Ulcerative ColitisPhase 3SELECTIONLTENCT02914535
Filgotinib in Long-Term Extension Study of Adults With Ulcerative Colitis
A Phase 3 study testing Filgotinib in people with Ulcerative Colitis, run by Alfasigma S.p.A. at 323 sites in 39 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Filgotinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,173 participants
- Where
- 323 sitesin 39 countries
- Study dates
- 23 Feb 2017to 8 Sep 2026
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
323 sites in 39 countries.
323 sites in 39 countries
United States57 sites
Investigative Clinical Research
Annapolis, Maryland, 21401
Massachusetts General Hospital - Crohn's and Colitis Center
Boston, Massachusetts, 02114
NY Scientific
Brooklyn, New York, 11235
University of Virginia Health System
Charlottesville, Virginia, 22908
Gastroenterology Associates of Tidewater
Chesapeake, Virginia, 23320
Clinical Research Institute of Michigan, LLC
Chesterfield, Michigan, 48047
MGG Group Co., Inc., Chevy Chase Clinical Research
Chevy Chase, Maryland, 20815
Consultants for Clinical Research
Cincinnati, Ohio, 45219
UC Health Physicians Clifton
Cincinnati, Ohio, 45219
Gastro Center of Maryland
Columbia, Maryland, 21045
Digestive Health Specialists Of The Southeast
Dothan, Alabama, 36305
Fargo Gastroenterology and Hepatology Clinic
Fargo, North Dakota, 58103
Connecticut GI PC-Research Division
Farmington, Connecticut, 06032
San Antonio Military Medical Center
Fort Sam Houston, Texas, 78219
UF Clinical Research Center
Gainesville, Florida, 32610
DHAT Research Institute
Garland, Texas, 75044
Gastro One
Germantown, Tennessee, 38138
NYU Langone Long Island Clinical Research Associates
Great Neck, New York, 11021
Meritus Center for Clinical Research
Hagerstown, Maryland, 21742
Baylor College of Medicine - Baylor Medical Center
Houston, Texas, 77030
The University of Texas Health Science Center at Houston
Houston, Texas, 77030
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242
Kansas City Research Institute
Kansas City, Missouri, 64131
Florida Research Institute
Lakewood Rch, Florida, 34211
South Denver Gastroenterology, PC
Lone Tree, Colorado, 80124
VA Long Beach Healthcare System
Long Beach, California, 90822
Cedars Sinai Medical Center
Los Angeles, California, 90048
University of Louisville, Clinical Trials Unit
Louisville, Kentucky, 40202
Gastroenterology Associates Of Central Georgia, LLC
Macon, Georgia, 31201
University of Wisconsin Hospital & Clinics
Madison, Wisconsin, 53705
Gastrointestinal Specialists of Georgia
Marietta, Georgia, 30060
Great Lakes Gastroenterology Research, LLC
Mentor, Ohio, 44060
University of Miami Crohn's and Colitis Center
Miami, Florida, 33136
Cordova Research Institute
Miami, Florida, 33155
Delta Research Partners, LLC
Monroe, Louisiana, 71201
Gastroenterology Group of Naples
Naples, Florida, 34102
