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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02914522
Other study ID # GS-US-418-3898
Secondary ID 2016-001392-78
Status Completed
Phase Phase 3
First received
Last updated
Start date November 14, 2016
Est. completion date March 31, 2020

Study information

Verified date March 2021
Source Gilead Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


Recruitment information / eligibility

Status Completed
Enrollment 1351
Est. completion date March 31, 2020
Est. primary completion date March 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
Filgotinib
Tablet(s) administered orally once daily
PTM filgotinib
Tablet(s) administered orally once daily

Locations

Country Name City State
Argentina Instituto de Investigaciones Clinicas Mar del Plata Mar del Plata
Argentina Instituto Médico Cer Quilmes
Australia Monash Medical Centre Clayton Victoria
Australia St. Vincent's Hospital Sydney Darlinghurst New South Wales
Australia Footscray Hospital Footscray Victoria
Australia Austin Health Heidelberg Victoria
Australia Nepean Hospital Kingswood New South Wales
Australia Cabrini Hospital Malvern Victoria
Australia Alfred Hospital Melbourne Victoria
Australia Coastal Digestive Health Mountain Creek Queensland
Australia Mater Misericordiae Ltd South Brisbane Queensland
Australia The Queen Elizabeth Hospital Woodville South South Australia
Australia Princess Alexandra Hospital Woolloongabba Queensland
Austria Universitatsklinik Innsbruck Innsbruck
Austria AKH-Medizinische Universitat Wien Wien
Belgium GZA Ziekenhuizen campus Sint-Vincentius Antwerpen
Belgium CUB Hopital Erasme Brussels
Belgium Universitair Ziekenhuis Leuven Leuven
Belgium Centre Hospitalier Chretien (CHC) - Clinique Saint-Joseph Liège
Bulgaria MHAT Sveti Pantaleymon - Pleven OOD Pleven
Bulgaria "MDHAT Dr. St.Cherkezov" AD Veliko Turnovo
Bulgaria MHAT "Sveta Petka" AD Vidin
Canada University of Calgary, Heritage Medical Research Clinic Calgary Alberta
Canada Hamilton Health Sciences Corporation, McMaster University Medical Centre Hamilton Ontario
Canada Royal University Hospital Saskatoon Saskatchewan
Canada The Gordon and Leslie Diamond Health Care Centre Vancouver British Columbia
Canada Toronto Digestive Disease Associates Inc. Vaughan
Croatia Clinical Hospital Dubrava Zagreb
Croatia University Hospital Center Zagreb Zagreb
Czechia Hepato-Gastroenterologie HK, s.r.o. Hradec Kralove
Czechia Oblastni nemocnice Mlada Boleslav, a.s., nemocnice Stredoceskeho kraje, Gastroenterologicke oddeleni Mladá Boleslav
Czechia G.E.P. Clinic, s r.o. Praha 3
Czechia ISCARE a.s. (Klinicke centrum ISCARE), Klinicke a vyzkumne centrum pro strevni zanety Praha 9
France CHU Amiens Picardie Amiens
France CHU de Caen Caen
France CHU de Clermont-Ferrand - Hopital d'Estaing Clermont-Ferrand
France APHP - Hopital Beaujon - Clichy - Universite Paris VII Clichy
France CHU de Dijon Bourgogne - Hopital Francois Mitterand Dijon
France CHU Grenoble Alpes La Tronche
France Hopital Universitaire de Bicetre Le Kremlin-Bicêtre
France Centre Hospitalier Regional Universitaire de Lille Lille
France Hopital Nord Marseille
France CHU de Montpellier-Hopital Saint Eloi Montpellier
France CHU Hotel-Dieu Nantes
France Hopital de l'Archet 2 Nice
France Institut Mutualiste Montsouris Paris
France CHU de Bordeaux - Hopital Haut Leveque Pessac
France Centre Hospitalier Universitaire de Lyon Sud Pierre-Benite
France Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou Rennes Cedex 9
France CHU de Saint-Etienne - Hopital Nord Saint Priest en Jarez
France CHU de Toulouse - Hopital Rangueil Toulouse
France CHU de Nancy - Hopital Brabois Adultes Vandœuvre-lès-Nancy
Georgia Unimed Ajara LLC - Batumi Referral Hospital Batumi
Georgia Medi Club Georgia LLC Tbilisi
