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

Primary Purpose

Ulcerative Colitis

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Filgotinib
Placebo
Sponsored by
Galapagos NV
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Digestive Health Specialists Of The Southeast
  • Mayo Clinic Arizona
  • VA Long Beach Healthcare System
  • Cedars Sinai Medical Center
  • South Denver Gastroenterology, PC
  • Connecticut GI PC-Research Division
  • UF Clinical Research Center
  • Florida Research Institute
  • University of Miami Crohn's and Colitis Center
  • Cordova Research Institute
  • Gastroenterology Group of Naples
  • Advanced Medical Research Center
  • Tampa General Hospital
  • Florida Medical Clinic, P.A
  • Gastroenterology Associates Of Central Georgia, LLC
  • Gastrointestinal Specialists of Georgia
  • Atlanta Gastroenterology Specialist, PC
  • University of Iowa Hospitals and Clinics
  • University of Louisville, Clinical Trials Unit
  • Delta Research Partners, LLC
  • Louisiana Research Center, LLC
  • Investigative Clinical Research
  • MGG Group Co., Inc., Chevy Chase Clinical Research
  • Gastro Center of Maryland
  • Meritus Center for Clinical Research
  • Massachusetts General Hospital - Crohn's and Colitis Center
  • Clinical Research Institute of Michigan, LLC
  • Center for Digestive Health Research
  • Mayo Clinic
  • Kansas City Research Institute
  • Washington University School of Medicine
  • NY Scientific
  • NYU Langone Long Island Clinical Research Associates
  • Carolina's GI Research LLC
  • Fargo Gastroenterology and Hepatology Clinic
  • Consultants for Clinical Research
  • UC Health Physicians Clifton
  • Great Lakes Gastroenterology Research, LLC
  • Gastroenterology Associates of Orangeburg
  • Rapid City Medical Center
  • Gastro One
  • Quality Medical Research
  • Vanderbilt University Medical Center - IBD Clinic
  • San Antonio Military Medical Center
  • DHAT Research Institute
  • Baylor College of Medicine - Baylor Medical Center
  • The University of Texas Health Science Center at Houston
  • Clinical Associates in Research Therapeutics of America, LLC
  • Gastroenterology Research of San Antonio
  • TDDC San Marcos
  • Texas Digestive Disease Consultants
  • Spring Gastroenterology
  • University of Virginia Health System
  • Gastroenterology Associates of Tidewater
  • McGuire DVAMC
  • University of Wisconsin Hospital & Clinics
  • Allegiance Research Specialists, LLC
  • Instituto de Investigaciones Clinicas Mar del Plata
  • Instituto Médico Cer
  • Monash Medical Centre
  • St. Vincent's Hospital Sydney
  • Nepean Hospital
  • Coastal Digestive Health
  • Mater Misericordiae Ltd
  • Princess Alexandra Hospital
  • The Queen Elizabeth Hospital
  • Footscray Hospital
  • Cabrini Hospital
  • Alfred Hospital
  • Universitatsklinik Innsbruck
  • AKH-Medizinische Universitat Wien
  • GZA Ziekenhuizen, campus Sint-Vincentius
  • CUB Hopital Erasme
  • Universitair Ziekenhuis Leuven
  • Centre Hospitalier Chretien (CHC) - Clinique Saint-Joseph
  • MHAT Sveti Pantaleymon- Pleven OOD
  • "MDHAT Dr. St.Cherkezov" AD
  • MHAT "Sveta Petka" AD
  • University of Calgary, Heritage Medical Research Clinic
  • The Gordon and Leslie Diamond Health Care Centre
  • Hamilton Health Sciences Corporation, McMaster University Medical Centre
  • Toronto Digestive Disease Associates Inc.
  • Royal University Hospital
  • Clinical Hospital Dubrava
  • University Hospital Center Zagreb
  • Hepato-Gastroenterology HK, s.r.o.
  • Oblastni nemocnice Mlada Boleslav, a.s., nemocnice Stredoceskeho kraje, Gastroenterologicke oddeleni
  • G.E.P. Clinic, s r.o.
  • ISCARE a.s. (Klinicke centrum ISCARE), Klinicke a vyzkumne centrum pro strevni zanety
  • CHU Amiens Picardie
  • CHU de Caen
  • CHU de Clermont-Ferrand - Hopital d'Estaing
  • APHP - Hopital Beaujon - Clichy - Universite Paris VII
  • CHU de Dijon Bourgogne - Hopital Francois Mitterand
  • CHU Grenoble Alpes
  • Hopital Universitaire de Bicetre
  • Centre Hospitalier Regional Universitaire de Lille
  • Hopital Nord
  • CHU de Montpellier-Hopital Saint Eloi
  • CHU Hotel-Dieu
  • Hopital de l'Archet 2
  • CHU de Bordeaux - Hopital Haut Leveque
  • Centre Hospitalier Universitaire de Lyon Sud
  • Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
  • CHU de Saint Etienne - Hopital Nord
  • CHU de Toulouse - Hopital Rangueil
  • CHU de Nancy - Hopital Brabois Adultes
  • Unimed Ajara LLC - Batumi Referral Hospital
  • Medi Club Georgia LLC
  • Universitatsklinikum Schleswig-Holstein
  • Charite Universitaetsmedizin Berlin
  • Charite - Universitatsmedizin Berlin
  • DRK Kliniken Berlin - Westend - Klinik fuer Innere Medizin
  • Stadtisches Klinikum Braunschweig gGmbH
  • Agaplesion Markus Krankenhaus
  • Universitatsklinikum Freiburg
  • Asklepios Westklinikum Hamburg
  • Medizinische Hochschule Hannover
  • Gastroenterologische Gemeinschaftspraxis Herne
  • Universitatsklinikum Jena
  • Universitaetsklinik Koln
  • EUGASTRO GmbH
  • Klinikum Luneburg
  • Gastroenterologische Gemeinschaftspraxis Minden
  • Klinikum der Universitat Munchen - Grosshadern
  • Universitaetsklinikum Tuebingen
  • Universitatsklinikum Ulm, Zentrum Fur Innere Medizin
  • General Hospital of Athens "Hippokratio", 2nd Internal Medicine Clinic of Athens University, Hepato-gastroenterology Unit
  • Princess Margaret Hospital
  • Queen Mary Hospital
  • Department of Medicine & Therapeutics, The Chinese University of Hong Kong, Prince of Wales Hospital
  • Bekes Megyei Kosponti Korhaz, Dr. Rethy Pal Tagkorhaz, IV. Belgyogyaszat - 2. Gasztroenterologia
  • Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet, Kozponti Felnott Szakrendelo
  • Szent Janos Korhaz es Eszak-budai Egitett Korhazak, I. Belgyogyaszati - Gasztroenterologiai Osztaly
  • Debreceni Egyetem Klinikai Kozpont, II. sz. Belgyogyaszati Klinika, Gasztroenterologia
  • Bugat Pal Korhaz, Belgyogyaszat
  • Karolina Korhaz es Rendelointezet, Altalanos Belgyogyaszat-Gasztroenterologia
  • Kaizen Hospital
  • M S Ramaiah Medical College and Hospital
  • Apollo Speciality Hospital
  • VGM Hospital Institute of Gastroenterology
  • Gleneagles Global Hospitals
  • Citizens Specialty Hospital
  • Centre for Liver Research & Diagnostics
  • SR Kalla Memorial Gastro and General Hospital
  • S.M.S Medical College & Hospitals
  • Dayanand Medical College & Hospital
  • Kasturba Medical College (KMC) Hospital
  • Lokmanya Tilak Municipal General Hospital
  • Midas Multispeciality Hospital Pvt. Ltd
  • Suretech Hospital & Research Centre Ltd
  • Grant Medical Foundation Ruby Hall Clinic
  • Shree Giriraj Multispeciality Hospital
  • Gandhi Hospital
  • Surat Institute of Digestive Sciences
  • Kasturba Hospital Medical College
  • Sterling Hospital
  • Samvedna Hospital
  • Beaumont Hospital
  • Bnai Zion Medical Center
  • Rambam Medical Health Care Campus
  • Shaare Zedek Medical Center
  • Hadassah Medical Center
  • Rabin Medical Center
  • UOC Gastroenterologia II
  • U.O. Fisiopatologia Digestiva
  • Ospedale Clinicizzato SS. Annunziata - Dipartimento di Medicina
  • Endocsopia Digestiva Centralizzata - ASST Fatebenefratelli Sacco, Ospedale Fatebenefratelli e Oftalmico
  • UOC Gastroenterologia
  • Azienda Ospedaliero-Universitaria Pisana - Presidio Ospedaliero Cisanello
  • UOC Gastroenterologia ed Endoscopia Digestiva
  • Istituto Clinico Humanitas
  • Nagasaki University Hospital
  • Osaka University Hospital
  • Medical Hospital, Tokyo Medical and Dental University
  • Fukuoka University Chikushi Hospital
  • Hokkaido P.W.F.A.C Sapporo-Kosei General Hospital
  • Japanese Red Cross Fukuoka Hospital
  • Tokai University Hachioji Hospital
  • Hiroshima University Hospital
  • Fukuoka University Hospital
  • Ofuna Chuo Hospital
  • Kitakyushu City Hospital Organization Kitakyushu Municipal Medical Center
