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Filgotinib in Long-Term Extension Study of Adults With Ulcerative Colitis (SELECTIONLTE)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02914535
Recruitment Status : Enrolling by invitation
First Posted : September 26, 2016
Last Update Posted : November 6, 2019
Sponsor:
Collaborator:
Galapagos NV
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:
The primary objective of this study is to observe the long-term safety of filgotinib in adults who have completed or met protocol specified efficacy discontinuation criteria in a prior Gilead-sponsored filgotinib treatment study in ulcerative colitis (UC).

Condition or disease Intervention/treatment Phase
Ulcerative Colitis Drug: Filgotinib Drug: Placebo Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Masking Description: Only 3 arms are blinded in this study.
Primary Purpose: Treatment
Official Title: A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects With Ulcerative Colitis
Actual Study Start Date : February 23, 2017
Estimated Primary Completion Date : October 2026
Estimated Study Completion Date : November 2026

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Filgotinib Dose A (blinded dosing)
Filgotinib dose A + placebo to match dose B for up to 336 weeks
Drug: Filgotinib
Tablet(s) administered orally once daily
Other Names:
  • GS-6034
  • GLPG0634

Drug: Placebo
Tablet(s) administered orally once daily

Experimental: Filgotinib Dose B (blinded dosing)
Filgotinib dose B + placebo to match dose A for up to 336 weeks
Drug: Filgotinib
Tablet(s) administered orally once daily
Other Names:
  • GS-6034
  • GLPG0634

Drug: Placebo
Tablet(s) administered orally once daily

Placebo Comparator: Placebo (blinded dosing)
Placebo for up to 336 weeks
Drug: Placebo
Tablet(s) administered orally once daily

Experimental: Filgotinib Dose A (open-label)
Filgotinib dose A for up to 336 weeks
Drug: Filgotinib
Tablet(s) administered orally once daily
Other Names:
  • GS-6034
  • GLPG0634

Experimental: Filgotinib Dose B (open-label)
Filgotinib dose B for up to 336 weeks
Drug: Filgotinib
Tablet(s) administered orally once daily
Other Names:
  • GS-6034
  • GLPG0634




Primary Outcome Measures :
  1. Overall Safety Profile of Filgotinib Evaluated by Proportion of Participants Experiencing Adverse Events and Abnormal Clinical Laboratory Tests [ Time Frame: Up to 336 weeks plus 30 days ]

Secondary Outcome Measures :
  1. Change From Baseline in Components of Mayo Clinic Score (MCS) [ Time Frame: Baseline and up to 336 weeks ]


Information from the National Library of Medicine

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Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Must have the ability to understand and sign a written informed consent form (ICF), which must be obtained prior to initiation of study procedures associated with this trial
  • Must have enrolled in Gilead-sponsored UC parent protocol GS-US-418-3898
  • Must have completed all required procedures or met protocol specified efficacy discontinuation criteria in a prior Gilead-sponsored filgotinib treatment study for UC
  • Females of childbearing potential must have a negative pregnancy test at Day 1
  • Male and female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception as described in the protocol for the duration described
  • Willingness to refrain from live or attenuated vaccines during the study and for 12 weeks after last dose of study drug

Key Exclusion Criteria:

  • Known hypersensitivity to the study drug
  • Any chronic medical condition (including, but not limited to, cardiac or pulmonary disease, alcohol or drug abuse) that, in the opinion of the Investigator or sponsor, would make the subject unsuitable for the study or would prevent compliance with the study protocol
  • Males or females of reproductive potential who are unwilling to abide by protocol-specified contraceptive methods as defined in the participants
  • Use of prohibited medications as outlined in the protocol

