Clinical trial NCT02914522: 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
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ulcerative Colitis
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
Collaborators: name: Galapagos NV
First posted: 2016-09-26
Enrollment: 1351
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).


Eligibility criteria: 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.

Primary outcomes:
measure: Induction Study: Percentage of Participants Who Achieved Endoscopy/Bleeding/Stool Frequency (EBS) Remission at Week 10
timeFrame: Week 10
measure: Maintenance Study: Percentage of Participants Who Achieved EBS Remission at Week 58
timeFrame: Week 58
Secondary outcomes:
measure: Induction Study: Percentage of Participants Who Achieved MCS Remission at Week 10
timeFrame: Week 10
measure: Induction Study: Percentage of Participants Who Achieved an Endoscopic Subscore of 0 at Week 10
timeFrame: Week 10
measure: Induction Study: Percentage of Participants Who Achieved Geboes Histologic Remission at Week 10
timeFrame: Week 10
measure: Induction Study: Percentage of Participants Who Achieved MCS Remission (Alternative Definition) at Week 10
timeFrame: Week 10
measure: Induction Study: Pharmacokinetic (PK) Parameter: Cmax of Filgotinib and Its Metabolite GS-829845
timeFrame: Predose and at 0.5, 1, 2, 3, 4 and 6 hours postdose at a single visit between Week 2 and Week 10
measure: Induction Study: PK Parameter: Tmax of Filgotinib and Its Metabolite GS-829845
timeFrame: Predose and at 0.5, 1, 2, 3, 4 and 6 hours postdose at a single visit between Week 2 and Week 10
measure: Induction Study: PK Parameter: AUCtau of Filgotinib and Its Metabolite GS-82984
timeFrame: Predose and at 0.5, 1, 2, 3, 4 and 6 hours postdose at a single visit between Week 2 and Week 10
measure: Induction Study: PK Parameter: AUClast of Filgotinib and Its Metabolite GS-82984
timeFrame: Predose and at 0.5, 1, 2, 3, 4 and 6 hours postdose at a single visit between Week 2 and Week 10
measure: Induction Study: PK Parameter: Ctau of Filgotinib and Its Metabolite GS-82984
timeFrame: Predose and at 0.5, 1, 2, 3, 4 and 6 hours postdose at a single visit between Week 2 and Week 10
measure: Maintenance Study: Percentage of Participants Who Achieved MCS Remission at Week 58
timeFrame: Week 58
measure: Maintenance Study: Percentage of Participants Who Achieved Sustained EBS Remission at Week 58
timeFrame: Week 58
measure: Maintenance Study: Percentage of Participants Who Achieved 6-Month Corticosteroid-Free EBS Remission at Week 58
timeFrame: Week 58
measure: Maintenance Study: Percentage of Participants Who Achieved Endoscopic Subscore of 0 at Weeks 58
timeFrame: Week 58
measure: Maintenance Study: Percentage of Participants Who Achieved Geboes Histologic Remission at Week 58
timeFrame: Week 58
measure: Maintenance Study: Percentage of Participants Who Achieved MCS Remission (Alternative Definition) at Week 58
timeFrame: Week 58
measure: Maintenance Study: Plasma Concentration of Filgotinib and Its Metabolite GS-829845
timeFrame: Week 26 (any Time) and Week 58 (predose)
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Digestive Health Specialists of the Southeast
state: Alabama
city: Scottsdale
country: United States
facility: Mayo Clinic Arizona
state: Arizona
city: Long Beach
country: United States
facility: VA Long Beach Healthcare System
state: California
city: Los Angeles
country: United States
facility: Cedars Sinai Medical Center
state: California
city: Lone Tree
country: United States
facility: South Denver Gastroenterology, PC
state: Colorado
city: Farmington
country: United States
facility: Connecticut GI PC-Research Division
state: Connecticut
city: Gainesville
country: United States
facility: UF Health at Shands Hospital
state: Florida
city: Lakewood Ranch
country: United States
facility: Florida Research Institute
state: Florida
city: Miami
country: United States
facility: University of Miami Crohn's and Colitis Center
state: Florida
city: Miami
country: United States
facility: Cordova Research Institute
state: Florida
city: Naples
country: United States
facility: Gastroenterology Group of Naples
state: Florida
city: Port Orange
country: United States
facility: Advanced Medical Research Center
state: Florida
city: Tampa
country: United States
facility: Tampa General Hospital
state: Florida
city: Winter Park
country: United States
facility: Shafran Gastroenterology Center
state: Florida
city: Zephyrhills
country: United States
facility: Florida Medical Clinic, P.A.