  • Yamanashi Prefectural Central Hospital
  • Kurume University Hospital
  • Hidaka Coloproctology Clinic
  • University Hospital, Kyoto Prefectural University of Medicine
  • The Jikei University Hospital
  • Kitasato University Kitasato Institute Hospital
  • Kyorin University Hospital
  • Iwate Medical University Hospital
  • Aichi Medical University Hospital
  • Saiseikai Niigata Daini Hospital
  • Hyogo College of Medicine College Hospital
  • Ishida IBD Clinic
  • Okayama University Hospital
  • Kinshukai Infusion Clinic
  • Osaka City University Hospital
  • Wakakusa-Daiichi Hospital
  • Shiga University of Medical Science Hospital
  • Saga-Ken Medical Centre Koseikan
  • Kitasato University Hospital,THE KITASATO INSTITUTE
  • Saga University Hospital
  • Tokito Clinic
  • Toho University Sakura Medical Center
  • Sapporo Higashi Tokushukai Hospital
  • National Hospital Organization Sendai Medical Center
  • Tokyo Yamate Medical Center
  • Kagawa Prefectural Central Hospital
  • National Hospital Organization Takasaki General Medical Center
  • Osaka Medical College Hospital
  • Ieda Hospital
  • Wakayama Medical University Hospital
  • Colo-proctology Center Matsushima Clinic
  • The Catholic University of Korea, St. Vincent's Hospital
  • Pusan National University Hospital
  • Yeungnam University Hospital
  • Kangbuk Samsung Hospital
  • Yonsei University Health System, Severance Hospital
  • Asan Medical Center
  • Division of Gastroenterology, Department of Medicine, Samsung Medical Center
  • Kyung Hee University Hospital
  • Yonsei University Wonju Severance Christian Hospital
  • Hospital Pulau Pinang
  • Hospital Queen Elizabeth
  • PCR-Phylasis Clinicas Research S. de R.L. de C.V.
  • Academic Medical Center (AMC)
  • Gelre Hospital
  • University Medical Center Utrecht
  • Christchurch Hospital
  • Auckland City Hospital
  • Wellington Hospital
  • Bay of Plenty District Health Board - Tauranga Hospital
  • Uniwersytecki Szpital Kliniczny w Bialymstoku, Klinika Gastroenterologii i Chorob Wewnetrznych
  • VITAMED Galaj i Cichomski spólka jawna
  • Gabinet Lekarski Janusz Rudzinski
  • NZOZ INTER-MED, Centrum Endoskopowe
  • Niepubliczny Zaklad Opieki Zdrowotnej ALL-MEDICUS
  • Gabinet Endoskopii Przewodu Pokarmowego
  • Krakowskie Centrum Medyczne Sp. z o.o
  • Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp. J.
  • Santa Familia, Centrum Badan, Profilaktyki i Leczenia
  • Centrum Innowacyjnych Terapii Sp. z o.o.
  • Clinical Research Center Spolka z ograniczna odpowiedzialnoscia Medic-R Sp. k.
  • Gabinet Lekarski Dr. Hab. N. Med. Bartosz Korczowski
  • Endoskopia Sp. z o.o.
  • Twoja Przychodnia-Szczecinskie Centrum Medyczne
  • GASTROMED Kopon, Zmudzinski i Wspolnicy Sp. j. Specjalistyczne Centrum Gastrologii i Endoskopii
  • H-T.Centrum Medyczne Spolka z Ograniczona Odpowiedzialnoscia Sp.K.
  • Centrum Zdrowia MDM
  • Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administacji w Warszawie
  • Niepubliczny Zaklad Opieki Zrodotnej VIVAMED Jadwige Miecz
  • Bodyclinic
  • Centrum Medyczne Oporow
  • Hospital da Senhora da Oliveira Guimaraes, E.P.E.
  • Centro Hospitalar de Sao Joao, EPE
  • MedLife, Gastroenterologie
  • Spitalul Clinic Colentina - Sectia de Spitulal Clinic Colentina, Gastroenterologie
  • Cabinet Medical Individual Dr Tirnaveanue Amelita, Gastroenterologie
  • Cabinet Particular Policlinic Algomed SRL
  • State Budgetary Healthcare Institution "Chelyabinski Regional Clinical Hospital"
  • State Budgetary Institution of Health Irkustsk Order "Badge of Honor" Regional Clinical Hospital
  • Federal State Budgetary Institution of Science Federal Research Center of Nutrition, Biotechnology and Food Safety
  • State Budgetary Healthcare Institution of Moscow "City Clinical Hospital # 24 of Healthcare Department of Moscow"
  • State Budgetary Healthcare Institution of Moscow Region "Moscow Regional Clinical Research Institute n.a. M.F. Vladimirskiy"
  • State Budgetary Healthcare Institution of Nizhny Novgorod Region "Nizhny Novgorod Regional Clinical Hospital n.a. N.A.
  • State Budgetary Institution of Health of Novosibirsk Region "City Clinical Hospital #12"
  • State Budgetary Healthcare Institution of the Novosibirsk Region "State Novosibirsk Regional Clinical Hospital"
  • "Riat" LLC
  • Saint Petersburg State Budgetary Healthcare Institution "City Polyclinic #38"
  • "Scientific Research Centre ECO-safety" LLC
  • State Healthcare Institution "Regional Clinical Hospital"
  • Treatment and Prevention Interdistrict Institution "Smolenskie kliniki" LLC
  • Tyumen Regional State Autonomous Healthcare Institution << Consulting and Diagnostic Centre <<Endos>>
  • Zvezdara University Medical Center
  • Singapore General Hospital
  • KM Management, s.r.o., Gastroenterologicke a hepatologicke centrum Nitra
  • Dr MJ Prins
  • Peermed Clinical Trial Centre
  • Centro Medico Teknon
  • Hospital Clinico San Carlos
  • Hospital Universitario de Fuenlabrada
  • Hospital Universitario Central de Asturias
  • Hospital Universitario Virgen del Rocío
  • Skane University Hospital
  • Danderyd University Hospital Corp
  • Akademiska Sjukhuset
  • Gastroenterologische Praxis Balsiger, Seibold und Partner
  • Universitätsspital Zürich
  • Changhua Christian Hospital
  • National Taiwan University Hospital
  • Mackay Memorial Hospital, Taipei
  • Chang Gung Medical Foundation, Chang Gung Memorial Hospital, Linkou Branch
  • Municipal Institution "Cherkasy Regional Hospital of Cherkasy Regional Council", Gastroenterology Department
  • Municipal City Clinical Hospital of the Emergency Medical Care, 1 st Therapy Department. Danylo Halytsky Lviv National Medical
  • Regional Municipal Institution "Chernivtsi Regional Clinical Hospital", Surgical Department
  • State Institution "Institute of Gastroenterology of National Academy of Medical Sciences of Ukraine"
  • Ivanto-Frankivsk Central City Clinic Hospital, Therapy Department #1. State Higher Education Institution Ivano-Frankivsk National
  • Municipal Health Care Institution "Kharkiv City Clinical Hospital #2 named after prof. O. O. Shalimov", Proctology Department
  • L.T. Mala State Institution "National Institute of Therapy of National Academy of Medical Sciences of Ukraine"
  • Municipal Institution of Health Care "Regional Hospital of War Veterans", Therapeutic Department No1
  • Kyiv City Clinical Hospital No. 18, Proctology Department
  • Municipal Non-profit Enterprise "Consultative and Diagnostic Center" of Pechersk District of Kyiv, Therapy Department
  • Odesa Clinical Railway Hospital Branch of "Healthcare Center" of Public joint stock company "Ukrainian Railway"
  • Municipal Institution "Odesa Regional Clinical Hospital", Regional Gastroenterology Center based on Surgery Department
  • Ternopil University Hospital, Regional Center of Gastroenterology with Hepatology
  • Vinnytsia Regional Clinical Hospital of War Veterans, Therapy Department #1
  • M.I. Pyrogov Vinnytsia Regional Clinical Hospital, Gastroenterology Department
  • Medical Center LLC "Health Clinic"
  • Municipal Institution "Zaporizhzhya Regional Clinical Hospital" of Zaporizhzhya Regional Council
  • Norfolk and Norwich University Hospital NHS Foundation Trust
  • The Pennine Acute Hospitals NHS Trust
  • Cambridge University Hospital NHS Foundation Trust
  • Royal Derby Hospital
  • NHS Lothian
  • Glasgow Clinical Research Facility - Queen Elizabeth University Hospital
  • NHS Greater Glasgow and Clyde
  • Wycombe Hospital
  • Imperial College Healthcare NHS Trust, St Mary's Hospital
  • Biomedical Research Unit
  • Oxford University Hospitals NHS Trust
  • St Helens and Knowsley Teaching Hospitals NHS Trust
  • Southampton National Institute for Health Research, Wellcome Trust Clinical Research Facility

