AzTrials
AzTrials

Ulcerative ColitisPhase 3SELECTIONNCT02914522

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

A Phase 3 study testing Filgotinib and PTM filgotinib in people with Ulcerative Colitis, run by Gilead Sciences at 343 sites in 40 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Ulcerative Colitis
What is being tested?
Filgotinib and PTM filgotinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,351 participants
Where
343 sitesin 40 countries
Study dates
14 Nov 2016to 31 Mar 2020
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

343 sites in 40 countries.

343 sites in 40 countries

United States61 sites

  • Investigative Clinical Research

    Annapolis, Maryland, 21401

  • Massachusetts General Hospital - Crohn's and Colitis Center

    Boston, Massachusetts, 02114

  • HP Clinical Research

    Bountiful, Utah, 84010

  • NY Scientific

    Brooklyn, New York, 11235

  • University of Virginia Health System

    Charlottesville, Virginia, 22908

  • WR-ClinSearch, LLC

    Chattanooga, Tennessee, 37421

  • Gastroenterology Associates Of Tidewater

    Chesapeake, Virginia, 23320

  • Clinical Research Institute of Michigan, LLC

    Chesterfield, Michigan, 48047

  • MGG Group Co., Inc., Chevy Chase Clinical Research

    Chevy Chase, Maryland, 20815

  • Consultants for Clinical Research

    Cincinnati, Ohio, 45219

  • UC Health Physicians Clifton

    Cincinnati, Ohio, 45219

  • Gastro Center of Maryland

    Columbia, Maryland, 21045

  • Digestive Health Specialists of the Southeast

    Dothan, Alabama, 36305

  • Fargo Gastroenterology and Hepatology Clinic

    Fargo, North Dakota, 58103

  • Connecticut GI PC-Research Division

    Farmington, Connecticut, 06032

  • San Antonio Military Medical Center

    Fort Sam Houston, Texas, 78219

  • UF Health at Shands Hospital

    Gainesville, Florida, 32610

  • DHAT Research Institute

    Garland, Texas, 75044

  • Gastro One

    Germantown, Tennessee, 38138

  • NYU Langone Long Island Clinical Research Associates

    Great Neck, New York, 11021

  • Meritus Center for Clinical Research

    Hagerstown, Maryland, 21742

  • Baylor College of Medicine- Baylor Medical Center

    Houston, Texas, 77030

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77030

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • Kansas City Research Institute

    Kansas City, Missouri, 64131

  • Florida Research Institute

    Lakewood Rch, Florida, 34211

  • Emeritas Research Group LLC

    Lansdowne Town Center, Virginia, 20176

  • South Denver Gastroenterology, PC

    Lone Tree, Colorado, 80124

  • VA Long Beach Healthcare System

    Long Beach, California, 90822

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048

  • University of Louisville, Clinical Trials Unit

    Louisville, Kentucky, 40202

  • Gastroenterology Associates of Central Georgia, LLC

    Macon, Georgia, 31201

  • University of Wisconsin Hospital & Clinics

    Madison, Wisconsin, 53705

  • Gastrointestinal Specialists of Georgia

    Marietta, Georgia, 30060

  • Great Lakes Gastroenterology Research, LLC

    Mentor, Ohio, 44060

  • University of Miami Crohn's and Colitis Center

    Miami, Florida, 33136

  • Cordova Research Institute

    Miami, Florida, 33155

  • Delta Research Partners, LLC

    Monroe, Louisiana, 71201

  • Gastroenterology Group of Naples

    Naples, Florida, 34102

  • Quality Medical Research

    Nashville, Tennessee, 37211

  • Vanderbilt University Medical Center - IBD Clinic

    Nashville, Tennessee, 37212-1375

  • Gastroenterology Associates of Orangeburg

    Orangeburg, South Carolina, 29118

  • Advanced Medical Research Center

    Port Orange, Florida, 32127

  • Carolina's GI Research, LLC

    Raleigh, North Carolina, 27607

  • Rapid City Medical Center

    Rapid City, South Dakota, 57701

  • McGuire DVAMC

    Richmond, Virginia, 23249

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • Clinical Associates in Research Therapeutics of America, LLC

    San Antonio, Texas, 78212

  • Gastroenterology Research of San Antonio

    San Antonio, Texas, 78229

  • Texas Digestive Disease Consultants

    San Marcos, Texas, 78666

  • Mayo Clinic Arizona

    Scottsdale, Arizona, 85259

  • Louisiana Research Center, LLC

    Shreveport, Louisiana, 71105

  • Texas Digestive Disease Consultants

    Southlake, Texas, 76092

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Atlanta Gastroenterology Specialist, PC

    Suwanee, Georgia, 30024

  • Tampa General Hospital

    Tampa, Florida, 33606

  • Spring Gastroenterology

    The Woodlands, Texas, 77380

  • Center for Digestive Health

    Troy, Michigan, 48098

  • Allegiance Research Specialists, LLC

    Wauwatosa, Wisconsin, 53225

  • Shafran Gastroenterology Center

    Winter Park, Florida, 32789

  • Florida Medical Clinic, P.A.