state: Florida
city: Macon
country: United States
facility: Gastroenterology Associates of Central Georgia, LLC
state: Georgia
city: Marietta
country: United States
facility: Gastrointestinal Specialists of Georgia
state: Georgia
city: Suwanee
country: United States
facility: Atlanta Gastroenterology Specialist, PC
state: Georgia
city: Iowa City
country: United States
facility: University of Iowa Hospitals and Clinics
state: Iowa
city: Louisville
country: United States
facility: University of Louisville, Clinical Trials Unit
state: Kentucky
city: Monroe
country: United States
facility: Delta Research Partners, LLC
state: Louisiana
city: Shreveport
country: United States
facility: Louisiana Research Center, LLC
state: Louisiana
city: Annapolis
country: United States
facility: Investigative Clinical Research
state: Maryland
city: Chevy Chase
country: United States
facility: MGG Group Co., Inc., Chevy Chase Clinical Research
state: Maryland
city: Columbia
country: United States
facility: Gastro Center of Maryland
state: Maryland
city: Hagerstown
country: United States
facility: Meritus Center for Clinical Research
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital - Crohn's and Colitis Center
state: Massachusetts
city: Chesterfield
country: United States
facility: Clinical Research Institute of Michigan, LLC
state: Michigan
city: Troy
country: United States
facility: Center for Digestive Health
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
city: Kansas City
country: United States
facility: Kansas City Research Institute
state: Missouri
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
city: Brooklyn
country: United States
facility: NY Scientific
state: New York
city: Great Neck
country: United States
facility: NYU Langone Long Island Clinical Research Associates
state: New York
city: Raleigh
country: United States
facility: Carolina's GI Research, LLC
state: North Carolina
city: Fargo
country: United States
facility: Fargo Gastroenterology and Hepatology Clinic
state: North Dakota
city: Cincinnati
country: United States
facility: Consultants for Clinical Research
state: Ohio
city: Cincinnati
country: United States
facility: UC Health Physicians Clifton
state: Ohio
city: Mentor
country: United States
facility: Great Lakes Gastroenterology Research, LLC
state: Ohio
city: Orangeburg
country: United States
facility: Gastroenterology Associates of Orangeburg
state: South Carolina
city: Rapid City
country: United States
facility: Rapid City Medical Center
state: South Dakota
city: Chattanooga
country: United States
facility: WR-ClinSearch, LLC
state: Tennessee
city: Germantown
country: United States
facility: Gastro One
state: Tennessee
city: Nashville
country: United States
facility: Quality Medical Research
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt University Medical Center - IBD Clinic
state: Tennessee
city: Fort Sam Houston
country: United States
facility: San Antonio Military Medical Center
state: Texas
city: Garland
country: United States
facility: DHAT Research Institute
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine- Baylor Medical Center
state: Texas
city: Houston
country: United States
facility: The University of Texas Health Science Center at Houston
state: Texas
city: San Antonio
country: United States
facility: Clinical Associates in Research Therapeutics of America, LLC
state: Texas
city: San Antonio
country: United States
facility: Gastroenterology Research of San Antonio
state: Texas
city: San Marcos
country: United States
facility: Texas Digestive Disease Consultants
state: Texas
city: Southlake
country: United States
facility: Texas Digestive Disease Consultants
state: Texas
city: The Woodlands
country: United States
facility: Spring Gastroenterology
state: Texas
city: Bountiful
country: United States
facility: HP Clinical Research
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
city: Chesapeake
country: United States
facility: Gastroenterology Associates Of Tidewater
state: Virginia
city: Lansdowne Town Center
country: United States
facility: Emeritas Research Group LLC
state: Virginia
city: Richmond
country: United States
facility: McGuire DVAMC
state: Virginia
city: Madison
country: United States
