AzTrials
AzTrials

Crohn's DiseasePhase 3DIVERSITY LTENCT02914600

Filgotinib in Long-Term Extension Study of Adults With Crohn's Disease

A Phase 3 study testing Filgotinib in people with Crohn's Disease, run by Lakefront Biotherapeutics NV at 486 sites in 40 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The primary objective of this study is to observe the long-term safety of filgotinib in adults who have completed or met protocol specified efficacy discontinuation criteria in a prior filgotinib treatment study in Crohn's disease (CD). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Crohn's Disease
What is being tested?
Filgotinib
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,188 participants
Where
486 sitesin 40 countries
Study dates
17 Mar 2017to 1 Aug 2023
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Must have the ability to understand and sign a written informed consent form (ICF), which must be obtained prior to initiation of study procedures associated with this trial
  • Must have enrolled in a CD parent protocol, GS-US-419-4015, GS-US-419-4016 or GS-US-419-3895 or any other Gilead/Galapagos sponsored filgotinib treatment study for CD
  • Females of childbearing potential must have a negative pregnancy test at Day 1 and must agree to continued monthly pregnancy testing during use of filgotinib treatment
  • Female participants of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception for the duration described in the protocol
  • Willingness to refrain from live or attenuated vaccines during the study and for 12 weeks after last dose of study drug
  • Must have completed all required procedures or met protocol specified efficacy discontinuation criteria in a prior filgotinib treatment study for CD

Who cannot join

  • Known hypersensitivity to the study drug
  • Any chronic medical condition (including, but not limited to, cardiac or pulmonary disease, alcohol or drug abuse) that, in the opinion of the Investigator or sponsor, would make the individual unsuitable for the study or would prevent compliance with the study protocol
  • Females of reproductive potential who are unwilling to abide by protocol-specified contraceptive methods as defined in the protocol
  • Use of prohibited concomitant medications as outlined in the study protocol
  • NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

Trial locations and contacts

486 sites in 40 countries.

486 sites in 40 countries

United States100 sites

  • Investigative Clinical Research

    Annapolis, Maryland, 21401

  • Texas Clinical Research Institute

    Arlington, Texas, 76012

  • Illinois Gastroenterology Group - Arlington Heights

    Arlington Heights, Illinois, 60005

  • University of Colorado Denver and Hospital

    Aurora, Colorado, 80045

  • Pinnacle Clinical Research

    Austin, Texas, 78757

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • Inquest Clinical Research

    Baytown, Texas, 77521

  • Massachusetts General Hospital - Crohn's and Colitis Center

    Boston, Massachusetts, 02114

  • HP Clinical Research

    Bountiful, Utah, 84010

  • NY Scientific

    Brooklyn, New York, 11235

  • Charlotte Gastroenterology & Hepatology, PLLC

    Charlotte, North Carolina, 28207

  • University of Virginia Health System

    Charlottesville, Virginia, 22908

  • Charlottesville Medical Research Center, LLC

    Charlottesville, Virginia, 22911

  • 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

  • Northwestern University Feinberg School of Medicine

    Chicago, Illinois, 60611

  • The University of Chicago Medical Center (Clinic)

    Chicago, Illinois, 60637

  • Consultants for Clinical Research

    Cincinnati, Ohio, 45219

  • UC Health Physicians Clifton

    Cincinnati, Ohio, 45219

  • Gastro Center of Maryland

    Columbia, Maryland, 21045

  • Advanced Research, LLC

    Coral Springs, Florida, 33067

  • Southern California Research Center, Inc.

    Coronado, California, 92118

  • Digestive Health Specialists Of The Southeast

    Dothan, Alabama, 36305

  • AGA Clinical Research Associates, LLC

    Egg Harbor, New Jersey, 08234

  • 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 Clinical Research Center

    Gainesville, Florida, 32610

  • DHAT Research Institute

    Garland, Texas, 75044

  • Gastro One

    Germantown, Tennessee, 38138

  • Spectrum Health Butterworth Hospital

    Grand Rapids, Michigan, 49546

  • NYU Langone Long Island Clinical Research Associates

    Great Neck, New York, 11021

  • Illinois Gastroenterology Group - Gurnee

    Gurnee, Illinois, 60031

  • Meritus Center for Clinical Research

    Hagerstown, Maryland, 21742

  • Great Lakes Medical Research, LLC

    Harrisburg, Pennsylvania, 17110

  • Kelsey-Seybold Clinic

    Houston, Texas, 77025

  • Baylor College of Medicine - McNair Campus

    Houston, Texas, 77030

  • The Methodist Hospital

    Houston, Texas, 77030

  • The University of Texas Health Science Center at Houston

    Houston, Texas, 77030

  • Centex Studies, Inc.