Georgia Ltd. Unimed Kakheti - Telavi Referral Hospital Telavi
Germany Charite - Universitatsmedizin Berlin Berlin
Germany Charite Universitatsmedizin Berlin Berlin
Germany DRK Kliniken Berlin - Westend - Klinik fuer Innere Medizin Berlin
Germany Stadtisches Klinikum Braunschweig gGmbH Braunschweig
Germany Agaplesion Markus Krankenhaus Frankfurt am Main
Germany Universitatsklinikum Freiburg Freiburg
Germany Asklepios Westklinikum Hamburg Hamburg
Germany Medizinische Hochschule Hannover Hannöver
Germany Gastroenterologische Gemeinschaftspraxis Herne Herne
Germany Universitatsklinikum Jena Jena
Germany Universitatsklinikum Schleswig-Holstein Kiel
Germany Universitaetsklinik Koln Koln
Germany EUGASTRO GmbH Leipzig
Germany Klinikum Luneburg Lüneburg
Germany Gastroenterologische Gemeinschaftspraxis Minden Minden
Germany Klinikum der Universitat Munchen - Grosshadern Muenchen
Germany Universitaetsklinikum Tuebingen Tuebingen
Germany Universitatsklinikum Ulm, Zentrum Fur Innere Medizin Ulm
Greece General Hospital of Athens "Hippokratio", 2nd Internal Medicine Clinic of Athens University, Hepato-gastroenterology Unit Athens
Greece General Hospital of Nikaias "Agios Pentelleimon", Gastroenterology Department Athens
Hong Kong Princess Margaret Hospital Hong Kong
Hong Kong Queen Mary Hospital Hong Kong
Hong Kong Department of Medicine & Therapeutics, The Chinese University of Hong Kong, Prince of Wales Hospital Sha Tin
Hungary Bekes Megyei Kosponti Korhaz, Dr. Rethy Pal Tagkorhaz, IV. Belgyogyaszat - 2. Gasztroenterologia Békéscsaba
Hungary Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet, Kozponti Felnott Szakrendelo Budapest
Hungary Szent Janos Korhaz es Eszak-budai Egitett Korhazak, I. Belgyogyaszati - Gasztroenterologiai Osztaly Budapest
Hungary Debreceni Egyetem Klinikai Kozpont, II. sz. Belgyogyaszati Klinika, Gasztroenterologia Debrecen
Hungary Bugat Pal Korhaz, Belgyogyaszat Gyöngyös
Hungary Karolina Korhaz es Rendelointezet, Altalanos Belgyogyaszat-Gasztroenterologia Mosonmagyaróvár
India Kaizen Hospital Ahmedabad
India M S Ramaiah Medical College and Hospital Bangalore
India Apollo Speciality Hospital Chennai
India VGM Hospital Institute of Gastroenterology Coimbatore
India Centre for Liver Research & Diagnostics Hyderabad
India Citizens Specialty Hospital Hyderabad
India Gleneagles Global Hospitals Hyderabad
India S.M.S Medical College & Hospitals Jaipur
India S.R.KallaMemorial Gastro.&General Hospital, Jaipur
India School of Digestive & Liver Diseases Kolkata
India Dayanand Medical College & Hospital Ludhiana
India Kasturba Medical College (KMC) Hospital Mangaluru
India Lokmanya Tilak Municipal General Hospital Mumbai
India Midas Multispeciality Hospital Pvt. Ltd Nagpur
India Suretech Hospital & Research Centre Ltd Nagpur
India All India Institute of Medical Sciences New Delhi
India Grant Medical Foundation Ruby Hall Clinic Pune
India Shree Giriraj Multispeciality Hospital Rajkot
India Gandhi Hospital Secunderabad
India Institute of Gastroenterology & Liver Disease, Sunshine Hospitals Secunderabad
India Surat Institute of Digestive Sciences Surat
India Kasturba Hospital Medical College Udupi
India Sterling Hospital Vadodara
India Samvedana Hospital Varanasi
Ireland Beaumont Hospital Dublin
Israel Soroka Medical Center Beer-Sheva
Israel Bnai Zion Medical Center Haifa
Israel Rambam Health Care Campus Haifa
Israel Hadassah Medical Center Jerusalem
Israel Shaare Zedek Medical Center Jerusalem
Israel Rabin Medical Center Petach Tikva
Italy UOC Gastroenterologia II Castellana Grotte
Italy U.O. Fisiopatologia Digestiva Catanzaro
Italy Ospedale Clinicizzato SS. Annunziata - Dipartimento di Medicina Chieti
Italy Endocsopia Digestiva Centralizzata - ASST Fatebenefratelli Sacco, Ospedale Fatebenefratelli e Oftalmico Milano