facility: University of Wisconsin Hospital & Clinics
state: Wisconsin
city: Wauwatosa
country: United States
facility: Allegiance Research Specialists, LLC
state: Wisconsin
city: Mar del Plata
country: Argentina
facility: Instituto de Investigaciones Clinicas Mar del Plata
city: Quilmes
country: Argentina
facility: Instituto Médico Cer
city: Darlinghurst
country: Australia
facility: St. Vincent's Hospital Sydney
state: New South Wales
city: Kingswood
country: Australia
facility: Nepean Hospital
state: New South Wales
city: Mountain Creek
country: Australia
facility: Coastal Digestive Health
state: Queensland
city: South Brisbane
country: Australia
facility: Mater Misericordiae Ltd
state: Queensland
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Woodville South
country: Australia
facility: The Queen Elizabeth Hospital
state: South Australia
city: Clayton
country: Australia
facility: Monash Medical Centre
state: Victoria
city: Footscray
country: Australia
facility: Footscray Hospital
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Health
state: Victoria
city: Malvern
country: Australia
facility: Cabrini Hospital
state: Victoria
city: Melbourne
country: Australia
facility: Alfred Hospital
state: Victoria
city: Innsbruck
country: Austria
facility: Universitatsklinik Innsbruck
city: Wien
country: Austria
facility: AKH-Medizinische Universitat Wien
city: Antwerpen
country: Belgium
facility: GZA Ziekenhuizen campus Sint-Vincentius
city: Brussels
country: Belgium
facility: CUB Hopital Erasme
city: Leuven
country: Belgium
facility: Universitair Ziekenhuis Leuven
city: Liège
country: Belgium
facility: Centre Hospitalier Chretien (CHC) - Clinique Saint-Joseph
city: Pleven
country: Bulgaria
facility: MHAT Sveti Pantaleymon - Pleven OOD
city: Veliko Tŭrnovo
country: Bulgaria
facility: "MDHAT Dr. St.Cherkezov" AD
city: Vidin
country: Bulgaria
facility: MHAT "Sveta Petka" AD
city: Calgary
country: Canada
facility: University of Calgary, Heritage Medical Research Clinic
state: Alberta
city: Vancouver
country: Canada
facility: The Gordon and Leslie Diamond Health Care Centre
state: British Columbia
city: Hamilton
country: Canada
facility: Hamilton Health Sciences Corporation, McMaster University Medical Centre
state: Ontario
city: Saskatoon
country: Canada
facility: Royal University Hospital
state: Saskatchewan
city: Vaughan
country: Canada
facility: Toronto Digestive Disease Associates Inc.
city: Zagreb
country: Croatia
facility: Clinical Hospital Dubrava
city: Zagreb
country: Croatia
facility: University Hospital Center Zagreb
city: Hradec Kralove
country: Czechia
facility: Hepato-Gastroenterologie HK, s.r.o.
city: Mladá Boleslav
country: Czechia
facility: Oblastni nemocnice Mlada Boleslav, a.s., nemocnice Stredoceskeho kraje, Gastroenterologicke oddeleni
city: Praha 3
country: Czechia
facility: G.E.P. Clinic, s r.o.
city: Praha 9
country: Czechia
facility: ISCARE a.s. (Klinicke centrum ISCARE), Klinicke a vyzkumne centrum pro strevni zanety
city: Amiens
country: France
facility: CHU Amiens Picardie
city: Caen
country: France
facility: CHU de Caen
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand - Hopital d'Estaing
city: Clichy
country: France
facility: APHP - Hopital Beaujon - Clichy - Universite Paris VII
city: Dijon
country: France
facility: CHU de Dijon Bourgogne - Hopital Francois Mitterand
city: La Tronche
country: France
facility: CHU Grenoble Alpes
city: Le Kremlin-Bicêtre
country: France
facility: Hopital Universitaire de Bicetre
city: Lille
country: France
facility: Centre Hospitalier Regional Universitaire de Lille
city: Marseille
country: France
facility: Hopital Nord
city: Montpellier
country: France
facility: CHU de Montpellier-Hopital Saint Eloi
city: Nantes
country: France
facility: CHU Hotel-Dieu
city: Nice
country: France
facility: Hopital de l'Archet 2
city: Paris
country: France
facility: Institut Mutualiste Montsouris
city: Pessac
country: France
facility: CHU de Bordeaux - Hopital Haut Leveque
city: Pierre-Benite
country: France
facility: Centre Hospitalier Universitaire de Lyon Sud
city: Rennes Cedex 9
country: France
facility: Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou
city: Saint Priest en Jarez
country: France
