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
|
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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 |
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 |

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:
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:
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:
Drug: Placebo to match filgotinib Tablet(s) administered orally once daily |
- Induction Study: Proportion of Participants Achieving Remission Based on Components of Mayo Clinic Score (MCS) at Week 10 [ Time Frame: Week 10 ]
- Maintenance Study: Proportion of Participants Achieving Remission Based on Components of MCS at Week 58 [ Time Frame: Week 58 ]
- Induction Study: Proportion of Participants Achieving MCS Remission at Week 10 [ Time Frame: Week 10 ]
- Induction Study: Proportion of Participants Achieving Endoscopic Subscore of 0 at Week 10 [ Time Frame: Week 10 ]
- Induction Study: Proportion of Participants Achieving Histologic Remission at Week 10 [ Time Frame: Week 10 ]
- Induction Study: Proportion of participants achieving MCS remission (alternative definition) at Week 10 [ Time Frame: Week 10 ]
- Induction Study: Pharmacokinetic Plasma Concentrations of Filgotinib and its Metabolite GS-829845 [ Time Frame: Week 4 postdose and Week 10 predose ]
- Maintenance Study: Proportion of Participants Achieving MCS Remission at Week 58 [ Time Frame: Week 58 ]
- Maintenance Study: Proportion of Participants Achieving Remission Based on Components of MCS at Weeks 10 and 58 [ Time Frame: Weeks 10 and 58 ]
- Maintenance Study: Proportion of Participants Achieving 6-Month Corticosteroid-Free Remission Based on Components of MCS at Week 58 [ Time Frame: Week 58 ]
- Maintenance Study: Proportion of Participants Achieving Endoscopic Subscore of 0 at Week 58 [ Time Frame: Weeks 58 ]
- Maintenance Study: Proportion of Participants Achieving Histologic Remission at Week 58 [ Time Frame: Week 58 ]
- Maintenance Study: Proportion of participants achieving MCS remission (alternative definition) at Week 58 [ Time Frame: Week 58 ]
- Maintenance Study: Pharmacokinetic Plasma Concentrations of Filgotinib and its Metabolite GS-829845 [ Time Frame: Week 26 (predose or postdose) and Week 58 predose ]

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.
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

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


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 |
Study Director: | Gilead Study Director | Gilead Sciences |
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 |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Colitis Colitis, Ulcerative Ulcer Gastroenteritis Gastrointestinal Diseases |
Digestive System Diseases Colonic Diseases Intestinal Diseases Pathologic Processes Inflammatory Bowel Diseases |