Italy UOC Gastroenterologia Padova
Italy Azienda Ospedaliero-Universitaria Pisana - Presidio Ospedaliero Cisanello Pisa
Italy UOC Gastroenterologia ed Endoscopia Digestiva Roma
Italy Istituto Clinico Humanitas Rozzano
Japan Medical Hospital, Tokyo Medical and Dental University Bunkyo-ku
Japan Fukuoka University Chikushi Hospital Chikushino-shi
Japan Hokkaido P.W.F.A.C Sapporo-Kosei General Hospital Chuo-Ku
Japan Japanese Red Cross Fukuoka Hospital Fukuoka-shi
Japan Tokai University Hachioji Hospital Hachioji-shi
Japan Hiroshima University Hospital Hiroshima-shi
Japan Fukuoka University Hospital Jonan-ku
Japan Ofuna Chuo Hospital Kamakura
Japan Kitakyushu City Hospital Organization Kitakyushu Municipal Medical Center Kitakyushu-shi
Japan Yamanashi Prefectural Central Hospital Kofu-shi
Japan Hidaka Coloproctology Clinic Kurume-shi
Japan Kurume University Hospital Kurume-shi
Japan University Hospital, Kyoto Prefectural University of Medicine Kyoto-shi
Japan Kitasato University Kitasato Institute Hospital Minato-ku
Japan The Jikei University Hospital Minato-Ku
Japan Kyorin University Hospital Mitaka-shi
Japan Iwate Medical University Hospital Morioka-shi
Japan Aichi Medical University Hospital Nagakute-shi
Japan Nagasaki University Hospital Nagasaki-shi
Japan Saiseikai Niigata Daini Hospital Nishi-ku
Japan Hyogo College of Medicine College Hospital Nishinomiya
Japan Ishida IBD Clinic Oita-shi
Japan Okayama University Hospital Okayama-city
Japan Kinshukai Infusion Clinic Osaka
Japan Osaka City University Hospital Osaka
Japan Wakakusa-Daiichi Hospital Osaka
Japan Shiga University of Medical Science Hospital Otsu
Japan Saga University Hospital Saga
Japan Saga-Ken Medical Centre Koseikan Saga-shi
Japan Kitasato University Hospital, THE KITASATO INSTITUTE Sagamihara
Japan Tokito Clinic Saitama
Japan Toho University Sakura Medical Center Sakura
Japan Sapporo Tokushukai Hospital Sapporo
Japan Sapporo Higashi Tokushukai Hospital Sapporo-shi
Japan National Hospital Organization Sendai Medical Center Sendai
Japan Tokyo Yamate Medical Center Shinjuku-ku
Japan Osaka University Hospital Suita
Japan Kagawa Prefectural Central Hospital Takamatsu-shi
Japan National Hospital Organization Takasaki General Medical Center Takasaki-shi
Japan Osaka Medical College Hospital Takatsuki
Japan Ieda Hospital Toyota-shi
Japan Wakayama Medical University Hospital Wakayama-shi
Japan Colo-proctology Center Matsushima Clinic Yokohama-shi
Japan Yokohama Health Medicine Association Kannai Suzuki Clinic Yokohama-shi
Korea, Republic of Pusan National University Hospital Busan
Korea, Republic of Yeungnam University Hospital Daegu
Korea, Republic of Asan Medical Center Seoul
Korea, Republic of Division of Gastroenterology, Department of Medicine, Samsung Medical Center Seoul
Korea, Republic of Hyung Hee University Hospital Seoul
Korea, Republic of Kangbuk Samsung Hospital Seoul
Korea, Republic of Yonsei University Health System, Severance Hospital Seoul
Korea, Republic of The Catholic University of Korea, St. Vincent's Hospital Suwon-si Gyeonggi-do
Korea, Republic of Yonsei University Wonju Severance Christian Hospital Wonju
Malaysia University Kebangsaan Malaysia Medical Centre Cheras
Malaysia Hospital Pulau Pinang George Town
Malaysia Hospital Queen Elizabeth Kota Kinabalu
Mexico PCR-Phylasis Clinicas Research S. de R.L. de C.V. Cuautitlán Izcalli
Netherlands Academic Medical Center (AMC) Amsterdam
Netherlands Gelre Hospital Apeldoorn
Netherlands University Medical Center Utrecht Utrecht
New Zealand Christchurch Hospital Christchurch
New Zealand Auckland City Hospital Grafton
New Zealand Waikato Hospital Hamilton
New Zealand Wellington Hospital Newtown
New Zealand Bay of Plenty District Health Board - Tauranga Hospital Tauranga
Norway Vestre Viken Hospital Trust, Baerum Hospital Drammen