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Placebo Comparator

Experimental

Experimental

Arm Label

Filgotinib 200 mg (blinded dosing)

Filgotinib 100 mg (blinded dosing)

Placebo (blinded dosing)

Filgotinib 200 mg (open-label)

Filgotinib 100 mg (open-label)

Arm Description

Filgotinib 200 mg + placebo to match filgotinib 100 mg for up to 336 weeks

Filgotinib 100 mg + placebo to match filgotinib 200 mg for up to 336 weeks

Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg for up to 336 weeks

Filgotinib 200 mg for up to 336 weeks

Filgotinib 100 mg for up to 336 weeks

Outcomes

Primary Outcome Measures

Overall Safety Profile of Filgotinib Evaluated by Proportion of Participants Experiencing Adverse Events and Abnormal Clinical Laboratory Tests

Secondary Outcome Measures

Change From Baseline in Components of Mayo Clinic Score (MCS)

Full Information

First Posted
September 22, 2016
Last Updated
January 24, 2023
Sponsor
Galapagos NV
Collaborators
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT02914535
Brief Title
Filgotinib in Long-Term Extension Study of Adults With Ulcerative Colitis
Acronym
SELECTIONLTE
Official Title
A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects With Ulcerative Colitis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 23, 2017 (Actual)
Primary Completion Date
September 2026 (Anticipated)
Study Completion Date
September 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galapagos NV
Collaborators
Gilead Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 filgotinib treatment study in ulcerative colitis (UC).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Masking Description
Only 3 arms are blinded in this study.
Allocation
Non-Randomized
Enrollment
1173 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Filgotinib 200 mg (blinded dosing)
Arm Type
Experimental
Arm Description
Filgotinib 200 mg + placebo to match filgotinib 100 mg for up to 336 weeks
Arm Title
Filgotinib 100 mg (blinded dosing)
Arm Type
Experimental
Arm Description
Filgotinib 100 mg + placebo to match filgotinib 200 mg for up to 336 weeks
Arm Title
Placebo (blinded dosing)
Arm Type
Placebo Comparator
Arm Description
Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg for up to 336 weeks
Arm Title
Filgotinib 200 mg (open-label)
Arm Type
Experimental
Arm Description
Filgotinib 200 mg for up to 336 weeks
Arm Title
Filgotinib 100 mg (open-label)
Arm Type
Experimental
Arm Description
Filgotinib 100 mg for up to 336 weeks
Intervention Type
Drug
Intervention Name(s)
Filgotinib
Other Intervention Name(s)
GS-6034, GLPG0634
Intervention Description
Tablet(s) administered orally once daily
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Tablet(s) administered orally once daily
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
Change From Baseline in Components of Mayo Clinic Score (MCS)
Time Frame
Baseline and up to 336 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 or any other Gilead/Galapagos-sponsored filgotinib treatment study for UC Must have completed all required procedures or met protocol-specified efficacy discontinuation criteria in a prior filgotinib treatment study for UC Females of childbearing potential must have a negative pregnancy test at Day 1 Female individuals of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception 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 Females of reproductive potential who are unwilling to abide by protocol-specified contraceptive methods as defined Use of prohibited medications as outlined in the protocol NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Galapagos Study Director
Organizational Affiliation
Galapagos NV
Official's Role
Study Director
Facility Information:
Facility Name
Digestive Health Specialists Of The Southeast
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36305
Country
United States
Facility Name
Mayo Clinic Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
VA Long Beach Healthcare System
City
Long Beach
State/Province
California
ZIP/Postal Code
90822
Country
United States
Facility Name
Cedars Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
South Denver Gastroenterology, PC
City
Lone Tree
State/Province
Colorado
ZIP/Postal Code
80124
Country
United States
Facility Name
Connecticut GI PC-Research Division
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06032
Country
United States
Facility Name
UF Clinical Research Center
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Facility Name
Florida Research Institute
City
Lakewood Ranch
State/Province
Florida
ZIP/Postal Code
34211
Country
United States
Facility Name
University of Miami Crohn's and Colitis Center
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Cordova Research Institute
City
Miami
State/Province
Florida
ZIP/Postal Code
33155
Country
United States
Facility Name
Gastroenterology Group of Naples
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
Advanced Medical Research Center
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Florida Medical Clinic, P.A
City
Zephyrhills
State/Province
Florida
ZIP/Postal Code
33540
Country
United States
Facility Name
Gastroenterology Associates Of Central Georgia, LLC
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Facility Name
Gastrointestinal Specialists of Georgia
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Atlanta Gastroenterology Specialist, PC
City
Suwanee
State/Province
Georgia
ZIP/Postal Code
30024
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
University of Louisville, Clinical Trials Unit
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Delta Research Partners, LLC
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71201
Country
United States
Facility Name
Louisiana Research Center, LLC
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71105
Country
United States
Facility Name
Investigative Clinical Research
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
MGG Group Co., Inc., Chevy Chase Clinical Research
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Gastro Center of Maryland
City
Columbia
State/Province
Maryland
ZIP/Postal Code
21045
Country
United States
Facility Name
Meritus Center for Clinical Research
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21742
Country
United States
Facility Name
Massachusetts General Hospital - Crohn's and Colitis Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Clinical Research Institute of Michigan, LLC
City
Chesterfield
State/Province
Michigan
ZIP/Postal Code
48047
Country
United States
Facility Name
Center for Digestive Health Research