    Zephyrhills, Florida, 33540

Other trials in United States

Japan44 sites

  • Medical Hospital, Tokyo Medical and Dental University

    Bunkyō City, 113-8519

  • Fukuoka University Chikushi Hospital

    Chikushino-shi, 818-8502

  • Hokkaido P.W.F.A.C Sapporo-Kosei General Hospital

    Chūōku, 060-0033

  • Japanese Red Cross Fukuoka Hospital

    Fukuoka, 815-8555

  • Tokai University Hachioji Hospital

    Hachioji-shi, 192-0032

  • Hiroshima University Hospital

    Hiroshima, 734-8551

  • Fukuoka University Hospital

    Jonan-ku, 814-0180

  • Ofuna Chuo Hospital

    Kamakura, 247-0056

  • Kitakyushu City Hospital Organization Kitakyushu Municipal Medical Center

    Kitakyushu-shi, 802-0077

  • Yamanashi Prefectural Central Hospital

    Kofu, 400-8506

  • Kurume University Hospital

    Kurume-shi, 830-0011

  • Hidaka Coloproctology Clinic

    Kurume-shi, 839-0809

  • University Hospital, Kyoto Prefectural University of Medicine

    Kyoto, 602-8566

  • The Jikei University Hospital

    Minatoku, 105-8471

  • Kitasato University Kitasato Institute Hospital

    Minatoku, 108-8642

  • Kyorin University Hospital

    Mitaka-shi, 181-8611

  • Iwate Medical University Hospital

    Morioka, 020-8505

  • Aichi Medical University Hospital

    Nagakute-shi, 480-1195

  • Nagasaki University Hospital

    Nagasaki, 852-8501

  • Saiseikai Niigata Daini Hospital

    Nishiku, 950-1104

  • Hyogo College of Medicine College Hospital

    Nishinomiya, 663-8501

  • Ishida IBD Clinic

    Ōita, 870-0823

  • Okayama University Hospital

    Okayama, 700-8558

  • Wakakusa-Daiichi Hospital

    Osaka, 579-8056

  • Kinshukai Infusion Clinic

    Ōsaka, 530-0011

  • Osaka City University Hospital

    Ōsaka, 545-8586

  • Shiga University of Medical Science Hospital

    Ōtsu, 520-2912

  • Saga-Ken Medical Centre Koseikan

    Saga, 840-8571

  • Saga University Hospital

    Saga, 849-8501

  • Kitasato University Hospital, THE KITASATO INSTITUTE

    Sagamihara, 252-0375

  • Tokito Clinic

    Saitama, 336-0963

  • Toho University Sakura Medical Center

    Sakura, 285-8741

  • Sapporo Tokushukai Hospital

    Sapporo, 004-0041

  • Sapporo Higashi Tokushukai Hospital

    Sapporo, 065-0033

  • National Hospital Organization Sendai Medical Center

    Sendai, 983-8520

  • Tokyo Yamate Medical Center

    Shinjuku-ku, 169-0073

  • Osaka University Hospital

    Suita, 565-0871

  • Kagawa Prefectural Central Hospital

    Takamatsu, 760-8557

  • National Hospital Organization Takasaki General Medical Center

    Takasaki-shi, 3700829

  • Osaka Medical College Hospital

    Takatsuki, 569-8686

  • Ieda Hospital

    Toyota-shi, 470-1219

  • Wakayama Medical University Hospital

    Wakayama, 641-8509

  • Colo-proctology Center Matsushima Clinic

    Yokohama, 220-0045

  • Yokohama Health Medicine Association Kannai Suzuki Clinic

    Yokohama, 231-0012

Other trials in Japan

India24 sites

  • Kaizen Hospital

    Ahmedabad, 380052

  • M S Ramaiah Medical College and Hospital

    Bangalore, 560054

  • Apollo Speciality Hospital

    Chennai, 600035

  • VGM Hospital Institute of Gastroenterology

    Coimbatore, 641005

  • Gleneagles Global Hospitals

    Hyderabad, 500004

  • Citizens Specialty Hospital

    Hyderabad, 500019

  • Centre for Liver Research & Diagnostics

    Hyderabad, 500058

  • S.R.KallaMemorial Gastro.&General Hospital,

    Jaipur, 302001

  • S.M.S Medical College & Hospitals

    Jaipur, 302004

  • School of Digestive & Liver Diseases

    Kolkata, 700020

  • Dayanand Medical College & Hospital

    Ludhiana, 141001

  • Kasturba Medical College (KMC) Hospital

    Mangaluru, 575001

  • Lokmanya Tilak Municipal General Hospital

    Mumbai, 400022

  • Midas Multispeciality Hospital Pvt. Ltd

    Nagpur, 400010

  • Suretech Hospital & Research Centre Ltd

    Nagpur, 440012

  • All India Institute of Medical Sciences

    New Delhi, 110029

  • Grant Medical Foundation Ruby Hall Clinic

    Pune, 411001

  • Shree Giriraj Multispeciality Hospital

    Rajkot, 360005

  • Gandhi Hospital

    Secunderabad, 500003

  • Institute of Gastroenterology & Liver Disease, Sunshine Hospitals

    Secunderabad, 500003

  • Surat Institute of Digestive Sciences

    Surat, 395002

  • Kasturba Hospital Medical College

    Udupi, 576104

  • Sterling Hospital

    Vadodara, 390007

  • Samvedana Hospital

    Varanasi, 221005

Other trials in India

Poland21 sites

  • Uniwersytecki Szpital Kliniczny w Bialymstoku, Klinika Gastroenterologii i Chorob Wewnetrznych

    Bialystok, 15-276

  • VITAMED Galaj i Cichomski spolka jawna

    Bydgoszcz, 85-079

  • Gabinet Lekarski Janusz Rudzinski

    Bydgoszcz, 85-681

  • NZOZ INTER-MED, Centrum Endoskopowe

    Częstochowa, 42-217

  • Niepubliczny Zaklad Opieki Zdrowotnej ALL-MEDICUS

    Katowice, 40-659

  • Gabinet Endoskopii Przewodu Pokarmowego

    Krakow, 31-009

  • Krakowskie Centrum Medyczne Sp. z o.o

    Krakow, 31-501

  • Centrum Opieki Zdrowotnej Orkan-Med Stec-Michalska Sp.J.

