A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects With Ulcerative Colitis
Who is this study for? Patients with Ulcerative Colitis
What treatments are being studied? Filgotinib
Status: Active_not_recruiting
Location: See all (319) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
United States
Alabama
Digestive Health Specialists Of The Southeast
Dothan
Arizona
Mayo Clinic Arizona
Scottsdale
California
VA Long Beach Healthcare System
Long Beach
Cedars Sinai Medical Center
Los Angeles
Colorado
South Denver Gastroenterology, PC
Lone Tree
Connecticut
Connecticut GI PC-Research Division
Farmington
Florida
UF Clinical Research Center
Gainesville
Florida Research Institute
Lakewood Rch
Cordova Research Institute
Miami
University of Miami Crohn's and Colitis Center
Miami
Gastroenterology Group of Naples
Naples
Advanced Medical Research Center
Port Orange
Tampa General Hospital
Tampa
Florida Medical Clinic, P.A
Zephyrhills
Georgia
Gastroenterology Associates Of Central Georgia, LLC
Macon
Gastrointestinal Specialists of Georgia
Marietta
Atlanta Gastroenterology Specialist, PC
Suwanee
Iowa
University of Iowa Hospitals and Clinics
Iowa City
Kentucky
University of Louisville, Clinical Trials Unit
Louisville
Louisiana
Delta Research Partners, LLC
Monroe
Louisiana Research Center, LLC
Shreveport
Massachusetts
Massachusetts General Hospital - Crohn's and Colitis Center
Boston
Maryland
Investigative Clinical Research
Annapolis
MGG Group Co., Inc., Chevy Chase Clinical Research
Chevy Chase
Gastro Center of Maryland
Columbia
Meritus Center for Clinical Research
Hagerstown
Michigan
Clinical Research Institute of Michigan, LLC
Chesterfield
Center for Digestive Health Research
Troy
Minnesota
Mayo Clinic
Rochester
Missouri
Kansas City Research Institute
Kansas City
Washington University School of Medicine
St Louis
North Carolina
Carolina's GI Research LLC
Raleigh
North Dakota
Fargo Gastroenterology and Hepatology Clinic
Fargo
New York
NY Scientific
Brooklyn
NYU Langone Long Island Clinical Research Associates
Great Neck
Ohio
Consultants for Clinical Research
Cincinnati
UC Health Physicians Clifton
Cincinnati
Great Lakes Gastroenterology Research, LLC
Mentor
South Carolina
Gastroenterology Associates of Orangeburg
Orangeburg
South Dakota
Rapid City Medical Center
Rapid City
Tennessee
Gastro One
Germantown
Quality Medical Research
Nashville
Vanderbilt University Medical Center - IBD Clinic
Nashville
Texas
San Antonio Military Medical Center
Fort Sam Houston
DHAT Research Institute
Garland
Baylor College of Medicine - Baylor Medical Center
Houston
The University of Texas Health Science Center at Houston
Houston
Clinical Associates in Research Therapeutics of America, LLC
San Antonio
Gastroenterology Research of San Antonio
San Antonio
TDDC San Marcos
San Marcos
Texas Digestive Disease Consultants
Southlake
Spring Gastroenterology
The Woodlands
Virginia
University of Virginia Health System
Charlottesville
Gastroenterology Associates of Tidewater
Chesapeake
McGuire DVAMC
Richmond
Wisconsin
University of Wisconsin Hospital & Clinics
Madison
Allegiance Research Specialists, LLC
Wauwatosa
Other Locations
Argentina
Instituto de Investigaciones Clinicas Mar del Plata
Mar Del Plata
Instituto Médico Cer
Quilmes
Australia
Monash Medical Centre
Clayton
St. Vincent's Hospital Sydney
Darlinghurst
Footscray Hospital
Footscray
Nepean Hospital
Kingswood
Cabrini Hospital
Malvern
Alfred Hospital
Melbourne
Coastal Digestive Health
Mountain Creek
Mater Misericordiae Ltd
South Brisbane
The Queen Elizabeth Hospital
Woodville South
Princess Alexandra Hospital
Woolloongabba
Austria
Universitatsklinik Innsbruck
Innsbruck
AKH-Medizinische Universitat Wien
Vienna
Belgium
GZA Ziekenhuizen, campus Sint-Vincentius
Antwerp
CUB Hopital Erasme
Brussels
Universitair Ziekenhuis Leuven
Leuven
Centre Hospitalier Chretien (CHC) - Clinique Saint-Joseph
Liège
Bulgaria
MHAT Sveti Pantaleymon- Pleven OOD
Pleven
MDHAT Dr. St.Cherkezov AD
Veliko Tarnovo
MHAT Sveta Petka AD
Vidin
Canada
University of Calgary, Heritage Medical Research Clinic
Calgary
Hamilton Health Sciences Corporation, McMaster University Medical Centre
Hamilton
Royal University Hospital
Saskatoon
The Gordon and Leslie Diamond Health Care Centre
Vancouver
Toronto Digestive Disease Associates Inc.