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
Kansas City Research Institute
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64131
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
NY Scientific
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11235
Country
United States
Facility Name
NYU Langone Long Island Clinical Research Associates
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Carolina's GI Research LLC
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27607
Country
United States
Facility Name
Fargo Gastroenterology and Hepatology Clinic
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
Facility Name
Consultants for Clinical Research
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
UC Health Physicians Clifton
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Great Lakes Gastroenterology Research, LLC
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
Facility Name
Gastroenterology Associates of Orangeburg
City
Orangeburg
State/Province
South Carolina
ZIP/Postal Code
29118
Country
United States
Facility Name
Rapid City Medical Center
City
Rapid City
State/Province
South Dakota
ZIP/Postal Code
57701
Country
United States
Facility Name
Gastro One
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Quality Medical Research
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37211
Country
United States
Facility Name
Vanderbilt University Medical Center - IBD Clinic
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212-1375
Country
United States
Facility Name
San Antonio Military Medical Center
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78219
Country
United States
Facility Name
DHAT Research Institute
City
Garland
State/Province
Texas
ZIP/Postal Code
75044
Country
United States
Facility Name
Baylor College of Medicine - Baylor Medical Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
The University of Texas Health Science Center at Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Clinical Associates in Research Therapeutics of America, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78212
Country
United States
Facility Name
Gastroenterology Research of San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
TDDC San Marcos
City
San Marcos
State/Province
Texas
ZIP/Postal Code
78666
Country
United States
Facility Name
Texas Digestive Disease Consultants
City
Southlake
State/Province
Texas
ZIP/Postal Code
76092
Country
United States
Facility Name
Spring Gastroenterology
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77380
Country
United States
Facility Name
University of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
Facility Name
Gastroenterology Associates of Tidewater
City
Chesapeake
State/Province
Virginia
ZIP/Postal Code
23320
Country
United States
Facility Name
McGuire DVAMC
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23249
Country
United States
Facility Name
University of Wisconsin Hospital & Clinics
City
Madison
State/Province
Wisconsin
ZIP/Postal Code
53705
Country
United States
Facility Name
Allegiance Research Specialists, LLC
City
Wauwatosa
State/Province
Wisconsin
ZIP/Postal Code
53225
Country
United States
Facility Name
Instituto de Investigaciones Clinicas Mar del Plata
City
Mar del Plata
ZIP/Postal Code
B7600FZN
Country
Argentina
Facility Name
Instituto Médico Cer
City
Quilmes
ZIP/Postal Code
B1878
Country
Argentina
Facility Name
Monash Medical Centre
City
Clayton
State/Province
New South Wales
ZIP/Postal Code
3168
Country
Australia
Facility Name
St. Vincent's Hospital Sydney
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Nepean Hospital
City
Kingswood
State/Province
New South Wales
ZIP/Postal Code
2747
Country
Australia
Facility Name
Coastal Digestive Health
City
Mountain Creek
State/Province
Queensland
ZIP/Postal Code
4557
Country
Australia
Facility Name
Mater Misericordiae Ltd
City
South Brisbane
State/Province
Queensland
ZIP/Postal Code
4101
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
The Queen Elizabeth Hospital
City
Woodville South
State/Province
South Australia
ZIP/Postal Code
5011
Country
Australia
Facility Name
Footscray Hospital
City
Footscray
State/Province
Victoria
ZIP/Postal Code
3011
Country
Australia
Facility Name
Cabrini Hospital
City
Malvern
State/Province
Victoria
ZIP/Postal Code
3144
Country
Australia
Facility Name
Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Universitatsklinik Innsbruck
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
AKH-Medizinische Universitat Wien
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
GZA Ziekenhuizen, campus Sint-Vincentius
City
Antwerpen
ZIP/Postal Code
2018
Country
Belgium
Facility Name
CUB Hopital Erasme
City
Brussel
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Universitair Ziekenhuis Leuven
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Centre Hospitalier Chretien (CHC) - Clinique Saint-Joseph
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
MHAT Sveti Pantaleymon- Pleven OOD
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Facility Name
"MDHAT Dr. St.Cherkezov" AD
City
Veliko Tarnovo
ZIP/Postal Code
5000
Country
Bulgaria
Facility Name
MHAT "Sveta Petka" AD
City
Vidin
ZIP/Postal Code
3700
Country
Bulgaria
Facility Name
University of Calgary, Heritage Medical Research Clinic
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
The Gordon and Leslie Diamond Health Care Centre
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
Hamilton Health Sciences Corporation, McMaster University Medical Centre
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8S 4K1
Country
Canada
Facility Name
Toronto Digestive Disease Associates Inc.
City
Vaughan
State/Province
Ontario
ZIP/Postal Code
L4L 4Y7
Country
Canada
Facility Name
Royal University Hospital
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7N 0W8
Country
Canada
Facility Name
Clinical Hospital Dubrava
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
University Hospital Center Zagreb
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Hepato-Gastroenterology HK, s.r.o.
City
Hradec Kralove
ZIP/Postal Code
500 12
Country
Czechia
Facility Name
Oblastni nemocnice Mlada Boleslav, a.s., nemocnice Stredoceskeho kraje, Gastroenterologicke oddeleni
City
Mlada Boleslav
ZIP/Postal Code
293 01
Country
Czechia
Facility Name
G.E.P. Clinic, s r.o.
City
Praha 3
ZIP/Postal Code
130 00
Country
Czechia
Facility Name
ISCARE a.s. (Klinicke centrum ISCARE), Klinicke a vyzkumne centrum pro strevni zanety
City
Praha 9
ZIP/Postal Code
190 00
Country
Czechia
Facility Name
CHU Amiens Picardie
City
Amiens Cedex 1
ZIP/Postal Code
80054
Country
France
Facility Name
CHU de Caen
City
Caen Cedex 9