    Ksawerów, 95-054

  • Santa Familia, Centrum Badan, Profilaktyki i Leczenia

    Lodz, 90-302

  • Centrum Innowacyjnych Terapii Sp. z o.o.

    Piaseczno, 05-500

  • Clinical Research Center Spolka z organiczna odpowiedzialnoscia Medic-R Sp. k.

    Poznan, 60-848

  • Gabinet Lekarski Dr. Hab. N. Med. Bartosz Korczowski

    Rzeszów, 35-301

  • Endoskopia Sp. z o.o.

    Sopot, 81-756

  • Twoja Przychodnia-Szczecinskie Centrum Medyczne

    Szczecin, 71-434

  • GASTROMED Kopon, Zmudzkinski i Wspolnicy Sp. j. Specjalistyczne Centrum Gastrologii i Endoskopii

    Torun, 87-100

  • H-T.Centrum Medyczne Spolka z Ograniczona Odpowiedzialnoscia Sp.K.

    Tychy, 43-100

  • Centrum Zdrowia MDM

    Warsaw, 0-635

  • Bodyclinic

    Warsaw, 00-332

  • Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administacji w Warszawie

    Warsaw, 02-507

  • Niepubliczny Zaklad Opieki Zrodotnej VIVAMED Jadwige Miecz

    Warsaw, 03-580

  • Centrum Medyczne Oporow

    Wroclaw, 52-416

Other trials in Poland

France19 sites

  • CHU Amiens Picardie

    Amiens, 80054

  • CHU de Caen

    Caen, 14033

  • CHU de Clermont-Ferrand - Hopital d'Estaing

    Clermont-Ferrand, 63003

  • APHP - Hopital Beaujon - Clichy - Universite Paris VII

    Clichy, 92110

  • CHU de Dijon Bourgogne - Hopital Francois Mitterand

    Dijon, 21079

  • CHU Grenoble Alpes

    La Tronche, 38700

  • Hopital Universitaire de Bicetre

    Le Kremlin-Bicêtre, 94270

  • Centre Hospitalier Regional Universitaire de Lille

    Lille, 59000

  • Hopital Nord

    Marseille, 13015

  • CHU de Montpellier-Hopital Saint Eloi

    Montpellier, 34295

  • CHU Hotel-Dieu

    Nantes, 44093

  • Hopital de l'Archet 2

    Nice, 06202

  • Institut Mutualiste Montsouris

    Paris, 75014

  • CHU de Bordeaux - Hopital Haut Leveque

    Pessac, 33600

  • Centre Hospitalier Universitaire de Lyon Sud

    Pierre-Bénite, 69495

  • Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou

    Rennes, 35033

  • CHU de Saint-Etienne - Hopital Nord

    Saint-Priest-en-Jarez, 42055

  • CHU de Toulouse - Hopital Rangueil

    Toulouse, 31059

  • CHU de Nancy - Hopital Brabois Adultes

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Germany18 sites

  • Charite Universitatsmedizin Berlin

    Berlin, 10117

  • Charite - Universitatsmedizin Berlin

    Berlin, 13353

  • DRK Kliniken Berlin - Westend - Klinik fuer Innere Medizin

    Berlin, 14050

  • Stadtisches Klinikum Braunschweig gGmbH

    Braunschweig, 38126

  • Universitaetsklinik Koln

    Cologne, 50937

  • Agaplesion Markus Krankenhaus

    Frankfurt am Main, 60431

  • Universitatsklinikum Freiburg

    Freiburg im Breisgau, 79106

  • Asklepios Westklinikum Hamburg

    Hamburg, 22559

  • Medizinische Hochschule Hannover

    Hannover, 30625

  • Gastroenterologische Gemeinschaftspraxis Herne

    Herne, 44623

  • Universitatsklinikum Jena

    Jena, 07747

  • Universitatsklinikum Schleswig-Holstein

    Kiel, 24105

  • EUGASTRO GmbH

    Leipzig, 04103

  • Klinikum Luneburg

    Lüneburg, 21339

  • Gastroenterologische Gemeinschaftspraxis Minden

    Minden, 32423

  • Klinikum der Universitat Munchen - Grosshadern

    München, 81377

  • Universitaetsklinikum Tuebingen

    Tübingen, 72074

  • Universitatsklinikum Ulm, Zentrum Fur Innere Medizin

    Ulm, 89081

Other trials in Germany

Ukraine18 sites

  • Municipal Institution "Cherkasy Regional Hospital of Cherkasy Regional Council", Gastroenterology Department

    Cherkasy, 18000

  • Municipal City Clinical Hospital of the Emergency Medical Care, 1 st Therapy Department. Danylo Halytsky Lviv National Medical

    Chernivtsi, 58000

  • Regional Municipal Institution "Chernivtsi Regional Clinical Hospital", Surgical Department

