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Trial record 1 of 1 for:    NCT02914522
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Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Ulcerative Colitis (SELECTION1)

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: NCT02914522
Recruitment Status : Completed
First Posted : September 26, 2016
Last Update Posted : May 4, 2020
Sponsor:
Collaborator:
Galapagos NV
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:

The primary objectives of this study are to evaluate the safety and efficacy of filgotinib in the induction and maintenance treatment of moderately to severely active ulcerative colitis (UC) in participants who are biologic-naive and biologic-experienced.

Participants who complete the study, or do not meet protocol response or remission criteria at Week 10 will have the option to enter a separate, long-term extension (LTE) study (Gilead Study GS-US-418-3899).


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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1351 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Combined Phase 2b/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 Ulcerative Colitis
Actual Study Start Date : November 14, 2016
Actual Primary Completion Date : March 31, 2020
Actual Study Completion Date : March 31, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Filgotinib 200 mg (Induction Study)
Filgotinib 200 mg + placebo to match filgotinib 100 mg for 10 weeks
Drug: Filgotinib
Tablet(s) administered orally once daily
Other Names:
  • GS-6034
  • GLPG0634

Drug: Placebo to match filgotinib
Tablet(s) administered orally once daily

Experimental: Filgotinib 100 mg (Induction Study)
Filgotinib 100 mg + placebo to match filgotinib 200 mg for 10 weeks
Drug: Filgotinib
Tablet(s) administered orally once daily
Other Names:
  • GS-6034
  • GLPG0634

Drug: Placebo to match filgotinib
Tablet(s) administered orally once daily

Placebo Comparator: Placebo (Induction Study)
Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg for 10 weeks
Drug: Placebo to match filgotinib
Tablet(s) administered orally once daily

Experimental: Maintenance Study
Participants who meet response or remission criteria at Week 10 will continue into Maintenance Study and will receive filgotinib and/or placebo for 48 weeks.
Drug: Filgotinib
Tablet(s) administered orally once daily
Other Names:
  • GS-6034
  • GLPG0634

Drug: Placebo to match filgotinib
Tablet(s) administered orally once daily




Primary Outcome Measures :
  1. Induction Study: Proportion of Participants Achieving Remission Based on Components of Mayo Clinic Score (MCS) at Week 10 [ Time Frame: Week 10 ]
  2. Maintenance Study: Proportion of Participants Achieving Remission Based on Components of MCS at Week 58 [ Time Frame: Week 58 ]

Secondary Outcome Measures :
  1. Induction Study: Proportion of Participants Achieving MCS Remission at Week 10 [ Time Frame: Week 10 ]
  2. Induction Study: Proportion of Participants Achieving Endoscopic Subscore of 0 at Week 10 [ Time Frame: Week 10 ]
  3. Induction Study: Proportion of Participants Achieving Histologic Remission at Week 10 [ Time Frame: Week 10 ]
  4. Induction Study: Proportion of participants achieving MCS remission (alternative definition) at Week 10 [ Time Frame: Week 10 ]
  5. Induction Study: Pharmacokinetic Plasma Concentrations of Filgotinib and its Metabolite GS-829845 [ Time Frame: Week 4 postdose and Week 10 predose ]
  6. Maintenance Study: Proportion of Participants Achieving MCS Remission at Week 58 [ Time Frame: Week 58 ]
  7. Maintenance Study: Proportion of Participants Achieving Remission Based on Components of MCS at Weeks 10 and 58 [ Time Frame: Weeks 10 and 58 ]
  8. Maintenance Study: Proportion of Participants Achieving 6-Month Corticosteroid-Free Remission Based on Components of MCS at Week 58 [ Time Frame: Week 58 ]
  9. Maintenance Study: Proportion of Participants Achieving Endoscopic Subscore of 0 at Week 58 [ Time Frame: Weeks 58 ]
  10. Maintenance Study: Proportion of Participants Achieving Histologic Remission at Week 58 [ Time Frame: Week 58 ]
  11. Maintenance Study: Proportion of participants achieving MCS remission (alternative definition) at Week 58 [ Time Frame: Week 58 ]
  12. Maintenance Study: Pharmacokinetic Plasma Concentrations of Filgotinib and its Metabolite GS-829845 [ Time Frame: Week 26 (predose or postdose) and Week 58 predose ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  • Males or non-pregnant, non-lactating females, ages 18 to 75 years, inclusive based on the date of the screening visit
  • Documented diagnosis of UC of at least 6 months AND with a minimum disease extent of 15 cm from the anal verge. Documentation should include endoscopic and histopathologic evidence of UC.
  • A surveillance colonoscopy is required at screening in individuals with a history of UC for 8 or more years, if one was not performed in the prior 24 months
  • Moderately to severely active UC
  • 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, immunomodulators, tumor necrosis factor alpha (TNFa) antagonists, or vedolizumab