Quality Medical Research
Nashville, Tennessee, 37211
Vanderbilt University Medical Center - IBD Clinic
Nashville, Tennessee, 37212-1375
Gastroenterology Associates of Orangeburg
Orangeburg, South Carolina, 29118
Advanced Medical Research Center
Port Orange, Florida, 32127
Carolina's GI Research LLC
Raleigh, North Carolina, 27607
Rapid City Medical Center
Rapid City, South Dakota, 57701
McGuire DVAMC
Richmond, Virginia, 23249
Mayo Clinic
Rochester, Minnesota, 55905
Clinical Associates in Research Therapeutics of America, LLC
San Antonio, Texas, 78212
Gastroenterology Research of San Antonio
San Antonio, Texas, 78229
TDDC San Marcos
San Marcos, Texas, 78666
Mayo Clinic Arizona
Scottsdale, Arizona, 85259
Louisiana Research Center, LLC
Shreveport, Louisiana, 71105
Texas Digestive Disease Consultants
Southlake, Texas, 76092
Washington University School of Medicine
St Louis, Missouri, 63110
Atlanta Gastroenterology Specialist, PC
Suwanee, Georgia, 30024
Tampa General Hospital
Tampa, Florida, 33606
Spring Gastroenterology
The Woodlands, Texas, 77380
Center for Digestive Health Research
Troy, Michigan, 48098
Allegiance Research Specialists, LLC
Wauwatosa, Wisconsin, 53225
Florida Medical Clinic, P.A
Zephyrhills, Florida, 33540
Japan42 sites
Medical Hospital, Tokyo Medical and Dental University
Bunkyō City, 113-8519
Fukuoka University Chikushi Hospital
Chikushino-shi, 818-8502
Hokkaido P.W.F.A.C Sapporo-Kosei General Hospital
Chūōku, 060-0033
Japanese Red Cross Fukuoka Hospital
Fukuoka, 815-8555
Tokai University Hachioji Hospital
Hachiōji, 192-0032
Hiroshima University Hospital
Hiroshima, 734-8551
Fukuoka University Hospital
Jonan-ku, 814-0180
Ofuna Chuo Hospital
Kamakura, 247-0056
Kitakyushu City Hospital Organization Kitakyushu Municipal Medical Center
Kitakyushu-shi, 802-0077
Yamanashi Prefectural Central Hospital
Kofu, 400-8506
Kurume University Hospital
Kurume-shi, 830-0011
Hidaka Coloproctology Clinic
Kurume-shi, 839-0809
University Hospital, Kyoto Prefectural University of Medicine
Kyoto, 602-8566
The Jikei University Hospital
Minatoku, 105-8471
Kitasato University Kitasato Institute Hospital
Minatoku, 108-8642
Kyorin University Hospital
Mitaka-shi, 181-8611
Iwate Medical University Hospital
Morioka, 020-8505
Aichi Medical University Hospital
Nagakute-shi, 480-1195
Nagasaki University Hospital
Nagasaki, Nagasaki, 8528501
Saiseikai Niigata Daini Hospital
Nishiku, 950-1104
Hyogo College of Medicine College Hospital
Nishinomiya, 663-8501
Ishida IBD Clinic
Ōita, 870-0823
Okayama University Hospital
Okayama, 700-8558
Kinshukai Infusion Clinic
Osaka, 530-0011
Osaka City University Hospital
Osaka, 545-8586
Wakakusa-Daiichi Hospital
Osaka, 579-8056
Shiga University of Medical Science Hospital
Ōtsu, 520-2192
Saga-Ken Medical Centre Koseikan
Saga, 840-8571
Saga University Hospital
Saga, 849-8501
Kitasato University Hospital,THE KITASATO INSTITUTE