ZIP/Postal Code
14033
Country
France
Facility Name
CHU de Clermont-Ferrand - Hopital d'Estaing
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
APHP - Hopital Beaujon - Clichy - Universite Paris VII
City
Clichy
ZIP/Postal Code
92110
Country
France
Facility Name
CHU de Dijon Bourgogne - Hopital Francois Mitterand
City
Dijon
ZIP/Postal Code
21079
Country
France
Facility Name
CHU Grenoble Alpes
City
La Tronche
ZIP/Postal Code
38700
Country
France
Facility Name
Hopital Universitaire de Bicetre
City
Le Kremlin Bicetre
ZIP/Postal Code
94270
Country
France
Facility Name
Centre Hospitalier Regional Universitaire de Lille
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
Hopital Nord
City
Marseille
ZIP/Postal Code
13915
Country
France
Facility Name
CHU de Montpellier-Hopital Saint Eloi
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
CHU Hotel-Dieu
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Hopital de l'Archet 2
City
Nice
ZIP/Postal Code
06202
Country
France
Facility Name
CHU de Bordeaux - Hopital Haut Leveque
City
Pessac
ZIP/Postal Code
33600
Country
France
Facility Name
Centre Hospitalier Universitaire de Lyon Sud
City
Pierre-Benite
ZIP/Postal Code
69495
Country
France
Facility Name
Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
City
Rennes Cedex 9
ZIP/Postal Code
35033
Country
France
Facility Name
CHU de Saint Etienne - Hopital Nord
City
Saint Priest en Jarez
ZIP/Postal Code
42055
Country
France
Facility Name
CHU de Toulouse - Hopital Rangueil
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
CHU de Nancy - Hopital Brabois Adultes
City
Vandoeuvre Les Nancy
ZIP/Postal Code
54511
Country
France
Facility Name
Unimed Ajara LLC - Batumi Referral Hospital
City
Batumi
ZIP/Postal Code
6010
Country
Georgia
Facility Name
Medi Club Georgia LLC
City
Tbilisi
ZIP/Postal Code
0160
Country
Georgia
Facility Name
Universitatsklinikum Schleswig-Holstein
City
Kiel
State/Province
Schleswig Holstein
ZIP/Postal Code
24105
Country
Germany
Facility Name
Charite Universitaetsmedizin Berlin
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Charite - Universitatsmedizin Berlin
City
Berlin
ZIP/Postal Code
13353
Country
Germany
Facility Name
DRK Kliniken Berlin - Westend - Klinik fuer Innere Medizin
City
Berlin
ZIP/Postal Code
14050
Country
Germany
Facility Name
Stadtisches Klinikum Braunschweig gGmbH
City
Braunschweig
ZIP/Postal Code
38126
Country
Germany
Facility Name
Agaplesion Markus Krankenhaus
City
Frankfurt am Main
ZIP/Postal Code
60431
Country
Germany
Facility Name
Universitatsklinikum Freiburg
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Asklepios Westklinikum Hamburg
City
Hamburg
ZIP/Postal Code
22559
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hannover
ZIP/Postal Code
30625
Country
Germany
Facility Name
Gastroenterologische Gemeinschaftspraxis Herne
City
Herne
ZIP/Postal Code
44623
Country
Germany
Facility Name
Universitatsklinikum Jena
City
Jena
ZIP/Postal Code
07747
Country
Germany
Facility Name
Universitaetsklinik Koln
City
Koln
ZIP/Postal Code
50937
Country
Germany
Facility Name
EUGASTRO GmbH
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Klinikum Luneburg
City
Lüneburg
ZIP/Postal Code
21339
Country
Germany
Facility Name
Gastroenterologische Gemeinschaftspraxis Minden
City
Minden
ZIP/Postal Code
32423
Country
Germany
Facility Name
Klinikum der Universitat Munchen - Grosshadern
City
Muenchen
ZIP/Postal Code
81377
Country
Germany
Facility Name
Universitaetsklinikum Tuebingen
City
Tuebingen
ZIP/Postal Code
72074
Country
Germany
Facility Name
Universitatsklinikum Ulm, Zentrum Fur Innere Medizin
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
General Hospital of Athens "Hippokratio", 2nd Internal Medicine Clinic of Athens University, Hepato-gastroenterology Unit
City
Athens
ZIP/Postal Code
11527
Country
Greece
Facility Name
Princess Margaret Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
Queen Mary Hospital
City
Hong Kong
Country
Hong Kong
Facility Name
Department of Medicine & Therapeutics, The Chinese University of Hong Kong, Prince of Wales Hospital
City
Shatin
Country
Hong Kong
Facility Name
Bekes Megyei Kosponti Korhaz, Dr. Rethy Pal Tagkorhaz, IV. Belgyogyaszat - 2. Gasztroenterologia
City
Bekescsaba
ZIP/Postal Code
5600
Country
Hungary
Facility Name
Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet, Kozponti Felnott Szakrendelo
City
Budapest
ZIP/Postal Code
1097
Country
Hungary
Facility Name
Szent Janos Korhaz es Eszak-budai Egitett Korhazak, I. Belgyogyaszati - Gasztroenterologiai Osztaly
City
Budapest
ZIP/Postal Code
1125
Country
Hungary
Facility Name
Debreceni Egyetem Klinikai Kozpont, II. sz. Belgyogyaszati Klinika, Gasztroenterologia
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
Bugat Pal Korhaz, Belgyogyaszat
City
Gyöngyös
ZIP/Postal Code
3200
Country
Hungary
Facility Name
Karolina Korhaz es Rendelointezet, Altalanos Belgyogyaszat-Gasztroenterologia
City
Mosonmagyarovar
ZIP/Postal Code
9200
Country
Hungary
Facility Name
Kaizen Hospital
City
Ahmedabad
ZIP/Postal Code
380052
Country
India
Facility Name
M S Ramaiah Medical College and Hospital
City
Bangalore
ZIP/Postal Code
560054
Country
India
Facility Name
Apollo Speciality Hospital
City
Chennai
ZIP/Postal Code
600035
Country
India
Facility Name
VGM Hospital Institute of Gastroenterology
City
Coimbatore
ZIP/Postal Code
641005
Country
India
Facility Name
Gleneagles Global Hospitals
City
Hyderabad
ZIP/Postal Code
500004
Country
India
Facility Name
Citizens Specialty Hospital
City
Hyderabad
ZIP/Postal Code
500019
Country
India
Facility Name
Centre for Liver Research & Diagnostics
City
Hyderabad
ZIP/Postal Code
500058
Country
India
Facility Name
SR Kalla Memorial Gastro and General Hospital
City
Jaipur
ZIP/Postal Code
302001
Country
India
Facility Name
S.M.S Medical College & Hospitals
City
Jaipur
ZIP/Postal Code
302004
Country
India
Facility Name
Dayanand Medical College & Hospital
City
Ludhiana
ZIP/Postal Code
141001
Country
India
Facility Name
Kasturba Medical College (KMC) Hospital
City
Mangaluru
ZIP/Postal Code
575001
Country
India
Facility Name
Lokmanya Tilak Municipal General Hospital
City
Mumbai
ZIP/Postal Code
400022
Country
India
Facility Name
Midas Multispeciality Hospital Pvt. Ltd
City
Nagpur
ZIP/Postal Code
440010
Country
India
Facility Name
Suretech Hospital & Research Centre Ltd
City
Nagpur
ZIP/Postal Code
440012
Country
India
Facility Name
Grant Medical Foundation Ruby Hall Clinic
City
Pune
ZIP/Postal Code
411001
Country
India
Facility Name
Shree Giriraj Multispeciality Hospital
City
Rajkot
ZIP/Postal Code
360002
Country
India
Facility Name
Gandhi Hospital
City
Secunderabad
