Study to Evaluate the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Ulcerative Colitis (SELECTION)

March 23, 2021 updated by: Gilead Sciences

Combined Phase 2b/3, Double-Blind, Randomized, Placebo-Controlled Studies Evaluating the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Subjects With Moderately to Severely Active Ulcerative Colitis

The primary objectives of this study are to evaluate the efficacy of filgotinib in the induction and maintenance treatment of moderately to severely active ulcerative colitis (UC) in participants who are biologic-naive and biologic-experienced.

Participants who complete the study, or met protocol specified efficacy discontinuation criteria will have the option to enter a separate, long-term extension (LTE) study (Gilead Study GS-US-418-3899: NCT02914535).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1351

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
      • 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
      • Clayton, Victoria, Australia, 3168
        • Monash Medical Centre
      • Footscray, Victoria, Australia, 3011
        • Footscray Hospital
      • Heidelberg, Victoria, Australia, 3084
        • Austin Health
      • 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
      • Brussels, Belgium, 1070
        • CUB Hôpital Erasme
      • Leuven, Belgium, B-3000
        • Universitair Ziekenhuis Leuven
      • Liège, Belgium, 4000
        • Centre Hospitalier Chretien (CHC) - Clinique Saint-Joseph
  • Bulgaria
      • Pleven, Bulgaria, 5800
        • MHAT Sveti Pantaleymon - Pleven OOD
      • Veliko Tŭrnovo, Bulgaria, 5000
        • "MDHAT Dr. St.Cherkezov" AD
      • Vidin, Bulgaria, 3700
        • MHAT "Sveta Petka" AD
  • Canada
      • Vaughan, Canada, L4L 4Y7
        • Toronto Digestive Disease Associates Inc.
    • 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
    • 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-Gastroenterologie HK, s.r.o.
      • Mladá 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, France, 80054
        • CHU Amiens Picardie
      • Caen, 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-Bicêtre, France, 94270
        • Hopital Universitaire de Bicetre
      • Lille, France, 59000
        • Centre Hospitalier Regional Universitaire de Lille
      • Marseille, France, 13015
        • 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
      • Paris, France, 75014
        • Institut Mutualiste Montsouris
      • 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
      • Vandœuvre-lès-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
      • Telavi, Georgia, 2200
        • Ltd. Unimed Kakheti - Telavi Referral Hospital
  • Germany
      • Berlin, Germany, 13353
        • Charité - Universitätsmedizin Berlin
      • Berlin, Germany, 10117
        • Charite Universitatsmedizin 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
      • Hannöver, Germany, 30625
        • Medizinische Hochschule Hannover
      • Herne, Germany, 44623
        • Gastroenterologische Gemeinschaftspraxis Herne
      • Jena, Germany, 07747
        • Universitätsklinikum Jena
      • Kiel, Germany, 24105
        • Universitätsklinikum Schleswig-Holstein
      • 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
  • Greece
      • Athens, Greece, 11527
        • General Hospital of Athens "Hippokratio", 2nd Internal Medicine Clinic of Athens University, Hepato-gastroenterology Unit
      • Athens, Greece, 18454
        • General Hospital of Nikaias "Agios Pentelleimon", Gastroenterology Department
  • Hong Kong
      • Hong Kong, Hong Kong
        • Queen Mary Hospital
      • Hong Kong, Hong Kong
        • Princess Margaret Hospital
      • Sha Tin, Hong Kong
        • Department of Medicine & Therapeutics, The Chinese University of Hong Kong, Prince of Wales Hospital
  • Hungary
      • 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
      • Békéscsaba, Hungary, 5600
        • Bekes Megyei Kosponti Korhaz, Dr. Rethy Pal Tagkorhaz, IV. Belgyogyaszat - 2. Gasztroenterologia
      • Debrecen, Hungary, 4032
        • Debreceni Egyetem Klinikai Kozpont, II. sz. Belgyogyaszati Klinika, Gasztroenterologia
      • Gyöngyös, Hungary, 3200
        • Bugat Pal Korhaz, Belgyogyaszat
      • Mosonmagyaróvár, 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, 302004
        • S.M.S Medical College & Hospitals
      • Jaipur, India, 302001