Sagamihara, 252-0375
Tokito Clinic
Saitama, 336-0963
Toho University Sakura Medical Center
Sakura, 285-8741
Sapporo Higashi Tokushukai Hospital
Sapporo, 065-0033
National Hospital Organization Sendai Medical Center
Sendai, 983-8520
Tokyo Yamate Medical Center
Shinjuku-ku, 169-0073
Osaka University Hospital
Suita, Osaka, 565-0871
Kagawa Prefectural Central Hospital
Takamatsu, 760-8557
National Hospital Organization Takasaki General Medical Center
Takasaki-shi, 3700829
Osaka Medical College Hospital
Takatsuki, 569-8686
Ieda Hospital
Toyota-shi, 470-1219
Wakayama Medical University Hospital
Wakayama, 641-8509
Colo-proctology Center Matsushima Clinic
Yokohama, 220-0045
India21 sites
Kaizen Hospital
Ahmedabad, 380052
M S Ramaiah Medical College and Hospital
Bangalore, 560054
Apollo Speciality Hospital
Chennai, 600035
VGM Hospital Institute of Gastroenterology
Coimbatore, 641005
Gleneagles Global Hospitals
Hyderabad, 500004
Citizens Specialty Hospital
Hyderabad, 500019
Centre for Liver Research & Diagnostics
Hyderabad, 500058
SR Kalla Memorial Gastro and General Hospital
Jaipur, 302001
S.M.S Medical College & Hospitals
Jaipur, 302004
Dayanand Medical College & Hospital
Ludhiana, 141001
Kasturba Medical College (KMC) Hospital
Mangaluru, 575001
Lokmanya Tilak Municipal General Hospital
Mumbai, 400022
Midas Multispeciality Hospital Pvt. Ltd
Nagpur, 440010
Suretech Hospital & Research Centre Ltd
Nagpur, 440012
Grant Medical Foundation Ruby Hall Clinic
Pune, 411001
Shree Giriraj Multispeciality Hospital
Rajkot, 360002
Gandhi Hospital
Secunderabad, 500003
Surat Institute of Digestive Sciences
Surat, 395002
Kasturba Hospital Medical College
Udupi, 576104
Sterling Hospital
Vadodara, 390007
Samvedna Hospital
Varanasi, 221005
Poland21 sites
Uniwersytecki Szpital Kliniczny w Bialymstoku, Klinika Gastroenterologii i Chorob Wewnetrznych
Bialystok, 15-276
VITAMED Galaj i Cichomski spólka jawna
Bydgoszcz, 85-079
Gabinet Lekarski Janusz Rudzinski
Bydgoszcz, 85-681
NZOZ INTER-MED, Centrum Endoskopowe
Częstochowa, 42-217
Niepubliczny Zaklad Opieki Zdrowotnej ALL-MEDICUS
Katowice, 40-659
Gabinet Endoskopii Przewodu Pokarmowego
Krakow, 31-009
Krakowskie Centrum Medyczne Sp. z o.o
Krakow, 31-501
Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp. J.
Ksawerów, 95-054
Santa Familia, Centrum Badan, Profilaktyki i Leczenia
Lodz, 90-302
Centrum Innowacyjnych Terapii Sp. z o.o.
Piaseczno, 05-500
Clinical Research Center Spolka z ograniczna odpowiedzialnoscia Medic-R Sp. k.
Poznan, 60-848
Gabinet Lekarski Dr. Hab. N. Med. Bartosz Korczowski
Rzeszów, 35-301
Endoskopia Sp. z o.o.
Sopot, 81-756
Twoja Przychodnia-Szczecinskie Centrum Medyczne
Szczecin, 71-434
GASTROMED Kopon, Zmudzinski i Wspolnicy Sp. j. Specjalistyczne Centrum Gastrologii i Endoskopii
Torun, 87-100
H-T.Centrum Medyczne Spolka z Ograniczona Odpowiedzialnoscia Sp.K.