    Chernivtsi, 58000

  • State Institution "Institute of Gastroenterology of National Academy of Medical Sciences of Ukraine"

    Dnipropetrovsk, 49000

  • Ivanto-Frankivsk Central City Clinic Hospital, Therapy Department #1. State Higher Education Institution Ivano-Frankivsk National

    Ivano-Frankivsk, 76000-490

  • Municipal Health Care Institution "Kharkiv City Clinical Hospital #2 named after prof. O. O. Shalimov", Proctology Department

    Kharkiv, 61037

  • L.T. Mala State Institution "National Institute of Therapy of National Academy of Medical Sciences of Ukraine"

    Kharkiv, 61039

  • Municipal Institution of Health Care "Regional Hospital of War Veterans", Therapeutic Department No1

    Kharkiv, 63101

  • Treatment and Diagnostic Center of Private Enterprise of Private Production Company "Acinus"

    Kropyvnytskyi, 25006

  • Kyiv City Clinical Hospital No. 18, Proctology Department

    Kyiv, 01030

  • Municipal Non-profit Enterprise "Consultative and Diagnostic Center" of Pechersk District of Kyiv, Therapy Department

    Kyiv, 1103

  • Odesa Clinical Railway Hospital Branch of "Healthcare Center" of Public joint stock company "Ukrainian Railway"

    Odesa, 65010

  • Municipal Institution "Odesa Regional Clinical Hospital", Regional Gastroenterology Center based on Surgery Department

    Odesa, 65025

  • Ternopil University Hospital, Regional Center of Gastroenterology with Hepatology

    Ternopil, 46002

  • Vinnytsia Regional Clinical Hospital of War Veterans, Therapy Department #1

    Vinnytsia, 21005

  • M.I. Pyrogov Vinnytsia Regional Clinical Hospital, Gastroenterology Department

    Vinnytsia, 21018

  • Medical Center LLC "Health Clinic"

    Vinnytsia, 21029

  • Municipal Institution "Zaporizhzhya Regional Clinical Hospital" of Zaporizhzhya Regional Council

    Zaporizhzhya, 69600

Other trials in Ukraine

Russia15 sites

  • State Budgetary Healthcare Institution "Chelyabinski Regional Clinical Hospital"

    Chelyabinsk, 454076

  • State Budgetary Institution of Health Irkustsk Order "Badge of Honor" Regional Clinical Hospital

    Irkutsk, 669079

  • Federal State Budgetary Institution of Science Federal Research Center of Nutrition, Biotechnology and Food Safety

    Moscow, 115446

  • State Budgetary Healthcare Institution of Moscow "City Clinical Hospital # 24 of Healthcare Department of Moscow"

    Moscow, 127015

  • State Budgetary Healthcare Institution of Moscow Region "Moscow Regional Clinical Research Institute n.a. M.F. Vladimirskiy"

    Moscow, 129110

  • State Budgetary Healthcare Institution of Nizhny Novgorod Region "Nizhny Novgorod Regional Clinical Hospital n.a. N.A.

    Nizhny Novgorod, 603126

  • State Budgetary Institution of Health of Novosibirsk Region "City Clinical Hospital #12"

    Novosibirsk, 630084

  • State Budgetary Healthcare Institution of the Novosibirsk Region "State Novosibirsk Regional Clinical Hospital"

    Novosibirsk, 630087

  • Saint Petersburg State Budgetary Healthcare Institution "City Polyclinic #38"

    Saint Petersburg, 191015

  • "Riat" LLC

    Saint Petersburg, 193163

  • "Scientific Research Centre ECO-safety" LLC

    Saint Petersburg, 196143

  • "PolyClinic EXPERT" LLC

    Saint Petersburg, 197110

  • State Healthcare Institution "Regional Clinical Hospital"

    Saratov, 410053

  • Treatment and Prevention Interdistrict Institution "Smolenskie kliniki" LLC

    Smolensk, 214019

  • State Autonomous Health Institution of the Tyumen Region "Multidisciplinary Consultative and Diagnostic Center"

    Tyumen, 625026

Other trials in Russia

United Kingdom13 sites

  • The Pennine Acute Hospitals NHS Trust

    Bury, BL9 7TD

  • Cambridge University Hospital NHS Foundation Trust

    Cambridge, CB2 0QQ

  • Royal Derby Hospital

    Derby, DE22 3NE

  • NHS Lothian

    Edinburgh, EH4 2XU

  • Glasgow Clinical Research Facility - Queen Elizabeth University Hospital

    Glasgow, G51 4TF

  • NHS Greater Glasgow and Clyde

    Glasgow, G52 3NQ

  • Wycombe Hospital

    High Wycombe, HP11 2TT

  • Imperial College Healthcare NHS Trust, St Mary's Hospital

    London, W2 1NY

  • Norfolk and Norwich University Hospital NHS Foundation Trust

    Norwich, NR4 7UY

  • Biomedical Research Unit

    Nottingham, NG7 2UH

  • Oxford University Hospitals NHS Foundation Trust

    Oxford, OX3 9DU

  • St Helens and Knowsley Teaching Hospitals NHS Trust

    Prescot, L35 5DR

  • Southampton National Institute for Health Research, Wellcome Trust Clinical Research Facility