facility: CHU de Saint-Etienne - Hopital Nord
city: Toulouse
country: France
facility: CHU de Toulouse - Hopital Rangueil
city: Vandœuvre-lès-Nancy
country: France
facility: CHU de Nancy - Hopital Brabois Adultes
city: Batumi
country: Georgia
facility: Unimed Ajara LLC - Batumi Referral Hospital
city: Tbilisi
country: Georgia
facility: Medi Club Georgia LLC
city: Telavi
country: Georgia
facility: Ltd. Unimed Kakheti - Telavi Referral Hospital
city: Berlin
country: Germany
facility: Charite Universitatsmedizin Berlin
city: Berlin
country: Germany
facility: Charite - Universitatsmedizin Berlin
city: Berlin
country: Germany
facility: DRK Kliniken Berlin - Westend - Klinik fuer Innere Medizin
city: Braunschweig
country: Germany
facility: Stadtisches Klinikum Braunschweig gGmbH
city: Frankfurt am Main
country: Germany
facility: Agaplesion Markus Krankenhaus
city: Freiburg
country: Germany
facility: Universitatsklinikum Freiburg
city: Hamburg
country: Germany
facility: Asklepios Westklinikum Hamburg
city: Hannöver
country: Germany
facility: Medizinische Hochschule Hannover
city: Herne
country: Germany
facility: Gastroenterologische Gemeinschaftspraxis Herne
city: Jena
country: Germany
facility: Universitatsklinikum Jena
city: Kiel
country: Germany
facility: Universitatsklinikum Schleswig-Holstein
city: Koln
country: Germany
facility: Universitaetsklinik Koln
city: Leipzig
country: Germany
facility: EUGASTRO GmbH
city: Lüneburg
country: Germany
facility: Klinikum Luneburg
city: Minden
country: Germany
facility: Gastroenterologische Gemeinschaftspraxis Minden
city: Muenchen
country: Germany
facility: Klinikum der Universitat Munchen - Grosshadern
city: Tuebingen
country: Germany
facility: Universitaetsklinikum Tuebingen
city: Ulm
country: Germany
facility: Universitatsklinikum Ulm, Zentrum Fur Innere Medizin
city: Athens
country: Greece
facility: General Hospital of Athens "Hippokratio", 2nd Internal Medicine Clinic of Athens University, Hepato-gastroenterology Unit
city: Athens
country: Greece
facility: General Hospital of Nikaias "Agios Pentelleimon", Gastroenterology Department
city: Hong Kong
country: Hong Kong
facility: Princess Margaret Hospital
city: Hong Kong
country: Hong Kong
facility: Queen Mary Hospital
city: Sha Tin
country: Hong Kong
facility: Department of Medicine & Therapeutics, The Chinese University of Hong Kong, Prince of Wales Hospital
city: Budapest
country: Hungary
facility: Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet, Kozponti Felnott Szakrendelo
city: Budapest
country: Hungary
facility: Szent Janos Korhaz es Eszak-budai Egitett Korhazak, I. Belgyogyaszati - Gasztroenterologiai Osztaly
city: Békéscsaba
country: Hungary
facility: Bekes Megyei Kosponti Korhaz, Dr. Rethy Pal Tagkorhaz, IV. Belgyogyaszat - 2. Gasztroenterologia
city: Debrecen
country: Hungary
facility: Debreceni Egyetem Klinikai Kozpont, II. sz. Belgyogyaszati Klinika, Gasztroenterologia
city: Gyöngyös
country: Hungary
facility: Bugat Pal Korhaz, Belgyogyaszat
city: Mosonmagyaróvár
country: Hungary
facility: Karolina Korhaz es Rendelointezet, Altalanos Belgyogyaszat-Gasztroenterologia
city: Ahmedabad
country: India
facility: Kaizen Hospital
city: Bangalore
country: India
facility: M S Ramaiah Medical College and Hospital
city: Chennai
country: India
facility: Apollo Speciality Hospital
city: Coimbatore
country: India
facility: VGM Hospital Institute of Gastroenterology
city: Hyderabad
country: India
facility: Gleneagles Global Hospitals
city: Hyderabad
country: India
facility: Citizens Specialty Hospital
city: Hyderabad
country: India
facility: Centre for Liver Research & Diagnostics
city: Jaipur
country: India
facility: S.R.KallaMemorial Gastro.&General Hospital,
city: Jaipur
country: India
facility: S.M.S Medical College & Hospitals
city: Kolkata
country: India
facility: School of Digestive & Liver Diseases
city: Ludhiana
country: India
facility: Dayanand Medical College & Hospital
city: Mangaluru
country: India
facility: Kasturba Medical College (KMC) Hospital
city: Mumbai
country: India
facility: Lokmanya Tilak Municipal General Hospital
city: Nagpur
country: India
facility: Midas Multispeciality Hospital Pvt. Ltd
city: Nagpur
country: India
facility: Suretech Hospital & Research Centre Ltd