Tychy, 43-100
Centrum Zdrowia MDM
Warsaw, 00-635
Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administacji w Warszawie
Warsaw, 02-507
Niepubliczny Zaklad Opieki Zrodotnej VIVAMED Jadwige Miecz
Warsaw, 03-580
Bodyclinic
Warsaw, 03-712
Centrum Medyczne Oporow
Wroclaw, 52-416
France18 sites
CHU Amiens Picardie
Amiens, 80054
CHU de Caen
Caen, 14033
CHU de Clermont-Ferrand - Hopital d'Estaing
Clermont-Ferrand, 63003
APHP - Hopital Beaujon - Clichy - Universite Paris VII
Clichy, 92110
CHU de Dijon Bourgogne - Hopital Francois Mitterand
Dijon, 21079
CHU Grenoble Alpes
La Tronche, 38700
Hopital Universitaire de Bicetre
Le Kremlin-Bicêtre, 94270
Centre Hospitalier Regional Universitaire de Lille
Lille, 59000
Hopital Nord
Marseille, 13915
CHU de Montpellier-Hopital Saint Eloi
Montpellier, 34295
CHU Hotel-Dieu
Nantes, 44093
Hopital de l'Archet 2
Nice, 06202
CHU de Bordeaux - Hopital Haut Leveque
Pessac, 33600
Centre Hospitalier Universitaire de Lyon Sud
Pierre-Bénite, 69495
Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
Rennes, 35033
CHU de Saint Etienne - Hopital Nord
Saint-Priest-en-Jarez, 42055
CHU de Toulouse - Hopital Rangueil
Toulouse, 31059
CHU de Nancy - Hopital Brabois Adultes
Vandœuvre-lès-Nancy, 54511
Germany18 sites
Charite Universitaetsmedizin Berlin
Berlin, 10117
Charite - Universitatsmedizin Berlin
Berlin, 13353
DRK Kliniken Berlin - Westend - Klinik fuer Innere Medizin
Berlin, 14050
Stadtisches Klinikum Braunschweig gGmbH
Braunschweig, 38126
Universitaetsklinik Koln
Cologne, 50937
Agaplesion Markus Krankenhaus
Frankfurt am Main, 60431
Universitatsklinikum Freiburg
Freiburg im Breisgau, 79106
Asklepios Westklinikum Hamburg
Hamburg, 22559
Medizinische Hochschule Hannover
Hanover, 30625
Gastroenterologische Gemeinschaftspraxis Herne
Herne, 44623
Universitatsklinikum Jena
Jena, 07747
Universitatsklinikum Schleswig-Holstein
Kiel, Schleswig-Holstein, 24105
EUGASTRO GmbH
Leipzig, 04103
Klinikum Luneburg
Lüneburg, 21339
Gastroenterologische Gemeinschaftspraxis Minden
Minden, 32423
Klinikum der Universitat Munchen - Grosshadern
München, 81377
Universitaetsklinikum Tuebingen
Tübingen, 72074
Universitatsklinikum Ulm, Zentrum Fur Innere Medizin
Ulm, 89081
Ukraine17 sites
Municipal Institution "Cherkasy Regional Hospital of Cherkasy Regional Council", Gastroenterology Department
Cherkasy, 18000
Municipal City Clinical Hospital of the Emergency Medical Care, 1 st Therapy Department. Danylo Halytsky Lviv National Medical
Chernivtsi, 58000
Regional Municipal Institution "Chernivtsi Regional Clinical Hospital", Surgical Department
Chernivtsi, 58000
State Institution "Institute of Gastroenterology of National Academy of Medical Sciences of Ukraine"
Dnipropetrovsk, 49000
Ivanto-Frankivsk Central City Clinic Hospital, Therapy Department #1. State Higher Education Institution Ivano-Frankivsk National
Ivano-Frankivsk, 76018
Municipal Health Care Institution "Kharkiv City Clinical Hospital #2 named after prof. O. O. Shalimov", Proctology Department
Kharkiv, 61037
L.T. Mala State Institution "National Institute of Therapy of National Academy of Medical Sciences of Ukraine"
Kharkiv, 61039
Municipal Institution of Health Care "Regional Hospital of War Veterans", Therapeutic Department No1
Kharkiv, 63101
Kyiv City Clinical Hospital No. 18, Proctology Department