Norway Akerskus University Hospital Lørenskog
Poland Uniwersytecki Szpital Kliniczny w Bialymstoku, Klinika Gastroenterologii i Chorob Wewnetrznych Bialystok
Poland Gabinet Lekarski Janusz Rudzinski Bydgoszcz
Poland VITAMED Galaj i Cichomski spolka jawna Bydgoszcz
Poland NZOZ INTER-MED, Centrum Endoskopowe Czestochowa
Poland Niepubliczny Zaklad Opieki Zdrowotnej ALL-MEDICUS Katowice
Poland Gabinet Endoskopii Przewodu Pokarmowego Kraków
Poland Krakowskie Centrum Medyczne Sp. z o.o Kraków
Poland Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp.J. Ksawerów
Poland Santa Familia, Centrum Badan, Profilaktyki i Leczenia Lódz
Poland Centrum Innowacyjnych Terapii Sp. z o.o. Piaseczno
Poland Clinical Research Center Spolka z organiczna odpowiedzialnoscia Medic-R Sp. k. Poznan
Poland Gabinet Lekarski Dr. Hab. N. Med. Bartosz Korczowski Rzeszów
Poland Endoskopia Sp. z o.o. Sopot
Poland Twoja Przychodnia-Szczecinskie Centrum Medyczne Szczecin
Poland GASTROMED Kopon, Zmudzkinski i Wspolnicy Sp. j. Specjalistyczne Centrum Gastrologii i Endoskopii Torun
Poland H-T.Centrum Medyczne Spolka z Ograniczona Odpowiedzialnoscia Sp.K. Tychy
Poland Bodyclinic Warszawa
Poland Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administacji w Warszawie Warszawa
Poland Centrum Zdrowia MDM Warszawa
Poland Niepubliczny Zaklad Opieki Zrodotnej VIVAMED Jadwige Miecz Warszawa
Poland Centrum Medyczne Oporow Wroclaw
Portugal Hospital da Senhora da Oliveira Guimaraes, E.P.E. Guimarães
Portugal Centro Hospitalar de Sao Joao, EPE Porto
Romania SC MedLife SA, Gastroenterologie Bucuresti
Romania Spitalul Clinic Colentina - Sectia de Spitulal Clinic Colentina, Gastroenterologie Bucuresti
Romania Cabinet Medical Individual Dr Tirnaveanue Amelita, Gastroenterologie Oradea
Romania Cabinet Particular Policlinic Algomed SRL Timisoara
Russian Federation State Budgetary Healthcare Institution "Chelyabinski Regional Clinical Hospital" Chelyabinsk
Russian Federation State Budgetary Institution of Health Irkustsk Order "Badge of Honor" Regional Clinical Hospital Irkutsk
Russian Federation Federal State Budgetary Institution of Science Federal Research Center of Nutrition, Biotechnology and Food Safety Moscow
Russian Federation State Budgetary Healthcare Institution of Moscow "City Clinical Hospital # 24 of Healthcare Department of Moscow" Moscow
Russian Federation State Budgetary Healthcare Institution of Moscow Region "Moscow Regional Clinical Research Institute n.a. M.F. Vladimirskiy" Moscow
Russian Federation State Budgetary Healthcare Institution of Nizhny Novgorod Region "Nizhny Novgorod Regional Clinical Hospital n.a. N.A. Nizhniy Novgorod
Russian Federation State Budgetary Healthcare Institution of the Novosibirsk Region "State Novosibirsk Regional Clinical Hospital" Novosibirsk
Russian Federation State Budgetary Institution of Health of Novosibirsk Region "City Clinical Hospital #12" Novosibirsk
Russian Federation "PolyClinic EXPERT" LLC Saint Petersburg
Russian Federation "Riat" LLC Saint Petersburg
Russian Federation "Scientific Research Centre ECO-safety" LLC Saint-Petersburg
Russian Federation Saint Petersburg State Budgetary Healthcare Institution "City Polyclinic #38" Saint-Petersburg
Russian Federation State Healthcare Institution "Regional Clinical Hospital" Saratov
Russian Federation Treatment and Prevention Interdistrict Institution "Smolenskie kliniki" LLC Smolensk
Russian Federation State Autonomous Health Institution of the Tyumen Region "Multidisciplinary Consultative and Diagnostic Center" Tyumen
Serbia Zvezdara University Medical Center Belgrade
Singapore Singapore General Hospital Singapore
Slovakia KM Management, s.r.o., Gastroenterologicke a hepatologicke centrum Nitra Nitra
South Africa Dr MJ Prins Cape Town