    Southampton, SO16 6YD

Other trials in United Kingdom

Australia11 sites

  • Monash Medical Centre

    Clayton, Victoria, 3168

  • St. Vincent's Hospital Sydney

    Darlinghurst, New South Wales, 2010

  • Footscray Hospital

    Footscray, Victoria, 3011

  • Austin Health

    Heidelberg, Victoria, 3084

  • Nepean Hospital

    Kingswood, New South Wales, 2747

  • Cabrini Hospital

    Malvern, Victoria, 3144

  • Alfred Hospital

    Melbourne, Victoria, 3004

  • Coastal Digestive Health

    Mountain Creek, Queensland, 4557

  • Mater Misericordiae Ltd

    South Brisbane, Queensland, 4101

  • The Queen Elizabeth Hospital

    Woodville South, South Australia, 5011

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

South Korea9 sites

  • Pusan National University Hospital

    Busan, 609801

  • Yeungnam University Hospital

    Daegu, 42415

  • Kangbuk Samsung Hospital

    Seoul, 03181

  • Yonsei University Health System, Severance Hospital

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

  • Division of Gastroenterology, Department of Medicine, Samsung Medical Center

    Seoul, 06351

  • Hyung Hee University Hospital

    Seoul, 130-872

  • The Catholic University of Korea, St. Vincent's Hospital

    Suwon, Gyeonggi-do, 16247

  • Yonsei University Wonju Severance Christian Hospital

    Wŏnju, 220-701

Other trials in South Korea

Italy8 sites

  • UOC Gastroenterologia II

    Castellana Grotte, Bari 70013

  • U.O. Fisiopatologia Digestiva

    Catanzaro, 88100

  • Ospedale Clinicizzato SS. Annunziata - Dipartimento di Medicina

    Chieti, 66100

  • Endocsopia Digestiva Centralizzata - ASST Fatebenefratelli Sacco, Ospedale Fatebenefratelli e Oftalmico

    Milan, 20121

  • UOC Gastroenterologia

    Padova, 35128

  • Azienda Ospedaliero-Universitaria Pisana - Presidio Ospedaliero Cisanello

    Pisa, 56124

  • UOC Gastroenterologia ed Endoscopia Digestiva

    Roma, 128

  • Istituto Clinico Humanitas

    Rozzano, 20089

Other trials in Italy

Hungary6 sites

  • Bekes Megyei Kosponti Korhaz, Dr. Rethy Pal Tagkorhaz, IV. Belgyogyaszat - 2. Gasztroenterologia

    Békéscsaba, 5600

  • Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet, Kozponti Felnott Szakrendelo

    Budapest, 1097

  • Szent Janos Korhaz es Eszak-budai Egitett Korhazak, I. Belgyogyaszati - Gasztroenterologiai Osztaly

    Budapest, 1125

  • Debreceni Egyetem Klinikai Kozpont, II. sz. Belgyogyaszati Klinika, Gasztroenterologia

    Debrecen, 4032

  • Bugat Pal Korhaz, Belgyogyaszat

    Gyöngyös, 3200

  • Karolina Korhaz es Rendelointezet, Altalanos Belgyogyaszat-Gasztroenterologia

    Mosonmagyaróvár, 9200

Other trials in Hungary

Israel6 sites

  • Soroka Medical Center

    Beersheba, 8410101

  • Bnai Zion Medical Center

    Haifa, 31048

  • Rambam Health Care Campus

    Haifa, 3109601

  • Shaare Zedek Medical Center

    Jerusalem, 9103102

  • Hadassah Medical Center

    Jerusalem, 91120

  • Rabin Medical Center

    Petah Tikva, 4941492

Other trials in Israel

Canada5 sites

  • University of Calgary, Heritage Medical Research Clinic

    Calgary, Alberta, T2N 4Z6

  • Hamilton Health Sciences Corporation, McMaster University Medical Centre

    Hamilton, Ontario, L8S 4K1

  • Royal University Hospital

    Saskatoon, Saskatchewan, S7N 0W8

  • The Gordon and Leslie Diamond Health Care Centre

    Vancouver, British Columbia, V5Z 1M9

  • Toronto Digestive Disease Associates Inc.

    Vaughan, L4L 4Y7

Other trials in Canada

New Zealand5 sites

  • Christchurch Hospital

    Christchurch, 8011

  • Auckland City Hospital

    Grafton, 1023

  • Waikato Hospital

    Hamilton, 3240

  • Wellington Hospital

    Newtown, WE 6021

  • Bay of Plenty District Health Board - Tauranga Hospital

    Tauranga, 3134

Other trials in New Zealand

Spain5 sites

  • Centro Medico Teknon

    Barcelona, 08022

  • Hospital Clinico San Carlos

    Madrid, 28040

  • Hospital Universitario de Fuenlabrada

    Madrid, 28942

  • Hospital Universitario Central de Asturias

    Oviedo, 33006

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

Other trials in Spain

Belgium4 sites

  • GZA Ziekenhuizen campus Sint-Vincentius

    Antwerp, 2018

  • CUB Hopital Erasme

    Brussels, 1070

  • Universitair Ziekenhuis Leuven

    Leuven, B-3000

  • Centre Hospitalier Chretien (CHC) - Clinique Saint-Joseph

    Liège, 4000

Other trials in Belgium

Czechia4 sites

  • Hepato-Gastroenterologie HK, s.r.o.

    Hradec Králové, 500 12

  • Oblastni nemocnice Mlada Boleslav, a.s., nemocnice Stredoceskeho kraje, Gastroenterologicke oddeleni

    Mladá Boleslav, 293 01

  • G.E.P. Clinic, s r.o.