    Houston, Texas, 77058

  • Gulf Coast Research Group

    Houston, Texas, 77098

  • Indiana University

    Indianapolis, Indiana, 46202

  • University of Iowa Hospitals and Clinics

    Iowa City, Iowa, 52242

  • University of Mississippi Medical Center

    Jackson, Mississippi, 39216

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Kansas City Research Institute

    Kansas City, Missouri, 64131

  • Florida Research Institute

    Lakewood Rch, Florida, 34211

  • Florida Center for Gastroenterology

    Largo, Florida, 33777

  • Las Vegas Medical Research

    Las Vegas, Nevada, 89113

  • South Denver Gastroenterology, PC

    Lone Tree, Colorado, 80124

  • 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

  • Advanced Pharma CR, LLC

    Miami, Florida, 33147

  • Cordova Research Institute

    Miami, Florida, 33155

  • Vista Health Research, LLC

    Miami, Florida, 33176

  • Paramount Medical Research & Consulting, LLC

    Middleburg Heights, Ohio, 44130

  • Wisconsin Center for Advanced Research, a division of GI Associates, LLC

    Milwaukee, Wisconsin, 53215

  • 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

  • New York University School of Medicine / NYU Gastroenterology Associates

    New York, New York, 10016

  • Lenox Hill Hospital

    New York, New York, 10028

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • Gastroenterology Associates of Orangeburg

    Orangeburg, South Carolina, 29118

  • Center for Interventional Endoscopy - Florida Hospital

    Orlando, Florida, 32803

  • Gulf Region Clinical Research Institute

    Pensacola, Florida, 32514

  • Advanced Medical Research Center

    Port Orange, Florida, 32127

  • Premier Medical Group of the Hudson Valley

    Poughkeepsie, New York, 12601

  • Carolina's GI Research LLC

    Raleigh, North Carolina, 27607

  • Inland Empire Clinical Trials, LLC

    Rialto, California, 92377

  • McGuire DVAMC

    Richmond, Virginia, 23249

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

  • Mayo Clinic

    Rochester, Minnesota, 55902

  • Clinical Associates in Research Therapeutics of America, LLC

    San Antonio, Texas, 78212

  • Gastroenterology Research of San Antonio

    San Antonio, Texas, 78229

  • Pinnacle Clinical Research

    San Antonio, Texas, 78229

  • UC San Diego Health Systems

    San Diego, California, 92093

  • Kaiser Permanente

    San Francisco, California, 94118

  • TDDC San Marcos

    San Marcos, Texas, 78666

  • Clearview Medical Research, LLC

    Santa Clarita, California, 91351

  • Louisiana Research Center, LLC

    Shreveport, Louisiana, 71105

  • Texas Digestive Disease Consultants

    Southlake, Texas, 76092

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Arizona Digestive Health - Sun City

    Sun City, Arizona, 85351

  • Atlanta Gastroenterology Specialist, PC

    Suwanee, Georgia, 30024

  • Tampa General Hospital

    Tampa, Florida, 33606

  • Spring Gastroenterology

    The Woodlands, Texas, 77380

  • Options Health Research LLC

    Tulsa, Oklahoma, 74104

  • Tyler Research Institute, LLC

    Tyler, Texas, 75701

  • Medstar Georgetown University Hospital

    Washington D.C., District of Columbia, 20007

  • Gastroenterology Associates of Western Michigan, PLC d.b.a. West Michigan Clinical Research Center