South Africa Peermed Clinical Trial Centre Johannesburg
Spain Centro Medico Teknon Barcelona
Spain Hospital Clinico San Carlos Madrid
Spain Hospital Universitario de Fuenlabrada Madrid
Spain Hospital Universitario Central de Asturias Oviedo
Spain Hospital Universitario Virgen del Rocio Sevilla
Sweden Danderyds Sjukhus AB Danderyd
Sweden Skane University Hospital Malmo
Sweden Akademiska Sjukhuset Uppsala
Switzerland Gastroenterologische Praxis Balsiger, Seibold und Partner Bern
Switzerland Universitatsspital Zurich Zürich
Taiwan Changhua Christian Hospital Chang-hua
Taiwan Mackay Memorial Hospital, Taipei Taipei
Taiwan National Taiwan University Hospital Taipei
Taiwan Chang Gung Medical Foundation, Chang Gung Memorial Hospital, Linkou Branch Taoyuan
Ukraine Municipal Institution "Cherkasy Regional Hospital of Cherkasy Regional Council", Gastroenterology Department Cherkasy
Ukraine Municipal City Clinical Hospital of the Emergency Medical Care, 1 st Therapy Department. Danylo Halytsky Lviv National Medical Chernivtsi
Ukraine Regional Municipal Institution "Chernivtsi Regional Clinical Hospital", Surgical Department Chernivtsi
Ukraine State Institution "Institute of Gastroenterology of National Academy of Medical Sciences of Ukraine" Dnipropetrovsk
Ukraine Ivanto-Frankivsk Central City Clinic Hospital, Therapy Department #1. State Higher Education Institution Ivano-Frankivsk National Ivano-Frankivs'k
Ukraine L.T. Mala State Institution "National Institute of Therapy of National Academy of Medical Sciences of Ukraine" Kharkiv
Ukraine Municipal Health Care Institution "Kharkiv City Clinical Hospital #2 named after prof. O. O. Shalimov", Proctology Department Kharkiv
Ukraine Municipal Institution of Health Care "Regional Hospital of War Veterans", Therapeutic Department No1 Kharkiv
Ukraine Treatment and Diagnostic Center of Private Enterprise of Private Production Company "Acinus" Kropyvnytskyi
Ukraine Kyiv City Clinical Hospital No. 18, Proctology Department Kyiv
Ukraine Municipal Non-profit Enterprise "Consultative and Diagnostic Center" of Pechersk District of Kyiv, Therapy Department Kyiv
Ukraine Municipal Institution "Odesa Regional Clinical Hospital", Regional Gastroenterology Center based on Surgery Department Odessa
Ukraine Odesa Clinical Railway Hospital Branch of "Healthcare Center" of Public joint stock company "Ukrainian Railway" Odessa
Ukraine Ternopil University Hospital, Regional Center of Gastroenterology with Hepatology Ternopil
Ukraine Medical Center LLC "Health Clinic" Vinnytsia
Ukraine M.I. Pyrogov Vinnytsia Regional Clinical Hospital, Gastroenterology Department Vinnytsya
Ukraine Vinnytsia Regional Clinical Hospital of War Veterans, Therapy Department #1 Vinnytsya
Ukraine Municipal Institution "Zaporizhzhya Regional Clinical Hospital" of Zaporizhzhya Regional Council Zaporizhzhya
United Kingdom The Pennine Acute Hospitals NHS Trust Bury
United Kingdom Cambridge University Hospital NHS Foundation Trust Cambridge
United Kingdom Royal Derby Hospital Derby
United Kingdom NHS Lothian Edinburgh
United Kingdom Glasgow Clinical Research Facility - Queen Elizabeth University Hospital Glasgow
United Kingdom NHS Greater Glasgow and Clyde Glasgow
United Kingdom Wycombe Hospital High Wycombe
United Kingdom Imperial College Healthcare NHS Trust, St Mary's Hospital London
United Kingdom Norfolk and Norwich University Hospital NHS Foundation Trust Norwich
United Kingdom Biomedical Research Unit Nottingham
United Kingdom Oxford University Hospitals NHS Foundation Trust Oxford
United Kingdom St Helens and Knowsley Teaching Hospitals NHS Trust Prescot
United Kingdom Southampton National Institute for Health Research, Wellcome Trust Clinical Research Facility Southampton
United States Investigative Clinical Research Annapolis Maryland