Vaughan
Croatia
Clinical Hospital Dubrava
Zagreb
University Hospital Center Zagreb
Zagreb
France
CHU Amiens Picardie
Amiens
CHU de Caen
Caen
CHU de Clermont-Ferrand - Hopital d'Estaing
Clermont-ferrand
APHP - Hopital Beaujon - Clichy - Universite Paris VII
Clichy
CHU de Dijon Bourgogne - Hopital Francois Mitterand
Dijon
CHU Grenoble Alpes
La Tronche
Hopital Universitaire de Bicetre
Le Kremlin-bicêtre
Centre Hospitalier Regional Universitaire de Lille
Lille
Hopital Nord
Marseille
CHU de Montpellier-Hopital Saint Eloi
Montpellier
CHU Hotel-Dieu
Nantes
Hopital de l'Archet 2
Nice
CHU de Bordeaux - Hopital Haut Leveque
Pessac
Centre Hospitalier Universitaire de Lyon Sud
Pierre-bénite
Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
Rennes
CHU de Saint Etienne - Hopital Nord
Saint-priest-en-jarez
CHU de Toulouse - Hopital Rangueil
Toulouse
CHU de Nancy - Hopital Brabois Adultes
Vandœuvre-lès-nancy
Georgia
Unimed Ajara LLC - Batumi Referral Hospital
Batumi
Medi Club Georgia LLC
Tbilisi
Germany
Charite - Universitatsmedizin Berlin
Berlin
Charite Universitaetsmedizin Berlin
Berlin
DRK Kliniken Berlin - Westend - Klinik fuer Innere Medizin
Berlin
Stadtisches Klinikum Braunschweig gGmbH
Braunschweig
Universitaetsklinik Koln
Cologne
Agaplesion Markus Krankenhaus
Frankfurt Am Main
Universitatsklinikum Freiburg
Freiburg Im Breisgau
Asklepios Westklinikum Hamburg
Hamburg
Medizinische Hochschule Hannover
Hanover
Gastroenterologische Gemeinschaftspraxis Herne
Herne
Universitatsklinikum Jena
Jena
Universitatsklinikum Schleswig-Holstein
Kiel
EUGASTRO GmbH
Leipzig
Klinikum Luneburg
Lüneburg
Gastroenterologische Gemeinschaftspraxis Minden
Minden
Klinikum der Universitat Munchen - Grosshadern
München
Universitaetsklinikum Tuebingen
Tübingen
Universitatsklinikum Ulm, Zentrum Fur Innere Medizin
Ulm
Greece
General Hospital of Athens Hippokratio, 2nd Internal Medicine Clinic of Athens University, Hepato-gastroenterology Unit
Athens
Hong Kong Special Administrative Region
Princess Margaret Hospital
Hong Kong
Queen Mary Hospital
Hong Kong
Department of Medicine & Therapeutics, The Chinese University of Hong Kong, Prince of Wales Hospital
Shatin
Hungary
Bekes Megyei Kosponti Korhaz, Dr. Rethy Pal Tagkorhaz, IV. Belgyogyaszat - 2. Gasztroenterologia
Békéscsaba
Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet, Kozponti Felnott Szakrendelo
Budapest
Szent Janos Korhaz es Eszak-budai Egitett Korhazak, I. Belgyogyaszati - Gasztroenterologiai Osztaly
Budapest
Debreceni Egyetem Klinikai Kozpont, II. sz. Belgyogyaszati Klinika, Gasztroenterologia
Debrecen
Bugat Pal Korhaz, Belgyogyaszat
Gyöngyös
Karolina Korhaz es Rendelointezet, Altalanos Belgyogyaszat-Gasztroenterologia
Mosonmagyaróvár
India
Kaizen Hospital
Ahmedabad
M S Ramaiah Medical College and Hospital
Bangalore
Apollo Speciality Hospital
Chennai
VGM Hospital Institute of Gastroenterology
Coimbatore
Centre for Liver Research & Diagnostics
Hyderabad
Citizens Specialty Hospital
Hyderabad
Gleneagles Global Hospitals
Hyderabad
S.M.S Medical College & Hospitals
Jaipur
SR Kalla Memorial Gastro and General Hospital
Jaipur
Dayanand Medical College & Hospital
Ludhiana