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02914535


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Locations
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United States, Alabama
Digestive Health Specialists Of The Southeast
Dothan, Alabama, United States, 36305
United States, Arizona
Mayo Clinic Arizona
Scottsdale, Arizona, United States, 85259
United States, California
VA Long Beach Healthcare System
Long Beach, California, United States, 90822
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048
Clearview Medical Research, LLC
Santa Clarita, California, United States, 91351
United States, Colorado
University of Colorado Denver and Hospital
Aurora, Colorado, United States, 80045
South Denver Gastroenterology, PC
Lone Tree, Colorado, United States, 80124
United States, Connecticut
Connecticut GI PC-Research Division
Farmington, Connecticut, United States, 06032
United States, District of Columbia
Medstar Georgetown University Hospital
Washington, District of Columbia, United States, 20007
United States, Florida
UF Clinical Research Center
Gainesville, Florida, United States, 32610
Florida Research Institute
Lakewood Ranch, Florida, United States, 34211
University of Miami Crohn's and Colitis Center
Miami, Florida, United States, 33136
Advanced Pharma CR, LLC
Miami, Florida, United States, 33147
Cordova Research Institute
Miami, Florida, United States, 33155
Gastroenterology Group of Naples
Naples, Florida, United States, 34102
Center for Interventional Endoscopy - Florida Hospital
Orlando, Florida, United States, 32803
Gulf Region Clinical Research Institute
Pensacola, Florida, United States, 32514
Advanced Medical Research Center
Port Orange, Florida, United States, 32127
Tampa General Hospital
Tampa, Florida, United States, 33606
Shafran Gastroenterology Center
Winter Park, Florida, United States, 32789
Florida Medical Clinic, P.A
Zephyrhills, Florida, United States, 33540
United States, Georgia
Atlanta Gastroenterology Specialist, PC
Atlanta, Georgia, United States, 30308
Gastroenterology Associates Of Central Georgia, LLC
Macon, Georgia, United States, 31201
Gastrointestinal Specialists of Georgia
Marietta, Georgia, United States, 30060
United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
United States, Kentucky
University of Louisville, Clinical Trials Unit
Louisville, Kentucky, United States, 40202
United States, Louisiana
Delta Research Partners, LLC
Monroe, Louisiana, United States, 71201
Louisiana Research Center, LLC
Shreveport, Louisiana, United States, 71105
United States, Maryland
Investigative Clinical Research
Annapolis, Maryland, United States, 21401
MGG Group Co., Inc., Chevy Chase Clinical Research
Chevy Chase, Maryland, United States, 20815
Gastro Center of Maryland
Columbia, Maryland, United States, 21045
Meritus Center for Clinical Research
Hagerstown, Maryland, United States, 21742
United States, Massachusetts
Massachusetts General Hospital - Crohn's and Colitis Center
Boston, Massachusetts, United States, 02114
United States, Michigan
Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan, United States, 48047
Center for Digestive Health
Troy, Michigan, United States, 48098
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
United States, Missouri
Kansas City Research Institute
Kansas City, Missouri, United States, 64131
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, Nevada
Las Vegas Medical Research
Las Vegas, Nevada, United States, 89113
United States, New Jersey
AGA Clinical Research Associates, LLC
Egg Harbor Township, New Jersey, United States, 08234
United States, New York
NY Scientific
Brooklyn, New York, United States, 11235
NYU Langone Long Island Clinical Research Associates
Great Neck, New York, United States, 11021
Lenox Hill Hospital
New York, New York, United States, 10028
United States, North Carolina
Carolina's GI Research LLC
Raleigh, North Carolina, United States, 27607
United States, North Dakota
Fargo Gastroenterology and Hepatology Clinic
Fargo, North Dakota, United States, 58103
United States, Ohio
Consultants for Clinical Research
Cincinnati, Ohio, United States, 45219
UC Health Physicians Clifton
Cincinnati, Ohio, United States, 45219
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio, United States, 44060
Paramount Medical Research & Consulting, LLC
Middleburg Heights, Ohio, United States, 44130
United States, South Carolina
Gastroenterology Associates of Orangeburg
Orangeburg, South Carolina, United States, 29118
United States, South Dakota
Rapid City Medical Center
Rapid City, South Dakota, United States, 57701
United States, Tennessee
WR-ClinSearch, LLC
Chattanooga, Tennessee, United States, 37421
Gastro One
Germantown, Tennessee, United States, 38138
Quality Medical Research
Nashville, Tennessee, United States, 37211
Vanderbilt University Medical Center - IBD Clinic
Nashville, Tennessee, United States, 37212-1375
United States, Texas
Texas Clinical Research Institute
Arlington, Texas, United States, 76012