    Wyoming, Michigan, 49519

  • Florida Medical Clinic, P.A

    Zephyrhills, Florida, 33540

Other trials in United States

Japan40 sites

  • Ohmori Toshihide gastro-intestinal Clinic

    Ageo-shi, 362-0075

  • Tokyo Medical and Dental University Hospital

    Bunkyō City, 113-8519

  • 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

    Hachiōji, 192-0032

  • Hiroshima Prefectural Hospital

    Hiroshima, 734-8530

  • Fukuoka University Hospital

    Jonan-ku, 814-0180

  • Saitama Medical Center, Saitama Medical University

    Kawagoe, 350-8550

  • 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, 8528501

  • Nagoya City University Hospital

    Nagoya, 467-8602

  • 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

  • Kinshukai Infusion Clinic

    Osaka, 530-0011

  • Osaka City University Hospital

    Osaka, 545-8586

  • Wakakusa-Daiichi Hospital

    Osaka, 579-8056

  • Shiga University of Medical Science Hospital

    Ōtsu, 520-2192

  • Saga-Ken Medical Centre Koseikan

    Saga, 840-8571

  • Saga University Hospital

    Saga, 849-8501

  • Tokito Clinic

    Saitama, 336-0963

  • Toho University Sakura Medical Center

    Sakura, 285-8741

  • Sapporo Higashi Tokushukai Hospital

    Sapporo, 065-0033

  • National Hospital Organization Sendai Medical Center

    Sendai, 983-8520

  • Osaka University Hospital

    Suita, 565-0871

  • Kagawa Prefectural Central Hospital

    Takamatsu, 760-8557

  • National Hospital Organization Takasaki General Medical Center

    Takasaki-shi, 3700829

  • Ieda Hospital

    Toyota-shi, 470-1219

  • Wakayama Medical University Hospital

    Wakayama, 641-8509

  • Yokohama Health Medicine Association Kannai Suzuki Clinic

    Yokohama, 231-0012

Other trials in Japan

India33 sites

  • Kaizen Hospital

    Ahmedabad, 380052

  • Victoria Hospital, Bangalore Medical College and Research Institute (BMCRI)

    Bangalore, 560002

  • M S Ramaiah Medical College and Hospital

    Bangalore, 560054

  • Apollo Speciality Hospital

    Chennai, 600035

  • VGM Hospital Institute of Gastroenterology

    Coimbatore, 641005

  • Lourdes Hospital

    Ernākulam, 682012

  • Fortis Memorial Research Institute

    Gūrgaon, 122002

  • Gleneagles Global Hospital

    Hyderabad, 500004

  • Citizens Specialty Hospital

    Hyderabad, 500019

  • Centre for Liver Research & Diagnostics

    Hyderabad, 500058

  • SR Kalla Memorial Gastro and General Hospital

    Jaipur, 302001

  • S.M.S Hospital

    Jaipur, 302004

  • Lakeshore Hospital and Research Centre Ltd

    Kochi, Kerala, 682040

  • School of Digestive & Liver Diseases

    Kolkata, 700020

  • King George's Medical University

    Lucknow, 226003

  • Dayanand Medical College & Hospital

    Ludhiana, 141001

  • Kasturba Medical College (KMC) Hospital

    Mangaluru, 575001

  • Seth G.S. Medical College & KEM Hospital

    Mumbai, 400012

  • S.L. Raheja Hospital (A Fortis Associate)

    Mumbai, 400016

  • Lokmanya Tilak Municipal General Hospital

    Mumbai, 400022

  • Midas Multispeciality Hospital Pvt. Ltd

    Nagpur, 440010

  • Suretech Hospital & Research Centre Ltd

    Nagpur, 440012

  • All India Institute of Medical Sciences

    New Delhi, 110029

  • Department of Surgery, B.J. Government Medical College & Sassoon General Hospital

    Pune, 411001

  • Grant Medical Foundation Ruby Hall Clinic

    Pune, 411001

  • Universal Hospital

    Pune, 411011

  • Shree Giriraj Multispeciality Hospital

    Rajkot, 360002

  • 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

  • Samvedna Hospital

    Varanasi, 221005

Other trials in India

Germany25 sites

  • Charite Universitaetsmedizin Berlin

    Berlin, 10117

  • Medizinisches Versorgungszentrum Delitzsch

    Berlin, 10825

  • 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

  • Universitatsklinikum Dresden

    Dresden, 01307

  • Agaplesion Markus Krankenhaus

    Frankfurt am Main, 60431

  • CED Studien UG, Interdisciplinary Crohn Colitis Center (iCCC)