Kasturba Medical College (KMC) Hospital
Mangaluru
Lokmanya Tilak Municipal General Hospital
Mumbai
Midas Multispeciality Hospital Pvt. Ltd
Nagpur
Suretech Hospital & Research Centre Ltd
Nagpur
Grant Medical Foundation Ruby Hall Clinic
Pune
Shree Giriraj Multispeciality Hospital
Rajkot
Gandhi Hospital
Secunderabad
Surat Institute of Digestive Sciences
Surat
Kasturba Hospital Medical College
Udupi
Sterling Hospital
Vadodara
Samvedna Hospital
Varanasi
Ireland
Beaumont Hospital
Dublin
Israel
Bnai Zion Medical Center
Haifa
Rambam Medical Health Care Campus
Haifa
Hadassah Medical Center
Jerusalem
Shaare Zedek Medical Center
Jerusalem
Rabin Medical Center
Petah Tikva
Italy
UOC Gastroenterologia II
Castellana Grotte
U.O. Fisiopatologia Digestiva
Catanzaro
Ospedale Clinicizzato SS. Annunziata - Dipartimento di Medicina
Chieti
Endocsopia Digestiva Centralizzata - ASST Fatebenefratelli Sacco, Ospedale Fatebenefratelli e Oftalmico
Milan
UOC Gastroenterologia
Padua
Azienda Ospedaliero-Universitaria Pisana - Presidio Ospedaliero Cisanello
Pisa
UOC Gastroenterologia ed Endoscopia Digestiva
Roma
Istituto Clinico Humanitas
Rozzano
Japan
Medical Hospital, Tokyo Medical and Dental University
Bunkyō City
Fukuoka University Chikushi Hospital
Chikushino-shi
Hokkaido P.W.F.A.C Sapporo-Kosei General Hospital
Chūōku
Japanese Red Cross Fukuoka Hospital
Fukuoka
Tokai University Hachioji Hospital
Hachiōji
Hiroshima University Hospital
Hiroshima
Fukuoka University Hospital
Jonan-ku
Ofuna Chuo Hospital
Kamakura
Kitakyushu City Hospital Organization Kitakyushu Municipal Medical Center
Kitakyushu-shi
Yamanashi Prefectural Central Hospital
Kofu
Hidaka Coloproctology Clinic
Kurume-shi
Kurume University Hospital
Kurume-shi
University Hospital, Kyoto Prefectural University of Medicine
Kyoto
Kitasato University Kitasato Institute Hospital
Minatoku
The Jikei University Hospital
Minatoku
Kyorin University Hospital
Mitaka-shi
Iwate Medical University Hospital
Morioka
Aichi Medical University Hospital
Nagakute-shi
Nagasaki University Hospital
Nagasaki
Saiseikai Niigata Daini Hospital
Nishiku
Hyogo College of Medicine College Hospital
Nishinomiya
Ishida IBD Clinic
Ōita
Okayama University Hospital
Okayama
Kinshukai Infusion Clinic
Osaka
Osaka City University Hospital
Osaka
Wakakusa-Daiichi Hospital
Osaka
Shiga University of Medical Science Hospital
Ōtsu
Saga University Hospital
Saga
Saga-Ken Medical Centre Koseikan
Saga
Kitasato University Hospital,THE KITASATO INSTITUTE
Sagamihara
Tokito Clinic
Saitama
Toho University Sakura Medical Center
Sakura
Sapporo Higashi Tokushukai Hospital
Sapporo
National Hospital Organization Sendai Medical Center
Sendai
Tokyo Yamate Medical Center
Shinjuku-ku
Osaka University Hospital
Suita
Kagawa Prefectural Central Hospital
Takamatsu
National Hospital Organization Takasaki General Medical Center
Takasaki-shi
Osaka Medical College Hospital
Takatsuki
Ieda Hospital
Toyota-shi
Wakayama Medical University Hospital
Wakayama
Colo-proctology Center Matsushima Clinic
Yokohama
Malaysia
Hospital Pulau Pinang
George Town
Hospital Queen Elizabeth
Kota Kinabalu
Mexico
PCR-Phylasis Clinicas Research S. de R.L. de C.V.