Inquest Clinical Research
Baytown, Texas, United States, 77521
San Antonio Military Medical Center
Fort Sam Houston, Texas, United States, 78219
DHAT Research Institute
Garland, Texas, United States, 75044
Kelsey-Seybold Clinic
Houston, Texas, United States, 77025
Baylor College of Medicine - Baylor Medical Center
Houston, Texas, United States, 77030
The University of Texas Health Science Center at Houston
Houston, Texas, United States, 77030
Gulf Coast Research Group
Houston, Texas, United States, 77098
Clinical Associates in Research Therapeutics of America, LLC
San Antonio, Texas, United States, 78212
Gastroenterology Research of San Antonio
San Antonio, Texas, United States, 78229
TDDC San Marcos
San Marcos, Texas, United States, 78666
Texas Digestive Disease Consultants
Southlake, Texas, United States, 76092
Spring Gastroenterology
The Woodlands, Texas, United States, 77380
United States, Utah
HP Clinical Research
Bountiful, Utah, United States, 84010
Synexus Clinical Research US, Inc./Wasatch Peak Family Practice
Layton, Utah, United States, 84041
United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
Charlottesville Medical Research Center, LLC
Charlottesville, Virginia, United States, 22911
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, United States, 23320
Emeritas Research Group
Leesburg, Virginia, United States, 20176
Digestive and Liver Disease Specialists
Norfolk, Virginia, United States, 23502
McGuire DVAMC
Richmond, Virginia, United States, 23249
Virginia Commonwealth University
Richmond, Virginia, United States, 23298-0341
United States, Wisconsin
University of Wisconsin Hospital & Clinics
Madison, Wisconsin, United States, 53705
Allegiance Research Specialists, LLC
Wauwatosa, Wisconsin, United States, 53225
Argentina
Instituto de Investigaciones Clinicas Mar del Plata
Mar del Plata, Argentina, B7600FZN
Instituto Médico Cer
Quilmes, Argentina, B1878
Fundacion Estudios Clinicos CiRec
Rosario, Argentina, S2000DEF
Australia, New South Wales
Monash Medical Centre
Clayton, New South Wales, Australia, 3168
St. Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia, 2010
Nepean Hospital
Kingswood, New South Wales, Australia, 2747
Wollongong Hospital
Wollongong, New South Wales, Australia, 2500
Australia, Queensland
Wesley Medical Research
Auchenflower, Queensland, Australia, 4066
Coastal Digestive Health
Mountain Creek, Queensland, Australia, 4557
Mater Misericordiae Ltd
South Brisbane, Queensland, Australia, 4101
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Australia, South Australia
Flinders Medical Centre
Bedford Park, South Australia, Australia, 5042
Australia, Victoria
Footscray Hospital
Footscray, Victoria, Australia, 3011
Austin Health
Heidelberg, Victoria, Australia, 3084
Cabrini Hospital
Malvern, Victoria, Australia, 3144
Alfred Hospital
Melbourne, Victoria, Australia, 3004
Australia
The Canberra Hospital
Garran, Australia, 2605
The Queen Elizabeth Hospital
Woodville South, Australia, 5011
Austria
Universitatsklinik Innsbruck
Innsbruck, Austria, 6020
AKH-Medizinische Universitat Wien
Wien, Austria, 1090
Belgium
GZA Ziekenhuizen, campus Sint-Vincentius
Antwerpen, Belgium, 2018
CUB Hopital Erasme
Brussel, Belgium, 1070
Universitair Ziekenhuis Leuven
Leuven, Belgium, 3000
CHR Citadelle
Liege, Belgium, 4000
Centre Hospitalier Chretien (CHC) - Clinique Saint-Joseph
Liège, Belgium, 4000
Bulgaria
MHAT Sveti Pantaleymon- Pleven OOD
Pleven, Bulgaria, 5800
Medical Center - Complete Medical Solutions OOD
Samokov, Bulgaria, 2000
"MHAT - Silistra" AD
Silistra, Bulgaria, 7500
Medical Center - "Tsaritsa Yoanna" EOOD
Sliven, Bulgaria, 8800
"MDHAT Dr. St.Cherkezov" AD
Veliko Tarnovo, Bulgaria, 5000
MHAT "Sveta Petka" AD
Vidin, Bulgaria, 3700
Canada
University of Calgary, Heritage Medical Research Clinic
Calgary, Canada, T2N 4Z6
Hamilton Health Sciences Corporation, McMaster University Medical Centre
Hamilton, Canada, L8S 4K1
London Health Sciences Centre - University Hospital
London, Canada, N6A 5A5
Royal University Hospital
Saskatoon, Canada, S7N 0W8
The Gordon and Leslie Diamond Health Care Centre
Vancouver, Canada, V5Z 1M9
Toronto Digestive Disease Associates Inc.
Vaughan, Canada, L4L 4Y7
Discovery Clinical Services Ltd.
Victoria, Canada, V8T 5G4
Croatia
University Hospital Center Osijek
Osijek, Croatia, 31 000
Clinical Hospital Dubrava
Zagreb, Croatia, 10000
Clinical Hospital Merkur
Zagreb, Croatia, 10000
University Hospital Center Zagreb
Zagreb, Croatia, 10000
Czechia
Hepato-Gastroenterology HK, s.r.o.
Hradec Kralove, Czechia, 500 12
Oblastni nemocnice Mlada Boleslav, a.s., nemocnice Stredoceskeho kraje, Gastroenterologicke oddeleni
Mlada Boleslav, Czechia, 293 01
G.E.P. Clinic, s r.o.
Praha 3, Czechia, 130 00
ISCARE I.V.F. a.s., Klinicke a vyzkumne centrum pro strevni zanety
Praha 7, Czechia, 170 04
France
CHU Amiens Picardie
Amiens, France, 80054
CHU de Caen
Caen, France, 14033
CHU de Clermont-Ferrand - Hopital d'Estaing
Clermont-Ferrand, France, 63003