    Frankfurt am Main, 60594

  • Universitatsklinikum Freiburg

    Freiburg im Breisgau, 79106

  • Asklepios Westklinikum Hamburg

    Hamburg, 22559

  • Medizinische Hochschule Hannover

    Hanover, 30625

  • Universitatsklinikum Heidelberg

    Heidelberg, 69120

  • Praxis fur Gastroenterologie

    Heidelberg, 69121

  • Gastroenterologische Gemeinschaftspraxis Herne

    Herne, 44623

  • Universitatsklinikum Jena

    Jena, 07747

  • Universitatsklinikum Schleswig-Holstein

    Kiel, 24105

  • EUGASTRO GmbH

    Leipzig, 04103

  • Universitatsklinikum Leipzig

    Leipzig, 04103

  • Klinikum Luneburg

    Lüneburg, 21339

  • Gastroenterologische Gemeinschaftspraxis Minden

    Minden, 32423

  • Klinikum der Universitat Munchen - Grosshadern

    München, 81377

  • Universitaetsmedizin Rostock, Zentrum fuer Innere Medizin

    Rostock, 18057

  • Universitaetsklinikum Tuebingen

    Tübingen, 72074

  • Universitatsklinikum Ulm, Zentrum Fur Innere Medizin

    Ulm, 89081

Other trials in Germany

Poland24 sites

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

    Bialystok, 15-276

  • VITAMED Galaj i Cichomski spólka jawna

    Bydgoszcz, 85-079

  • Szpital Uniwersytecki nr 2 im. Dr. Jana Biziela w Bydgoszczy, Centrum Endoskopii Zabiegowej, Poradnia Chorob Jelitowych

    Bydgoszcz, 85-168

  • 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

  • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwerstyeckiego Szpitala Klinicznego nr 1 im. Norberta Barlickiego

    Lodz, 90-153

  • Trialmed Crs

    Piotrkow Trybunalski, 97-300

  • Clinical Research Center Sp. z o.o. 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, 00-635

  • WIP Warsaw IBD Point Profesor Kierkus

    Warsaw, 00-728

  • Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administacji w Warszawie

    Warsaw, 02-507

  • Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie

    Warsaw, 02-781

  • Medical Concierge Centrum Medyczne

    Warsaw, 02-798

  • Niepubliczny Zaklad Opieki Zrodotnej VIVAMED Jadwige Miecz

    Warsaw, 03-580

  • Bodyclinic

    Warsaw, 03-712

  • Centrum Medyczne Oporow

    Wroclaw, 52-416

Other trials in Poland

France23 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

  • Centre Hospitalier Intercommunal de Creteil

    Créteil, 94010

  • 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

  • Hopital Saint Joseph

    Marseille, 13285

  • CHU de Montpellier-Hopital Saint Eloi

    Montpellier, 34295

  • CHU Hotel-Dieu

    Nantes, 44093

  • Hopital de l'Archet 2

    Nice, 06202

  • CHU de Bordeaux - Hopital Haut Leveque

    Pessac, 33600

  • Centre Hospitalier Universitaire de Lyon Sud

    Pierre-Bénite, 69495

  • CH Annecy Genevois - Site d'Annecy

    Pringy, 74374

  • Centre Hospitalier Universitaire de Rennes - Hopital Pontchaillou

    Rennes, 35033

  • CHU de Saint Etienne - Hopital Nord

    Saint-Priest-en-Jarez, 42055

  • Nouvel Hopital Civil

    Strasbourg, 67091

  • Hopitaux Universitaires de Strasbourg - Hopital de Hautepierre

    Strasbourg, 67098

  • CHU de Toulouse - Hopital Rangueil

    Toulouse, 31059

  • CHU de Nancy - Hopital Brabois Adultes

    Vandœuvre-lès-Nancy, 54511

Other trials in France

Australia16 sites

  • Emeritus Research

    Camberwell, Victoria, 3124

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050

  • 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

  • Coral Sea Clinical Research Institute (Mackay)

    North Mackay, Queensland, 4740

  • Royal Melbourne Hospital

    Parkville, Victoria, 3050

  • Mater Misericordiae Ltd

    South Brisbane, Queensland, 4101

  • Wollongong Hospital

    Wollongong, New South Wales, 2500

  • The Queen Elizabeth Hospital

    Woodville South, South Australia, 5011

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

Ukraine16 sites

  • Multispecialty Clinical Hospital of Intensive Treatments and Emergency Medical Care

    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, 76018

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

    Kharkiv, 61037

  • 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

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

    Odesa, 65025

  • Ternopil Regional Clinical Hospital, Regional Center of Gastroenterology with Hepatology

