Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Crohn's Disease

Recruitment Status
COMPLETED - HAS RESULTS
(See Contacts and Locations)Verified October 2023 by Lakefront Biotherapeutics NV
Sponsor
Lakefront Biotherapeutics NV
Information Provided by (Responsible Party)
Lakefront Biotherapeutics NV
Clinicaltrials.gov Identifier
NCT02914561
Other Study ID Numbers:
GS-US-419-3895
First Submitted
September 21, 2016
First Posted
September 25, 2016
Results First Posted
October 22, 2023
Last Update Posted
December 17, 2023
Last Verified
October 2023

ClinicalTrials.gov processed this data on November 2023. Link to the current ClinicalTrials.gov record .

History of Changes

Study Details

Study Description

Condition or DiseaseIntervention/Treatment
Crohn's Disease
Drug: FilgotinibDrug: FilgotinibDrug: FilgotinibDrug: FilgotinibDrug: FilgotinibDrug: FilgotinibDrug: FilgotinibDrug: FilgotinibDrug: FilgotinibDrug: FilgotinibOther: Placebo

Study Design

Study TypeInterventional
Actual Enrollment1372 participants
Design AllocationRandomized
Interventional ModelParallel Assignment
MaskingDouble
Primary PurposeTreatment
Official TitleCombined Phase 3, Double-blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects With Moderately to Severely Active Crohn's Disease
Study Start DateOctober 30, 2016
Actual Primary Completion DateNovember 10, 2022
Actual Study Completion DateNovember 10, 2022

Groups and Cohorts

Group/CohortIntervention/Treatment
Cohort A: Filgotinib 200 (mg) (Induction Study)
Biologic naïve and biologic experienced participants received filgotinib 200 milligram (mg) with placebo-to-match (PTM) filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
Drug: Filgotinib
Filgotinib tablets administered orally once daily.
Cohort A: Filgotinib 100 mg (Induction Study)
Biologic naïve and biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.
Drug: Filgotinib
Filgotinib tablets administered orally once daily.
Cohort A: Placebo (Induction Study)
Biologic naïve and biologic experienced participants received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
Drug: Filgotinib
Filgotinib tablets administered orally once daily.
Cohort B: Filgotinib 200 mg (Induction Study)
Biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
Drug: Filgotinib
Filgotinib tablets administered orally once daily.
Cohort B: Filgotinib 100 mg (Induction Study)
Biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.
Drug: Filgotinib
Filgotinib tablets administered orally once daily.
Cohort B: Placebo (Induction Study)
Biologic experienced participants received PTM filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
Drug: Filgotinib
Filgotinib tablets administered orally once daily.
Filgotinib 200 mg to Filgotinib 200 mg (Maintenance Study)
Participants who received filgotinib 200 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, up to Week 58.
Drug: Filgotinib
Filgotinib tablets administered orally once daily.
Filgotinib 200 mg to Placebo (Maintenance Study)
Participants who received filgotinib 200 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.
Drug: Filgotinib
Filgotinib tablets administered orally once daily.
Filgotinib 100 mg to Filgotinib 100 mg (Maintenance Study)
Participants who received filgotinib 100 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.
Drug: Filgotinib
Filgotinib tablets administered orally once daily.
Filgotinib 100 mg to Placebo (Maintenance Study)
Participants who received filgotinib 100 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, up to Week 58.
Drug: Filgotinib
Filgotinib tablets administered orally once daily.
Placebo to Placebo (Maintenance Study)
Participants who received placebo in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58.
Other: Placebo
Placebo administered orally once daily.

Outcome Measures

Primary Outcome Measures
  1. Induction Study: Percentage of Participants Who Achieved Clinical Remission by Crohn's Disease Activity Index (CDAI) at Week 10
    The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The subscores of abdominal pain (0-3), general well-being (0-4), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome. Clinical remission was defined as a CDAI of \< 150 points.
  2. Induction Study: Percentage of Participants Who Achieved Endoscopic Response at Week 10
    The Simple Endoscopic Score for Crohn's Disease (SES-CD) assessed the degree of inflammation on the basis of 4 components: size of ulcers, ulcerated surface, affected surface, and presence of narrowing. Each of these components was scored on a scale of 0 to 3 (worst). In the SES-CD, each of these 4 components are assessed in the five segments: ileum, right colon, transverse colon, left colon, and rectum. The SES-CD was the sum of the individual scores of each of the components across the five segments. The range of SES-CD scores was 0 - 12 for each segment, and 0 - 60 for the overall SES-CD score, with larger scores indicating greater severity of disease. Endoscopic response was defined as ≥ 50% reduction from baseline in total SES-CD score.
  3. Maintenance Study: Percentage of Participants Who Achieved Clinical Remission by CDAI at Week 58
    The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The sub scores of abdominal pain (0-3), general well-being (0-4), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome. Clinical remission was defined as a CDAI of \< 150 points.
  4. Maintenance Study: Percentage of Participants Who Achieved Endoscopic Response at Week 58
    The SES-CD assessed the degree of inflammation on the basis of 4 components: size of ulcers, ulcerated surface, affected surface, and presence of narrowing. Each of these components was scored on a scale of 0 to 3 (worst). In the SES-CD, each of these 4 components are assessed in the five segments: ileum, right colon, transverse colon, left colon, and rectum. The SES-CD was the sum of the individual scores of each of the components across the five segments. The range of SES-CD scores was 0 - 12 for each segment, and 0 - 60 for the overall SES-CD score, with larger scores indicating greater severity of disease. Endoscopic response was defined as ≥ 50% reduction from baseline in total SES-CD score.
Secondary Outcome Measures
  1. Induction Study: Percentage of Participants Who Achieved Clinical Remission by PRO2 at Week 10
    The PRO2 was a composite score based on 2 components of the CDAI, the number of liquid or soft stools/day for 7 days, stool frequency and abdominal pain (rated on a scale of 0-3) assessed for 7 days. Clinical Remission was defined as the average daily stool score ≤3 points AND average daily abdominal pain score ≤1 point.
  2. Induction Study: Percentage of Participants Who Achieved Clinical Response by CDAI at Week 10
    The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The subscores of abdominal pain (0-3), general well-being (0-4), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome. Clinical response was defined as reduction in CDAI score from Induction baseline by at least 100 points or CDAI score \< 150 points.
  3. Maintenance Study: Percentage of Participants Who Achieved Clinical Remission by PRO2 at Week 58
    The PRO2 was a composite score based on 2 components of the CDAI, the number of liquid or soft stools/day for 7 days, stool frequency and abdominal pain (rated on a scale of 0-3) assessed for 7 days. Clinical Remission was defined as the average daily stool score ≤3 points AND average daily abdominal pain score ≤1 point.
  4. Maintenance Study: Percentage of Participants Who Achieved Clinical Response by CDAI at Week 58
    The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The sub scores of abdominal pain (0-3), general well-being (0-4), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome. Clinical response was defined as reduction in CDAI score from Induction baseline by at least 100 points or CDAI score \< 150 points.
  5. Maintenance Study: Percentage of Participants Who Achieved Sustained Clinical Remission by CDAI at Both Weeks 10 and 58
    The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The sub scores of abdominal pain (0-3), general well-being (0-4), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome. Sustained Clinical Remission by CDAI: CDAI \<150 combined at both Week 10 and Week 58.
  6. Maintenance Study: Percentage of Participants Who Achieved 6 Month Corticosteroid-Free Remission by CDAI at Week 58
    The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The subscores of abdominal pain (0-3), general well-being (0-4), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome. 6-Month Corticosteroid-Free Clinical remission by CDAI: CDAI \<150 with no corticosteroid use for indication of Crohn's disease for at least 6 months prior to Week 58.
  7. Maintenance Study: Percentage of Participants Who Achieved Sustained Clinical Remission by PRO2 at Both Weeks 10 and 58
    The PRO2 was a composite score based on 2 components of the CDAI, the number of liquid or soft stools/day for 7 days, stool frequency and abdominal pain (rated on a scale of 0-3) assessed for 7 days. Sustained Clinical Remission by PRO2: liquid or very soft stool ≤3 and abdominal pain ≤1 combined at both Week 10 and Week 58.
  8. Maintenance Study: Percentage of Participants Who Achieved 6 Month Corticosteroid-Free Remission by PRO2 at Week 58
    The PRO2 was a composite score based on 2 components of the CDAI, the number of liquid or soft stools/day for 7 days, stool frequency and abdominal pain (rated on a scale of 0-3) assessed for 7 days. 6-month Corticosteroid-Free Clinical Remission by PRO2: liquid or very soft stool ≤3 and abdominal pain ≤1 with no corticosteroid use for at least 6 months prior to Week 58.
  9. Induction Study:Pharmacokinetic Plasma Concentrations of Filgotinib at Week 4
    Plasma concentrations of filgotinib \[nanogram/milliliters (ng/mL)\].
  10. Induction Study: Pharmacokinetic Plasma Concentrations of Filgotinib at Week 10
    Plasma concentrations of filgotinib (ng/mL).
  11. Maintenance Study: Pharmacokinetic Plasma Concentrations of Filgotinib at Week 26
    Plasma concentrations of filgotinib (ng/mL).
  12. Maintenance Study: Pharmacokinetic Plasma Concentrations of Filgotinib at Week 58
    Plasma concentrations of filgotinib (ng/mL).
  13. Induction Study: Pharmacokinetic Plasma Concentrations of Filgotinib's Metabolite GS-829845 at Week 4
    Plasma concentrations of GS-829845 (ng/mL).
  14. Induction Study: Pharmacokinetic Plasma Concentrations of Filgotinib's Metabolite GS-829845 at Week 10
    Plasma concentrations of GS-829845 (ng/mL).
  15. Maintenance Study: Pharmacokinetic Plasma Concentrations of Filgotinib's Metabolite GS-829845 at Week 26
    Plasma concentrations of GS-829845 (ng/mL).
  16. Maintenance Study: Pharmacokinetic Plasma Concentrations of Filgotinib's Metabolite GS-829845 at Week 58
    Plasma concentrations of GS-829845 (ng/mL).