Key Exclusion Criteria:

  • Presence of Crohn's disease, indeterminate colitis, ischemic colitis, fulminant colitis, ulcerative proctitis, or toxic mega-colon
  • Active tuberculosis (TB) or history of latent TB that has not been treated
  • Use of any concomitant prohibited medications as described 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): NCT02914522


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
United States, Colorado
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, Florida
UF Health at Shands Hospital
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
Cordova Research Institute
Miami, Florida, United States, 33155
Gastroenterology Group of Naples
Naples, Florida, United States, 34102
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
Gastroenterology Associates of Central Georgia, LLC
Macon, Georgia, United States, 31201
Gastrointestinal Specialists of Georgia
Marietta, Georgia, United States, 30060
Atlanta Gastroenterology Specialist, PC
Suwanee, Georgia, United States, 30024
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, New York
NY Scientific
Brooklyn, New York, United States, 11235
NYU Langone Long Island Clinical Research Associates
Great Neck, New York, United States, 11021
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
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
San Antonio Military Medical Center
Fort Sam Houston, Texas, United States, 78219
DHAT Research Institute
Garland, Texas, United States, 75044
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
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
Texas Digestive Disease Consultants
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
United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
Gastroenterology Associates Of Tidewater
Chesapeake, Virginia, United States, 23320
Emeritas Research Group LLC
Lansdowne Town Center, Virginia, United States, 20176
McGuire DVAMC
Richmond, Virginia, United States, 23249
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
Australia, New South Wales
St. Vincent's Hospital Sydney
Darlinghurst, New South Wales, Australia, 2010
Nepean Hospital
Kingswood, New South Wales, Australia, 2747
Australia, Queensland
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
The Queen Elizabeth Hospital
Woodville South, South Australia, Australia, 5011
Australia, Victoria
Monash Medical Centre
Clayton, Victoria, Australia, 3168
Footscray Hospital
Footscray, Victoria, Australia, 3011
Austin Health
Heidelberg, Victoria, Australia, 3084
Cabrini Hospital
Malvern, Victoria, Australia, 3144
Alfred Hospital
Melbourne, Victoria, Australia, 3004
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
Brussels, Belgium, 1070
Universitair Ziekenhuis Leuven
Leuven, Belgium, B-3000
Centre Hospitalier Chretien (CHC) - Clinique Saint-Joseph
Liège, Belgium, 4000
Bulgaria
MHAT Sveti Pantaleymon - Pleven OOD
Pleven, Bulgaria, 5800
"MDHAT Dr. St.Cherkezov" AD
Veliko Tŭrnovo, Bulgaria, 5000
MHAT "Sveta Petka" AD
Vidin, Bulgaria, 3700
Canada, Alberta
University of Calgary, Heritage Medical Research Clinic
Calgary, Alberta, Canada, T2N 4Z6
Canada, British Columbia
The Gordon and Leslie Diamond Health Care Centre
Vancouver, British Columbia, Canada, V5Z 1M9
Canada, Ontario
Hamilton Health Sciences Corporation, McMaster University Medical Centre
Hamilton, Ontario, Canada, L8S 4K1
Canada, Saskatchewan
Royal University Hospital
Saskatoon, Saskatchewan, Canada, S7N 0W8
Canada
Toronto Digestive Disease Associates Inc.
Vaughan, Canada, L4L 4Y7