city: New Delhi
country: India
facility: All India Institute of Medical Sciences
city: Pune
country: India
facility: Grant Medical Foundation Ruby Hall Clinic
city: Rajkot
country: India
facility: Shree Giriraj Multispeciality Hospital
city: Secunderabad
country: India
facility: Gandhi Hospital
city: Secunderabad
country: India
facility: Institute of Gastroenterology & Liver Disease, Sunshine Hospitals
city: Surat
country: India
facility: Surat Institute of Digestive Sciences
city: Udupi
country: India
facility: Kasturba Hospital Medical College
city: Vadodara
country: India
facility: Sterling Hospital
city: Varanasi
country: India
facility: Samvedana Hospital
city: Dublin
country: Ireland
facility: Beaumont Hospital
city: Beer-Sheva
country: Israel
facility: Soroka Medical Center
city: Haifa
country: Israel
facility: Bnai Zion Medical Center
city: Haifa
country: Israel
facility: Rambam Health Care Campus
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Medical Center
city: Petach Tikva
country: Israel
facility: Rabin Medical Center
city: Castellana Grotte
country: Italy
facility: UOC Gastroenterologia II
city: Catanzaro
country: Italy
facility: U.O. Fisiopatologia Digestiva
city: Chieti
country: Italy
facility: Ospedale Clinicizzato SS. Annunziata - Dipartimento di Medicina
city: Milano
country: Italy
facility: Endocsopia Digestiva Centralizzata - ASST Fatebenefratelli Sacco, Ospedale Fatebenefratelli e Oftalmico
city: Padova
country: Italy
facility: UOC Gastroenterologia
city: Pisa
country: Italy
facility: Azienda Ospedaliero-Universitaria Pisana - Presidio Ospedaliero Cisanello
city: Roma
country: Italy
facility: UOC Gastroenterologia ed Endoscopia Digestiva
city: Rozzano
country: Italy
facility: Istituto Clinico Humanitas
city: Bunkyo-ku
country: Japan
facility: Medical Hospital, Tokyo Medical and Dental University
city: Chikushino-shi
country: Japan
facility: Fukuoka University Chikushi Hospital
city: Chuo-Ku
country: Japan
facility: Hokkaido P.W.F.A.C Sapporo-Kosei General Hospital
city: Fukuoka-shi
country: Japan
facility: Japanese Red Cross Fukuoka Hospital
city: Hachioji-shi
country: Japan
facility: Tokai University Hachioji Hospital
city: Hiroshima-shi
country: Japan
facility: Hiroshima University Hospital
city: Jonan-ku
country: Japan
facility: Fukuoka University Hospital
city: Kamakura
country: Japan
facility: Ofuna Chuo Hospital
city: Kitakyushu-shi
country: Japan
facility: Kitakyushu City Hospital Organization Kitakyushu Municipal Medical Center
city: Kofu-shi
country: Japan
facility: Yamanashi Prefectural Central Hospital
city: Kurume-shi
country: Japan
facility: Kurume University Hospital
city: Kurume-shi
country: Japan
facility: Hidaka Coloproctology Clinic
city: Kyoto-shi
country: Japan
facility: University Hospital, Kyoto Prefectural University of Medicine
city: Minato-Ku
country: Japan
facility: The Jikei University Hospital
city: Minato-ku
country: Japan
facility: Kitasato University Kitasato Institute Hospital
city: Mitaka-shi
country: Japan
facility: Kyorin University Hospital
city: Morioka-shi
country: Japan
facility: Iwate Medical University Hospital
city: Nagakute-shi
country: Japan
facility: Aichi Medical University Hospital
city: Nagasaki-shi
country: Japan
facility: Nagasaki University Hospital
city: Nishi-ku
country: Japan
facility: Saiseikai Niigata Daini Hospital
city: Nishinomiya
country: Japan
facility: Hyogo College of Medicine College Hospital
city: Oita-shi
country: Japan
facility: Ishida IBD Clinic
city: Okayama-city
country: Japan
facility: Okayama University Hospital
city: Osaka
country: Japan
facility: Wakakusa-Daiichi Hospital
city: Saga-shi
country: Japan
facility: Saga-Ken Medical Centre Koseikan
city: Sagamihara
country: Japan
facility: Kitasato University Hospital, THE KITASATO INSTITUTE
city: Saga
country: Japan
facility: Saga University Hospital
city: Saitama
country: Japan
facility: Tokito Clinic
city: Sakura
country: Japan
facility: Toho University Sakura Medical Center
city: Sapporo-shi
country: Japan
facility: Sapporo Higashi Tokushukai Hospital
city: Sapporo
country: Japan
facility: Sapporo Tokushukai Hospital
city: Sendai
country: Japan
facility: National Hospital Organization Sendai Medical Center