    Ternopil, 46002

  • Municipal Institution "Uzhgorod District Hospital", Therapy Department

    Uzhhorod, 88009

  • 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

Italy14 sites

  • UOC Gastroenterologia II

    Castellana Grotte, 70013

  • U.O. Fisiopatologia Digestiva

    Catanzaro, 88100

  • UOC Medicina Interna

    Cento, 44042

  • Ospedale Clinicizzato SS. Annunziata - Dipartimento di Medicina

    Chieti, 66100

  • Gastroenterologia clinica - Azienda Ospedaliero-Universitaria Careggi

    Florence, 50134

  • Endocsopia Digestiva Centralizzata

    Milan, 20121

  • UO Gastroenterologia

    Modena, 40124

  • UOC Gastroenterologia

    Padova, 35128

  • Azienda Ospedaliero-Universitaria Pisana - Presidio Ospedaliero Cisanello

    Pisa, 56124

  • UOC Gastroenterologia ed Endoscopia Digestiva

    Roma, 00128

  • UOC di Gastroenterologia ed Endoscopia Digestiva

    Roma, 00133

  • UOC Medicina Interna a Gastroenterologia

    Roma, 00168

  • Istituto Clinico Humanitas

    Rozzano, 20089

  • A.S.O. Ordine Mauriziano Di Torino S.C.

    Torino, 10122

Other trials in Italy

United Kingdom14 sites

  • Queen Elizabeth Hospital

    Birmingham, B15 2WB

  • The Pennine Acute Hospitals NHS Trust

    Bury, BL9 7TD

  • Cambridge University Hospitals NHS Foundation Trust

    Cambridge, CB20QQ

  • NHS Lothian

    Edinburgh, EH4 2XU

  • Royal Devon and Exeter NHS Foundation Trust

    Exeter, EX2 5DW

  • 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

  • St George's University Hospitals NHS Foundation Trust

    London, SW17 0QT

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

    London, W2 1NY

  • Norfolk and Norwich University Hospital NHS Foundation Trust

    Norwich, Norfolk, NR4 7UY

  • Oxford University Hospitals NHS 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

Spain13 sites

  • Hospital Universitari Germans Trias i Pujol

    Badalona, 08916

  • Centro Medico Teknon

    Barcelona, 08022

  • Hospital del Mar

    Barcelona, 8003

  • Complejo Hospitalario Universitario de Ferrol

    Ferrol, 15405

  • Hospital Universitario de Gran Canaria "Dr. Negrin"

    Las Palmas de Gran Canaria, 35010

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007

  • Hospital Clinico San Carlos

    Madrid, 28040

  • Hospital Universitario de Fuenlabrada

    Madrid, 28942

  • Hospital Universitario Central de Asturias

    Oviedo, 33006

  • Hospital de Montecelo

    Pontevedra, 36071

  • Hospital de Sagunto

    Sagunto, 46520

  • Hospital Universitario Virgen del Rocío

    Seville, 41013

  • Hospital de Galdakao-Usandolo

    Usansolo, 48960

Other trials in Spain

South Korea12 sites

  • Pusan National University Hospital

    Busan, 49241

  • Yeungnam University Hospital

    Daegu, 42415

  • Kyung Hee University Hospital

    Guri-si, 471-701

  • Hanyang University Guri Hospital

    Gyeonggi-do, 11923

  • CHA Bundang Medical Center, CHA University

    Seongnam-si, 463-712

  • Seoul National University Hospital

    Seoul, 03080

  • 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

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

    Suwon, 16247

  • Yonsei University Wonju Severance Christian Hospital

    Wŏnju, 220-701

Other trials in South Korea

Canada11 sites

  • Barrie GI Associates

    Barrie, L4M 7G1

  • University of Calgary, Heritage Medical Research Clinic

    Calgary, T2N 4Z6

  • Hamilton Health Sciences Corporation, McMaster University Medical Centre

    Hamilton, L8S 4K1

  • London Health Sciences Centre - University Hospital

    London, N6A 5A5

  • TIDHI Innovation, Inc.

    North York, M6A 3B4

  • ABP Research Services

    Oakville, L6L 5L7

  • Royal University Hospital

    Saskatoon, S7N 0W8

  • Mount Sinai Hospital

    Toronto, M5T 3L9

  • The Gordon and Leslie Diamond Health Care Centre

    Vancouver, V5Z 1M9

  • Toronto Digestive Disease Associates Inc.

