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

Ulcerative Colitis Clinical Trial

— SELECTION  

Official title:

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

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
• 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
• 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.

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

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)