Kyiv, 01030
Municipal Non-profit Enterprise "Consultative and Diagnostic Center" of Pechersk District of Kyiv, Therapy Department
Kyiv, 1103
Odesa Clinical Railway Hospital Branch of "Healthcare Center" of Public joint stock company "Ukrainian Railway"
Odesa, 65010
Municipal Institution "Odesa Regional Clinical Hospital", Regional Gastroenterology Center based on Surgery Department
Odesa, 65025
Ternopil University Hospital, Regional Center of Gastroenterology with Hepatology
Ternopil, 46002
Vinnytsia Regional Clinical Hospital of War Veterans, Therapy Department #1
Vinnytsia, 21005
M.I. Pyrogov Vinnytsia Regional Clinical Hospital, Gastroenterology Department
Vinnytsia, 21018
Medical Center LLC "Health Clinic"
Vinnytsia, 21029
Municipal Institution "Zaporizhzhya Regional Clinical Hospital" of Zaporizhzhya Regional Council
Zaporizhzhya, 69600
Russia14 sites
State Budgetary Healthcare Institution "Chelyabinski Regional Clinical Hospital"
Chelyabinsk, 454076
State Budgetary Institution of Health Irkustsk Order "Badge of Honor" Regional Clinical Hospital
Irkutsk, 669079
Federal State Budgetary Institution of Science Federal Research Center of Nutrition, Biotechnology and Food Safety
Moscow, 115446
State Budgetary Healthcare Institution of Moscow "City Clinical Hospital # 24 of Healthcare Department of Moscow"
Moscow, 127015
State Budgetary Healthcare Institution of Moscow Region "Moscow Regional Clinical Research Institute n.a. M.F. Vladimirskiy"
Moscow, 129110
State Budgetary Healthcare Institution of Nizhny Novgorod Region "Nizhny Novgorod Regional Clinical Hospital n.a. N.A.
Nizhny Novgorod, 603126
State Budgetary Institution of Health of Novosibirsk Region "City Clinical Hospital #12"
Novosibirsk, 630084
State Budgetary Healthcare Institution of the Novosibirsk Region "State Novosibirsk Regional Clinical Hospital"
Novosibirsk, 630087
Saint Petersburg State Budgetary Healthcare Institution "City Polyclinic #38"
Saint Petersburg, 191015
"Riat" LLC
Saint Petersburg, 193163
"Scientific Research Centre ECO-safety" LLC
Saint Petersburg, 196143
State Healthcare Institution "Regional Clinical Hospital"
Saratov, 410053
Treatment and Prevention Interdistrict Institution "Smolenskie kliniki" LLC
Smolensk, 214019
Tyumen Regional State Autonomous Healthcare Institution << Consulting and Diagnostic Centre <<Endos>>
Tyumen, 625026
United Kingdom13 sites
The Pennine Acute Hospitals NHS Trust
Bury, BL9 7TD
Cambridge University Hospital NHS Foundation Trust
Cambridge, CB2 0QQ
Royal Derby Hospital
Derby, DE22 3NE
NHS Lothian
Edinburgh, EH4 2XU
Glasgow Clinical Research Facility - Queen Elizabeth University Hospital
Glasgow, G51 4TF
NHS Greater Glasgow and Clyde
Glasgow, G52 3NQ
Wycombe Hospital
High Wycombe, HP11 2TT
Imperial College Healthcare NHS Trust, St Mary's Hospital
London, W2 1NY
Norfolk and Norwich University Hospital NHS Foundation Trust
Norwich, Norfolk, NR4 7UY
Biomedical Research Unit
Nottingham, NG7 2UH
Oxford University Hospitals NHS Trust
Oxford, OX3 9DU
St Helens and Knowsley Teaching Hospitals NHS Trust
Prescot, L35 5DR
Southampton National Institute for Health Research, Wellcome Trust Clinical Research Facility
Southampton, SO16 6YD
Australia10 sites
Monash Medical Centre
Clayton, New South Wales, 3168