ZIP/Postal Code
500003
Country
India
Facility Name
Surat Institute of Digestive Sciences
City
Surat
ZIP/Postal Code
395002
Country
India
Facility Name
Kasturba Hospital Medical College
City
Udupi
ZIP/Postal Code
576104
Country
India
Facility Name
Sterling Hospital
City
Vadodara
ZIP/Postal Code
390007
Country
India
Facility Name
Samvedna Hospital
City
Varanasi
ZIP/Postal Code
221005
Country
India
Facility Name
Beaumont Hospital
City
Dublin
ZIP/Postal Code
9
Country
Ireland
Facility Name
Bnai Zion Medical Center
City
Haifa
ZIP/Postal Code
31048
Country
Israel
Facility Name
Rambam Medical Health Care Campus
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Shaare Zedek Medical Center
City
Jerusalem
ZIP/Postal Code
9103102
Country
Israel
Facility Name
Hadassah Medical Center
City
Jerusalem
ZIP/Postal Code
9112001
Country
Israel
Facility Name
Rabin Medical Center
City
Petah Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
UOC Gastroenterologia II
City
Castellana Grotte
ZIP/Postal Code
70013
Country
Italy
Facility Name
U.O. Fisiopatologia Digestiva
City
Catanzaro
ZIP/Postal Code
88100
Country
Italy
Facility Name
Ospedale Clinicizzato SS. Annunziata - Dipartimento di Medicina
City
Chieti
ZIP/Postal Code
66100
Country
Italy
Facility Name
Endocsopia Digestiva Centralizzata - ASST Fatebenefratelli Sacco, Ospedale Fatebenefratelli e Oftalmico
City
Milano
ZIP/Postal Code
20121
Country
Italy
Facility Name
UOC Gastroenterologia
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria Pisana - Presidio Ospedaliero Cisanello
City
Pisa
ZIP/Postal Code
56124
Country
Italy
Facility Name
UOC Gastroenterologia ed Endoscopia Digestiva
City
Roma
ZIP/Postal Code
128
Country
Italy
Facility Name
Istituto Clinico Humanitas
City
Rozzano
ZIP/Postal Code
20089
Country
Italy
Facility Name
Nagasaki University Hospital
City
Nagasaki-shi
State/Province
Nagasaki
ZIP/Postal Code
8528501
Country
Japan
Facility Name
Osaka University Hospital
City
Suita
State/Province
Osaka
ZIP/Postal Code
565-0871
Country
Japan
Facility Name
Medical Hospital, Tokyo Medical and Dental University
City
Bunkyo-ku
ZIP/Postal Code
113-8519
Country
Japan
Facility Name
Fukuoka University Chikushi Hospital
City
Chikushino-shi
ZIP/Postal Code
818-8502
Country
Japan
Facility Name
Hokkaido P.W.F.A.C Sapporo-Kosei General Hospital
City
Chuo-ku
ZIP/Postal Code
060-0033
Country
Japan
Facility Name
Japanese Red Cross Fukuoka Hospital
City
Fukuoka-shi
ZIP/Postal Code
815-8555
Country
Japan
Facility Name
Tokai University Hachioji Hospital
City
Hachioji
ZIP/Postal Code
192-0032
Country
Japan
Facility Name
Hiroshima University Hospital
City
Hiroshima
ZIP/Postal Code
734-8551
Country
Japan
Facility Name
Fukuoka University Hospital
City
Jonan-ku
ZIP/Postal Code
814-0180
Country
Japan
Facility Name
Ofuna Chuo Hospital
City
Kamakura
ZIP/Postal Code
247-0056
Country
Japan
Facility Name
Kitakyushu City Hospital Organization Kitakyushu Municipal Medical Center
City
Kitakyushu-shi
ZIP/Postal Code
802-0077
Country
Japan
Facility Name
Yamanashi Prefectural Central Hospital
City
Kofu-shi
ZIP/Postal Code
400-8506
Country
Japan
Facility Name
Kurume University Hospital
City
Kurume-shi
ZIP/Postal Code
830-0011
Country
Japan
Facility Name
Hidaka Coloproctology Clinic
City
Kurume-shi
ZIP/Postal Code
839-0809
Country
Japan
Facility Name
University Hospital, Kyoto Prefectural University of Medicine
City
Kyoto-shi
ZIP/Postal Code
602-8566
Country
Japan
Facility Name
The Jikei University Hospital
City
Minato-Ku
ZIP/Postal Code
105-8471
Country
Japan
Facility Name
Kitasato University Kitasato Institute Hospital
City
Minato-ku
ZIP/Postal Code
108-8642
Country
Japan
Facility Name
Kyorin University Hospital
City
Mitaka-shi
ZIP/Postal Code
181-8611
Country
Japan
Facility Name
Iwate Medical University Hospital
City
Morioka-shi
ZIP/Postal Code
020-8505
Country
Japan
Facility Name
Aichi Medical University Hospital
City
Nagakute-shi
ZIP/Postal Code
480-1195
Country
Japan
Facility Name
Saiseikai Niigata Daini Hospital
City
Nishi-ku
ZIP/Postal Code
950-1104
Country
Japan
Facility Name
Hyogo College of Medicine College Hospital
City
Nishinomiya
ZIP/Postal Code
663-8501
Country
Japan
Facility Name
Ishida IBD Clinic
City
Oita-shi
ZIP/Postal Code
870-0823
Country
Japan
Facility Name
Okayama University Hospital
City
Okayama-city
ZIP/Postal Code
700-8558
Country
Japan
Facility Name
Kinshukai Infusion Clinic
City
Osaka
ZIP/Postal Code
530-0011
Country
Japan
Facility Name
Osaka City University Hospital
City
Osaka
ZIP/Postal Code
545-8586
Country
Japan
Facility Name
Wakakusa-Daiichi Hospital
City
Osaka
ZIP/Postal Code
579-8056
Country
Japan
Facility Name
Shiga University of Medical Science Hospital
City
Otsu
ZIP/Postal Code
520-2192
Country
Japan
Facility Name
Saga-Ken Medical Centre Koseikan
City
Saga-shi
ZIP/Postal Code
840-8571
Country
Japan
Facility Name
Kitasato University Hospital,THE KITASATO INSTITUTE
City
Sagamihara
ZIP/Postal Code
252-0375
Country
Japan
Facility Name
Saga University Hospital
City
Saga
ZIP/Postal Code
849-8501
Country
Japan
Facility Name
Tokito Clinic
City
Saitama
ZIP/Postal Code
336-0963
Country
Japan
Facility Name
Toho University Sakura Medical Center
City
Sakura
ZIP/Postal Code
285-8741
Country
Japan
Facility Name
Sapporo Higashi Tokushukai Hospital
City
Sapporo-shi
ZIP/Postal Code
065-0033
Country
Japan
Facility Name
National Hospital Organization Sendai Medical Center
City
Sendai
ZIP/Postal Code
983-8520
Country
Japan
Facility Name
Tokyo Yamate Medical Center
City
Shinjuku-ku
ZIP/Postal Code
169-0073
Country
Japan
Facility Name
Kagawa Prefectural Central Hospital
City
Takamatsu-shi
ZIP/Postal Code
760-8557
Country
Japan
Facility Name
National Hospital Organization Takasaki General Medical Center
City
Takasaki-shi
ZIP/Postal Code
3700829
Country
Japan
Facility Name
Osaka Medical College Hospital
City
Takatsuki
ZIP/Postal Code
569-8686
Country
Japan
Facility Name
Ieda Hospital
City
Toyota-shi
ZIP/Postal Code
470-1219
Country
Japan
Facility Name
Wakayama Medical University Hospital
City
Wakayama-shi
ZIP/Postal Code
641-8509
Country
Japan
Facility Name
Colo-proctology Center Matsushima Clinic
City
Yokohama-shi
ZIP/Postal Code
220-0045
Country
Japan
Facility Name
The Catholic University of Korea, St. Vincent's Hospital
City
Suwon-si
State/Province
Gyeonggi-do
ZIP/Postal Code
16247
Country
Korea, Republic of
Facility Name
Pusan National University Hospital
City
Busan
ZIP/Postal Code
49241
Country
Korea, Republic of
Facility Name
Yeungnam University Hospital
City
Daegu
ZIP/Postal Code
42415
Country
Korea, Republic of
Facility Name
Kangbuk Samsung Hospital
City
Seoul
ZIP/Postal Code
03181