Cuautitlán Izcalli
Netherlands
Academic Medical Center (AMC)
Amsterdam
Gelre Hospital
Apeldoorn
University Medical Center Utrecht
Utrecht
New Zealand
Christchurch Hospital
Christchurch
Auckland City Hospital
Grafton
Wellington Hospital
Newtown
Bay of Plenty District Health Board - Tauranga Hospital
Tauranga
Poland
Uniwersytecki Szpital Kliniczny w Bialymstoku, Klinika Gastroenterologii i Chorob Wewnetrznych
Bialystok
Gabinet Lekarski Janusz Rudzinski
Bydgoszcz
VITAMED Galaj i Cichomski spólka jawna
Bydgoszcz
NZOZ INTER-MED, Centrum Endoskopowe
Częstochowa
Niepubliczny Zaklad Opieki Zdrowotnej ALL-MEDICUS
Katowice
Gabinet Endoskopii Przewodu Pokarmowego
Krakow
Krakowskie Centrum Medyczne Sp. z o.o
Krakow
Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp. J.
Ksawerów
Santa Familia, Centrum Badan, Profilaktyki i Leczenia
Lodz
Centrum Innowacyjnych Terapii Sp. z o.o.
Piaseczno
Clinical Research Center Spolka z ograniczna odpowiedzialnoscia Medic-R Sp. k.
Poznan
Gabinet Lekarski Dr. Hab. N. Med. Bartosz Korczowski
Rzeszów
Endoskopia Sp. z o.o.
Sopot
Twoja Przychodnia-Szczecinskie Centrum Medyczne
Szczecin
GASTROMED Kopon, Zmudzinski i Wspolnicy Sp. j. Specjalistyczne Centrum Gastrologii i Endoskopii
Torun
H-T.Centrum Medyczne Spolka z Ograniczona Odpowiedzialnoscia Sp.K.
Tychy
Bodyclinic
Warsaw
Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administacji w Warszawie
Warsaw
Centrum Zdrowia MDM
Warsaw
Niepubliczny Zaklad Opieki Zrodotnej VIVAMED Jadwige Miecz
Warsaw
Centrum Medyczne Oporow
Wroclaw
Portugal
Hospital da Senhora da Oliveira Guimaraes, E.P.E.
Guimarães
Centro Hospitalar de Sao Joao, EPE
Porto
Republic of Korea
Pusan National University Hospital
Busan
Yeungnam University Hospital
Daegu
Asan Medical Center
Seoul
Division of Gastroenterology, Department of Medicine, Samsung Medical Center
Seoul
Kangbuk Samsung Hospital
Seoul
Kyung Hee University Hospital
Seoul
Yonsei University Health System, Severance Hospital
Seoul
The Catholic University of Korea, St. Vincent's Hospital
Suwon
Yonsei University Wonju Severance Christian Hospital
Wŏnju
Romania
MedLife, Gastroenterologie
Bucharest
Spitalul Clinic Colentina - Sectia de Spitulal Clinic Colentina, Gastroenterologie
Bucharest
Cabinet Medical Individual Dr Tirnaveanue Amelita, Gastroenterologie
Oradea
Cabinet Particular Policlinic Algomed SRL
Timișoara
Russian Federation
State Budgetary Healthcare Institution Chelyabinski Regional Clinical Hospital
Chelyabinsk
State Budgetary Institution of Health Irkustsk Order Badge of Honor Regional Clinical Hospital
Irkutsk
Federal State Budgetary Institution of Science Federal Research Center of Nutrition, Biotechnology and Food Safety
Moscow
State Budgetary Healthcare Institution of Moscow City Clinical Hospital # 24 of Healthcare Department of Moscow
Moscow
State Budgetary Healthcare Institution of Moscow Region Moscow Regional Clinical Research Institute n.a. M.F. Vladimirskiy
Moscow
State Budgetary Healthcare Institution of Nizhny Novgorod Region Nizhny Novgorod Regional Clinical Hospital n.a. N.A.