St. Vincent's Hospital Sydney
Darlinghurst, New South Wales, 2010
Footscray Hospital
Footscray, Victoria, 3011
Nepean Hospital
Kingswood, New South Wales, 2747
Cabrini Hospital
Malvern, Victoria, 3144
Alfred Hospital
Melbourne, Victoria, 3004
Coastal Digestive Health
Mountain Creek, Queensland, 4557
Mater Misericordiae Ltd
South Brisbane, Queensland, 4101
The Queen Elizabeth Hospital
Woodville South, South Australia, 5011
Princess Alexandra Hospital
Woolloongabba, Queensland, 4102
South Korea9 sites
Pusan National University Hospital
Busan, 49241
Yeungnam University Hospital
Daegu, 42415
Kangbuk Samsung Hospital
Seoul, 03181
Yonsei University Health System, Severance Hospital
Seoul, 03722
Asan Medical Center
Seoul, 05505
Division of Gastroenterology, Department of Medicine, Samsung Medical Center
Seoul, 06351
Kyung Hee University Hospital
Seoul, 130-872
The Catholic University of Korea, St. Vincent's Hospital
Suwon, Gyeonggi-do, 16247
Yonsei University Wonju Severance Christian Hospital
Wŏnju, 220-701
Italy8 sites
UOC Gastroenterologia II
Castellana Grotte, 70013
U.O. Fisiopatologia Digestiva
Catanzaro, 88100
Ospedale Clinicizzato SS. Annunziata - Dipartimento di Medicina
Chieti, 66100
Endocsopia Digestiva Centralizzata - ASST Fatebenefratelli Sacco, Ospedale Fatebenefratelli e Oftalmico
Milan, 20121
UOC Gastroenterologia
Padova, 35128
Azienda Ospedaliero-Universitaria Pisana - Presidio Ospedaliero Cisanello
Pisa, Pisa, 56124
UOC Gastroenterologia ed Endoscopia Digestiva
Roma, 128
Istituto Clinico Humanitas
Rozzano, 20089
Hungary6 sites
Bekes Megyei Kosponti Korhaz, Dr. Rethy Pal Tagkorhaz, IV. Belgyogyaszat - 2. Gasztroenterologia
Békéscsaba, 5600
Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet, Kozponti Felnott Szakrendelo
Budapest, 1097
Szent Janos Korhaz es Eszak-budai Egitett Korhazak, I. Belgyogyaszati - Gasztroenterologiai Osztaly
Budapest, 1125
Debreceni Egyetem Klinikai Kozpont, II. sz. Belgyogyaszati Klinika, Gasztroenterologia
Debrecen, 4032
Bugat Pal Korhaz, Belgyogyaszat
Gyöngyös, 3200
Karolina Korhaz es Rendelointezet, Altalanos Belgyogyaszat-Gasztroenterologia
Mosonmagyaróvár, 9200
Canada5 sites
University of Calgary, Heritage Medical Research Clinic
Calgary, Alberta, T2N 4Z6
Hamilton Health Sciences Corporation, McMaster University Medical Centre
Hamilton, Ontario, L8S 4K1
Royal University Hospital
Saskatoon, Saskatchewan, S7N 0W8
The Gordon and Leslie Diamond Health Care Centre
Vancouver, British Columbia, V5Z 1M9
Toronto Digestive Disease Associates Inc.
Vaughan, Ontario, L4L 4Y7
Israel5 sites
Bnai Zion Medical Center
Haifa, 31048
Rambam Medical Health Care Campus
Haifa, 3109601
Shaare Zedek Medical Center
Jerusalem, 9103102
Hadassah Medical Center
Jerusalem, 9112001
Rabin Medical Center
Petah Tikva, 4941492
Spain5 sites
Centro Medico Teknon
Barcelona, 08022
Hospital Clinico San Carlos
Madrid, 28040
Hospital Universitario de Fuenlabrada
Madrid, 28942
Hospital Universitario Central de Asturias
Oviedo, 33006
Hospital Universitario Virgen del Rocío
Seville, 41013
Belgium4 sites
GZA Ziekenhuizen, campus Sint-Vincentius
Antwerp, 2018
CUB Hopital Erasme
Brussels, 1070
Universitair Ziekenhuis Leuven
Leuven, 3000
Centre Hospitalier Chretien (CHC) - Clinique Saint-Joseph
Liège, 4000
Czechia4 sites
Hepato-Gastroenterology HK, s.r.o.