APHP - Hopital Beaujon - Clichy - Universite Paris VII
Clichy, France, 92110
CHU de Dijon Bourgogne - Hopital Francois Mitterand
Dijon, France, 21079
CHU Grenoble Alpes
La Tronche, France, 38700
Hopital Universitaire de Bicetre
Le Kremlin Bicetre, France, 94270
Centre Hospitalier Regional Universitaire de Lille
Lille, France, 59000
Hopital Nord
Marseille, France, 13015
CHU de Montpellier-Hopital Saint Eloi
Montpellier, France, 34295
CHU Hotel-Dieu
Nantes, France, 44093
Hopital de l'Archet 2
Nice, France, 06202
Institut Mutualiste Montsouris
Paris, France, 75014
CHU de Bordeaux - Hopital Haut Leveque
Pessac, France, 33600
Centre Hospitalier Universitaire de Lyon Sud
Pierre-Benite, France, 69495
CH Annecy Genevois - Site d'Annecy
Pringy, France, 74374
Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
Rennes, France, 35033
CHU de Saint Etienne - Hopital Nord
Saint Priest en Jarez, France, 42055
Nouvel Hopital Civil
Strasbourg, France, 67091
Hopitaux Universitaires de Strasbourg - Hopital de Hautepierre
Strasbourg, France, 67098
CHU de Toulouse - Hopital Purpan
Toulouse, France, 31059
CHU de Toulouse - Hopital Rangueil
Toulouse, France, 31059
CHU de Nancy - Hopital Brabois Adultes
Vandoeuvre Les Nancy, France, 54511
Georgia
Unimed Ajara LLC - Batumi Referral Hospital
Batumi, Georgia, 6010
Ltd. Acad. Fridon Todua Medical Center - Ltd. Research Institute of Clinical Medicine
Tbilisi, Georgia, 0112
Medi Club Georgia LLC
Tbilisi, Georgia, 0160
Ltd. Unimed Kakheti - Telavi Referral Hospital
Telavi, Georgia, 2200
Germany
Charite Universitaetsmedizin Berlin
Berlin, Germany, 10117
Charite - Universitatsmedizin Berlin
Berlin, Germany, 13353
DRK Kliniken Berlin - Westend - Klinik fuer Innere Medizin
Berlin, Germany, 14050
Stadtisches Klinikum Braunschweig gGmbH
Braunschweig, Germany, 38126
Agaplesion Markus Krankenhaus
Frankfurt am Main, Germany, 60431
CED Studien UG, Interdisciplinary Crohn Colitis Center (iCCC) Rhein-Main
Frankfurt am Main, Germany, 60594
Universitatsklinikum Freiburg
Freiburg, Germany, 79106
Asklepios Westklinikum Hamburg
Hamburg, Germany, 22559
Medizinische Hochschule Hannover
Hannover, Germany, 30625
Universitatsklinikum Heidelberg
Heidelberg, Germany, 60120
Praxis fur Gastroenterologie
Heidelberg, Germany, 69121
Gastroenterologische Gemeinschaftspraxis Herne
Herne, Germany, 44623
Universitatsklinikum Jena
Jena, Germany, 07747
Universitatsklinikum Schleswig-Holstein
Kiel, Germany, 24105
Universitaetsklinik Koeln
Koln, Germany, 50937
EUGASTRO GmbH
Leipzig, Germany, 04103
Universitatsklinikum Leipzig
Leipzig, Germany, 04103
Klinikum Luneburg
Lüneburg, Germany, 21339
Gastroenterologische Gemeinschaftspraxis
Mainz, Germany, 55122
Gastroenterologische Gemeinschaftspraxis Minden
Minden, Germany, 32423
Klinikum der Universitat Munchen - Grosshadern
Muenchen, Germany, 81377
Megan-Darm-Zentrum Remscheid, Praxis fuer Gastroenterologie und Hepatologie
Remscheid, Germany, 42859
Univeristaetsmedizin Rostock, Zentrum fuer Innere Medizin
Rostock, Germany, 18057
Universitaetsklinikum Tuebingen
Tuebingen, Germany, 72074
Universitatsklinikum Ulm, Zentrum Fur Innere Medizin
Ulm, Germany, 89081
Greece
General Hospital of Athens "Hippokratio", 2nd Internal Medicine Clinic of Athens University, Hepato-gastroenterology Unit
Athens, Greece, 11527
General Hospital of Nikaias "Agios Pentelleimon", Gastroenterology Department
Athens, Greece, 184 54
University General Hospital of Ioannina, Gastroenterology Department, Internal Medicine Division
Ioannina, Greece, 45332
University General Hospital of Patras "Panagia I Voithia", Gastroenterology Department, Internal Medicine Division
Patra, Greece, 26504
Hippokratio General Hospital of Thessaloniki "Hippokratio" 4th Internal Medicine Department of Aristotle University of Thessaloniki
Thessaloniki, Greece, 54642
Hong Kong
Princess 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
Hungary
Bekes Megyei Kosponti Korhaz, Dr. Rethy Pal Tagkorhaz, IV. Belgyogyaszat - 2. Gasztroenterologia
Bekescsaba, Hungary, 5600
Szent Margit Korhaz, Gasztroenterológiai Osztály
Budapest, Hungary, 1032
Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet, Kozponti Felnott Szakrendelo
Budapest, Hungary, 1097
Szent Janos Korhaz es Eszak-budai Egitett Korhazak, I. Belgyogyaszati - Gasztroenterologiai Osztaly
Budapest, Hungary, 1125
Debreceni Egyetem Klinikai Kozpont, II. sz. Belgyogyaszati Klinika, Gasztroenterologia
Debrecen, Hungary, 4032
Bugat Pal Korhaz, Belgyogyaszat
Gyöngyös, Hungary, 3200
Karolina Korhaz es Rendelointezet, Altalanos Belgyogyaszat-Gasztroenterologia
Mosonmagyarovar, Hungary, 9200
Iceland
Landspitali University Hospital
Reykjavík, Iceland, 101
India
Kaizen Hospital
Ahmedabad, India, 380052
Victoria Hospital, Bangalore Medical College and Research Institute (BMCRI)
Bangalore, India, 560002
M S Ramaiah Medical College and Hospital
Bangalore, India, 560054
Apollo Speciality Hospital
Chennai, India, 600035
VGM Hospital Institute of Gastroenterology