Croatia
Clinical Hospital Dubrava
Zagreb, Croatia, 10000
University Hospital Center Zagreb
Zagreb, Croatia, 10000
Czechia
Hepato-Gastroenterologie HK, s.r.o.
Hradec Kralove, Czechia, 500 12
Oblastni nemocnice Mlada Boleslav, a.s., nemocnice Stredoceskeho kraje, Gastroenterologicke oddeleni
Mladá Boleslav, Czechia, 293 01
G.E.P. Clinic, s r.o.
Praha 3, Czechia, 130 00
ISCARE a.s. (Klinicke centrum ISCARE), Klinicke a vyzkumne centrum pro strevni zanety
Praha 9, Czechia, 190 00
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-Bicêtre, 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
Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
Rennes Cedex 9, France, 35033
CHU de Saint-Etienne - Hopital Nord
Saint Priest en Jarez, France, 42055
CHU de Toulouse - Hopital Rangueil
Toulouse, France, 31059
CHU de Nancy - Hopital Brabois Adultes
Vandœuvre-lès-Nancy, France, 54511
Georgia
Unimed Ajara LLC - Batumi Referral Hospital
Batumi, Georgia, 6010
Medi Club Georgia LLC
Tbilisi, Georgia, 0160
Ltd. Unimed Kakheti - Telavi Referral Hospital
Telavi, Georgia, 2200
Germany
Charite Universitatsmedizin 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
Universitatsklinikum Freiburg
Freiburg, Germany, 79106
Asklepios Westklinikum Hamburg
Hamburg, Germany, 22559
Medizinische Hochschule Hannover
Hannöver, Germany, 30625
Gastroenterologische Gemeinschaftspraxis Herne
Herne, Germany, 44623
Universitatsklinikum Jena
Jena, Germany, 07747
Universitatsklinikum Schleswig-Holstein
Kiel, Germany, 24105
Universitaetsklinik Koln
Koln, Germany, 50937
EUGASTRO GmbH
Leipzig, Germany, 04103
Klinikum Luneburg
Lüneburg, Germany, 21339
Gastroenterologische Gemeinschaftspraxis Minden
Minden, Germany, 32423
Klinikum der Universitat Munchen - Grosshadern
Muenchen, Germany, 81377
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, 18454
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
Sha Tin, Hong Kong
Hungary
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
Bekes Megyei Kosponti Korhaz, Dr. Rethy Pal Tagkorhaz, IV. Belgyogyaszat - 2. Gasztroenterologia
Békéscsaba, Hungary, 5600
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
Mosonmagyaróvár, Hungary, 9200
India
Kaizen Hospital
Ahmedabad, India, 380052
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
S.R.KallaMemorial Gastro.&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, 400010
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
Rajkot, India, 360005
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
Samvedana Hospital
Varanasi, India, 221005
Ireland
Beaumont Hospital
Dublin, Ireland, 9
Israel
Soroka Medical Center
Beer-Sheva, Israel, 8410101
Bnai Zion Medical Center
Haifa, Israel, 31048
Rambam Health Care Campus
Haifa, Israel, 3109601
Shaare Zedek Medical Center
Jerusalem, Israel, 9103102
Hadassah Medical Center
Jerusalem, Israel, 91120
Rabin Medical Center
Petach Tikva, Israel, 4941492
Italy
UOC Gastroenterologia II
Castellana Grotte, Italy, Bari 70013
U.O. Fisiopatologia Digestiva
Catanzaro, Italy, 88100
Ospedale Clinicizzato SS. Annunziata - Dipartimento di Medicina
Chieti, Italy, 66100
Endocsopia Digestiva Centralizzata - ASST Fatebenefratelli Sacco, Ospedale Fatebenefratelli e Oftalmico
Milano, Italy, 20121
UOC Gastroenterologia
Padova, Italy, 35128
Azienda Ospedaliero-Universitaria Pisana - Presidio Ospedaliero Cisanello
Pisa, Italy, 56124
UOC Gastroenterologia ed Endoscopia Digestiva
Roma, Italy, 128
Istituto Clinico Humanitas
Rozzano, Italy, 20089
Japan
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-shi, Japan, 192-0032