Hradec Králové, 500 12
Oblastni nemocnice Mlada Boleslav, a.s., nemocnice Stredoceskeho kraje, Gastroenterologicke oddeleni
Mladá Boleslav, 293 01
G.E.P. Clinic, s r.o.
Prague, 130 00
ISCARE a.s. (Klinicke centrum ISCARE), Klinicke a vyzkumne centrum pro strevni zanety
Prague, 190 00
New Zealand4 sites
Christchurch Hospital
Christchurch, 8011
Auckland City Hospital
Grafton, 1023
Wellington Hospital
Newtown, 6021
Bay of Plenty District Health Board - Tauranga Hospital
Tauranga, 3112
Romania4 sites
MedLife, Gastroenterologie
Bucharest, 010719
Spitalul Clinic Colentina - Sectia de Spitulal Clinic Colentina, Gastroenterologie
Bucharest, 020125
Cabinet Medical Individual Dr Tirnaveanue Amelita, Gastroenterologie
Oradea, 410066
Cabinet Particular Policlinic Algomed SRL
Timișoara, 300002
Taiwan4 sites
Changhua Christian Hospital
Changhua, 500
National Taiwan University Hospital
Taipei, 100
Mackay Memorial Hospital, Taipei
Taipei, 10449
Chang Gung Medical Foundation, Chang Gung Memorial Hospital, Linkou Branch
Taoyuan, 33305
Bulgaria3 sites
MHAT Sveti Pantaleymon- Pleven OOD
Pleven, 5800
"MDHAT Dr. St.Cherkezov" AD
Veliko Tarnovo, 5000
MHAT "Sveta Petka" AD
Vidin, 3700
Hong Kong3 sites
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
Netherlands3 sites
Academic Medical Center (AMC)
Amsterdam, 1100
Gelre Hospital
Apeldoorn, 7334
University Medical Center Utrecht
Utrecht, 3584 CX
Sweden3 sites
Skane University Hospital
Malmö, SE-205-02
Danderyd University Hospital Corp
Stockholm, 182 88
Akademiska Sjukhuset
Uppsala, 75185
Argentina2 sites
Instituto de Investigaciones Clinicas Mar del Plata
Mar del Plata, B7600FZN
Instituto Médico Cer
Quilmes, B1878
Austria2 sites
Universitatsklinik Innsbruck
Innsbruck, 6020
AKH-Medizinische Universitat Wien
Vienna, 1090
Croatia2 sites
Clinical Hospital Dubrava
Zagreb, 10000
University Hospital Center Zagreb
Zagreb, 10000
Georgia2 sites
Unimed Ajara LLC - Batumi Referral Hospital
Batumi, 6010
Medi Club Georgia LLC
Tbilisi, 0160
Malaysia2 sites
Hospital Pulau Pinang
George Town, 10990
Hospital Queen Elizabeth
Kota Kinabalu, 88586
Portugal2 sites
Hospital da Senhora da Oliveira Guimaraes, E.P.E.
Guimarães, 4835-044
Centro Hospitalar de Sao Joao, EPE
Porto, 4200-319
South Africa2 sites
Dr MJ Prins
Cape Town, 7500
Peermed Clinical Trial Centre
Johannesburg, 1619
Switzerland2 sites
Gastroenterologische Praxis Balsiger, Seibold und Partner
Bern, 3012
Universitätsspital Zürich
Zurich, 8091
Greece1 site
General Hospital of Athens "Hippokratio", 2nd Internal Medicine Clinic of Athens University, Hepato-gastroenterology Unit
Athens, 11527
Mexico1 site
PCR-Phylasis Clinicas Research S. de R.L. de C.V.