Coimbatore, India, 641005
Gleneagles Global Hospitals
Hyderabad, India, 500004
Citizens Specialty Hospital
Hyderabad, India, 500019
Centre for Liver Research & Diagnostics
Hyderabad, India, 500058
SR Kalla Memorial Gastro and General Hospital
Jaipur, India, 302001
S.M.S Medical College & Hospitals
Jaipur, India, 302004
School of Digestive & Liver Diseases
Kolkata, India, 700020
Dayanand Medical College & Hospital
Ludhiana, India, 141001
Kasturba Medical College (KMC) Hospital
Mangaluru, India, 575001
Lokmanya Tilak Municipal General Hospital
Mumbai, India, 400022
Midas Multispeciality Hospital Pvt. Ltd
Nagpur, India, 440010
Suretech Hospital & Research Centre Ltd
Nagpur, India, 440012
All India Institute of Medical Sciences
New Delhi, India, 110029
Grant Medical Foundation Ruby Hall Clinic
Pune, India, 411001
Shree Giriraj Multispeciality Hospital
Rājkot, India, 360002
Gandhi Hospital
Secunderabad, India, 500003
Institute of Gastroenterology & Liver Disease. Sunshine Hospitals
Secunderabad, India, 500003
Surat Institute of Digestive Sciences
Surat, India, 395002
Kasturba Hospital Medical College
Udupi, India, 576104
Sterling Hospital
Vadodara, India, 390007
Samvedna Hospital
Varanasi, India, 221005
Ireland
Clinical Research Centre, Mater Misericordiae University Hospital
Dublin, Ireland, 7
Beaumont Hospital
Dublin, Ireland, 9
Israel
Emek Medical Center
Afula, Israel, 18101
Soroka Medical Center
Beer-Sheva, Israel, 8410101
Bnai Zion Medical Center
Haifa, Israel, 31048
Rambam Medical Health Care Campus
Haifa, Israel, 3109601
The Lady Davis Carmel Medical Center
Haifa, Israel, 3436212
Shaare Zedek Medical Center
Jerusalem, Israel, 9103102
Hadassah Medical Center
Jerusalem, Israel, 9112001
Rabin Medical Center
Petah Tikva, Israel, 4941492
Italy
UOC Gastroenterologia II
Castellana Grotte, Italy, 70013
U.O. Fisiopatologia Digestiva
Catanzaro, Italy, 88100
Ospedale Clinicizzato SS. Annunziata - Dipartimento di Medicina
Chieti, Italy, 66100
Gastroenterologia clinica - Azienda Ospedaliero-Universitaria Careggi
Firenze, Italy, 50134
Endocsopia Digestiva Centralizzata - ASST Fatebenefratelli Sacco, Ospedale Fatebenefratelli e Oftalmico
Milano, Italy, 20121
UO Gastroenterologia
Modena, Italy, 40124
UOC Gastroenterologia
Padova, Italy, 35128
Azienda Ospedaliero-Universitaria Pisana - Presidio Ospedaliero Cisanello
Pisa, Italy, 56124
UOC di Gastroenterologia ed Endoscopia Digestiva
Roma, Italy, 00133
UOC Gastroenterologia ed Endoscopia Digestiva
Roma, Italy, 128
Istituto Clinico Humanitas
Rozzano, Italy, 20089
Japan
Ohmori Toshihide gastro-intestinal Clinic
Ageo-shi, Japan, 362-0075
Medical Hospital, Tokyo Medical and Dental University
Bunkyo-ku, Japan, 113-8519
Fukuoka University Chikushi Hospital
Chikushino-shi, Japan, 818-8502
Hokkaido P.W.F.A.C Sapporo-Kosei General Hospital
Chuo-ku, Japan, 060-0033
Japanese Red Cross Fukuoka Hospital
Fukuoka-shi, Japan, 815-8555
Tokai University Hachioji Hospital
Hachioji, Japan, 192-0032
Kansai Medical University Hospital
Hirakata-shi, Japan, 573-1191
Hiroshima University Hospital
Hiroshima, Japan, 734-8551
Fukuoka University Hospital
Jonan-ku, Japan, 814-0180
Nanpuh Hospital
Kagoshima-shi, Japan, 892 -8512
Ofuna Chuo Hospital
Kamakura, Japan, 247-0056
Tsujinaka Hospital
Kashiwa-city, Japan, 277-0871
Saitama Medical Center, Saitama Medical University
Kawagoe, Japan, 350-8550
Kitakyushu City Hospital Organization Kitakyushu Municipal Medical Center
Kitakyushu-shi, Japan, 802-0077
Yamanashi Prefectural Central Hospital
Kofu-shi, Japan, 400-8506
Kurume University Hospital
Kurume-shi, Japan, 830-0011
Hidaka Coloproctology Clinic
Kurume-shi, Japan, 839-0809
University Hospital, Kyoto Prefectural University of Medicine
Kyoto-shi, Japan, 602-8566
The Jikei University Hospital
Minato-Ku, Japan, 105-8471
Kitasato University Kitasato Institute Hospital
Minato-ku, Japan, 108-8642
Kyorin University Hospital
Mitaka-shi, Japan, 181-8611
Iwate Medical University Hospital
Morioka-shi, Japan, 020-8505
Aichi Medical University Hospital
Nagakute-shi, Japan, 480-1195
Nagasaki University Hospital
Nagasaki-shi, Japan, 8528501
Saiseikai Niigata Daini Hospital
Nishi-ku, Japan, 950-1104
Hyogo College of Medicine College Hospital
Nishinomiya, Japan, 663-8501
Ishida IBD Clinic
Oita-shi, Japan, 870-0823
Okayama University Hospital
Okayama-city, Japan, 700-8558
Kinshukai Infusion Clinic
Osaka, Japan, 530-0011
Osaka City University Hospital
Osaka, Japan, 545-8586
Wakakusa-Daiichi Hospital
Osaka, Japan, 579-8056
Shiga University of Medical Science Hospital
Otsu, Japan, 520-2192
Saga-Ken Medical Centre Koseikan
Saga-shi, Japan, 840-8571
Kitasato University Hospital,THE KITASATO INSTITUTE
Sagamihara, Japan, 252-0375
Saga University Hospital
Saga, Japan, 849-8501
Tokito Clinic
Saitama, Japan, 336-0963
Toho University Sakura Medical Center
Sakura, Japan, 285-8741
Sapporo Higashi Tokushukai Hospital
Sapporo-shi, Japan, 065-0033
Sapporo Tokushukai Hospital
Sapporo, Japan, 004-0041