Hiroshima University Hospital
Hiroshima-shi, Japan, 734-8551
Fukuoka University Hospital
Jonan-ku, Japan, 814-0180
Ofuna Chuo Hospital
Kamakura, Japan, 247-0056
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, 852-8501
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
Wakakusa-Daiichi Hospital
Osaka, Japan, 579-8056
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
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
Kinshukai Infusion Clinic
Ōsaka, Japan, 530-0011
Osaka City University Hospital
Ōsaka, Japan, 545-8586
Shiga University of Medical Science Hospital
Ōtsu, Japan, 520-2912
Korea, Republic of
The Catholic University of Korea, St. Vincent's Hospital
Suwon-si, Gyeonggi-do, Korea, Republic of, 16247
Pusan National University Hospital
Busan, Korea, Republic of, 609801
Yeungnam University Hospital
Daegu, Korea, Republic of, 42415
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
Hyung Hee University Hospital
Seoul, Korea, Republic of, 130-872
Yonsei University Wonju Severance Christian Hospital
Wŏnju, Korea, Republic of, 220-701
Malaysia
University Kebangsaan Malaysia Medical Centre
Cheras, Malaysia, 56000
Hospital Pulau Pinang
George Town, Malaysia, 10990
Hospital Queen Elizabeth
Kota Kinabalu, Malaysia, 88586
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
University Medical Center Utrecht
Utrecht, Netherlands, 3584 CX
New Zealand
Christchurch Hospital
Christchurch, New Zealand, 8011
Auckland City Hospital
Grafton, New Zealand, 1023
Waikato Hospital
Hamilton, New Zealand, 3240
Wellington Hospital
Newtown, New Zealand, WE 6021
Bay of Plenty District Health Board - Tauranga Hospital
Tauranga, New Zealand, 3134
Norway
Vestre Viken Hospital Trust, Baerum Hospital
Drammen, Norway, 1346
Akerskus University Hospital
Lørenskog, Norway, N-1478
Poland
Uniwersytecki Szpital Kliniczny w Bialymstoku, Klinika Gastroenterologii i Chorob Wewnetrznych
Białystok, Poland, 15-276
VITAMED Galaj i Cichomski spolka jawna
Bydgoszcz, Poland, 85-079
Gabinet Lekarski Janusz Rudzinski
Bydgoszcz, Poland, 85-681
NZOZ INTER-MED, Centrum Endoskopowe
Częstochowa, Poland, 42-217
Niepubliczny Zaklad Opieki Zdrowotnej ALL-MEDICUS
Katowice, Poland, 40-659
Gabinet Endoskopii Przewodu Pokarmowego
Kraków, Poland, 31-009
Krakowskie Centrum Medyczne Sp. z o.o
Kraków, Poland, 31-501
Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp.J.
Ksawerów, Poland, 95-054
Centrum Innowacyjnych Terapii Sp. z o.o.
Piaseczno, Poland, 05-500
Clinical Research Center Spolka z organiczna 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
Toruń, Poland, 87-100
H-T.Centrum Medyczne Spolka z Ograniczona Odpowiedzialnoscia Sp.K.
Tychy, Poland, 43-100
Centrum Zdrowia MDM
Warszawa, Poland, 0-635
Bodyclinic
Warszawa, Poland, 00-332
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
Santa Familia, Centrum Badan, Profilaktyki i Leczenia
Łódź, Poland, 90-302
Portugal
Hospital da Senhora da Oliveira Guimaraes, E.P.E.
Guimarães, Portugal, 4835-044
Centro Hospitalar de Sao Joao, EPE
Porto, Portugal, 4200-319
Romania
SC MedLife SA, Gastroenterologie
Bucuresti, Romania, 010719
Spitalul Clinic Colentina - Sectia de Spitulal Clinic Colentina, Gastroenterologie
Bucuresti, Romania, 020125
Cabinet Medical Individual Dr Tirnaveanue Amelita, Gastroenterologie
Oradea, Romania, 410066
Cabinet Particular Policlinic Algomed SRL
Timişoara, Romania, 300002
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
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 Institution of Health of Novosibirsk Region "City Clinical Hospital #12"