Eligibility Criteria

Ages Eligible for Study(Adult, Older Adult)
Sexes Eligible for StudyAll
Accepts Healthy VolunteersNo
Inclusion Criteria
Documented diagnosis of CD with a minimum disease duration of 3 months with involvement of the ileum and/or colon at a minimum, as determined by histopathology and endoscopic assessment
Moderately to severely active CD
Cohort A (Biologic Naïve): Previously demonstrated an inadequate clinical response, loss of response to, or intolerance to at least 1 of the following agents (depending on current country treatment recommendations/guidelines): corticosteroids and immunomodulators
Cohort A (Biologic Experienced): Previously demonstrated an inadequate clinical response, loss of response to, or intolerance to at least 1 of the following agents (depending on current country treatment recommendations/guidelines) or discontinuation of use of at least one of the following agents for reasons other than inadequate clinical response, loss of response or intolerance: tumor necrosis factor alpha (TNFa) antagonists, vedolizumab, and ustekinumab
Cohort B (Biologic Experienced): Previously demonstrated an inadequate clinical response, loss of response to, or intolerance to at least 1 of the following agents (depending on current country treatment recommendations/guidelines): TNFa antagonists, vedolizumab, and ustekinumab Key
Exclusion Criteria
Current complications of CD such as symptomatic strictures, severe rectal/anal stenosis, fistulae other than perianal fistulae, short bowel syndrome, etc.
Presence of ulcerative colitis, indeterminate colitis, ischemic colitis, fulminant colitis, or toxic mega-colon
Active tuberculosis (TB) or history of latent TB that has not been treated
Use of any prohibited concomitant medications as described in the study protocol NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