National Hospital Organization Sendai Medical Center
Sendai, Japan, 983-8520
NTT Medical Center Tokyo
Shinagawa-ku, Japan, 141-8625
Tokyo Yamate Medical Center
Shinjuku-ku, Japan, 169-0073
Osaka University Hospital
Suita, Japan, 565-0871
Kagawa Prefectural Central Hospital
Takamatsu-shi, Japan, 760-8557
National Hospital Organization Takasaki General Medical Center
Takasaki-shi, Japan, 3700829
Osaka Medical College Hospital
Takatsuki, Japan, 569-8686
Ieda Hospital
Toyota-shi, Japan, 470-1219
Wakayama Medical University Hospital
Wakayama-shi, Japan, 641-8509
Colo-proctology Center Matsushima Clinic
Yokohama-shi, Japan, 220-0045
Yokohama Health Medicine Association Kannai Suzuki Clinic
Yokohama-shi, Japan, 231-0012
Korea, Republic of
Pusan National University Hospital
Busan, Korea, Republic of, 49241
Yeungnam University Hospital
Daegu, Korea, Republic of, 42415
Hanyang University Guri Hospital
Gyeonggi-do, Korea, Republic of, 11923
CHA Bundang Medical Center, CHA University
Seongnam-si, Korea, Republic of, 463-712
Seoul National University Hospital
Seoul, Korea, Republic of, 03080
Kangbuk Samsung Hospital
Seoul, Korea, Republic of, 03181
Yonsei University Health System, Severance Hospital
Seoul, Korea, Republic of, 03722
Asan Medical Center
Seoul, Korea, Republic of, 05505
Division of Gastroenterology, Department of Medicine, Samsung Medical Center
Seoul, Korea, Republic of, 06351
Kyung Hee University Hospital
Seoul, Korea, Republic of, 130-872
The Catholic University of Korea, St. Vincent's Hospital
Suwon-si, Korea, Republic of, 106247
Yonsei University Wonju Severance Christian Hospital
Wonju, Korea, Republic of, 220-701
Malaysia
Hospital Selayang
Batu Caves, Malaysia, 68100
Universiti Kebangsaan Malaysia Medical Center
Cheras, Malaysia, 56000
Hospital Pulau Pinang
George Town, Malaysia, 10990
Hospital Sultanah Aminah
Johor Bahru, Malaysia, 80100
Hospital Queen Elizabeth
Kota Kinabalu, Malaysia, 88586
Hospital Tengku Ampuan Afzan
Kuantan, Malaysia, 25100
Mexico
PCR-Phylasis Clinicas Research S. de R.L. de C.V.
Cuautitlán Izcalli, Mexico, 54750
Netherlands
Academic Medical Center (AMC)
Amsterdam, Netherlands, 1100
Gelre Hospital
Apeldoorn, Netherlands, 7334
Maastricht University Medical Centre
Maastricht, Netherlands, 6229 HX
Erasmus University Medical Center
Rotterdam, Netherlands, 3015 CE
University Medical Center Utrecht
Utrecht, Netherlands, 3584 CX
New Zealand
Christchurch Hospital
Christchurch, New Zealand, 8011
Southern District Health Board - Dunedin Hospital
Dunedin, New Zealand, 9016
Auckland City Hospital
Grafton, New Zealand, 1023
Waikato Hospital
Hamilton, New Zealand, 3240
Wellington Hospital
Newtown, New Zealand, 6021
Bay of Plenty District Health Board - Tauranga Hospital
Tauranga, New Zealand, 3134
Hutt Valley District Health Board - Hutt Valley Hospital
Wellington, New Zealand, 5010
Poland
Uniwersytecki Szpital Kliniczny w Bialymstoku, Klinika Gastroenterologii i Chorob Wewnetrznych
Bialystok, Poland, 15-276
VITAMED Galaj i Cichomski spólka jawna
Bydgoszcz, Poland, 85-079
Gabinet Lekarski Janusz Rudzinski
Bydgoszcz, Poland, 85-681
NZOZ INTER-MED, Centrum Endoskopowe
Czestochowa, Poland, 42-217
Niepubliczny Zaklad Opieki Zdrowotnej ALL-MEDICUS
Katowice, Poland, 40-659
Uniwersyteckie Centrum Kliniczne im. prof. Gibinskiego Slaskiego Uniwestytetu Medyznego w Katowicach
Katowice, Poland, 40-752
Gabinet Endoskopii Przewodu Pokarmowego
Krakow, Poland, 31-009
Centrum Medyczno-Diagnostyczne Prima-Med
Kraków, Poland, 30-015
Krakowskie Centrum Medyczne Sp. z o.o
Kraków, Poland, 31-501
Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp. J.
Ksawerów, Poland, 95-054
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwerstyeckiego Szpitala Klinicznego nr 1 im. Norbert Barlickiego
Lodz, Poland, 90-153
Santa Familia, Centrum Badan, Profilaktyki i Leczenia
Lodz, Poland, 90-302
Centrum Innowacyjnych Terapii Sp. z o.o.
Piaseczno, Poland, 05-500
Clinical Research Center Spolka z ograniczna odpowiedzialnoscia Medic-R Sp. k.
Poznan, Poland, 60-848
Gabinet Lekarski Dr. Hab. N. Med. Bartosz Korczowski
Rzeszów, Poland, 35-301
Endoskopia Sp. z o.o.
Sopot, Poland, 81-756
Twoja Przychodnia-Szczecinskie Centrum Medyczne
Szczecin, Poland, 71-434
GASTROMED Kopon, Zmudzkinski i Wspolnicy Sp. j. Specjalistyczne Centrum Gastrologii i Endoskopii
Torun, Poland, 87-100
H-T.Centrum Medyczne Spolka z Ograniczona Odpowiedzialnoscia Sp.K.
Tychy, Poland, 43-100
Bodyclinic
Warszawa, Poland, 00-332
Centrum Zdrowia MDM
Warszawa, Poland, 00-635
Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administacji w Warszawie
Warszawa, Poland, 02-507
Niepubliczny Zaklad Opieki Zrodotnej VIVAMED Jadwige Miecz
Warszawa, Poland, 03-580
Centrum Medyczne Oporow
Wroclaw, Poland, 52-416
Centrum Medyczne
Wrocław, Poland, 54-204
Portugal
Centro Hospitalar do Algarve EPE
Faro, Portugal, 8000-386
Hospital da Senhora da Oliveira Guimaraes, E.P.E.
Guimaraes, Portugal, 4835-044
Centro Hospitalar Lisboa Ocidental EPE-Hospital de Egas Moniz