        • S.R.KallaMemorial Gastro.&General Hospital,
      • Kolkata, India, 700020
        • School of Digestive & Liver Diseases
      • 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, 440012
        • Suretech Hospital & Research Centre Ltd
      • Nagpur, India, 400010
        • Midas Multispeciality Hospital Pvt. Ltd
      • New Delhi, India, 110029
        • All India Institute of Medical Sciences
      • Pune, India, 411001
        • Grant Medical Foundation Ruby Hall Clinic
      • Rajkot, India, 360005
        • Shree Giriraj Multispeciality Hospital
      • Secunderabad, India, 500003
        • Gandhi Hospital
      • Secunderabad, India, 500003
        • Institute of Gastroenterology & Liver Disease, Sunshine Hospitals
      • Surat, India, 395002
        • Surat Institute of Digestive Sciences
      • Udupi, India, 576104
        • Kasturba Hospital Medical College
      • Vadodara, India, 390007
        • Sterling Hospital
      • Varanasi, India, 221005
        • Samvedana Hospital
  • Ireland
      • Dublin, Ireland, 9
        • Beaumont Hospital
  • Israel
      • Beer-Sheva, Israel, 8410101
        • Soroka Medical Center
      • Haifa, Israel, 3109601
        • Rambam Health Care Campus
      • Haifa, Israel, 31048
        • Bnai Zion Medical Center
      • Jerusalem, Israel, 9103102
        • Shaare Zedek Medical Center
      • Jerusalem, Israel, 91120
        • Hadassah Medical Center
      • Petach Tikva, Israel, 4941492
        • Rabin Medical Center
  • Italy
      • Castellana Grotte, Italy, Bari 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-shi, Japan, 192-0032
        • Tokai University Hachioji Hospital
      • Hiroshima-shi, 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
      • Nagasaki-shi, Japan, 852-8501
        • Nagasaki 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, 579-8056
        • Wakakusa-Daiichi 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, Japan, 004-0041
        • Sapporo Tokushukai Hospital
      • 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
      • Suita, Japan, 565-0871
        • Osaka University Hospital
      • 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, 231-0012
        • Yokohama Health Medicine Association Kannai Suzuki Clinic
      • Yokohama-shi, Japan, 220-0045
        • Colo-Proctology Center Matsushima Clinic
      • Ōsaka, Japan, 530-0011
        • Kinshukai Infusion Clinic
      • Ōsaka, Japan, 545-8586
        • Osaka City University Hospital
      • Ōtsu, Japan, 520-2912
        • Shiga University of Medical Science Hospital
  • Korea, Republic of
      • Busan, Korea, Republic of, 609801
        • Pusan National University Hospital
      • Daegu, Korea, Republic of, 42415
        • Yeungnam University Hospital
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
      • 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
      • Seoul, Korea, Republic of, 130-872
        • Hyung Hee University Hospital
      • Wŏnju, 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
      • Cheras, Malaysia, 56000
        • University Kebangsaan Malaysia Medical Centre
      • 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
      • Hamilton, New Zealand, 3240
        • Waikato Hospital
      • Newtown, New Zealand, WE 6021
        • Wellington Hospital
      • Tauranga, New Zealand, 3134
        • Bay of Plenty District Health Board - Tauranga Hospital
  • Norway
      • Drammen, Norway, 1346
        • Vestre Viken Hospital Trust, Baerum Hospital
      • Lørenskog, Norway, N-1478
        • Akerskus University Hospital
  • Poland
      • Białystok, 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
      • Częstochowa, Poland, 42-217
        • NZOZ INTER-MED, Centrum Endoskopowe
      • Katowice, Poland, 40-659
        • Niepubliczny Zaklad Opieki Zdrowotnej All-Medicus
      • Kraków, 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.
      • Piaseczno, Poland, 05-500
        • Centrum Innowacyjnych Terapii Sp. z o.o.
      • Poznan, Poland, 60-848
        • Clinical Research Center Spolka z organiczna 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
      • Toruń, Poland, 87-100
        • GASTROMED Kopon, Zmudzkinski 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, 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, 0-635
        • Centrum Zdrowia MDM
      • Warszawa, Poland, 00-332
        • BodyClinic
      • Wroclaw, Poland, 52-416
        • Centrum Medyczne Oporów