    Vaughan, L4L 4Y7

  • Percuro Clinical Research Ltd.

    Victoria, V8V 3P9

Other trials in Canada

Israel11 sites

  • Emek Medical Center

    Afula, 18101

  • Soroka Medical Center

    Beersheba, 8410101

  • Bnai Zion Medical Center

    Haifa, 31048

  • Rambam Medical Health Care Campus

    Haifa, 3109601

  • The Edith Wolfson Medical Center

    Holon, 5822012

  • Shaare Zedek Medical Center

    Jerusalem, 9103102

  • Hadassah Medical Center

    Jerusalem, 9112001

  • Meir MC

    Kefar Sava, 4428164

  • Rabin Medical Center

    Petah Tikva, 4941492

  • The Chaim Sheba Medical Center

    Ramat Gan, 5265601

  • Tel Aviv Sourasky Medical Center

    Tel Aviv, 64239

Other trials in Israel

Romania11 sites

  • MedLife, Gastroenterologie

    Bucharest, 010719

  • Spitalul Universitar de Urgenta Militar Central Dr. Carol Davila - Sectia Clinica de Gastroenterologie

    Bucharest, 010825

  • S.C. Centrul Medical Sana S.R.L., Gastroenterologie

    Bucharest, 011025

  • Delta Health Care/ Ponderas Academic Hospital

    Bucharest, 014142

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

    Bucharest, 020125

  • MedLife, Gastroenterologie

    Bucharest, 031784

  • Spitalul Universitar de Urgenta Bucuresti - Sectia Medicina Interna II

    Bucharest, 050098

  • Gastromedica SRL, Gastroenterologie

    Iași, 700506

  • Cabinet Particular Policlinic Algomed SRL

    Timișoara, 300002

  • Centrul Medical Tuculanu, Gastroenterologie

    Timișoara, 300168

  • S.C. Policlinica Dr. Citu S.R.L.- Gastroenterologie

    Timișoara, 300594

Other trials in Romania

Taiwan11 sites

  • Changhua Christian Hospital

    Changhua, 500

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807

  • Far Eastern Memorial Hospital

    New Taipei City, 220

  • Chang Shan Medical University Hospital

    Taichung, 40201

  • China Medical University Hospital

    Taichung, 40447

  • National Cheng Kung University Hospital

    Tainan, 7428

  • National Taiwan University Hospital

    Taipei, 100

  • Mackay Memorial Hospital, Taipei

    Taipei, 104

  • Taipei Veterans General Hospital

    Taipei, 112

  • Tri-Service General Hospital

    Taipei, 114

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

    Taoyuan, 33305

Other trials in Taiwan

Russia10 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

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

    Novosibirsk, 630087

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

    Novosibirsk, 630091

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

    Saint Petersburg, 191015

  • "Scientific Research Centre ECO-safety" LLC

    Saint Petersburg, 196143

  • "PolyClinic EXPERT" LLC

    Saint Petersburg, 197110

  • State Healthcare Institution "Regional Clinical Hospital"

    Saratov, 410053

Other trials in Russia

Belgium9 sites

  • GZA Ziekenhuizen, campus Sint-Vincentius

    Antwerp, 2018

  • Imelda General Hospital

    Bonheiden, 2820

  • CUB Hopital Erasme

    Brussels, 1070

  • Universitair Ziekenhuis Antwerpen

    Edegem, 2650

  • Universitair Ziekenhuis Gent

    Ghent, 9000

  • Universitair Ziekenhuis Leuven

    Leuven, 3000

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

    Liège, 4000

  • CHR Citadelle

    Liège, 4000

  • AZ Delta

    Roeselare, 8800

Other trials in Belgium

Netherlands9 sites

  • NZW Alkmaar (Noordwest Ziekenhuisgroep)

    Alkmaar, 1815 JD

  • VU Medisch Centrum

    Amsterdam, 1081 HV

  • Academic Medical Center (AMC)

    Amsterdam, 1105 AZ

  • Gelre Hospital

    Apeldoorn, 7334

  • Universitair Medisch Centrum Groningen

    Groningen, 9700 RB

  • Maastricht University Medical Centre

    Maastricht, 6229 HX

  • Erasmus University Medical Center

    Rotterdam, 3015 CE

  • Elisabeth-TweeSteden Hospital

    Tilburg, 5022

  • University Medical Center Utrecht

    Utrecht, 3584 CX

Other trials in Netherlands

Hungary8 sites

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

    Békéscsaba, 5600

  • Szent Margit Korhaz, Gasztroenterológiai Osztály

    Budapest, 1032

  • Clinexpert Egeszsegugyi Szolgaltato es Kereskedelmi Kft.