Lisboa, Portugal, 1349-019
Hospital Beatriz Angelo
Loures, Portugal, 2674-514
Centro Hospitalar de Sao Joao, EPE
Porto, Portugal, 4200-319
Romania
S.C. Centrul Medical Sana S.R.L., Gastroenterologie
Bucharest, Romania, 011025
Spitalul Universitar de Urgenta Bucuresti - Sectia Medicina Interna II
Bucharest, Romania, 050098
MedLife, Gastroenterologie
Bucuresti, Romania, 010719
Spitalul Clinic Colentina - Sectia de Spitulal Clinic Colentina, Gastroenterologie
Bucuresti, Romania, 020125
MedLife, Gastroenterologie
Bucuresti, Romania, 031784
Medinsys Medical Center, Gastroenterologie
Craiova, Romania, 200130
Gastromedica SRL, Gastroenterologie
Iasi, Romania, 700506
Cabinet Medical Individual Dr Tirnaveanue Amelita, Gastroenterologie
Oradea, Romania, 410066
Cabinet Particular Policlinic Algomed SRL
Timisoara, Romania, 300002
Centrul Medical Tuculanu, Gastroenterologie
Timisoara, Romania, 300168
S.C. Policlinica Dr. Citu S.R.L.- Gastroenterologie
Timisoara, Romania, 300594
Spitalul Clinic Judetean Mures - Sectia Gastroenterologie
Tirgu Mures, Romania, 540103
Russian Federation
State Budgetary Healthcare Institution "Chelyabinski Regional Clinical Hospital"
Chelyabinsk, Russian Federation, 454076
State Budgetary Institution of Health Irkustsk Order "Badge of Honor" Regional Clinical Hospital
Irkutsk, Russian Federation, 669079
Federal State Budgetary Institution of Science Federal Research Center of Nutrition, Biotechnology and Food Safety
Moscow, Russian Federation, 115446
Federal State Budgetary Healthcare Institution Central Clinical Hospital of the Russian Academy of Sciences
Moscow, Russian Federation, 117593
State Budgetary Healthcare Institution of Moscow "City Clinical Hospital # 24 of Healthcare Department of Moscow"
Moscow, Russian Federation, 127015
State Budgetary Healthcare Institution of Moscow Region "Moscow Regional Clinical Research Institute n.a. M.F. Vladimirskiy"
Moscow, Russian Federation, 129110
State Budgetary Healthcare Institution of Nizhny Novgorod Region "Nizhny Novgorod Regional Clinical Hospital n.a. N.A.
Nizhniy Novgorod, Russian Federation, 603126
State Budgetary Healthcare Institution of the Novosibirsk Region "State Novosibirsk Regional Clinical Hospital"
Novosibirsk, Russian Federation, 630087
State Budgetary Institution of Health of Novosibirsk Region "City Clinical Hospital #12"
Novosibirsk, Russian Federation, 630091
Saint Petersburg State Budgetary Healthcare Institution "City Polyclinic #38"
Saint Petersburg, Russian Federation, 193015
"Riat" LLC
Saint Petersburg, Russian Federation, 193163
"PolyClinic EXPERT" LLC
Saint Petersburg, Russian Federation, 197110
"Scientific Research Centre ECO-safety" LLC
Saint-Petersburg, Russian Federation, 196143
State Healthcare Institution "Regional Clinical Hospital"
Saratov, Russian Federation, 410053
Treatment and Prevention Interdistrict Institution "Smolenskie kliniki" LLC
Smolensk, Russian Federation, 214019
Tyumen Regional State Autonomous Healthcare Institution << Consulting and Diagnostic Centre <<Endos>>
Tyumen, Russian Federation, 625026
Serbia
Clinical Hospital Center Zemun
Belgrade, Serbia, 11000
University Hospital Medical Center Bezanijska kosa
Belgrade, Serbia, 3010-777
Clinical Center of Serbia
Belgrade, Serbia, 3618-447
Zvezdara University Medical Center
Belgrade, Serbia, 3810-972
Clinical Center Nis
Nis, Serbia, 18000
Clinical Center of Vojvodina
Novi Sad, Serbia, 21000
Singapore
National University Hospital
Singapore, Singapore, 119074
Singapore General Hospital
Singapore, Singapore, 169608
Changi General Hospital
Singapore, Singapore, 529889
Khoo Teck Puat Hospital
Singapore, Singapore, 768828
Slovakia
IBDcentrum, s.r.o.
Bratislava, Slovakia, 81108
Univerztina nemocnica Bratislava, Nemocnica Ruzinov, V. interna klinika, Gastroenterologicke a hepatologicke oddelenie
Bratislava, Slovakia, 82626
KM Management, s.r.o., Gastroenterologicke a hepatologicke centrum Nitra
Nitra, Slovakia, 950 01
South Africa
Dr MJ Prins
Cape Town, South Africa, 7500
Dr John P Wright
Cape Town, South Africa, 7708
Peermed Clinical Trial Centre
Johannesburg, South Africa, 1619
Spain
Centro Medico Teknon
Barcelona, Spain, 08022
Hospital del Mar
Barcelona, Spain, 8003
Complejo Hospitalario Universitario de Ferrol
Ferrol, Spain, 15405
Hospital Universitario de Gran Canaria "Dr. Negrin"
Las Palmas de Gran Canaria, Spain, 35010
Hospital General Universitario Gregorio Maranon
Madrid, Spain, 28007
Hospital Clinico San Carlos
Madrid, Spain, 28040
Hospital Universitario de Fuenlabrada
Madrid, Spain, 28942
Hospital Universitario Central de Asturias
Oviedo, Spain, 33006
Hospital de Sagunto
Sagunto, Spain, 46520
Hospital Universitario Virgen del Rocío
Sevilla, Spain, 41013
Hospital de Galdakao-Usandolo
Usansolo, Spain, 48960
Hospital Clinico Universitario Lozano Blesa
Zaragoza, Spain, 50009
Sweden
Skane University Hospital
Lund, Sweden, 22185
Danderyd University Hospital Corp
Stockholm, Sweden, 182 88
Akademiska Sjukhuset
Uppsala, Sweden, 75185
Switzerland