Novosibirsk, Russian Federation, 630084
State Budgetary Healthcare Institution of the Novosibirsk Region "State Novosibirsk Regional Clinical Hospital"
Novosibirsk, Russian Federation, 630087
"Riat" LLC
Saint Petersburg, Russian Federation, 193163
"PolyClinic EXPERT" LLC
Saint Petersburg, Russian Federation, 197110
Saint Petersburg State Budgetary Healthcare Institution "City Polyclinic #38"
Saint-Petersburg, Russian Federation, 191015
"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
State Autonomous Health Institution of the Tyumen Region "Multidisciplinary Consultative and Diagnostic Center"
Tyumen, Russian Federation, 625026
Serbia
Zvezdara University Medical Center
Belgrade, Serbia, 3810-971
Singapore
Singapore General Hospital
Singapore, Singapore, 169608
Slovakia
KM Management, s.r.o., Gastroenterologicke a hepatologicke centrum Nitra
Nitra, Slovakia, 950 01
South Africa
Dr MJ Prins
Cape Town, South Africa, 7500
Peermed Clinical Trial Centre
Johannesburg, South Africa, 1619
Spain
Centro Medico Teknon
Barcelona, Spain, 08022
Hospital Clinico San Carlos
Madrid, Spain, 28040
Hospital Universitario de Fuenlabrada
Madrid, Spain, 28942
Hospital Universitario Central de Asturias
Oviedo, Spain, 33006
Hospital Universitario Virgen del Rocio
Sevilla, Spain, 41013
Sweden
Danderyds Sjukhus AB
Danderyd, Sweden, SE-18288
Skane University Hospital
Malmo, Sweden, SE-205-02
Akademiska Sjukhuset
Uppsala, Sweden, 75185
Switzerland
Gastroenterologische Praxis Balsiger, Seibold und Partner
Bern, Switzerland, 3012
Universitatsspital Zurich
Zürich, Switzerland, 8091
Taiwan
Changhua Christian Hospital
Chang-hua, Taiwan, 500
National Taiwan University Hospital
Taipei, Taiwan, 100
Mackay Memorial Hospital, Taipei
Taipei, Taiwan, 10449
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-Frankivs'k, 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
Kyiv City Clinical Hospital No. 18, Proctology Department
Kyiv, Ukraine, 01030
Municipal Non-profit Enterprise "Consultative and Diagnostic Center" of Pechersk District of Kyiv, Therapy Department
Kyiv, Ukraine, 1103
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
Medical Center LLC "Health Clinic"
Vinnytsia, Ukraine, 21029
Vinnytsia Regional Clinical Hospital of War Veterans, Therapy Department #1
Vinnytsya, Ukraine, 21005
M.I. Pyrogov Vinnytsia Regional Clinical Hospital, Gastroenterology Department
Vinnytsya, Ukraine, 21018
Municipal Institution "Zaporizhzhya Regional Clinical Hospital" of Zaporizhzhya Regional Council
Zaporizhzhya, Ukraine, 69600
United Kingdom
The Pennine Acute Hospitals NHS Trust
Bury, United Kingdom, BL9 7TD
Cambridge University Hospital NHS Foundation Trust
Cambridge, United Kingdom, CB2 0QQ
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
Norfolk and Norwich University Hospital NHS Foundation Trust
Norwich, United Kingdom, NR4 7UY
Biomedical Research Unit
Nottingham, United Kingdom, NG7 2UH
Oxford University Hospitals NHS Foundation 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
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Study Director: Gilead Study Director Gilead Sciences
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Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT02914522    
Other Study ID Numbers: GS-US-418-3898
2016-001392-78 ( EudraCT Number )
First Posted: September 26, 2016    Key Record Dates
Last Update Posted: May 4, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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