    Prague, 130 00

  • ISCARE a.s. (Klinicke centrum ISCARE), Klinicke a vyzkumne centrum pro strevni zanety

    Prague, 190 00

Other trials in Czechia

Romania4 sites

  • SC MedLife SA, Gastroenterologie

    Bucharest, 010719

  • Spitalul Clinic Colentina - Sectia de Spitulal Clinic Colentina, Gastroenterologie

    Bucharest, 020125

  • Cabinet Medical Individual Dr Tirnaveanue Amelita, Gastroenterologie

    Oradea, 410066

  • Cabinet Particular Policlinic Algomed SRL

    Timișoara, 300002

Other trials in Romania

Taiwan4 sites

  • Changhua Christian Hospital

    Chang-hua, 500

  • National Taiwan University Hospital

    Taipei, 100

  • Mackay Memorial Hospital, Taipei

    Taipei, 10449

  • Chang Gung Medical Foundation, Chang Gung Memorial Hospital, Linkou Branch

    Taoyuan, 33305

Other trials in Taiwan

Bulgaria3 sites

  • MHAT Sveti Pantaleymon - Pleven OOD

    Pleven, 5800

  • "MDHAT Dr. St.Cherkezov" AD

    Veliko Tarnovo, 5000

  • MHAT "Sveta Petka" AD

    Vidin, 3700

Other trials in Bulgaria

Georgia3 sites

  • Unimed Ajara LLC - Batumi Referral Hospital

    Batumi, 6010

  • Medi Club Georgia LLC

    Tbilisi, 0160

  • Ltd. Unimed Kakheti - Telavi Referral Hospital

    Telavi, 2200

Other trials in Georgia

Hong Kong3 sites

  • Princess Margaret Hospital

    Hong Kong

  • Queen Mary Hospital

    Hong Kong

  • Department of Medicine & Therapeutics, The Chinese University of Hong Kong, Prince of Wales Hospital

    Shatin

Other trials in Hong Kong

Malaysia3 sites

  • University Kebangsaan Malaysia Medical Centre

    Cheras, 56000

  • Hospital Pulau Pinang

    George Town, 10990

  • Hospital Queen Elizabeth

    Kota Kinabalu, 88586

Other trials in Malaysia

Netherlands3 sites

  • Academic Medical Center (AMC)

    Amsterdam, 1100

  • Gelre Hospital

    Apeldoorn, 7334

  • University Medical Center Utrecht

    Utrecht, 3584 CX

Other trials in Netherlands

Sweden3 sites

  • Danderyds Sjukhus AB

    Danderyd, SE-18288

  • Skane University Hospital

    Malmö, SE-205-02

  • Akademiska Sjukhuset

    Uppsala, 75185

Other trials in Sweden

Argentina2 sites

  • Instituto de Investigaciones Clinicas Mar del Plata

    Mar del Plata, B7600FZN

  • Instituto Médico Cer

    Quilmes, B1878

Other trials in Argentina

Austria2 sites

  • Universitatsklinik Innsbruck

    Innsbruck, 6020

  • AKH-Medizinische Universitat Wien

    Vienna, 1090

Other trials in Austria

Croatia2 sites

  • Clinical Hospital Dubrava

    Zagreb, 10000

  • University Hospital Center Zagreb

    Zagreb, 10000

Other trials in Croatia

Greece2 sites

  • General Hospital of Athens "Hippokratio", 2nd Internal Medicine Clinic of Athens University, Hepato-gastroenterology Unit

    Athens, 11527

  • General Hospital of Nikaias "Agios Pentelleimon", Gastroenterology Department

    Athens, 18454

Other trials in Greece

Norway2 sites

  • Vestre Viken Hospital Trust, Baerum Hospital

    Drammen, 1346

  • Akerskus University Hospital

    Lørenskog, N-1478

Other trials in Norway

Portugal2 sites

  • Hospital da Senhora da Oliveira Guimaraes, E.P.E.

    Guimarães, 4835-044

  • Centro Hospitalar de Sao Joao, EPE

    Porto, 4200-319

Other trials in Portugal

South Africa2 sites

  • Dr MJ Prins

    Cape Town, 7500

  • Peermed Clinical Trial Centre

    Johannesburg, 1619

Other trials in South Africa

Switzerland2 sites

  • Gastroenterologische Praxis Balsiger, Seibold und Partner

    Bern, 3012

  • Universitatsspital Zurich

    Zurich, 8091

Other trials in Switzerland

Ireland1 site

  • Beaumont Hospital

    Dublin, 9

Other trials in Ireland

Mexico1 site

  • PCR-Phylasis Clinicas Research S. de R.L. de C.V.

    Cuautitlán Izcalli, 54750

Other trials in Mexico

Serbia1 site

  • Zvezdara University Medical Center

    Belgrade, 3810-971

Other trials in Serbia

Singapore1 site

  • Singapore General Hospital

    Singapore, 169608

Other trials in Singapore

Slovakia1 site

  • KM Management, s.r.o., Gastroenterologicke a hepatologicke centrum Nitra

    Nitra, 950 01

Other trials in Slovakia

About this study

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

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).