United States Massachusetts General Hospital - Crohn's and Colitis Center Boston Massachusetts
United States HP Clinical Research Bountiful Utah
United States NY Scientific Brooklyn New York
United States University of Virginia Health System Charlottesville Virginia
United States WR-ClinSearch, LLC Chattanooga Tennessee
United States Gastroenterology Associates Of Tidewater Chesapeake Virginia
United States Clinical Research Institute of Michigan, LLC Chesterfield Michigan
United States MGG Group Co., Inc., Chevy Chase Clinical Research Chevy Chase Maryland
United States Consultants for Clinical Research Cincinnati Ohio
United States UC Health Physicians Clifton Cincinnati Ohio
United States Gastro Center of Maryland Columbia Maryland
United States Digestive Health Specialists of the Southeast Dothan Alabama
United States Fargo Gastroenterology and Hepatology Clinic Fargo North Dakota
United States Connecticut GI PC-Research Division Farmington Connecticut
United States San Antonio Military Medical Center Fort Sam Houston Texas
United States UF Health at Shands Hospital Gainesville Florida
United States DHAT Research Institute Garland Texas
United States Gastro One Germantown Tennessee
United States NYU Langone Long Island Clinical Research Associates Great Neck New York
United States Meritus Center for Clinical Research Hagerstown Maryland
United States Baylor College of Medicine- Baylor Medical Center Houston Texas
United States The University of Texas Health Science Center at Houston Houston Texas
United States University of Iowa Hospitals and Clinics Iowa City Iowa
United States Kansas City Research Institute Kansas City Missouri
United States Florida Research Institute Lakewood Ranch Florida
United States Emeritas Research Group LLC Lansdowne Town Center Virginia
United States South Denver Gastroenterology, PC Lone Tree Colorado
United States VA Long Beach Healthcare System Long Beach California
United States Cedars Sinai Medical Center Los Angeles California
United States University of Louisville, Clinical Trials Unit Louisville Kentucky
United States Gastroenterology Associates of Central Georgia, LLC Macon Georgia
United States University of Wisconsin Hospital & Clinics Madison Wisconsin
United States Gastrointestinal Specialists of Georgia Marietta Georgia
United States Great Lakes Gastroenterology Research, LLC Mentor Ohio
United States Cordova Research Institute Miami Florida
United States University of Miami Crohn's and Colitis Center Miami Florida
United States Delta Research Partners, LLC Monroe Louisiana
United States Gastroenterology Group of Naples Naples Florida
United States Quality Medical Research Nashville Tennessee
United States Vanderbilt University Medical Center - IBD Clinic Nashville Tennessee
United States Gastroenterology Associates of Orangeburg Orangeburg South Carolina
United States Advanced Medical Research Center Port Orange Florida
United States Carolina's GI Research, LLC Raleigh North Carolina
United States Rapid City Medical Center Rapid City South Dakota
United States McGuire DVAMC Richmond Virginia
United States Mayo Clinic Rochester Minnesota
United States Washington University School of Medicine Saint Louis Missouri
United States Clinical Associates in Research Therapeutics of America, LLC San Antonio Texas
United States Gastroenterology Research of San Antonio San Antonio Texas
United States Texas Digestive Disease Consultants San Marcos Texas
United States Mayo Clinic Arizona Scottsdale Arizona
United States Louisiana Research Center, LLC Shreveport Louisiana
United States Texas Digestive Disease Consultants Southlake Texas
United States Atlanta Gastroenterology Specialist, PC Suwanee Georgia
United States Tampa General Hospital Tampa Florida
United States Spring Gastroenterology The Woodlands Texas