Country
Korea, Republic of
Facility Name
Yonsei University Health System, Severance Hospital
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Facility Name
Division of Gastroenterology, Department of Medicine, Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Facility Name
Kyung Hee University Hospital
City
Seoul
ZIP/Postal Code
130-872
Country
Korea, Republic of
Facility Name
Yonsei University Wonju Severance Christian Hospital
City
Wonju
ZIP/Postal Code
220-701
Country
Korea, Republic of
Facility Name
Hospital Pulau Pinang
City
George Town
ZIP/Postal Code
10990
Country
Malaysia
Facility Name
Hospital Queen Elizabeth
City
Kota Kinabalu
ZIP/Postal Code
88586
Country
Malaysia
Facility Name
PCR-Phylasis Clinicas Research S. de R.L. de C.V.
City
Cuautitlán Izcalli
ZIP/Postal Code
54750
Country
Mexico
Facility Name
Academic Medical Center (AMC)
City
Amsterdam
ZIP/Postal Code
1100
Country
Netherlands
Facility Name
Gelre Hospital
City
Apeldoorn
ZIP/Postal Code
7334
Country
Netherlands
Facility Name
University Medical Center Utrecht
City
Utrecht
ZIP/Postal Code
3584 CX
Country
Netherlands
Facility Name
Christchurch Hospital
City
Christchurch
ZIP/Postal Code
8011
Country
New Zealand
Facility Name
Auckland City Hospital
City
Grafton
ZIP/Postal Code
1023
Country
New Zealand
Facility Name
Wellington Hospital
City
Newtown
ZIP/Postal Code
6021
Country
New Zealand
Facility Name
Bay of Plenty District Health Board - Tauranga Hospital
City
Tauranga
ZIP/Postal Code
3112
Country
New Zealand
Facility Name
Uniwersytecki Szpital Kliniczny w Bialymstoku, Klinika Gastroenterologii i Chorob Wewnetrznych
City
Bialystok
ZIP/Postal Code
15-276
Country
Poland
Facility Name
VITAMED Galaj i Cichomski spólka jawna
City
Bydgoszcz
ZIP/Postal Code
85-079
Country
Poland
Facility Name
Gabinet Lekarski Janusz Rudzinski
City
Bydgoszcz
ZIP/Postal Code
85-681
Country
Poland
Facility Name
NZOZ INTER-MED, Centrum Endoskopowe
City
Czestochowa
ZIP/Postal Code
42-217
Country
Poland
Facility Name
Niepubliczny Zaklad Opieki Zdrowotnej ALL-MEDICUS
City
Katowice
ZIP/Postal Code
40-659
Country
Poland
Facility Name
Gabinet Endoskopii Przewodu Pokarmowego
City
Krakow
ZIP/Postal Code
31-009
Country
Poland
Facility Name
Krakowskie Centrum Medyczne Sp. z o.o
City
Kraków
ZIP/Postal Code
31-501
Country
Poland
Facility Name
Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp. J.
City
Ksawerów
ZIP/Postal Code
95-054
Country
Poland
Facility Name
Santa Familia, Centrum Badan, Profilaktyki i Leczenia
City
Lodz
ZIP/Postal Code
90-302
Country
Poland
Facility Name
Centrum Innowacyjnych Terapii Sp. z o.o.
City
Piaseczno
ZIP/Postal Code
05-500
Country
Poland
Facility Name
Clinical Research Center Spolka z ograniczna odpowiedzialnoscia Medic-R Sp. k.
City
Poznan
ZIP/Postal Code
60-848
Country
Poland
Facility Name
Gabinet Lekarski Dr. Hab. N. Med. Bartosz Korczowski
City
Rzeszów
ZIP/Postal Code
35-301
Country
Poland
Facility Name
Endoskopia Sp. z o.o.
City
Sopot
ZIP/Postal Code
81-756
Country
Poland
Facility Name
Twoja Przychodnia-Szczecinskie Centrum Medyczne
City
Szczecin
ZIP/Postal Code
71-434
Country
Poland
Facility Name
GASTROMED Kopon, Zmudzinski i Wspolnicy Sp. j. Specjalistyczne Centrum Gastrologii i Endoskopii
City
Torun
ZIP/Postal Code
87-100
Country
Poland
Facility Name
H-T.Centrum Medyczne Spolka z Ograniczona Odpowiedzialnoscia Sp.K.
City
Tychy
ZIP/Postal Code
43-100
Country
Poland
Facility Name
Centrum Zdrowia MDM
City
Warszawa
ZIP/Postal Code
00-635
Country
Poland
Facility Name
Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administacji w Warszawie
City
Warszawa
ZIP/Postal Code
02-507
Country
Poland
Facility Name
Niepubliczny Zaklad Opieki Zrodotnej VIVAMED Jadwige Miecz
City
Warszawa
ZIP/Postal Code
03-580
Country
Poland
Facility Name
Bodyclinic
City
Warszawa
ZIP/Postal Code
03-712
Country
Poland
Facility Name
Centrum Medyczne Oporow
City
Wroclaw
ZIP/Postal Code
52-416
Country
Poland
Facility Name
Hospital da Senhora da Oliveira Guimaraes, E.P.E.
City
Guimaraes
ZIP/Postal Code
4835-044
Country
Portugal
Facility Name
Centro Hospitalar de Sao Joao, EPE
City
Porto
ZIP/Postal Code
4200-319
Country
Portugal
Facility Name
MedLife, Gastroenterologie
City
Bucuresti
ZIP/Postal Code
010719
Country
Romania
Facility Name
Spitalul Clinic Colentina - Sectia de Spitulal Clinic Colentina, Gastroenterologie
City
Bucuresti
ZIP/Postal Code
020125
Country
Romania
Facility Name
Cabinet Medical Individual Dr Tirnaveanue Amelita, Gastroenterologie
City
Oradea
ZIP/Postal Code
410066
Country
Romania
Facility Name
Cabinet Particular Policlinic Algomed SRL
City
Timisoara
ZIP/Postal Code
300002
Country
Romania
Facility Name
State Budgetary Healthcare Institution "Chelyabinski Regional Clinical Hospital"
City
Chelyabinsk
ZIP/Postal Code
454076
Country
Russian Federation
Facility Name
State Budgetary Institution of Health Irkustsk Order "Badge of Honor" Regional Clinical Hospital
City
Irkutsk
ZIP/Postal Code
669079
Country
Russian Federation
Facility Name
Federal State Budgetary Institution of Science Federal Research Center of Nutrition, Biotechnology and Food Safety
City
Moscow
ZIP/Postal Code
115446
Country
Russian Federation
Facility Name
State Budgetary Healthcare Institution of Moscow "City Clinical Hospital # 24 of Healthcare Department of Moscow"
City
Moscow
ZIP/Postal Code
127015
Country
Russian Federation
Facility Name
State Budgetary Healthcare Institution of Moscow Region "Moscow Regional Clinical Research Institute n.a. M.F. Vladimirskiy"
City
Moscow
ZIP/Postal Code
129110
Country
Russian Federation
Facility Name
State Budgetary Healthcare Institution of Nizhny Novgorod Region "Nizhny Novgorod Regional Clinical Hospital n.a. N.A.
City
Nizhniy Novgorod
ZIP/Postal Code
603126
Country
Russian Federation
Facility Name
State Budgetary Institution of Health of Novosibirsk Region "City Clinical Hospital #12"
City
Novosibirsk
ZIP/Postal Code
630084
Country
Russian Federation
Facility Name
State Budgetary Healthcare Institution of the Novosibirsk Region "State Novosibirsk Regional Clinical Hospital"
City
Novosibirsk
ZIP/Postal Code
630087
Country
Russian Federation
Facility Name
"Riat" LLC
City
Saint Petersburg
ZIP/Postal Code
193163
Country
Russian Federation
Facility Name
Saint Petersburg State Budgetary Healthcare Institution "City Polyclinic #38"
City
Saint-Petersburg
ZIP/Postal Code
191015
Country
Russian Federation
Facility Name
"Scientific Research Centre ECO-safety" LLC
City
Saint-Petersburg
ZIP/Postal Code
196143
Country
Russian Federation
Facility Name
State Healthcare Institution "Regional Clinical Hospital"
City
Saratov
ZIP/Postal Code
410053
Country
Russian Federation