Contacts and Locations

Sponsors and CollaboratorsLakefront Biotherapeutics NV
Locations
Digestive Health Specialists of the Southeast | Dothan Alabama, United States, 36305Arizona Digestive Health - Sun City | Sun City Arizona, United States, 85351Southern California Research Center, Inc. | Coronado California, United States, 92118VVCRD Research | Garden Grove California, United States, 92845UC San Diego Health System | La Jolla California, United States, 92037Cedars Sinai Medical Center | Los Angeles California, United States, 90048Inland Empire Clinical Trials, LLC | Rialto California, United States, 92377Kaiser Permanente | San Francisco California, United States, 94118Clearview Medical Research, LLC | Santa Clarita California, United States, 91351University of Colorado Denver and Hospital | Aurora Colorado, United States, 80045South Denver Gastroenterology, PC | Lone Tree Colorado, United States, 80124Connecticut GI, PC-Research Division | Farmington Connecticut, United States, 06032Medstar Georgetown University Hospital (Patient Exams) | Washington D.C. District of Columbia, United States, 20007Advanced Research, LLC | Coral Springs Florida, United States, 33067UF Clinical Research Center | Gainesville Florida, United States, 32610Florida Research Institute | Lakewood Rch Florida, United States, 34211Florida Center for Gastroenterology | Largo Florida, United States, 33777University of Miami Crohn's and Colitis Center | Miami Florida, United States, 33136Advanced Pharma CR | Miami Florida, United States, 33147Cordova Research Institute | Miami Florida, United States, 33155Vista Health Research, LLC | Miami Florida, United States, 33176Gastroenterology Group of Naples | Naples Florida, United States, 34102Center for Interventional Endoscopy - AdventHealth Orlando | Orlando Florida, United States, 32803Gulf Region Clinical Research Institute | Pensacola Florida, United States, 32514Advanced Medical Research Center | Port Orange Florida, United States, 32127Tampa General Hospital | Tampa Florida, United States, 33606Shafran Gastroenterology Center | Winter Park Florida, United States, 32789Florida Medical Clinic, P.A. | Zephyrhills Florida, United States, 33540Gastroenterology Associates of Central Georgia, LLC | Macon Georgia, United States, 31201Gastrointestinal Specialists of Georgia | Marietta Georgia, United States, 30060Atlanta Gastroenterology Specialist, PC | Suwanee Georgia, United States, 30024Illinois Gastroenterology Group - Arlington Heights | Arlington Heights Illinois, United States, 60005Northwestern University, Feinberg School of Medicine | Chicago Illinois, United States, 60611University of Chicago Medical Center | Chicago Illinois, United States, 60637Illinois Gastroenterology Group - Gurnee | Gurnee Illinois, United States, 60031Indiana University Health University Hospital | Indianapolis Indiana, United States, 46202University of Iowa Hospitals and Clinics | Iowa City Iowa, United States, 52242University of Kansas Medical Center | Kansas City Kansas, United States, 66160University of Louisville, School of Medicine | Louisville Kentucky, United States, 40202Delta Research Partners, LLC | Monroe Louisiana, United States, 71201Louisiana Research Center, LLC | Shreveport Louisiana, United States, 71105Investigative Clinical Research | Annapolis Maryland, United States, 21401University of Maryland Medical Center | Baltimore Maryland, United States, 21201MGG Group Co., Inc., Chevy Chase Clinical Research | Chevy Chase Maryland, United States, 20815Gastro Center of Maryland | Columbia Maryland, United States, 21045Meritus Center for Clinical Research | Hagerstown Maryland, United States, 21742Massachusetts General Hospital - Crohn's and Colitis Center | Boston Massachusetts, United States, 02114Clinical Research Institute of Michigan, LLC | Chesterfield Michigan, United States, 48047Spectrum Health Butterworth Hospital | Grand Rapids Michigan, United States, 49546Mayo Clinic | Rochester Minnesota, United States, 55902University of Mississippi Medical Center | Jackson Mississippi, United States, 39216Kansas City Research Institute | Kansas City Missouri, United States, 64131Washington University School of Medicine | St Louis Missouri, United States, 63110Las Vegas Medical Research | Las Vegas Nevada, United States, 89113AGA Clinical Research Associates, LLC | Egg Harbor New Jersey, United States, 08234NY Scientific | Brooklyn New York, United States, 11235NYU Langone Long Island Clinical Research Associates | Great Neck New York, United States, 11021New York University School of Medicine/NYU Gastroenterology Associates | New York New York, United States, 10016Lenox Hill Hospital | New York New York, United States, 10028Premier Medical Group of the Hudson Valley | Poughkeepsie New York, United States, 12601Charlotte Gastroenterology & Hepatology, PLLC | Charlotte North Carolina, United States, 28207Carolina's GI Research, LLC | Raleigh North Carolina, United States, 27607Fargo Gastroenterology and Hepatology Clinic | Fargo North Dakota, United States, 58103Consultants for Clinical Research | Cincinnati Ohio, United States, 45219UC Health Physicians Clifton | Cincinnati Ohio, United States, 45219Great Lakes Gastroenterology Research, LLC, | Mentor Ohio, United States, 44060Paramount Medical Research & Consulting, LLC | Middleburg Heights Ohio, United States, 44130Options Health Research LLC | Tulsa Oklahoma, United States, 74104Great Lakes Medical Research, LLC | Harrisburg Pennsylvania, United States, 17110Gastroenterology Associates of Orangeburg | Orangeburg South Carolina, United States, 29118WR-ClinSearch, LLC | Chattanooga Tennessee, United States, 37421Gastro One | Germantown Tennessee, United States, 38138Quality Medical Research | Nashville Tennessee, United States, 37211Vanderbilt University Medical Center - IBD Clinic | Nashville Tennessee, United States, 37212Texas Clinical Research Institute | Arlington Texas, United States, 76012Pinnacle Clinical Research | Austin Texas, United States, 78757Inquest Clinical Research | Baytown Texas, United States, 77521San Antonio Military Medical Center | Fort Sam Houston Texas, United States, 78219DHAT Research