Being tested
Filgotinib, PTM filgotinib
Medical subject headings
Colitis, Ulcerative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • FilgotinibDrug

    Also called GS-6034, GLPG0634

    Tablet(s) administered orally once daily

  • PTM filgotinibDrug

    Tablet(s) administered orally once daily

Study groups in NCT02914522
Study groupRoleWhat they receive
Induction Study (Cohort A): Filgotinib 200 mgExperimentalParticipants in Cohort A (biologic-naive) received filgotinib 200 milligrams (mg) and placebo-to-match (PTM) filgotinib 100 mg orally once daily for 10 weeks.
Receives: Drug: Filgotinib; Drug: PTM filgotinib
Induction Study (Cohort A): Filgotinib 100 mgExperimentalParticipants in Cohort A (biologic-naive) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.
Receives: Drug: Filgotinib; Drug: PTM filgotinib
Induction Study (Cohort A): PlaceboPlacebo comparatorParticipants in Cohort A (biologic-naive) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
Receives: Drug: PTM filgotinib
Induction Study (Cohort B): Filgotinib 200 mgExperimentalParticipants in Cohort B (biologic-experienced) received filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
Receives: Drug: Filgotinib; Drug: PTM filgotinib
Induction Study (Cohort B): Filgotinib 100 mgExperimentalParticipants in Cohort B (biologic-experienced) received filgotinib 100 mg and PTM filgotinib 200 mg orally once daily for 10 weeks.
Receives: Drug: Filgotinib; Drug: PTM filgotinib
Induction Study (Cohort B): PlaceboPlacebo comparatorParticipants in Cohort B (biologic-experienced) received PTM filgotinib 200 mg and PTM filgotinib 100 mg orally once daily for 10 weeks.
Receives: Drug: PTM filgotinib
Maintenance Study: Filgotinib 200 mg From Induction Filgotinib 200 mgExperimentalParticipants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either Endoscopy/Bleeding/Stool Frequency (EBS) remission or Mayo Clinic Score (MCS) response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 200 mg and PTM filgotinib 100 mg for an additional 47 weeks (up to Week 58).
Receives: Drug: Filgotinib; Drug: PTM filgotinib
Maintenance Study: Placebo From Induction Filgotinib 200 mgPlacebo comparatorParticipants in the Filgotinib 200 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58).
Receives: Drug: PTM filgotinib
Maintenance Study: Filgotinib 100 mg From Induction Filgotinib 100 mgExperimentalParticipants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive filgotinib 100 mg and PTM filgotinib 200 mg for an additional 47 weeks (up to Week 58).
Receives: Drug: Filgotinib; Drug: PTM filgotinib
Maintenance Study: Placebo From Induction Filgotinib 100 mgPlacebo comparatorParticipants in the Filgotinib 100 mg arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were rerandomized at Week 11 into the Maintenance Study to receive PTM filgotinib orally once daily for an additional 47 weeks (up to Week 58).
Receives: Drug: PTM filgotinib
Maintenance Study: Placebo From Induction PlaceboPlacebo comparatorParticipants in the Placebo arm who completed the Induction Study and achieved either EBS remission or MCS response at Week 10 were re-randomized at Week 11 into the Maintenance Study to receive PTM filgotinib for an additional 47 weeks (up to Week 58).
Receives: Drug: PTM filgotinib

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Week 10

  2. 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.

    Measured: Week 58

Secondary outcomes (16)

  1. 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.

    Measured: Week 10

  2. 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).

    Measured: Week 10

  3. 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).

    Measured: Week 10

  4. 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.

    Measured: Week 10

  5. Induction Study: Pharmacokinetic (PK) Parameter: Cmax of Filgotinib and Its Metabolite GS-829845

    Cmax is defined as the maximum observed concentration of drug.

    Measured: Predose and at 0.5, 1, 2, 3, 4 and 6 hours postdose at a single visit between Week 2 and Week 10

  6. 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.

    Measured: Predose and at 0.5, 1, 2, 3, 4 and 6 hours postdose at a single visit between Week 2 and Week 10

  7. 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).

    Measured: Predose and at 0.5, 1, 2, 3, 4 and 6 hours postdose at a single visit between Week 2 and Week 10

  8. 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.

    Measured: Predose and at 0.5, 1, 2, 3, 4 and 6 hours postdose at a single visit between Week 2 and Week 10

  9. 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.

    Measured: Predose and at 0.5, 1, 2, 3, 4 and 6 hours postdose at a single visit between Week 2 and Week 10

  10. 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.

    Measured: Week 58

  11. 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.

    Measured: Week 58

  12. 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.

    Measured: Week 58

  13. 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).

    Measured: Week 58

  14. 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).

    Measured: Week 58

  15. 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.

    Measured: Week 58

  16. 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.

    Measured: Week 26 (any Time) and Week 58 (predose)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Sep 2016 (estimated)
  2. Study start14 Nov 2016
  3. Primary completion31 Mar 2020
  4. Study completion31 Mar 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,351 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02914522
Sponsor's protocol ID
GS-US-418-3898
Other IDs
2016-001392-78, 2016
Acronym
SELECTION
Status last verified
Mar 2021
First submitted
22 Sep 2016
Last updated
21 Apr 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • Magro F, Rogler G, Feagan BG, Peyrin-Biroulet L, Oortwijn A, Cougnaud L, Faes M, Bauer Y, Randall M, Rudolph C, Reinisch W. Association between endo-histological outcomes and colonic mucosal transcriptomic profiles in patients with ulcerative colitis receiving filgotinib. J Crohns Colitis. 2026 Feb 5;20(2):jjaf228. doi: 10.1093/ecco-jcc/jjaf228.