      • Łódź, Poland, 90-302
        • Santa Familia, Centrum Badan, Profilaktyki i Leczenia
  • Portugal
      • Guimarães, 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, 010719
        • SC MedLife SA, Gastroenterologie
      • Bucuresti, Romania, 020125
        • Spitalul Clinic Colentina - Sectia de Spitulal Clinic Colentina, Gastroenterologie
      • Oradea, Romania, 410066
        • Cabinet Medical Individual Dr Tirnaveanue Amelita, Gastroenterologie
      • Timişoara, 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, 197110
        • "PolyClinic EXPERT" 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
        • State Autonomous Health Institution of the Tyumen Region "Multidisciplinary Consultative and Diagnostic Center"
  • Serbia
      • Belgrade, Serbia, 3810-971
        • 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 Medico 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 Rocio
  • Sweden
      • Danderyd, Sweden, SE-18288
        • Danderyds sjukhus AB
      • Malmo, Sweden, SE-205-02
        • Skåne University Hospital
      • Uppsala, Sweden, 75185
        • Akademiska sjukhuset
  • Switzerland
      • Bern, Switzerland, 3012
        • Gastroenterologische Praxis Balsiger, Seibold und Partner
      • Zürich, Switzerland, 8091
        • Universitatsspital Zurich
  • Taiwan
      • Chang-hua, 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-Frankivs'k, Ukraine, 76000-490
        • 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"
      • Kropyvnytskyi, Ukraine, 25006
        • Treatment and Diagnostic Center of Private Enterprise of Private Production Company "Acinus"
      • 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, 21029
        • Medical Center LLC "Health Clinic"
      • Vinnytsya, Ukraine, 21005
        • Vinnytsia Regional Clinical Hospital of War Veterans, Therapy Department #1
      • Vinnytsya, Ukraine, 21018
        • M.I. Pyrogov Vinnytsia Regional Clinical Hospital, Gastroenterology Department
      • 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
      • Norwich, United Kingdom, NR4 7UY
        • Norfolk and Norwich University Hospital Nhs Foundation Trust
      • Nottingham, United Kingdom, NG7 2UH
        • Biomedical Research Unit
      • Oxford, United Kingdom, OX3 9DU
        • Oxford University Hospitals NHS Foundation 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
  • 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 Health at Shands Hospital
      • 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
      • Winter Park, Florida, United States, 32789
        • Shafran Gastroenterology Center
      • 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
    • 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
      • Chattanooga, Tennessee, United States, 37421
        • WR-ClinSearch, LLC
      • 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
        • Texas Digestive Disease Consultants
      • Southlake, Texas, United States, 76092
        • Texas Digestive Disease Consultants
      • The Woodlands, Texas, United States, 77380
        • Spring Gastroenterology
    • Utah
      • Bountiful, Utah, United States, 84010
        • HP Clinical Research
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University of Virginia Health System
      • Chesapeake, Virginia, United States, 23320
        • Gastroenterology Associates of Tidewater
      • Lansdowne Town Center, Virginia, United States, 20176
        • Emeritas Research Group LLC
      • 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 to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  • Males or non-pregnant, non-lactating females, ages 18 to 75 years, inclusive based on the date of the screening visit
  • Documented diagnosis of UC of at least 6 months AND with a minimum disease extent of 15 cm from the anal verge. Documentation should include endoscopic and histopathologic evidence of UC.
  • A surveillance colonoscopy is required at screening in individuals with a history of UC for 8 or more years, if one was not performed in the prior 24 months
  • Moderately to severely active UC
  • Previously demonstrated an inadequate clinical response, loss of response to, or intolerance to at least 1 of the following agents (depending on current country treatment recommendations/guidelines): corticosteroids, immunomodulators, tumor necrosis factor alpha (TNFa) antagonists, or vedolizumab