city: Shinjuku-ku
country: Japan
facility: Tokyo Yamate Medical Center
city: Suita
country: Japan
facility: Osaka University Hospital
city: Takamatsu-shi
country: Japan
facility: Kagawa Prefectural Central Hospital
city: Takasaki-shi
country: Japan
facility: National Hospital Organization Takasaki General Medical Center
city: Takatsuki
country: Japan
facility: Osaka Medical College Hospital
city: Toyota-shi
country: Japan
facility: Ieda Hospital
city: Wakayama-shi
country: Japan
facility: Wakayama Medical University Hospital
city: Yokohama-shi
country: Japan
facility: Colo-proctology Center Matsushima Clinic
city: Yokohama-shi
country: Japan
facility: Yokohama Health Medicine Association Kannai Suzuki Clinic
city: Ōsaka
country: Japan
facility: Kinshukai Infusion Clinic
city: Ōsaka
country: Japan
facility: Osaka City University Hospital
city: Ōtsu
country: Japan
facility: Shiga University of Medical Science Hospital
city: Suwon-si
country: Korea, Republic of
facility: The Catholic University of Korea, St. Vincent's Hospital
state: Gyeonggi-do
city: Busan
country: Korea, Republic of
facility: Pusan National University Hospital
city: Daegu
country: Korea, Republic of
facility: Yeungnam University Hospital
city: Seoul
country: Korea, Republic of
facility: Kangbuk Samsung Hospital
city: Seoul
country: Korea, Republic of
facility: Yonsei University Health System, Severance Hospital
city: Seoul
country: Korea, Republic of
facility: Asan Medical Center
city: Seoul
country: Korea, Republic of
facility: Division of Gastroenterology, Department of Medicine, Samsung Medical Center
city: Seoul
country: Korea, Republic of
facility: Hyung Hee University Hospital
city: Wŏnju
country: Korea, Republic of
facility: Yonsei University Wonju Severance Christian Hospital
city: Cheras
country: Malaysia
facility: University Kebangsaan Malaysia Medical Centre
city: George Town
country: Malaysia
facility: Hospital Pulau Pinang
city: Kota Kinabalu
country: Malaysia
facility: Hospital Queen Elizabeth
city: Cuautitlán Izcalli
country: Mexico
facility: PCR-Phylasis Clinicas Research S. de R.L. de C.V.
city: Amsterdam
country: Netherlands
facility: Academic Medical Center (AMC)
city: Apeldoorn
country: Netherlands
facility: Gelre Hospital
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
city: Christchurch
country: New Zealand
facility: Christchurch Hospital
city: Grafton
country: New Zealand
facility: Auckland City Hospital
city: Hamilton
country: New Zealand
facility: Waikato Hospital
city: Newtown
country: New Zealand
facility: Wellington Hospital
city: Tauranga
country: New Zealand
facility: Bay of Plenty District Health Board - Tauranga Hospital
city: Drammen
country: Norway
facility: Vestre Viken Hospital Trust, Baerum Hospital
city: Lørenskog
country: Norway
facility: Akerskus University Hospital
city: Białystok
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Bialymstoku, Klinika Gastroenterologii i Chorob Wewnetrznych
city: Bydgoszcz
country: Poland
facility: VITAMED Galaj i Cichomski spolka jawna
city: Bydgoszcz
country: Poland
facility: Gabinet Lekarski Janusz Rudzinski
city: Częstochowa
country: Poland
facility: NZOZ INTER-MED, Centrum Endoskopowe
city: Katowice
country: Poland
facility: Niepubliczny Zaklad Opieki Zdrowotnej ALL-MEDICUS
city: Kraków
country: Poland
facility: Gabinet Endoskopii Przewodu Pokarmowego
city: Kraków
country: Poland
facility: Krakowskie Centrum Medyczne Sp. z o.o
city: Ksawerów
country: Poland
facility: Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp.J.
city: Piaseczno
country: Poland
facility: Centrum Innowacyjnych Terapii Sp. z o.o.
city: Poznan
country: Poland
facility: Clinical Research Center Spolka z organiczna odpowiedzialnoscia Medic-R Sp. k.
city: Rzeszów
country: Poland
facility: Gabinet Lekarski Dr. Hab. N. Med. Bartosz Korczowski
city: Sopot
country: Poland
facility: Endoskopia Sp. z o.o.
city: Szczecin
country: Poland
facility: Twoja Przychodnia-Szczecinskie Centrum Medyczne
city: Toruń
country: Poland
facility: GASTROMED Kopon, Zmudzkinski i Wspolnicy Sp. j. Specjalistyczne Centrum Gastrologii i Endoskopii
city: Tychy
country: Poland
facility: H-T.Centrum Medyczne Spolka z Ograniczona Odpowiedzialnoscia Sp.K.