Nizhny Novgorod
State Budgetary Healthcare Institution of the Novosibirsk Region State Novosibirsk Regional Clinical Hospital
Novosibirsk
State Budgetary Institution of Health of Novosibirsk Region City Clinical Hospital #12
Novosibirsk
Riat LLC
Saint Petersburg
Saint Petersburg State Budgetary Healthcare Institution City Polyclinic #38
Saint Petersburg
Scientific Research Centre ECO-safety LLC
Saint Petersburg
State Healthcare Institution Regional Clinical Hospital
Saratov
Treatment and Prevention Interdistrict Institution Smolenskie kliniki LLC
Smolensk
Tyumen Regional State Autonomous Healthcare Institution << Consulting and Diagnostic Centre <<Endos>>
Tyumen
Serbia
Zvezdara University Medical Center
Belgrade
Singapore
Singapore General Hospital
Singapore
Slovakia
KM Management, s.r.o., Gastroenterologicke a hepatologicke centrum Nitra
Nitra
South Africa
Dr MJ Prins
Cape Town
Peermed Clinical Trial Centre
Johannesburg
Spain
Centro Medico Teknon
Barcelona
Hospital Clinico San Carlos
Madrid
Hospital Universitario de Fuenlabrada
Madrid
Hospital Universitario Central de Asturias
Oviedo
Hospital Universitario Virgen del Rocío
Seville
Sweden
Skane University Hospital
Malmo
Danderyd University Hospital Corp
Stockholm
Akademiska Sjukhuset
Uppsala
Switzerland
Gastroenterologische Praxis Balsiger, Seibold und Partner
Bern
Universitätsspital Zürich
Zurich
Taiwan
Changhua Christian Hospital
Changhua
Mackay Memorial Hospital, Taipei
Taipei
National Taiwan University Hospital
Taipei
Chang Gung Medical Foundation, Chang Gung Memorial Hospital, Linkou Branch
Taoyuan District
Ukraine
Municipal Institution Cherkasy Regional Hospital of Cherkasy Regional Council, Gastroenterology Department
Cherkasy
Municipal City Clinical Hospital of the Emergency Medical Care, 1 st Therapy Department. Danylo Halytsky Lviv National Medical
Chernivtsi
Regional Municipal Institution Chernivtsi Regional Clinical Hospital, Surgical Department
Chernivtsi
State Institution Institute of Gastroenterology of National Academy of Medical Sciences of Ukraine
Dnipropetrovsk
Ivanto-Frankivsk Central City Clinic Hospital, Therapy Department #1. State Higher Education Institution Ivano-Frankivsk National
Ivano-frankivsk
L.T. Mala State Institution National Institute of Therapy of National Academy of Medical Sciences of Ukraine
Kharkiv
Municipal Health Care Institution Kharkiv City Clinical Hospital #2 named after prof. O. O. Shalimov, Proctology Department
Kharkiv
Municipal Institution of Health Care Regional Hospital of War Veterans, Therapeutic Department No1
Kharkiv
Kyiv City Clinical Hospital No. 18, Proctology Department
Kyiv
Municipal Non-profit Enterprise Consultative and Diagnostic Center of Pechersk District of Kyiv, Therapy Department
Kyiv
Municipal Institution Odesa Regional Clinical Hospital, Regional Gastroenterology Center based on Surgery Department
Odesa
Odesa Clinical Railway Hospital Branch of Healthcare Center of Public joint stock company Ukrainian Railway
Odesa
Ternopil University Hospital, Regional Center of Gastroenterology with Hepatology
Ternopil
M.I. Pyrogov Vinnytsia Regional Clinical Hospital, Gastroenterology Department
Vinnytsia
Medical Center LLC Health Clinic
Vinnytsia
Vinnytsia Regional Clinical Hospital of War Veterans, Therapy Department #1
Vinnytsia
Municipal Institution Zaporizhzhya Regional Clinical Hospital of Zaporizhzhya Regional Council
Zaporizhzhya
United Kingdom
The Pennine Acute Hospitals NHS Trust
Bury
Cambridge University Hospital NHS Foundation Trust
Cambridge
Royal Derby Hospital
Derby
NHS Lothian
Edinburgh
Glasgow Clinical Research Facility - Queen Elizabeth University Hospital
Glasgow
NHS Greater Glasgow and Clyde
Glasgow
Wycombe Hospital
High Wycombe
Imperial College Healthcare NHS Trust, St Mary's Hospital
London
Norfolk and Norwich University Hospital NHS Foundation Trust
Norwich
Biomedical Research Unit
Nottingham
Oxford University Hospitals NHS Trust
Oxford
St Helens and Knowsley Teaching Hospitals NHS Trust
Prescot
Southampton National Institute for Health Research, Wellcome Trust Clinical Research Facility
Southampton
Time Frame
Start Date: 2017-02-23
Completion Date: 2026-09
Participants
Target number of participants: 1173
Treatments
Experimental: Filgotinib 200 mg (blinded dosing)
Filgotinib 200 mg + placebo to match filgotinib 100 mg for up to 336 weeks
Experimental: Filgotinib 100 mg (blinded dosing)
Filgotinib 100 mg + placebo to match filgotinib 200 mg for up to 336 weeks
Placebo_comparator: Placebo (blinded dosing)
Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg for up to 336 weeks
Experimental: Filgotinib 200 mg (open-label)
Filgotinib 200 mg for up to 336 weeks
Experimental: Filgotinib 100 mg (open-label)
Filgotinib 100 mg for up to 336 weeks
Related Therapeutic Areas
Sponsors
Leads: Alfasigma S.p.A.
Collaborators: Gilead Sciences