    PubMed 41569324

  • Louis E, Schreiber S, Hisamatsu T, Hibi T, Jamoul C, Muller K, Taliadouros V, Oortwijn A, Peyrin-Biroulet L, Feagan BG. Factors associated with response to filgotinib and the prognostic power of faecal calprotectin for ulcerative colitis in the phase 2b/3 SELECTION trial. Dig Liver Dis. 2025 Jul;57(7):1411-1418. doi: 10.1016/j.dld.2025.04.036. Epub 2025 May 15.

    PubMed 40379541

  • Nakase H, Danese S, Reinisch W, Ritter T, Liang Y, Wendt E, Levesque BG, Yoon OK, Tian Y, Zhuo L, Karouzakis E, Bauer Y, Oortwijn A, Kaise T, Malkov VA, Hibi T. Mediators of Filgotinib Treatment Effects in Ulcerative Colitis: Exploring Circulating Biomarkers in the Phase 2b/3 SELECTION Study. Inflamm Bowel Dis. 2025 Apr 10;31(4):1095-1108. doi: 10.1093/ibd/izae278.

    PubMed 39656830

  • Schreiber S, Feagan BG, Louis E, Hisamatsu T, Hibi T, Dron L, Jamoul C, Patel H, Harris K, Taliadouros V, Oortwijn A, Peyrin-Biroulet L. Distinct trajectories of symptomatic response in ulcerative colitis during filgotinib therapy: A post hoc analysis from the SELECTION study. United European Gastroenterol J. 2024 Nov;12(9):1243-1255. doi: 10.1002/ueg2.12686. Epub 2024 Oct 25.

    PubMed 39452892

  • Watanabe K, Peyrin-Biroulet L, Danese S, Fujitani Y, Faes M, Oortwijn A, Lindsay JO, Rogler G, Hibi T. Impact of Concomitant Thiopurine on the Efficacy and Safety of Filgotinib in Patients with Ulcerative Colitis: Post Hoc Analysis of the Phase 2b/3 SELECTION Study. J Crohns Colitis. 2024 Jun 3;18(6):801-811. doi: 10.1093/ecco-jcc/jjad201.

    PubMed 38019901

  • Schreiber S, Rogler G, Watanabe M, Vermeire S, Maaser C, Danese S, Faes M, Van Hoek P, Hsieh J, Moerch U, Zhou Y, de Haas A, Rudolph C, Oortwijn A, Loftus EV Jr. Integrated safety analysis of filgotinib for ulcerative colitis: Results from SELECTION and SELECTIONLTE. Aliment Pharmacol Ther. 2023 Nov;58(9):874-887. doi: 10.1111/apt.17674. Epub 2023 Sep 18.

    PubMed 37718932

  • Vermeire S, Feagan BG, Peyrin-Biroulet L, Oortwijn A, Faes M, de Haas A, Rogler G. Withdrawal and Re-treatment with Filgotinib in Ulcerative Colitis: Post Hoc Analyses of the Phase 2b/3 SELECTION and SELECTIONLTE Studies. J Crohns Colitis. 2024 Jan 27;18(1):54-64. doi: 10.1093/ecco-jcc/jjad123.

    PubMed 37540206

  • Lu X, Zhou ZY, Xin Y, Wang MJ, Gray E, Jairath V, Lindsay JO. Matching-Adjusted Indirect Comparisons of Filgotinib vs Vedolizumab, Tofacitinib, and Ustekinumab for Moderately to Severely Active Ulcerative Colitis. Inflamm Bowel Dis. 2024 Jan 5;30(1):64-77. doi: 10.1093/ibd/izad037.

    PubMed 36946138

  • Dotan I, Feagan BG, Taliadouros V, Oortwijn A, Rudolph C, de Haas A, Santermans E, Hsieh J, Peyrin-Biroulet L, Hibi T. Efficacy of Filgotinib in Patients with Ulcerative Colitis by Line of Therapy in the Phase 2b/3 SELECTION Trial. J Crohns Colitis. 2023 Aug 21;17(8):1207-1216. doi: 10.1093/ecco-jcc/jjad039.

    PubMed 36928705

  • Schreiber S, Feagan BG, Peyrin-Biroulet L, Vermeire S, Faes M, Harris K, Oortwijn A, Daniele P, Patel H, Danese S. Filgotinib Improved Health-Related Quality of Life and Led to Comprehensive Disease Control in Individuals with Ulcerative Colitis: Data from the SELECTION Trial. J Crohns Colitis. 2023 Jun 16;17(6):863-875. doi: 10.1093/ecco-jcc/jjad018.

    PubMed 36756874

  • Loftus EV, Vermeire S, Feagan BG, Le Brun FO, Oortwijn A, Moerch U, Sandborn WJ, Hibi T. Corticosteroid-Sparing Effects of Filgotinib in Moderately to Severely Active Ulcerative Colitis: Data from the Phase 2b/3 SELECTION Study. J Crohns Colitis. 2023 Mar 18;17(2):211-220. doi: 10.1093/ecco-jcc/jjac122.

    PubMed 36006011

  • 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.

    PubMed 34090625

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Filgotinib and PTM filgotinib in people with Ulcerative Colitis, run by Gilead Sciences at 343 sites in 40 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 21 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 343 sites in United States, Japan, India, Poland, France and 35 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Induction Study: Percentage of Participants Who Achieved Endoscopy/Bleeding/Stool Frequency (EBS) Remission at Week 10 (time frame: Week 10). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02914522, which also lists 12 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Apr 2021.

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