Institute | Garland Texas, United States, 75044Kelsey-Seybold Clinic | Houston Texas, United States, 77025Baylor College of Medicine- Baylor Medical Center | Houston Texas, United States, 77030The Methodist Hospital | Houston Texas, United States, 77030The University of Texas Health Science Center at Houston | Houston Texas, United States, 77030Centex Studies, Inc. | Houston Texas, United States, 77058Gulf Coast Research Group | Houston Texas, United States, 77098Clinical Associates in Research Therapeutics of America, LLC | San Antonio Texas, United States, 78212Gastroenterology Research of San Antonio | San Antonio Texas, United States, 78229Pinnacle Clinical Research | San Antonio Texas, United States, 78229TDDC San Marcos | San Marcos Texas, United States, 78666Texas Digestive Disease Consultants (IP Shipment) | Southlake Texas, United States, 76092Spring Gastroenterology | The Woodlands Texas, United States, 77380Tyler Research Institute, LLC | Tyler Texas, United States, 75701HP Clinical Research | Bountiful Utah, United States, 84010University of Virginia Health System | Charlottesville Virginia, United States, 22908Charlottesville Medical Research Center, LLC | Charlottesville Virginia, United States, 22911Gastroenterology Associates of Tidewater | Chesapeake Virginia, United States, 23320Emeritas Research Group LLC | Leesburg Virginia, United States, 20176McGuire DVAMC, GI (111N) | Richmond Virginia, United States, 23249Virginia Commonwealth University | Richmond Virginia, United States, 23298University of Wisconsin Hospital & Clinics | Madison Wisconsin, United States, 53792Wisconsin Center for Advanced Research, a division of GI Associates, LLC | Milwaukee Wisconsin, United States, 53215Fundacion Estudios Clinicos CiRec | Rosario , Argentina, S2000DEFRoyal Prince Alfred Hospital | Camperdown New South Wales, Australia, 2050Monash Medical Centre | Clayton New South Wales, Australia, 3168St. Vincent's Hospital Sydney | Darlinghurst New South Wales, Australia, 2010Nepean Hospital | Kingswood New South Wales, Australia, 2747Wollongong Hospital | Wollongong New South Wales, Australia, 2500Coastal Digestive Health | Mountain Creek Queensland, Australia, 4557Coral Sea Clinical Research Institute (Mackay) | North Mackay Queensland, Australia, 4740Mater Misericordiae Ltd | South Brisbane Queensland, Australia, 4101Princess Alexandra Hospital | Woolloongabba Queensland, Australia, 4102Flinders Medical Centre | Bedford Park South Australia, Australia, 5042The Queen Elizabeth Hospital | Woodville South South Australia, Australia, 5011Emeritus Research | Camberwell Victoria, Australia, 3124Footscray Hospital | Footscray Victoria, Australia, 3011Austin Health | Heidelberg Victoria, Australia, 3084Cabrini Hospital | Malvern Victoria, Australia, 3144Alfred Hospital | Melbourne Victoria, Australia, 3004Royal Melbourne Hospital | Parkville Victoria, Australia, 3050Universitatsklinik Innsbruck | Innsbruck , Austria, 6020AKH-Medizinische Universitat Wien | Vienna , Austria, 1090GZA Ziekenhuizen campus Sint-Vincentius | Antwerp , Belgium, 2018Imelda General Hospital | Bonheiden , Belgium, 2820CUB Hopital Erasme | Brussels , Belgium, 1070Universitair Ziekenhuis Gent | Ghent , Belgium, 9000Universitair Ziekenhuis Leuven | Leuven , Belgium, 3000Centre Hospitalier Chretien (CHC) - Clinique Saint-Joseph | Liège , Belgium, 4000CHR Citadelle | Liège , Belgium, 4000AZ Delta Campus Wilgenstraat | Roeselare , Belgium, 8800Medical Center - Complete Medical Solutions OOD | Samokov , Bulgaria, 2000Medical Center - "Tsaritsa Yoanna" EOOD | Sliven , Bulgaria, 8800"MDHAT Dr. St.Cherkezov" AD | Veliko Tarnovo , Bulgaria, 5000MHAT "Sveta Petka" AD | Vidin , Bulgaria, 3700Barrie GI Associates | Barrie , Canada, L4M 7G1University of Calgary, Heritage Medical Research Clinic | Calgary , Canada, T2N 4Z6Hamilton Health Sciences Corporation, McMaster University Medical Centre | Hamilton , Canada, L8S 4K1London Health Sciences Centre - University Hospital | London , Canada, N6A 5A5TIDHI Innovation Inc. | North York , Canada, M6A 3B4ABP Research Services | Oakville , Canada, L6L 5L7Royal University Hospital | Saskatoon , Canada, S7N 0W8The Gordon and Leslie Diamond Health Care Centre | Vancouver , Canada, V5Z 1M9Toronto Digestive Disease Associates Inc. | Vaughan , Canada, L4L 4Y7Percuro Clinical Research Ltd. | Victoria , Canada, V8V 3M9University Hospital Center Osijek | Osijek , Croatia, 31 000Clinical Hospital Dubrava | Zagreb , Croatia, 10000University Hospital Center Zagreb | Zagreb , Croatia, 10000Hepato-Gastroenterologie HK, s.r.o. | Hradec Králové , Czechia, 500 12Oblastni nemocnice Mlada Boleslav, a.s., nemocnice Stredoceskeho kraje, Gastroenterologicke oddeleni | Mladá Boleslav , Czechia, 293 01G.E.P. Clinic, s r.o. | Prague , Czechia, 130 00Thomayerova nemocnice, Interni klinika 3. LF UK a TN (Interni Oddeleni) | Prague , Czechia, 140 00ISCARE a.s. (Klinicke centrum ISCARE), Klinicke a vyzkumne centrum pro strevni zanety | Prague , Czechia, 190 00CHU Amiens Picardie | Amiens , France, 80054CHU de Caen | Caen , France, 14033CHU de Clermont-Ferrand - Hopital d'Estaing | Clermont-Ferrand , France, 63003APHP - Hopital Beaujon - Clichy - Universite Paris VII | Clichy , France, 92110Centre Hospitalier Intercommunal de Creteil | Créteil , France, 94010CHU de Dijon Bourgogne - Hopital Francois Mitterand | Dijon , France, 21079CHU Grenoble Alpes | La Tronche , France, 38700Hopital Universitaire de Bicetre | Le Kremlin-Bicêtre , France, 94270Centre Hospitalier Regional Universitaire de Lille | Lille , France, 59000Hopital Nord | Marseille , France, 13015Hopital Saint Joseph | Marseille , France, 13285CHU de Montpellier-Hopital Saint Eloi | Montpellier , France, 34295Centre d'Investigation Clinique - CHU Hotel-Dieu | Nantes , France, 44093Hopital de l'Archet 2 | Nice , France, 06202CHU de Bordeaux - Hopital Haut Leveque | Pessac , France, 33600Centre Hospitalier Universitaire de Lyon Sud | Pierre-Bénite , France, 69495CH Annecy Genevois - Site d'Annecy | Pringy , France, 74374Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou | Rennes , France, 35033CHU de Saint-Etienne - Hopital Nord | Saint-Priest-en-Jarez , France, 42055Nouvel Hopital Civil | Strasbourg , France, 67091Hopitaux Universitaires de Strasbourg - Hopital de Hautepierre | Strasbourg , France, 67098CHU de Toulouse - Hopital Rangueil | Toulouse , France, 31059CHU de Nancy - Hopital Brabois Adultes | Vandœuvre-lès-Nancy , France, 54511Unimed Ajara LLC - Batumi Referral Hospital | Batumi , Georgia, 6010Medi Club Georgia LLC | Tbilisi , Georgia, 0160Ltd. Unimed Kakheti - Telavi Referral Hospital | Telavi , Georgia, 2200Charite Universitaetsmedizin Berlin | Berlin , Germany, 10117Gastro-Studien | Berlin , Germany, 10825Charite - Universitatsmedizin Berlin | Berlin , Germany, 13353DRK Kliniken Berlin - Westend - Klinik fuer Innere Medizin | Berlin , Germany, 14050Stadtisches Klinikum Braunschweig gGmbH | Braunschweig , Germany, 38126Universitatsklinik Koln | Cologne , Germany, 50937Agaplesion Markus Krankenhaus | Frankfurt am Main , Germany, 60431CED Studien UG, Interdisciplinary Crohn Colitis Center (iCCC) Rhein-Main | Frankfurt am Main , Germany, 60594Universitatsklinikum Freiburg | Freiburg im Breisgau , Germany, 79106Asklepios Westklinikum Hamburg | Hamburg , Germany, 22559Medizinische Hochschule Hannover | Hanover , Germany, 30625Universitatsklinikum Heidelberg | Heidelberg , Germany, 69120Praxis fur Gastroenterologie | Heidelberg , Germany, 69121Gastroenterologische Gemeinschaftspraxis Herne | Herne , Germany, 44623Universitatsklinikum Jena | Jena , Germany, 07747Universitatsklinikum Schleswig-Holstein | Kiel , Germany, 24105EUGASTRO GmbH | Leipzig , Germany, 04103Universitatsklinikum Leipzig | Leipzig , Germany, 04103Klinikum Luneburg | Lüneburg , Germany, 21339Gastroenterologische Gemeinschaftspraxis Minden | Minden , Germany, 32423Klinikum der Universitat Munchen - Grosshadern | München , Germany, 81377Universitaetsmedizin Rostock, Zentrum fuer Innere Medizin | Rostock , Germany, 18057Universitaetsklinikum Tuebingen | Tübingen , Germany, 72074Universitatsklinikum Ulm, Zentrum Fur Innere Medizin | Ulm , Germany, 89081General Hospital of Athens "Hippokratio", 2nd Internal Medicine Clinic of Athens University, Hepato-gastroenterology Unit | Athens , Greece, 11527University General Hospital "Attikon", 2nd Propaedeutic Internal Medicine Dept. and Research Unit, Hepatogastroenterology Unit | Athens , Greece, 12462University General Hospital of Ioannina, Gastroenterology Department, Internal Medicine Division | Ioannina , Greece, 45332University General Hospital of Patras "Panagia I Voithia", Gastroenterology Department, Internal Medicine Division | Pátrai , Greece, 26500General Hospital of Thessaloniki "Hippokratio", 4th Internal Medicine Department of Aristotle University of Thessaloniki | Thessaloniki , Greece, 54642Princess Margaret Hospital | Hong Kong , Hong Kong, Queen Mary Hospital | Hong Kong , Hong Kong, Department of Medicine & Therapeutics, The Chinese University of Hong Kong, Prince of Wales Hospital | Shatin , Hong Kong, Tuen Mun Hospital | Tuenmen , Hong Kong, Bekes Megyei Kosponti Korhaz, Dr. Rethy Pal Tagkorhaz, IV. Belgyogyaszat - 2. Gasztroenterologia | Békéscsaba , Hungary, 5600Szent Margit Korhaz, Gasztroenterológiai Osztály | Budapest , Hungary, 1032Clinexpert Egeszsegugyi Szolgaltato es Kereskedelmi Kft. | Budapest , Hungary, 1033Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet, Kozponti Felnott Szakrendelo | Budapest , Hungary, 1097Szent Janos Korhaz es Eszak-budai Egitett Korhazak, I. Belgyogyaszati - Gasztroenterologiai Osztaly | Budapest , Hungary, 1125Debreceni Egyetem Klinikai Kozpont, II. sz. Belgyogyaszati Klinika, Gasztroenterologia | Debrecen , Hungary, 4032Bugat Pal Korhaz, Belgyogyaszat | Gyöngyös , Hungary, 3200Karolina Korhaz es Rendelointezet, Altalanos Belgyogyaszat-Gasztroenterologia | Mosonmagyaróvár , Hungary, 9200Landspitali University Hospital | Reykjavik , Iceland, 101S.P. Medical College & AG of Hospitals | Bikaner Rajasthan, India, 334003Kaizen Hospital | Ahmedabad , India, 380052Gastroplus Digestive Disease Centre Pvt Ltd | Ahmedabad , India, 380054Sal Hospital and Medical Institute | Ahmedabad , India, 380054Victoria Hospital, Bangalore Medical College and Research Institute | Bangalore , India, 560002M S Ramaiah Medical College and Hospital | Bangalore , India, 560054KLES Dr. Prabhakar Kore Hospital & MRC | Belagavi , India, 590010BGS Global Hospital | Bengaluru , India, 560060Apollo Speciality Hospital | Chennai , India, 600035VGM Hospital Institute of Gastroenterology | Coimbatore , India, 641005Maharaja Agrasen Hospital | Delhi , India, 110026Lourdes Hospital | Ernākulam , India, 682012PVS Memorial Hospital Private Limited | Ernākulam , India, 682017Fortis Medical Research Institute | Gurgaon , India, 122002Institute of Digestive & Liver Diseases | Guwahati , India, 781006Gleneagles Global Hospitals | Hyderabad , India, 500004Citizens Specialty Hospital | Hyderabad , India, 500019Aware Gleneagles Global Hospitals | Hyderabad , India, 500035Centre for Liver Research & Diagnostics | Hyderabad , India, 500058Asian Institute of Gastroenterology Pvt Ltd | Hyderabad , India, 500082S.R.Kalla Memorial Gastro.&General Hospital | Jaipur , India, 302001S.M.S Medical College & Hospitals | Jaipur , India, 302004GSVM Medical College | Kanpur , India, 208002Lakeshore Hospital and Research Centre Ltd. | Kochi , India, 682040Amrita Institute of Medical Sciences and Research Centre | Kochi , India, 682041School of Digestive & Liver Diseases | Kolkata , India, 700020Apollo Gleneagles Hospitals | Kolkata , India, 700054King George's Medical University | Lucknow , India, 226003Dayanand Medical College & Hospital | Ludhiana , India, 141001Kasturba Medical College (KMC) Hospital | Mangaluru , India, 575001Seth G.S Medical College & KEM Hospital | Mumbai , India, 400012Lokmanya Tilak Municipal General Hospital | Mumbai , India, 400022Midas Multispeciality Hospital Pvt. Ltd | Nagpur , India, 440010Suretech Hospital & Research Centre Ltd | Nagpur , India, 440012Max Smart Super Speciality Hospital | New Delhi , India, 110017All India Institute of Medical Sciences | New Delhi , India, 110029Dr. B.L. Kapur Memorial Hospital | New Delhi , India, 11005Fortis Flt. Lt. Rajan Dhall Hospital | New Delhi , India, 110070S.L Raheja Hospital | Pārel , India, 400012Department of Surgery, B.J. Government Medical College & Sassoon General Hospital | Pune , India, 411001Grant Medical Foundation Ruby Hall Clinic | Pune , India, 411001Universal Hospital | Pune , India, 411011Shree Giriraj Multispeciality Hospital | Rajkot , India, 360002Gandhi Hospital | Secunderabad , India, 500003Institute of Gastroenterology & Liver Disease. Sunshine Hospitals | Secunderabad , India, 500003Surat Institute of Digestive Sciences | Surat , India, 395002BAPS Pramukh Swami Hospital | Surat , India, 395009Kasturba Hospital Medical College | Udupi , India, 576104Sterling Hospital | Vadodara , India, 390007Samvedna Hospital | Varanasi , India, 221005St. Vincent's University Hospital | Dublin , Ireland, 4Beaumont Hospital | Dublin , Ireland, 9Wellcome Trust HRB Clinical Research Facility | Dublin , Ireland, DUBLIN 8University Hospital Galway | Galway , Ireland, H91 YR71Emek Medical Center | Afula , Israel, 18101Soroka Medical Center | Beersheba , Israel, 8410101Bnai Zion Medical Center | Haifa , Israel, 31048Rambam Health Care Campus | Haifa , Israel, 3109601The Edith Wolfson Medical Center | Holon , Israel, 5822012Shaare Zedek Medical Center | Jerusalem , Israel, 9103102Hadassah Medical Center | Jerusalem , Israel, 91120Meir Medical Center | Kefar Sava , Israel, 4428164Rabin Medical Center | Petah Tikva , Israel, 4941492The Chaim Sheba Medical Center | Ramat Gan , Israel, 5265601Tel Aviv Sourasky Medical Center | Tel Aviv , Israel, 64239UOC Gastroenterologia II | Castellana Grotte , Italy, 70013U.O. Fisiopatologia Digestiva | Catanzaro , Italy, 88100UOC Medicina Interna | Cento , Italy, 44042Ospedale Clinicizzato SS. Annunziata - Dipartimento di Medicina | Chieti , Italy, 66100Gastroenterologia clinica - Azienda Ospedaliero-Universitaria Careggi | Florence , Italy, 50134Endoscopia Digestiva Centralizzata | Milan , Italy, 20121UO Gastroenterologia | Modena , Italy, 40124UOC Gastroenterologia | Padova , Italy, 35128Azienda Ospedaliero-Universitaria Pisana - Presidio Ospedaliero Cisanello | Pisa , Italy, 56124UOC di Gastroenterologia ed Endoscopia Digestiva | Roma , Italy, 00133Istituto Clinico Humanitas | Rozzano , Italy, 20089A.O. Ordine Mauriziano di Torino | Torino , Italy, 10122Ohmori Toshihide gastro-intestinal Clinic | Ageo-shi , Japan, 362-0075Tokyo Medical and Dental University Hospital | Bunkyō City , Japan, 113-8519Hokkaido P.W.F.A.C Sapporo-Kosei General Hospital | Chūōku , Japan, 060-0033Japanese Red Cross Fukuoka Hospital | Fukuoka , Japan, 815-8555Tokai University Hachioji Hospital | Hachiōji , Japan, 192-0032Medical corporation Ryowakai, Hamamatsu South Hospital | Hamamatsu , Japan, 430-0846Hiroshima Prefectural Hospital | Hiroshima , Japan, 734-8530Hiroshima University Hospital | Hiroshima , Japan, 734-8551Fukuoka University Hospital | Jonan-ku , Japan, 814-0180Nanpuh Hospital | Kagoshima , Japan, 892 -8512Ofuna Chuo Hospital | Kamakura , Japan, 247-0056Tsujinaka Hospital | Kashiwa , Japan, 277-0871Saitama Medical Center, Saitama Medical University | Kawagoe , Japan, 350-8550Kitakyushu City Hospital Organization Kitakyushu Municipal Medical Center | Kitakyushu-shi , Japan, 802-0077Yamanashi Prefectural Central Hospital | Kofu , Japan, 400-8506Kurume University Hospital | Kurume-shi , Japan, 830-0011Hidaka Coloproctology Clinic | Kurume-shi , Japan, 839-0809University Hospital, Kyoto Prefectural University of Medicine | Kyoto , Japan, 602-8566The Jikei University Hospital | Minatoku , Japan, 105-8471Kitasato University Kitasato Institute Hospital | Minatoku , Japan, 108-8642Kyorin University Hospital | Mitaka-shi , Japan, 181-8611Iwate Medical University Hospital | Morioka , Japan, 020-8505Aichi Medical University Hospital | Nagakute-shi , Japan, 480-1195Nagasaki University Hospital | Nagasaki , Japan, 8528501Nagoya City University Hospital | Nagoya , Japan, 467-8602Saiseikai Niigata Daini Hospital | Nishiku , Japan, 950-1104Hyogo College of Medicine College Hospital | Nishinomiya , Japan, 663-8501Okayama University Hospital | Okayama , Japan, 700-8558Kinshukai Infusion Clinic | Osaka , Japan, 530-0011Osaka City University Hospital | Osaka , Japan, 545-8586Wakakusa-Daiichi Hospital | Osaka , Japan, 579-8056Ishida IBD Clinic | Ōita , Japan, 870-0823Shiga University of Medical Science Hospital | Ōtsu , Japan, 520-2192Saga-Ken Medical Centre Koseikan | Saga , Japan, 840-8571Saga University Hospital | Saga , Japan, 849-8501Kitasato University Hospital, THE KITASATO INSTITUTE | Sagamihara , Japan, 252-0375Tokito Clinic | Saitama , Japan, 336-0963Toho University Sakura Medical Center | Sakura , Japan, 285-8741Sapporo Tokushukai Hospital | Sapporo , Japan, 004-0041Sapporo Higashi Tokushukai Hospital | Sapporo , Japan, 065-0033National Hospital Organization Sendai Medical Center | Sendai , Japan, 983-8520Tokyo Yamate Medical Center | Shinjuku-ku , Japan, 169-0073Osaka University Hospital | Suita , Japan, 565-0871Kagawa Prefectural Central Hospital | Takamatsu , Japan, 760-8557National Hospital Organization Takasaki General Medical Center | Takasaki-shi , Japan, 3700829Osaka Medical College Hospital | Takatsuki , Japan, 569-8686Ieda Hospital | Toyota-shi , Japan, 470-1219Wakayama Medical University Hospital | Wakayama , Japan, 641-8509Yokohama Health Medicine Association Kannai Suzuki Clinic | Yokohama , Japan, 231-0012Universiti Kebangsaan Malaysia Medical Center | Cheras , Malaysia, 56000Hospital Pulau Pinang | George Town , Malaysia, 10990Hospital Queen Elizabeth | Kota Kinabalu , Malaysia, 88586University Malaya Medical Centre | Kuala Lumpur , Malaysia, 59100Hospital Tengku Ampuan Afzan | Kuantan , Malaysia, 25100NZW Alkmaar (Noordwest Ziekenhuisgroep) | Alkmaar , Netherlands, 1815 JDVU University Medical Centre | Amsterdam , Netherlands, 1081 HVAcademic Medical Center (AMC) | Amsterdam , Netherlands, 1100Gelre Hospital | Apeldoorn , Netherlands, 7334University Medical Center Groningen (UMCG) | Groningen , Netherlands, 9700 RBMaastricht University Medical Centre | Maastricht , Netherlands, 6229 HXErasmus University Medical Center | Rotterdam , Netherlands, 3015 CEElisabeth-TweeSteden Hospital | Tilburg , Netherlands, 5022University Medical Center Utrecht | Utrecht , Netherlands, 3584 CXChristchurch Hospital | Christchurch , New Zealand, 8011Southern District Health Board - Dunedin Hospital | Dunedin , New Zealand, 9016Auckland City Hospital | Grafton , New Zealand, 1023Waikato Hospital | Hamilton , New Zealand, 3240Wellington Hospital | Newtown , New Zealand, 6021Bay of Plenty District Health Board - Tauranga Hospital | Tauranga , New Zealand, 3112Hutt Valley District Health Board - Hutt Valley Hospital | Wellington , New Zealand, 5010Vestre Viken Hospital Trust, Baerum Hospital | Drammen , Norway, 3004Uniwersytecki Szpital Kliniczny w Bialymstoku, Klinika Gastroenterologii i Chorob Wewnetrznych | Bialystok , Poland, 15-276VITAMED Galaj i Cichomski spolka jawna | Bydgoszcz , Poland, 85-079Szpital Uniwersytecki nr 2 im. Dr. Jana Biziela w Bydgoszczy, Centrum Endoskopii Zabiegowej, Poradnia Chorob Jelitowych | Bydgoszcz , Poland, 85-168Gabinet Lekarski Janusz Rudzinski | Bydgoszcz , Poland, 85-681NZOZ INTER-MED, Centrum Endoskopowe | Częstochowa , Poland, 42-217Niepubliczny Zaklad Opieki Zdrowotnej ALL-MEDICUS | Katowice , Poland, 40-659Centrum Medyczno-Diagnostyczne Prima-Med | Krakow , Poland, 30-015Gabinet Endoskopii Przewodu Pokarmowego | Krakow , Poland, 31-009Krakowskie Centrum Medyczne Sp. z o.o. | Krakow , Poland, 31-501Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwerstyeckiego Szpitala Klinicznego nr 1 im. Norbert Barlickiego | Lodz , Poland, 90-153Trialmed Crs | Piotrkow Trybunalski , Poland, 97-300Clinical Research Center Spolka z ograniczna odpowiedzialnoscia Medic-R Sp. k. | Poznan , Poland, 60-848Gabinet Lekarski Dr. Hab. N. Med. Bartosz Korczowski | Rzeszów , Poland, 35-301Endoskopia Sp. Z o.o. | Sopot , Poland, 81-756Twoja Przychodnia-Szczecinskie Centrum Medyczne | Szczecin , Poland, 71-434GASTROMED Kopon, Zmudzkinski i Wspolnicy Sp. j. Specjalistyczne Centrum Gastrologii i Endoskopii | Torun , Poland, 87-100H-T.Centrum Medyczne Spolka z Ograniczona Odpowiedzialnoscia Sp.K. | Tychy , Poland, 43-100Centrum Zdrowia MDM | Warsaw , Poland, 00-635WIP Warsaw IBD Point Profesor Kierkus | Warsaw , Poland, 00-728Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administacji w Warszawie | Warsaw , Poland, 02-507Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie | Warsaw , Poland, 02-781Medical Concierge Centrum Medyczne | Warsaw , Poland, 02-798Niepubliczny Zaklad Opieki Zrodotnej VIVAMED Jadwige Miecz | Warsaw , Poland, 03-580Bodyclinic | Warsaw , Poland, 03-712Centrum Medyczne Oporow | Wroclaw , Poland, 52-416Centrum Medyczne | Wroclaw , Poland, 54-204Hospital de Braga | Braga , Portugal, 4710-243Centro Hospitalar e Universitario de Coimbra, E.P.E. | Coimbra , Portugal, 3000-075Centro Hospitalar Cova de Beira, EPE | Covilha , Portugal, 6200-251Centro Hospitalar do Algarve EPE | Faro , Portugal, 8000-386Hospital da Senhora da Oliveira Guimaraes, E.P.E. | Guimarães , Portugal, 4835-044Hospital Beatriz Angelo | Loures , Portugal, 2674-514Centro Hospitalar de Sao Joao, EPE | Porto , Portugal, 4200-319Unidade Local de Saude do Alto Minho, EPE | Viana do Castelo , Portugal, 4904-858SC MedLife SA, Gastroenterologie | Bucharest , Romania, 010719Spitalul Universitar de Urgenta Militar Central Dr. Carol Davila - Sectia Clinica de Gastroenterologie | Bucharest , Romania, 010825S.C. Centrul Medical Sana S.R.L., Gastroenterologie | Bucharest , Romania, 011025Delta Health Care/ Ponderas Academic Hospital | Bucharest , Romania, 014142Spitalul Clinic Colentina, Gastroenterologie | Bucharest , Romania, 020125MedLife, Gastroenterologie | Bucharest , Romania, 031784Spitalul Universitar de Urgenta Bucuresti - Sectia Medicina Interna II | Bucharest , Romania, 050098Gastromedica SRL, Gastroenterologie | Iași , Romania, 700506Cabinet Particular Policlinic Algomed SRL | Timișoara , Romania, 300002Centrul Medical Tuculanu, Gastroenterologie | Timișoara , Romania, 300168S.C. Policlinica Dr. Citu S.R.L.- Gastroenterologie | Timișoara , Romania, 300594State Budgetary Healthcare Institute "Chelyabinsk Regional Clinical Hospital" | Chelyabinsk , Russia, 454076State Budgetary Institution of Health Irkustsk Order "Badge of Honor" Regional Clinical Hospital | Irkutsk , Russia, 669079State Budgetary Healthcare Institution of Moscow "City Clinical Hospital # 24 of Healthcare Department of Moscow" | Moscow , Russia, 127015State Budgetary Healthcare Institution of Moscow Region "Moscow Regional Clinical Research Institute n.a. M.F. Vladimirskiy" | Moscow , Russia, 129110State Budgetary Healthcare Institution of Nizhny Novgorod Region "Nizhny Novgorod Regional Clinical Hospital n.a. N.A. | Nizhny Novgorod , Russia, 603126State Budgetary Healthcare Institution of the Novosibirsk Region "State Novosibirsk Regional Clinical Hospital" | Novosibirsk , Russia, 630087State Budgetary Institution of Health of Novosibirsk Region "City Clinical Hospital #12" | Novosibirsk , Russia, 630091Saint Petersburg State Budgetary Healthcare Institution "City Polyclinic #38" | Saint Petersburg , Russia, 191015"Scientific Research Centre ECO-safety" LLC | Saint Petersburg , Russia, 196143"PolyClinic EXPERT" LLC | Saint Petersburg , Russia, 197110State Healthcare Institution "Regional Clinical Hospital" | Saratov , Russia, 410053Clinical Center of Serbia | Belgrade , Serbia, 11000Clinical Hospital Center Zemun | Belgrade , Serbia, 11000University Hospital Medical Center Bezanijska kosa | Belgrade , Serbia, 3010-777Zvezdara University Medical Center | Belgrade , Serbia, 3810-969Clinical Center of Vojvodina | Novi Sad , Serbia, 21000National University Hospital | Singapore , Singapore, 119074Singapore General Hospital | Singapore , Singapore, 169608Tan Tock Seng Hospital | Singapore , Singapore, 308433Changi General Hospital | Singapore , Singapore, 529889Cliniq s. r. o., Gastroenterologicke centrum Ruzinov | Bratislava , Slovakia, 82007KM Management, s.r.o., Gastroenterologicke a hepatologicke centrum Nitra | Nitra , Slovakia, 950 01Gastro I., s.r.o. | Prešov , Slovakia, 8001Dr MJ Prins | Cape Town , South Africa, 7500Dr John P Wright | Cape Town , South Africa, 7708Peermed Clinical Trial Centre | Johannesburg , South Africa, 1619Pusan National University Hospital | Busan , South Korea, 49241Yeungnam University Hospital | Daegu , South Korea, 42415Kyung Hee University Hospital | Guri-si , South Korea, 471-701Hanyang University Guri Hospital | Gyeonggi-do , South Korea, 11923CHA Bundang Medical Center, CHA University | Seongnam-si , South Korea, 13496Seoul National University Hospital | Seoul , South Korea, 03080Kangbuk Samsung Hospital | Seoul , South Korea, 03181Yonsei University Health System, Severance Hospital | Seoul , South Korea, 03722Asan Medical Center | Seoul , South Korea, 05505Division of Gastroenterology, Department of Medicine, Samsung Medical Center | Seoul , South Korea, 06351The Catholic University of Korea, St. Vincent's Hospital | Suwon , South Korea, 16247Yonsei University Wonju Severance Christian Hospital | Wŏnju , South Korea, 220-701Hospital Universitari Germans Trias i Pujol | Badalona , Spain, 08916Centro Medico Teknon | Barcelona , Spain, 08022Hospital del Mar | Barcelona , Spain, 8003Complejo Hospitalario Universitario de Ferrol | Ferrol , Spain, 15405Hospital Universitario de Gran Canaria "Dr. Negrin" | Las Palmas de Gran Canaria , Spain, 35010Hospital General Universitario Gregorio Maranon | Madrid , Spain, 28007Hospital Clinico San Carlos | Madrid , Spain, 28040Hospital Universitario de Fuenlabrada | Madrid , Spain, 28942Hospital Universitario Central de Asturias | Oviedo , Spain, 33006Complejo Hospitalario Universitario de Pontevedra | Pontevedra , Spain, 36071Hospital de Sagunto | Sagunto , Spain, 46520Hospital Universitario Virgen del Rocio | Seville , Spain, 41013Hospital de Galdakao-Usandolo | Usansolo , Spain, 48960National Hospital of Sri Lanka | Colombo , Sri Lanka, 00700Teaching hospital Karapitiya | Galle , Sri Lanka, 80000Kandy Teaching Hospital | Kandy , Sri Lanka, 20000Colombo North Teaching Hospital | Ragama , Sri Lanka, 11010Danderyds Sjukhus AB | Danderyd , Sweden, SE-18288Akademiska Sjukhuset | Uppsala , Sweden, 75185Gastroenterologische Praxis Balsiger, Seibold und Partner | Bern , Switzerland, 3012Universitatsspital Zurich | Zurich , Switzerland, 8091Changhua Christian Hospital | Changhua , Taiwan, 500Kaohsiung Medical University Chung-Ho Memorial Hospital | Kaohsiung City , Taiwan, 807Far Eastern Memorial Hospital | New Taipei City , Taiwan, 220Chang Shan Medical University Hospital | Taichung , Taiwan, 40201China Medical University Hospital | Taichung , Taiwan, 40447National Cheng Kung University Hospital | Tainan , Taiwan, 7428National Taiwan University Hospital | Taipei , Taiwan, 100Mackay Memorial Hospital, Taipei | Taipei , Taiwan, 104Taipei Veterans General Hospital | Taipei , Taiwan, 112Tri-Service General Hospital | Taipei , Taiwan, 114Chang Gung Medical Foundation, Chang Gung Memorial Hospital, Linkou Branch | Taoyuan , Taiwan, 33305Bukovinian State Medical University | Chernivtsi , Ukraine, 58000Municipal City Clinical Hospital of the Emergency Medical Care, 1 st Therapy Department. Danylo Halytsky Lviv National Medical | Chernivtsi , Ukraine, 58000State Institution "Institute of Gastroenterology of National Academy of Medical Sciences of Ukraine" | Dnipropetrovsk , Ukraine, 49000Ivanto-Frankivsk Central City Clinic Hospital, Therapy Department #1. State Higher Education Institution Ivano-Frankivsk National | Ivano-Frankivsk , Ukraine, 76018Municipal Health Care Institution "Kharkiv City Clinical Hospital #2 named after prof. O. O. Shalimov", Proctology Department | Kharkiv , Ukraine, 61037Municipal Institution of Health Care "Regional Hospital of War Veterans", Therapeutic Department No1 | Kharkiv , Ukraine, 63101Treatment and Diagnostic Center of Private Enterprise of Private Production Company "Acinus" | Kropyvnytskyi , Ukraine, 25006Kyiv City Clinical Hospital No. 18, Proctology Department | Kyiv , Ukraine, 01030Municipal Non-profit Enterprise "Consultative and Diagnostic Center" of Pechersk District of Kyiv, Therapy Department | Kyiv , Ukraine, 1103Municipal Institution "Odesa Regional Clinical Hospital", Regional Gastroenterology Center based on Surgery Department | Odesa , Ukraine, 65025Ternopil University Hospital, Regional Center of Gastroenterology with Hepatology | Ternopil , Ukraine, 46002Municipal Institution "Uzhgorod District Hospital", Therapy Department | Uzhhorod , Ukraine, 88009Vinnytsia Regional Clinical Hospital of War Veterans, Therapy Department #1 | Vinnytsia , Ukraine, 21005Medical Center LLC "Health Clinic" | Vinnytsia , Ukraine, 21009M.I. Pyrogov Vinnytsia Regional Clinical Hospital, Gastroenterology Department | Vinnytsia , Ukraine, 21018Municipal Institution "Zaporizhzhya Regional Clinical Hospital" of Zaporizhzhya Regional Council | Zaporizhzhya , Ukraine, 69600Norfolk and Norwich University Hospital NHS Foundation Trust | Norwich Norfolk, United Kingdom, NR4 7UYQueen Elizabeth Hospital | Birmingham , United Kingdom, B15 2WBThe Pennine Acute Hospitals NHS Trust | Bury , United Kingdom, BL9 7TDCambridge University Hospital NHS Foundation Trust | Cambridge , United Kingdom, CB2 0QQRoyal Derby Hospital | Derby , United Kingdom, DE22 3NENHS Lothian | Edinburgh , United Kingdom, EH4 2XUMedical Outpatient Department | Exeter , United Kingdom, EX2 5DWGlasgow Clinical Research Facility - Queen Elizabeth University Hospital | Glasgow , United Kingdom, G51 4TFNHS Greater Glasgow and Clyde | Glasgow , United Kingdom, G52 3NQWycombe Hospital | High Wycombe , United Kingdom, HP11 2TTHull Royal Infirmary | Hull , United Kingdom, HU3 2JZImperial College Healthcare NHS Trust, St Mary's Hospital | London , United Kingdom, W2 1NYOxford University Hospitals NHS Foundation Trust | Oxford , United Kingdom, OX3 9DUSt Helens and Knowsley Teaching Hospitals NHS Trust | Prescot , United Kingdom, L35 5DRSouthampton National Institute for Health Research, Wellcome Trust Clinical Research Facility | Southampton , United Kingdom, SO16 6YD
Investigators
Study Director: Galapagos Study Director, Lakefront Biotherapeutics NV
Study Documents (Full Text)
Documents provided by Lakefront Biotherapeutics NV: Study Protocol  December 1, 2021Documents provided by Lakefront Biotherapeutics NV: Statistical Analysis Plan  January 14, 2023