Gastroenterologische Praxis Balsiger, Seibold und Partner
Bern, Switzerland, 3012
Universitätsspital Zürich
Zurich, Switzerland, 8091
Taiwan
Changhua Christian Hospital
Changhua, Taiwan, 500
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung, Taiwan, 83301
Far-Eastern Memorial Hospital
New Taipei City, Taiwan, 220
Chang Shan Medical University Hospital
Taichung, Taiwan, 402
China Medical University Hospital
Taichung, Taiwan, 40447
National Cheng Kung University Hospital
Tainan City, Taiwan, 7428
National Taiwan University Hospital
Taipei, Taiwan, 100
Mackay Memorial Hospital, Taipei
Taipei, Taiwan, 10449
Taipei Veterans General Hospital
Taipei, Taiwan, 112
Tri-Service General Hospital
Taipei, Taiwan, 114
Chang Gung Medical Foundation, Chang Gung Memorial Hospital, Linkou Branch
Taoyuan, Taiwan, 33305
Ukraine
Municipal Institution "Cherkasy Regional Hospital of Cherkasy Regional Council", Gastroenterology Department
Cherkasy, Ukraine, 18000
Municipal City Clinical Hospital of the Emergency Medical Care, 1 st Therapy Department. Danylo Halytsky Lviv National Medical
Chernivtsi, Ukraine, 58000
Regional Municipal Institution "Chernivtsi Regional Clinical Hospital", Surgical Department
Chernivtsi, Ukraine, 58000
State Institution "Institute of Gastroenterology of National Academy of Medical Sciences of Ukraine"
Dnipropetrovsk, Ukraine, 49000
Ivanto-Frankivsk Central City Clinic Hospital, Therapy Department #1. State Higher Education Institution Ivano-Frankivsk National
Ivano-Frankivsk, Ukraine, 76000-490
Municipal Health Care Institution "Kharkiv City Clinical Hospital #2 named after prof. O. O. Shalimov", Proctology Department
Kharkiv, Ukraine, 61037
L.T. Mala State Institution "National Institute of Therapy of National Academy of Medical Sciences of Ukraine"
Kharkiv, Ukraine, 61039
Municipal Institution of Health Care "Regional Hospital of War Veterans", Therapeutic Department No1
Kharkiv, Ukraine, 63101
Treatment and Diagnostic Center of Private Enterprise of Private Production Company "Acinus"
Kropyvnytskyi, Ukraine, 25006
Municipal Non-profit Enterprise "Consultative and Diagnostic Center" of Pechersk District of Kyiv, Therapy Department
Kyiv, Ukraine, 1103
Kyiv City Clinical Hospital No. 18, Proctology Department
Kyiv, Ukraine, 61037
Odesa Clinical Railway Hospital Branch of "Healthcare Center" of Public joint stock company "Ukrainian Railway"
Odessa, Ukraine, 65010
Municipal Institution "Odesa Regional Clinical Hospital", Regional Gastroenterology Center based on Surgery Department
Odessa, Ukraine, 65025
Ternopil University Hospital, Regional Center of Gastroenterology with Hepatology
Ternopil, Ukraine, 46002
Municipal Institution "Uzhgorod District Hospital", Therapy Department
Uzhgorod, Ukraine, 88009
Vinnytsia Regional Clinical Hospital of War Veterans, Therapy Department #1
Vinnytsia, Ukraine, 21005
M.I. Pyrogov Vinnytsia Regional Clinical Hospital, Gastroenterology Department
Vinnytsia, Ukraine, 21018
Medical Center LLC "Health Clinic"
Vinnytsia, Ukraine, 21029
Municipal Institution "Zaporizhzhya Regional Clinical Hospital" of Zaporizhzhya Regional Council
Zaporizhzhya, Ukraine, 69600
United Kingdom
Norfolk and Norwich University Hospital NHS Foundation Trust
Norwich, Norfolk, United Kingdom, NR4 7UY
The Pennine Acute Hospitals NHS Trust
Bury, United Kingdom, BL9 7TD
Cambridge University Hospital NHS Foundation Trust
Cambridge, United Kingdom, CB2 0QQ
University Hospitals Coventry and Warwickshire NHS Trust
Coventry, United Kingdom, CV 2DX
Royal Derby Hospital
Derby, United Kingdom, DE22 3NE
NHS Lothian
Edinburgh, United Kingdom, EH4 2XU
Glasgow Clinical Research Facility - Queen Elizabeth University Hospital
Glasgow, United Kingdom, G51 4TF
NHS Greater Glasgow and Clyde
Glasgow, United Kingdom, G52 3NQ
Wycombe Hospital
High Wycombe, United Kingdom, HP11 2TT
Imperial College Healthcare NHS Trust, St Mary's Hospital
London, United Kingdom, W2 1NY
Biomedical Research Unit
Nottingham, United Kingdom, NG7 2UH
Oxford University Hospitals NHS Trust
Oxford, United Kingdom, OX3 9DU
St Helens and Knowsley Teaching Hospitals NHS Trust
Prescot, United Kingdom, L35 5DR
Southampton National Institute for Health Research, Wellcome Trust Clinical Research Facility
Southampton, United Kingdom, SO16 6YD
Sponsors and Collaborators
Gilead Sciences
Galapagos NV
Investigators
Layout table for investigator information
Study Director: Gilead Study Director Gilead Sciences

Layout table for additonal information
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02914535     History of Changes
Other Study ID Numbers: GS-US-418-3899
2016-002765-58 ( EudraCT Number )
First Posted: September 26, 2016    Key Record Dates
Last Update Posted: November 6, 2019
Last Verified: November 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Colitis
Colitis, Ulcerative
Ulcer
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Colonic Diseases
Intestinal Diseases
Pathologic Processes
Inflammatory Bowel Diseases