Cuautitlán Izcalli, 54750
Slovakia1 site
KM Management, s.r.o., Gastroenterologicke a hepatologicke centrum Nitra
Nitra, 950 01
About this study
Official title: A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects With Ulcerative Colitis
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).
- Conditions
- Ulcerative Colitis
- Being tested
- Filgotinib, Placebo
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FilgotinibDrug
Also called GS-6034, GLPG0634
Tablet(s) administered orally once daily
PlaceboDrug
Tablet(s) administered orally once daily
| Study group | Role | What they receive |
|---|---|---|
| Filgotinib 200 mg (blinded dosing) | Experimental | Filgotinib 200 mg + placebo to match filgotinib 100 mg for up to 336 weeks Receives: Drug: Filgotinib; Drug: Placebo |
| Filgotinib 100 mg (blinded dosing) | Experimental | Filgotinib 100 mg + placebo to match filgotinib 200 mg for up to 336 weeks Receives: Drug: Filgotinib; Drug: Placebo |
| Placebo (blinded dosing) | Placebo comparator | Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg for up to 336 weeks Receives: Drug: Placebo |
| Filgotinib 200 mg (open-label) | Experimental | Filgotinib 200 mg for up to 336 weeks Receives: Drug: Filgotinib |
| Filgotinib 100 mg (open-label) | Experimental | Filgotinib 100 mg for up to 336 weeks Receives: Drug: Filgotinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Safety Profile of Filgotinib Evaluated by Proportion of Participants Experiencing Adverse Events and Abnormal Clinical Laboratory Tests
Measured: Up to 336 weeks plus 30 days
Secondary outcomes (1)
Change From Baseline in Components of Mayo Clinic Score (MCS)
Measured: Baseline and up to 336 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2016 (estimated)
- Study start23 Feb 2017
- Primary completion8 Sep 2026
- Study completion8 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1,173 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alfasigma S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor
- Investigators
- Alfasigma Study Director, Study director, Alfasigma S.p.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02914535
- Sponsor's protocol ID
- GS-US-418-3899
- Other IDs
- 2016-002765-58, 2016
- Acronym
- SELECTIONLTE
- Status last verified
- Sep 2026
- First submitted
- 22 Sep 2016
- Last updated
- 17 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Feagan BG, Matsuoka K, Rogler G, Laharie D, Vermeire S, Danese S, Loftus EV Jr, Beales I, Schreiber S, Kim HJ, Faes M, de Haas A, Masior T, Rudolph C, Peyrin-Biroulet L. Long-term safety and efficacy of filgotinib for the treatment of moderately to severely active ulcerative colitis: Interim analysis from up to 4 years of follow-up in the SELECTION open-label long-term extension study. Aliment Pharmacol Ther. 2024 Sep;60(5):563-584. doi: 10.1111/apt.18158. Epub 2024 Jul 31.
PubMed 39086130Schreiber S, Rogler G, Watanabe M, Vermeire S, Maaser C, Danese S, Faes M, Van Hoek P, Hsieh J, Moerch U, Zhou Y, de Haas A, Rudolph C, Oortwijn A, Loftus EV Jr. Integrated safety analysis of filgotinib for ulcerative colitis: Results from SELECTION and SELECTIONLTE. Aliment Pharmacol Ther. 2023 Nov;58(9):874-887. doi: 10.1111/apt.17674. Epub 2023 Sep 18.
PubMed 37718932Vermeire S, Feagan BG, Peyrin-Biroulet L, Oortwijn A, Faes M, de Haas A, Rogler G. Withdrawal and Re-treatment with Filgotinib in Ulcerative Colitis: Post Hoc Analyses of the Phase 2b/3 SELECTION and SELECTIONLTE Studies. J Crohns Colitis. 2024 Jan 27;18(1):54-64. doi: 10.1093/ecco-jcc/jjad123.
PubMed 37540206