037Kyiv Railway Clinical Hospital No.2 of Branch Health Center of the Public Joint Stock Company Ukrainian Railway | Kyiv , Ukraine, 03049Communal institution of the Kyiv Regional Council "Kyiv Regional Clinical Oncology Dispensary" | Kyiv , Ukraine, 04078Communal institution of the Kyiv Regional Council "Kyiv Regional Clinical Oncology Dispensary" | Kyiv , Ukraine, 04107Communal Enterprise "Odesa Regional Clinical Hospital" | Odesa , Ukraine, 65117A. Novak Transcarpathian Regional Clinical Hospital | Uzhhorod , Ukraine, 88000Medical Center "Health Clinic" LLC | Vinnitsa , Ukraine, 21009Vinnytsia RCH of Veterans of War Dept of Therapy#1 Vinnytsia M.I.Pyrogov NMU | Vinnytsia , Ukraine, 21005Vinnytsya Regional Clinical Hospital | Vinnytsia , Ukraine, 21018CCH #1 Vinnytsia M.I. Pyrogov NMU Ch of Propaedeutics of IM | Vinnytsia , Ukraine, 21029Zaporozhye City Clinical Hospital #6 | Zaporizhzhia , Ukraine, 69000Diacenter LLC | Zaporizhzhia , Ukraine, 69076Addenbrookes Hospital | Cambridge Cambridgeshire, United Kingdom, CB2 0QQWhipps Cross University Hospital | London England, United Kingdom, E11 1NRSynexus Manchester Clinical Research Centre | Manchester Greater Manchester, United Kingdom, M15 6SEChelsea and Westminster Hospital | Fulham London, United Kingdom, SW10 9NHSynexus Wales Clinical Research Centre | Cardiff South Glamorgan, United Kingdom, CF15 9SSSynexus Midlands Clinical Research Center | Birmingham Wstmid, United Kingdom, B15 2SQDoncaster and Bassetlaw Teaching Hospitals NHS Foundation Trust | Doncaster , United Kingdom, DN2 5LTPaediatric Clinical Research Facility Royal Hospital for Children and Young People | Edinburgh , United Kingdom, EH16 4TJSynexus North East Clinical Research Centre | Hexham , United Kingdom, NE46 1QJ
Investigators
Study Director: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM -5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
Study Documents (Full Text)
Documents provided by Eli Lilly and Company: Study Protocol: Main  February 22, 2022Documents provided by Eli Lilly and Company: Study Protocol: Addendum  October 6, 2022Documents provided by Eli Lilly and Company: Statistical Analysis Plan: Main  August 22, 2023Documents provided by Eli Lilly and Company: Statistical Analysis Plan: Addendum  October 2, 2023