Key Exclusion Criteria:

  • Presence of Crohn's disease, indeterminate colitis, ischemic colitis, fulminant colitis, ulcerative proctitis, or toxic mega-colon
  • Active tuberculosis (TB) or history of latent TB that has not been treated
  • Use of any concomitant prohibited medications as described in the protocol

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Induction Study (Cohort A): Filgotinib 200 mg
Participants in Cohort A (biologic-naive) received filgotinib 200 milligrams (mg) and placebo-to-match (PTM) filgotinib 100 mg orally once daily for 10 weeks.
Drug: Filgotinib
Tablet(s) administered orally once daily
Other Names:
  • GS-6034
  • GLPG0634
Drug: PTM filgotinib
Tablet(s) administered orally once daily
Experimental: Induction Study (Cohort A): Filgotinib 100 mg
Participants in Cohort A (biologic-naive) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.
Drug: Filgotinib
Tablet(s) administered orally once daily
Other Names:
  • GS-6034
  • GLPG0634
Drug: PTM filgotinib
Tablet(s) administered orally once daily
Placebo Comparator: Induction Study (Cohort A): Placebo
Participants in Cohort A (biologic-naive) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
Drug: PTM filgotinib
Tablet(s) administered orally once daily
Experimental: Induction Study (Cohort B): Filgotinib 200 mg
Participants in Cohort B (biologic-experienced) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
Drug: Filgotinib
Tablet(s) administered orally once daily
Other Names:
  • GS-6034
  • GLPG0634
Drug: PTM filgotinib
Tablet(s) administered orally once daily
Experimental: Induction Study (Cohort B): Filgotinib 100 mg
Participants in Cohort B (biologic-experienced) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.
Drug: Filgotinib
Tablet(s) administered orally once daily
Other Names:
  • GS-6034
  • GLPG0634
Drug: PTM filgotinib
Tablet(s) administered orally once daily
Placebo Comparator: Induction Study (Cohort B): Placebo
Participants in Cohort B (biologic-experienced) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
Drug: PTM filgotinib
Tablet(s) administered orally once daily
Experimental: Maintenance Study: Filgotinib 200 mg From Induction Filgotinib 200 mg
Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either Endoscopy/Bleeding/Stool Frequency (EBS) remission or Mayo Clinic Score (MCS) response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 200 mg and PTM filgotinib 100 mg for an additional 47 weeks (up to Week 58).
Drug: Filgotinib
Tablet(s) administered orally once daily
Other Names:
  • GS-6034
  • GLPG0634
Drug: PTM filgotinib
Tablet(s) administered orally once daily
Placebo Comparator: Maintenance Study: Placebo From Induction Filgotinib 200 mg
Participants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58).
Drug: PTM filgotinib
Tablet(s) administered orally once daily
Experimental: Maintenance Study: Filgotinib 100 mg From Induction Filgotinib 100 mg
Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 100 mg and PTM filgotinib 200 mg for an additional 47 weeks (up to Week 58).
Drug: Filgotinib
Tablet(s) administered orally once daily
Other Names:
  • GS-6034
  • GLPG0634
Drug: PTM filgotinib
Tablet(s) administered orally once daily
Placebo Comparator: Maintenance Study: Placebo From Induction Filgotinib 100 mg
Participants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were rerandomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58).
Drug: PTM filgotinib
Tablet(s) administered orally once daily
Placebo Comparator: Maintenance Study: Placebo From Induction Placebo
Participants in the Placebo arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive PTM filgotinib for an additional 47 weeks (up to Week 58).
Drug: PTM filgotinib
Tablet(s) administered orally once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Induction Study: Percentage of Participants Who Achieved Endoscopy/Bleeding/Stool Frequency (EBS) Remission at Week 10
Time Frame: Week 10
EBS remission was defined as an endoscopic subscore of 0 or 1; rectal bleeding subscore of 0; and at least a 1-point decrease in stool frequency from baseline to achieve a subscore of 0 or 1. Endoscopic subscore range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease (spontaneous bleeding, ulceration); rectal bleeding subscore range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes; stool frequency subscore range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal. Total score for EBS ranged from 0 to 9 (sum of all subscores), with higher scores indicating more severe disease.
Week 10
Maintenance Study: Percentage of Participants Who Achieved EBS Remission at Week 58
Time Frame: Week 58
EBS remission was defined as an endoscopic subscore of 0 or 1; rectal bleeding subscore of 0; and at least a 1-point decrease in stool frequency from baseline to achieve a subscore of 0 or 1. Endoscopic subscore range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease (spontaneous bleeding, ulceration); rectal bleeding subscore range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes; stool frequency subscore range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal. Total score for EBS ranged from 0 to 9 (sum of all subscores), with higher scores indicating more severe disease.
Week 58