    Budapest, 1033

  • 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

Portugal8 sites

  • Hospital de Braga

    Braga, 4710-243

  • Centro Hospitalar e Universitario de Coimbra, E.P.E.

    Coimbra, 3000-075

  • Centro Hospitalar Cova de Beira, EPE

    Covilha, 6200-251

  • Centro Hospitalar do Algarve EPE

    Faro, 8000-386

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

    Guimarães, 4835-044

  • Hospital Beatriz Angelo

    Loures, 2674-514

  • Centro Hospitalar de Sao Joao, EPE

    Porto, 4200-319

  • Unidade Local de Saúde do Alto Minho

    Viana do Castelo, 4904-858

Other trials in Portugal

New Zealand7 sites

  • Christchurch Hospital

    Christchurch, 8011

  • Southern District Health Board - Dunedin Hospital

    Dunedin, 9016

  • Auckland City Hospital

    Grafton, 1023

  • Waikato Hospital

    Hamilton, 3240

  • Wellington Hospital

    Newtown, 6021

  • Bay of Plenty District Health Board - Tauranga Hospital

    Tauranga, 3112

  • Hutt Valley District Health Board - Hutt Valley Hospital

    Wellington, 5010

Other trials in New Zealand

Czechia5 sites

  • Hepato-Gastroenterology 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

  • Thomayerova nemocnice, Interni klinika 3. LF UK a TN

    Prague, 140 00

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

    Prague, 190 00

Other trials in Czechia

Greece5 sites

  • Hippokration Hospital of Athens

    Athens, 11527

  • University General Hospital "Attikon", 2nd Propaedeutic Internal Medicine Dept. and Research Unit, Hepatogastroenterology Unit

    Athens, 12462

  • University General Hospital of Ioannina, Gastroenterology Department, Internal Medicine Division

    Ioannina, 45332

  • University General Hospital of Patras "Panagia I Voithia", Gastroenterology Department, Internal Medicine Division

    Pátrai, 26504

  • Hippokratio General Hospital of Thessaloniki "Hippokratio" 4th Internal Medicine Department of Aristotle University of Thessaloniki

