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

November 24, 2023 updated by: Galapagos NV

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1173

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Filgotinib 200 mg (blinded dosing)
Filgotinib 200 mg + placebo to match filgotinib 100 mg for up to 336 weeks
Drug: Filgotinib
Tablet(s) administered orally once daily
Other Names:
  • GS-6034
  • GLPG0634
Drug: Placebo
Tablet(s) administered orally once daily
Experimental: Filgotinib 100 mg (blinded dosing)
Filgotinib 100 mg + placebo to match filgotinib 200 mg for up to 336 weeks
Drug: Filgotinib
Tablet(s) administered orally once daily
Other Names:
  • GS-6034
  • GLPG0634
Drug: Placebo
Tablet(s) administered orally once daily
Placebo Comparator: Placebo (blinded dosing)
Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg for up to 336 weeks
Drug: Placebo
Tablet(s) administered orally once daily
Experimental: Filgotinib 200 mg (open-label)
Filgotinib 200 mg for up to 336 weeks
Drug: Filgotinib
Tablet(s) administered orally once daily
Other Names:
  • GS-6034
  • GLPG0634
Experimental: Filgotinib 100 mg (open-label)
Filgotinib 100 mg for up to 336 weeks
Drug: Filgotinib
Tablet(s) administered orally once daily
Other Names:
  • GS-6034
  • GLPG0634

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Up to 336 weeks plus 30 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Change From Baseline in Components of Mayo Clinic Score (MCS)
Time Frame: Baseline and up to 336 weeks
Baseline and up to 336 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Galapagos NV

Collaborators

Gilead Sciences

Investigators

  • Study Director: Galapagos Study Director, Galapagos NV

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 23, 2017

Primary Completion (Estimated)

September 1, 2026

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

September 22, 2016

First Submitted That Met QC Criteria

September 22, 2016

First Posted (Estimated)

September 26, 2016

Study Record Updates

Last Update Posted (Actual)

November 27, 2023

Last Update Submitted That Met QC Criteria

November 24, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS-US-418-3899
  • 2016-002765-58 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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