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Induction Study: Percentage of Participants Who Achieved MCS Remission at Week 10
Time Frame: Week 10
MCS remission was defined as having a MCS of 2 or less and no single subscore higher than 1. The MCS was composed of subscores from endoscopy (range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease [spontaneous bleeding, ulceration]), rectal bleeding (range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes), stool frequency (range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal), and physician's global assessment (PGA). The PGA acknowledged the participant's daily recollection of abdominal discomfort and general sense of wellbeing, and other observations, such as physical findings and the participant's performance status. The PGA score ranged from 0 to 3 with higher score indicating the severe disease. Total score for MCS ranged from 0 to 12 (sum of all subscores), with higher scores indicating more severe disease.
Week 10
Induction Study: Percentage of Participants Who Achieved an Endoscopic Subscore of 0 at Week 10
Time Frame: Week 10
Endoscopic subscore range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease (spontaneous bleeding, ulceration).
Week 10
Induction Study: Percentage of Participants Who Achieved Geboes Histologic Remission at Week 10
Time Frame: Week 10
Geboes histologic remission was assessed using the Geboes histologic scores for evaluation of disease severity in ulcerative colitis and classifies histologic changes. Remission was defined as having Grade 0 of <= 0.3, Grade 1 of <= 1.1, Grade 2A of <= 2A.3, Grade 2B of 2B.0, Grade 3 of 3.0, Grade 4 of 4.0, and Grade 5 of 5.0. Possible scores are Grade 0: Architectural changes (0.0=No abnormality to 0.3=Severe diffuse or multifocal abnormalities); Grade 1: Chronic inflammatory infiltrate (1.0=No increase to 1.3=Marked increase); Grade 2A: Eosinophils in lamina propria (2A.0=No increase to 2A.3-=Marked increase; Grade 2B: Neutrophils in lamina propria (2B.0= No increase to 2B.3=Marked increase); Grade 3: Neutrophils in epithelium (3.0=None to 3.3=>50% crypts involved); Grade 4: Crypt destruction (4.0=none to 4.3=Unequivocal crypt destruction), and Grade 5: Erosions and ulcerations: (5.0=No erosion, ulceration or granulation to 5.4=Ulcer or granulation tissue).
Week 10
Induction Study: Percentage of Participants Who Achieved MCS Remission (Alternative Definition) at Week 10
Time Frame: Week 10
MCS remission (alternative definition) was defined as having rectal bleeding, stool frequency, and PGA subscores of 0 and an endoscopic subscore of 0 or 1; overall MCS of ≤ 1. MCS possible subscores: rectal bleeding (range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes), stool frequency (range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal), PGA subscore (range: 0 to 3 with higher score indicating the severe disease), and an endoscopic subscore (range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease [spontaneous bleeding, ulceration]. Total score for MCS ranged from 0 to 12 (sum of all subscores), with higher scores indicating more severe disease.
Week 10
Induction Study: Pharmacokinetic (PK) Parameter: Cmax of Filgotinib and Its Metabolite GS-829845
Time Frame: Predose and at 0.5, 1, 2, 3, 4 and 6 hours postdose at a single visit between Week 2 and Week 10
Cmax is defined as the maximum observed concentration of drug.
Predose and at 0.5, 1, 2, 3, 4 and 6 hours postdose at a single visit between Week 2 and Week 10
Induction Study: PK Parameter: Tmax of Filgotinib and Its Metabolite GS-829845
Time Frame: Predose and at 0.5, 1, 2, 3, 4 and 6 hours postdose at a single visit between Week 2 and Week 10
Tmax is defined as the time to reach maximum observed concentration of drug.
Predose and at 0.5, 1, 2, 3, 4 and 6 hours postdose at a single visit between Week 2 and Week 10
Induction Study: PK Parameter: AUCtau of Filgotinib and Its Metabolite GS-82984
Time Frame: Predose and at 0.5, 1, 2, 3, 4 and 6 hours postdose at a single visit between Week 2 and Week 10
AUCtau is defined as concentration of drug over time (the area under the concentration verses time curve over the dosing interval).
Predose and at 0.5, 1, 2, 3, 4 and 6 hours postdose at a single visit between Week 2 and Week 10
Induction Study: PK Parameter: AUClast of Filgotinib and Its Metabolite GS-82984
Time Frame: Predose and at 0.5, 1, 2, 3, 4 and 6 hours postdose at a single visit between Week 2 and Week 10
AUClast is defined as the concentration of drug from time zero to the last observable concentration.
Predose and at 0.5, 1, 2, 3, 4 and 6 hours postdose at a single visit between Week 2 and Week 10
Induction Study: PK Parameter: Ctau of Filgotinib and Its Metabolite GS-82984
Time Frame: Predose and at 0.5, 1, 2, 3, 4 and 6 hours postdose at a single visit between Week 2 and Week 10
Ctau is defined as the observed drug concentration at the end of the dosing interval.