city: Warszawa
country: Poland
facility: Centrum Zdrowia MDM
city: Warszawa
country: Poland
facility: Bodyclinic
city: Warszawa
country: Poland
facility: Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administacji w Warszawie
city: Warszawa
country: Poland
facility: Niepubliczny Zaklad Opieki Zrodotnej VIVAMED Jadwige Miecz
city: Wroclaw
country: Poland
facility: Centrum Medyczne Oporow
city: Łódź
country: Poland
facility: Santa Familia, Centrum Badan, Profilaktyki i Leczenia
city: Guimarães
country: Portugal
facility: Hospital da Senhora da Oliveira Guimaraes, E.P.E.
city: Porto
country: Portugal
facility: Centro Hospitalar de Sao Joao, EPE
city: Bucuresti
country: Romania
facility: SC MedLife SA, Gastroenterologie
city: Bucuresti
country: Romania
facility: Spitalul Clinic Colentina - Sectia de Spitulal Clinic Colentina, Gastroenterologie
city: Oradea
country: Romania
facility: Cabinet Medical Individual Dr Tirnaveanue Amelita, Gastroenterologie
city: Timişoara
country: Romania
facility: Cabinet Particular Policlinic Algomed SRL
city: Chelyabinsk
country: Russian Federation
facility: State Budgetary Healthcare Institution "Chelyabinski Regional Clinical Hospital"
city: Irkutsk
country: Russian Federation
facility: State Budgetary Institution of Health Irkustsk Order "Badge of Honor" Regional Clinical Hospital
city: Moscow
country: Russian Federation
facility: Federal State Budgetary Institution of Science Federal Research Center of Nutrition, Biotechnology and Food Safety
city: Moscow
country: Russian Federation
facility: State Budgetary Healthcare Institution of Moscow "City Clinical Hospital # 24 of Healthcare Department of Moscow"
city: Moscow
country: Russian Federation
facility: State Budgetary Healthcare Institution of Moscow Region "Moscow Regional Clinical Research Institute n.a. M.F. Vladimirskiy"
city: Nizhniy Novgorod
country: Russian Federation
facility: State Budgetary Healthcare Institution of Nizhny Novgorod Region "Nizhny Novgorod Regional Clinical Hospital n.a. N.A.
city: Novosibirsk
country: Russian Federation
facility: State Budgetary Institution of Health of Novosibirsk Region "City Clinical Hospital #12"
city: Novosibirsk
country: Russian Federation
facility: State Budgetary Healthcare Institution of the Novosibirsk Region "State Novosibirsk Regional Clinical Hospital"
city: Saint Petersburg
country: Russian Federation
facility: "Riat" LLC
city: Saint Petersburg
country: Russian Federation
facility: "PolyClinic EXPERT" LLC
city: Saint-Petersburg
country: Russian Federation
facility: Saint Petersburg State Budgetary Healthcare Institution "City Polyclinic #38"
city: Saint-Petersburg
country: Russian Federation
facility: "Scientific Research Centre ECO-safety" LLC
city: Saratov
country: Russian Federation
facility: State Healthcare Institution "Regional Clinical Hospital"
city: Smolensk
country: Russian Federation
facility: Treatment and Prevention Interdistrict Institution "Smolenskie kliniki" LLC
city: Tyumen
country: Russian Federation
facility: State Autonomous Health Institution of the Tyumen Region "Multidisciplinary Consultative and Diagnostic Center"
city: Belgrade
country: Serbia
facility: Zvezdara University Medical Center
city: Singapore
country: Singapore
facility: Singapore General Hospital
city: Nitra
country: Slovakia
facility: KM Management, s.r.o., Gastroenterologicke a hepatologicke centrum Nitra
city: Cape Town
country: South Africa
facility: Dr MJ Prins
city: Johannesburg
country: South Africa
facility: Peermed Clinical Trial Centre
city: Barcelona
country: Spain
facility: Centro Medico Teknon
city: Madrid
country: Spain
facility: Hospital Clinico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario de Fuenlabrada
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocio
city: Danderyd
country: Sweden
facility: Danderyds Sjukhus AB
city: Malmo
country: Sweden
facility: Skane University Hospital
city: Uppsala
country: Sweden
facility: Akademiska Sjukhuset
city: Bern
country: Switzerland
facility: Gastroenterologische Praxis Balsiger, Seibold und Partner
city: Zürich
country: Switzerland
facility: Universitatsspital Zurich
city: Chang-hua
country: Taiwan
facility: Changhua Christian Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital, Taipei
city: Taoyuan
country: Taiwan
facility: Chang Gung Medical Foundation, Chang Gung Memorial Hospital, Linkou Branch