Facility Name
Treatment and Prevention Interdistrict Institution "Smolenskie kliniki" LLC
City
Smolensk
ZIP/Postal Code
214019
Country
Russian Federation
Facility Name
Tyumen Regional State Autonomous Healthcare Institution << Consulting and Diagnostic Centre <<Endos>>
City
Tyumen
ZIP/Postal Code
625026
Country
Russian Federation
Facility Name
Zvezdara University Medical Center
City
Belgrade
ZIP/Postal Code
3810-972
Country
Serbia
Facility Name
Singapore General Hospital
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
Facility Name
KM Management, s.r.o., Gastroenterologicke a hepatologicke centrum Nitra
City
Nitra
ZIP/Postal Code
950 01
Country
Slovakia
Facility Name
Dr MJ Prins
City
Cape Town
ZIP/Postal Code
7500
Country
South Africa
Facility Name
Peermed Clinical Trial Centre
City
Johannesburg
ZIP/Postal Code
1619
Country
South Africa
Facility Name
Centro Medico Teknon
City
Barcelona
ZIP/Postal Code
08022
Country
Spain
Facility Name
Hospital Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario de Fuenlabrada
City
Madrid
ZIP/Postal Code
28942
Country
Spain
Facility Name
Hospital Universitario Central de Asturias
City
Oviedo
ZIP/Postal Code
33006
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocío
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Skane University Hospital
City
Malmo
ZIP/Postal Code
SE-205-02
Country
Sweden
Facility Name
Danderyd University Hospital Corp
City
Stockholm
ZIP/Postal Code
182 88
Country
Sweden
Facility Name
Akademiska Sjukhuset
City
Uppsala
ZIP/Postal Code
75185
Country
Sweden
Facility Name
Gastroenterologische Praxis Balsiger, Seibold und Partner
City
Bern
ZIP/Postal Code
3012
Country
Switzerland
Facility Name
Universitätsspital Zürich
City
Zurich
ZIP/Postal Code
8091
Country
Switzerland
Facility Name
Changhua Christian Hospital
City
Changhua
ZIP/Postal Code
500
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
ZIP/Postal Code
100
Country
Taiwan
Facility Name
Mackay Memorial Hospital, Taipei
City
Taipei
ZIP/Postal Code
10449
Country
Taiwan
Facility Name
Chang Gung Medical Foundation, Chang Gung Memorial Hospital, Linkou Branch
City
Taoyuan
ZIP/Postal Code
33305
Country
Taiwan
Facility Name
Municipal Institution "Cherkasy Regional Hospital of Cherkasy Regional Council", Gastroenterology Department
City
Cherkasy
ZIP/Postal Code
18000
Country
Ukraine
Facility Name
Municipal City Clinical Hospital of the Emergency Medical Care, 1 st Therapy Department. Danylo Halytsky Lviv National Medical
City
Chernivtsi
ZIP/Postal Code
58000
Country
Ukraine
Facility Name
Regional Municipal Institution "Chernivtsi Regional Clinical Hospital", Surgical Department
City
Chernivtsi
ZIP/Postal Code
58000
Country
Ukraine
Facility Name
State Institution "Institute of Gastroenterology of National Academy of Medical Sciences of Ukraine"
City
Dnipropetrovsk
ZIP/Postal Code
49000
Country
Ukraine
Facility Name
Ivanto-Frankivsk Central City Clinic Hospital, Therapy Department #1. State Higher Education Institution Ivano-Frankivsk National
City
Ivano-Frankivsk
ZIP/Postal Code
76018
Country
Ukraine
Facility Name
Municipal Health Care Institution "Kharkiv City Clinical Hospital #2 named after prof. O. O. Shalimov", Proctology Department
City
Kharkiv
ZIP/Postal Code
61037
Country
Ukraine
Facility Name
L.T. Mala State Institution "National Institute of Therapy of National Academy of Medical Sciences of Ukraine"
City
Kharkiv
ZIP/Postal Code
61039
Country
Ukraine
Facility Name
Municipal Institution of Health Care "Regional Hospital of War Veterans", Therapeutic Department No1
City
Kharkiv
ZIP/Postal Code
63101
Country
Ukraine
Facility Name
Kyiv City Clinical Hospital No. 18, Proctology Department
City
Kyiv
ZIP/Postal Code
01030
Country
Ukraine
Facility Name
Municipal Non-profit Enterprise "Consultative and Diagnostic Center" of Pechersk District of Kyiv, Therapy Department
City
Kyiv
ZIP/Postal Code
1103
Country
Ukraine
Facility Name
Odesa Clinical Railway Hospital Branch of "Healthcare Center" of Public joint stock company "Ukrainian Railway"
City
Odessa
ZIP/Postal Code
65010
Country
Ukraine
Facility Name
Municipal Institution "Odesa Regional Clinical Hospital", Regional Gastroenterology Center based on Surgery Department
City
Odessa
ZIP/Postal Code
65025
Country
Ukraine
Facility Name
Ternopil University Hospital, Regional Center of Gastroenterology with Hepatology
City
Ternopil
ZIP/Postal Code
46002
Country
Ukraine
Facility Name
Vinnytsia Regional Clinical Hospital of War Veterans, Therapy Department #1
City
Vinnytsia
ZIP/Postal Code
21005
Country
Ukraine
Facility Name
M.I. Pyrogov Vinnytsia Regional Clinical Hospital, Gastroenterology Department
City
Vinnytsia
ZIP/Postal Code
21018
Country
Ukraine
Facility Name
Medical Center LLC "Health Clinic"
City
Vinnytsia
ZIP/Postal Code
21029
Country
Ukraine
Facility Name
Municipal Institution "Zaporizhzhya Regional Clinical Hospital" of Zaporizhzhya Regional Council
City
Zaporizhzhya
ZIP/Postal Code
69600
Country
Ukraine
Facility Name
Norfolk and Norwich University Hospital NHS Foundation Trust
City
Norwich
State/Province
Norfolk
ZIP/Postal Code
NR4 7UY
Country
United Kingdom
Facility Name
The Pennine Acute Hospitals NHS Trust
City
Bury
ZIP/Postal Code
BL9 7TD
Country
United Kingdom
Facility Name
Cambridge University Hospital NHS Foundation Trust
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Royal Derby Hospital
City
Derby
ZIP/Postal Code
DE22 3NE
Country
United Kingdom
Facility Name
NHS Lothian
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
Glasgow Clinical Research Facility - Queen Elizabeth University Hospital
City
Glasgow
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Facility Name
NHS Greater Glasgow and Clyde
City
Glasgow
ZIP/Postal Code
G52 3NQ
Country
United Kingdom
Facility Name
Wycombe Hospital
City
High Wycombe
ZIP/Postal Code
HP11 2TT
Country
United Kingdom
Facility Name
Imperial College Healthcare NHS Trust, St Mary's Hospital
City
London
ZIP/Postal Code
W2 1NY
Country
United Kingdom
Facility Name
Biomedical Research Unit
City
Nottingham
ZIP/Postal Code
NG7 2UH
Country
United Kingdom
Facility Name
Oxford University Hospitals NHS Trust
City
Oxford
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Facility Name
St Helens and Knowsley Teaching Hospitals NHS Trust
City
Prescot
ZIP/Postal Code
L35 5DR
Country
United Kingdom
Facility Name
Southampton National Institute for Health Research, Wellcome Trust Clinical Research Facility
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom

12. IPD Sharing Statement

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

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