Predose and at 0.5, 1, 2, 3, 4 and 6 hours postdose at a single visit between Week 2 and Week 10
Maintenance Study: Percentage of Participants Who Achieved MCS Remission at Week 58
Time Frame: Week 58
MCS remission was defined as having a MCS of 2 or less and no single subscore higher than 1. The MCS was composed of subscores from endoscopy (range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease [spontaneous bleeding, ulceration]), rectal bleeding (range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes), stool frequency (range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal), and PGA. The PGA acknowledged the participant's daily recollection of abdominal discomfort and general sense of wellbeing, and other observations, such as physical findings and the participant's performance status. The PGA score ranged from 0 to 3 with higher score indicating the severe disease. Total score for MCS ranged from 0 to 12 (sum of all subscores), with higher scores indicating more severe disease.
Week 58
Maintenance Study: Percentage of Participants Who Achieved Sustained EBS Remission at Week 58
Time Frame: Week 58
Sustained EBS remission was defined as having achieved EBS remission at both Weeks 10 and 58.
Week 58
Maintenance Study: Percentage of Participants Who Achieved 6-Month Corticosteroid-Free EBS Remission at Week 58
Time Frame: Week 58
Six-month corticosteroid-free EBS remission at Week 58 was defined as achieving EBS remission with no corticosteroid use for the indication of ulcerative colitis for at least 6 months prior to Week 58.
Week 58
Maintenance Study: Percentage of Participants Who Achieved Endoscopic Subscore of 0 at Weeks 58
Time Frame: Week 58
Endoscopic subscore range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease (spontaneous bleeding, ulceration).
Week 58
Maintenance Study: Percentage of Participants Who Achieved Geboes Histologic Remission at Week 58
Time Frame: Week 58
Geboes histologic remission was assessed using the Geboes histologic scores for evaluation of disease severity in ulcerative colitis and classifies histologic changes. Remission was defined as having Grade 0 of <= 0.3, Grade 1 of <= 1.1, Grade 2A of <= 2A.3, Grade 2B of 2B.0, Grade 3 of 3.0, Grade 4 of 4.0, and Grade 5 of 5.0. Possible scores are Grade 0: Architectural changes (0.0=No abnormality to 0.3=Severe diffuse or multifocal abnormalities); Grade 1: Chronic inflammatory infiltrate (1.0=No increase to 1.3=Marked increase); Grade 2A: Eosinophils in lamina propria (2A.0=No increase to 2A.3-=Marked increase; Grade 2B: Neutrophils in lamina propria (2B.0= No increase to 2B.3=Marked increase); Grade 3: Neutrophils in epithelium (3.0=None to 3.3=>50% crypts involved); Grade 4: Crypt destruction (4.0=none to 4.3=Unequivocal crypt destruction), and Grade 5: Erosions and ulcerations: (5.0=No erosion, ulceration or granulation to 5.4=Ulcer or granulation tissue).
Week 58
Maintenance Study: Percentage of Participants Who Achieved MCS Remission (Alternative Definition) at Week 58
Time Frame: Week 58
MCS remission (alternative definition) was defined as having rectal bleeding, stool frequency, and PGA subscores of 0 and an endoscopic subscore of 0 or 1; overall MCS of ≤ 1. MCS possible subscores: rectal bleeding (range: 0 to 3, where 0 = no blood seen and 3 = blood alone passes), stool frequency (range: 0 to 3, where 0 = normal number of stools and 3 = at least 5 stools more than normal), PGA subscore (range: 0 to 3 with higher score indicating the severe disease), and an endoscopic subscore (range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease [spontaneous bleeding, ulceration]. Total score for MCS ranged from 0 to 12 (sum of all subscores), with higher scores indicating more severe disease.
Week 58
Maintenance Study: Plasma Concentration of Filgotinib and Its Metabolite GS-829845
Time Frame: Week 26 (any Time) and Week 58 (predose)
Plasma concentration is defined as the measured drug concentration of filgotinib and its metabolite GS-829845. Lower limit of quantitation (LLOQ) was defined as 1 ng/mL for analyte filgotinib and 2 ng/mL for analyte GS-829845.
Week 26 (any Time) and Week 58 (predose)

Collaborators and Investigators

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

Sponsor

Gilead Sciences

Collaborators

Galapagos NV

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

November 14, 2016

Primary Completion (Actual)

March 31, 2020

Study Completion (Actual)

March 31, 2020

Study Registration Dates

First Submitted

September 22, 2016

First Submitted That Met QC Criteria

September 22, 2016

First Posted (Estimate)

September 26, 2016

Study Record Updates

Last Update Posted (Actual)

April 21, 2021

Last Update Submitted That Met QC Criteria

March 23, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS-US-418-3898
  • 2016-001392-78 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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