United States Center for Digestive Health Troy Michigan
United States Allegiance Research Specialists, LLC Wauwatosa Wisconsin
United States Shafran Gastroenterology Center Winter Park Florida
United States Florida Medical Clinic, P.A. Zephyrhills Florida

Sponsors (2)

Lead Sponsor Collaborator
Gilead Sciences Galapagos NV

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belgium,  Bulgaria,  Canada,  Croatia,  Czechia,  France,  Georgia,  Germany,  Greece,  Hong Kong,  Hungary,  India,  Ireland,  Israel,  Italy,  Japan,  Korea, Republic of,  Malaysia,  Mexico,  Netherlands,  New Zealand,  Norway,  Poland,  Portugal,  Romania,  Russian Federation,  Serbia,  Singapore,  Slovakia,  South Africa,  Spain,  Sweden,  Switzerland,  Taiwan,  Ukraine,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Induction Study: Percentage of Participants Who Achieved Endoscopy/Bleeding/Stool Frequency (EBS) Remission at 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
Primary Maintenance Study: Percentage of Participants Who Achieved EBS Remission at 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 Induction Study: Percentage of Participants Who Achieved MCS Remission at 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
Secondary Induction Study: Percentage of Participants Who Achieved an Endoscopic Subscore of 0 at Week 10 Endoscopic subscore range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease (spontaneous bleeding, ulceration). Week 10
Secondary Induction Study: Percentage of Participants Who Achieved Geboes Histologic Remission at 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
Secondary Induction Study: Percentage of Participants Who Achieved MCS Remission (Alternative Definition) at 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
Secondary Induction Study: Pharmacokinetic (PK) Parameter: Cmax of Filgotinib and Its Metabolite GS-829845 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
Secondary Induction Study: PK Parameter: Tmax of Filgotinib and Its Metabolite GS-829845 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
Secondary Induction Study: PK Parameter: AUCtau of Filgotinib and Its Metabolite GS-82984 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
Secondary Induction Study: PK Parameter: AUClast of Filgotinib and Its Metabolite GS-82984 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
Secondary Induction Study: PK Parameter: Ctau of Filgotinib and Its Metabolite GS-82984 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
Secondary Maintenance Study: Percentage of Participants Who Achieved MCS Remission at 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
Secondary Maintenance Study: Percentage of Participants Who Achieved Sustained EBS Remission at Week 58 Sustained EBS remission was defined as having achieved EBS remission at both Weeks 10 and 58. Week 58
Secondary Maintenance Study: Percentage of Participants Who Achieved 6-Month Corticosteroid-Free EBS Remission at 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
Secondary Maintenance Study: Percentage of Participants Who Achieved Endoscopic Subscore of 0 at Weeks 58 Endoscopic subscore range: 0 to 3, where 0 = normal or inactive disease and 3 = severe disease (spontaneous bleeding, ulceration). Week 58
Secondary Maintenance Study: Percentage of Participants Who Achieved Geboes Histologic Remission at 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
Secondary Maintenance Study: Percentage of Participants Who Achieved MCS Remission (Alternative Definition) at 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
Secondary Maintenance Study: Plasma Concentration of Filgotinib and Its Metabolite GS-829845 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)
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