city: Cherkasy
country: Ukraine
facility: Municipal Institution "Cherkasy Regional Hospital of Cherkasy Regional Council", Gastroenterology Department
city: Chernivtsi
country: Ukraine
facility: Municipal City Clinical Hospital of the Emergency Medical Care, 1 st Therapy Department. Danylo Halytsky Lviv National Medical
city: Chernivtsi
country: Ukraine
facility: Regional Municipal Institution "Chernivtsi Regional Clinical Hospital", Surgical Department
city: Dnipropetrovsk
country: Ukraine
facility: State Institution "Institute of Gastroenterology of National Academy of Medical Sciences of Ukraine"
city: Ivano-Frankivs'k
country: Ukraine
facility: Ivanto-Frankivsk Central City Clinic Hospital, Therapy Department #1. State Higher Education Institution Ivano-Frankivsk National
city: Kharkiv
country: Ukraine
facility: Municipal Health Care Institution "Kharkiv City Clinical Hospital #2 named after prof. O. O. Shalimov", Proctology Department
city: Kharkiv
country: Ukraine
facility: L.T. Mala State Institution "National Institute of Therapy of National Academy of Medical Sciences of Ukraine"
city: Kharkiv
country: Ukraine
facility: Municipal Institution of Health Care "Regional Hospital of War Veterans", Therapeutic Department No1
city: Kropyvnytskyi
country: Ukraine
facility: Treatment and Diagnostic Center of Private Enterprise of Private Production Company "Acinus"
city: Kyiv
country: Ukraine
facility: Kyiv City Clinical Hospital No. 18, Proctology Department
city: Kyiv
country: Ukraine
facility: Municipal Non-profit Enterprise "Consultative and Diagnostic Center" of Pechersk District of Kyiv, Therapy Department
city: Odessa
country: Ukraine
facility: Odesa Clinical Railway Hospital Branch of "Healthcare Center" of Public joint stock company "Ukrainian Railway"
city: Odessa
country: Ukraine
facility: Municipal Institution "Odesa Regional Clinical Hospital", Regional Gastroenterology Center based on Surgery Department
city: Ternopil
country: Ukraine
facility: Ternopil University Hospital, Regional Center of Gastroenterology with Hepatology
city: Vinnytsia
country: Ukraine
facility: Medical Center LLC "Health Clinic"
city: Vinnytsya
country: Ukraine
facility: Vinnytsia Regional Clinical Hospital of War Veterans, Therapy Department #1
city: Vinnytsya
country: Ukraine
facility: M.I. Pyrogov Vinnytsia Regional Clinical Hospital, Gastroenterology Department
city: Zaporizhzhya
country: Ukraine
facility: Municipal Institution "Zaporizhzhya Regional Clinical Hospital" of Zaporizhzhya Regional Council
city: Bury
country: United Kingdom
facility: The Pennine Acute Hospitals NHS Trust
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospital NHS Foundation Trust
city: Derby
country: United Kingdom
facility: Royal Derby Hospital
city: Edinburgh
country: United Kingdom
facility: NHS Lothian
city: Glasgow
country: United Kingdom
facility: Glasgow Clinical Research Facility - Queen Elizabeth University Hospital
city: Glasgow
country: United Kingdom
facility: NHS Greater Glasgow and Clyde
city: High Wycombe
country: United Kingdom
facility: Wycombe Hospital
city: London
country: United Kingdom
facility: Imperial College Healthcare NHS Trust, St Mary's Hospital
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich University Hospital NHS Foundation Trust
city: Nottingham
country: United Kingdom
facility: Biomedical Research Unit
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Foundation Trust
city: Prescot
country: United Kingdom
facility: St Helens and Knowsley Teaching Hospitals NHS Trust
city: Southampton
country: United Kingdom
facility: Southampton National Institute for Health Research, Wellcome Trust Clinical Research Facility
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References:
citation: Feagan BG, Danese S, Loftus EV Jr, Vermeire S, Schreiber S, Ritter T, Fogel R, Mehta R, Nijhawan S, Kempinski R, Filip R, Hospodarskyy I, Seidler U, Seibold F, Beales ILP, Kim HJ, McNally J, Yun C, Zhao S, Liu X, Hsueh CH, Tasset C, Besuyen R, Watanabe M, Sandborn WJ, Rogler G, Hibi T, Peyrin-Biroulet L. Filgotinib as induction and maintenance therapy for ulcerative colitis (SELECTION): a phase 2b/3 double-blind, randomised, placebo-controlled trial. Lancet. 2021 Jun 19;397(10292):2372-2384. doi: 10.1016/S0140-6736(21)00666-8. Epub 2021 Jun 3.