    Thessaloniki, 54642

Other trials in Greece

Malaysia5 sites

  • Universiti Kebangsaan Malaysia Medical Center

    Cheras, 56000

  • Hospital Pulau Pinang

    George Town, 10990

  • Hospital Queen Elizabeth

    Kota Kinabalu, 88586

  • University Malaya Medical Centre

    Kuala Lumpur, 59100

  • Hospital Tengku Ampuan Afzan

    Kuantan, 25100

Other trials in Malaysia

Serbia5 sites

  • Clinical Hospital Center Zemun

    Belgrade, 11000

  • University Hospital Medical Center Bezanijska kosa

    Belgrade, 3010-777

  • Clinical Center of Serbia

    Belgrade, 3618-445

  • Zvezdara University Medical Center

    Belgrade, 3810-970

  • Clinical Center of Vojvodina

    Novi Sad, 21000

Other trials in Serbia

Bulgaria4 sites

  • Medical Center - Complete Medical Solutions OOD

    Samokov, 2000

  • Medical Center - "Tsaritsa Yoanna" EOOD

    Sliven, 8800

  • "MDHAT Dr. St.Cherkezov" AD

    Veliko Tarnovo, 5000

  • MHAT "Sveta Petka" AD

    Vidin, 3700

Other trials in Bulgaria

Hong Kong4 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

  • Tuen Mun Hospital

    Tuenmen

Other trials in Hong Kong

Ireland4 sites

  • St. Vincent's University Hospital

    Dublin, 4

  • Beaumont Hospital

    Dublin, 9

  • Wellcome Trust HRB Clinical Research Facility

    Dublin, DUBLIN 8

  • University Hospital Galway

    Galway, H91 YR71

Other trials in Ireland

Singapore4 sites

  • National University Hospital

    Singapore, 119074

  • Singapore General Hospital

    Singapore, 169608

  • Tan Tock Seng Hospital

    Singapore, 308433

  • Changi General Hospital

    Singapore, 529889

Other trials in Singapore

Sri Lanka4 sites

  • National Hospital of Sri Lanka

    Colombo, 00700

  • Karapitiya Teaching Hospital

    Galle, 80000

  • Kandy Teaching Hospital

    Kandy, 20000

  • Colombo North Teaching Hospital

    Ragama, 11010

Other trials in Sri Lanka

Austria3 sites

  • Universitatsklinik Innsbruck

    Innsbruck, 6020

  • Klinikum Klagenfurt am Wörthersee, Abt. Für Inn. Med. & Gastroenterol, (IMuG), Hepatol., Endokrinol., Rheumatol., & Nephrol.

    Klagenfurt, 9020

  • AKH-Medizinische Universitat Wien

    Vienna, 1090

Other trials in Austria

Croatia3 sites

  • University Hospital Center Osijek

    Osijek, 31 000

  • Clinical Hospital Dubrava

    Zagreb, 10000

  • University Hospital Center Zagreb

    Zagreb, 10000

Other trials in Croatia

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

Slovakia3 sites

  • Cliniq s. r. o., Gastroenterologicke centrum Ruzinov

    Bratislava, 82007

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

    Nitra, 950 01

  • Gastro I., s.r.o.

    Prešov, 8001

Other trials in Slovakia

South Africa3 sites

  • Dr MJ Prins

    Cape Town, 7500

  • Dr John P Wright

    Cape Town, 7708

  • Peermed Clinical Trial Centre

    Johannesburg, 1619

Other trials in South Africa

Sweden2 sites

  • Danderyds Sjukhus AB

    Danderyd, SE-18288

  • Akademiska Sjukhuset

    Uppsala, 75185

Other trials in Sweden

Switzerland2 sites

  • Intesto Gastroenterologische Praxis & Crohn-Colitis-Zentrum Bern

    Bern, 3012

  • Universitätsspital Zürich

    Zurich, 8091

Other trials in Switzerland

Argentina1 site

  • Fundacion Estudios Clinicos CiRec

    Rosario, S2000DEF

Other trials in Argentina

Iceland1 site

  • Landspitali University Hospital

    Reykjavik, 101

Other trials in Iceland

About this study

Official title: A Long-Term Extension Study to Evaluate the Safety of Filgotinib in Subjects With Crohn's Disease

The primary objective of this study is to observe the long-term safety of filgotinib in adults who have completed or met protocol specified efficacy discontinuation criteria in a prior filgotinib treatment study in Crohn's disease (CD).

Conditions
Crohn's Disease
Being tested
Filgotinib, Placebo
Medical subject headings
Crohn Disease

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, Jyseleca®

    Tablet administered orally once a day

  • PlaceboDrug

    Tablet administered orally once a day

Study groups in NCT02914600
Study groupRoleWhat they receive
Filgotinib 200 mgExperimentalParticipants who received filgotinib 200 milligrams (mg) blinded and completed the parent study, continued to receive filgotinib 200 mg blinded in this study. After unblinding of the parent study, participants continued open-label on filgotinib 200 mg. Participants who exited the parent study due to disease worsening or failure to meet response or remission criteria, with the exception of US and Korean males who were not considered dual-biologic refractory, received filgotinib 200 mg open-label in this study. Treatment was administered orally once a day until filgotinib becomes commercially available or until the early termination (up to 308 weeks).
Receives: Drug: Filgotinib
Filgotinib 100 mgExperimentalParticipants who received filgotinib 100 mg blinded and completed the parent study, continued to receive filgotinib 100 mg blinded in this study. After unblinding of the parent study, participants continued open-label on filgotinib 100 mg. Male participants from the US \& Korea who were not considered dual biologic refractory, and who exited the parent study due to disease worsening or failure to meet response or remission criteria, received filgotinib 100 mg open-label in this study. Treatment was administered orally once a day until filgotinib becomes commercially available or until the early termination (up to 308 weeks).
Receives: Drug: Filgotinib
PlaceboPlacebo comparatorParticipants who received placebo and completed the parent study, continued to receive placebo in this extension study. After unblinding of the parent study, participants on placebo treatment discontinued study drug and study participation. Treatment was administered orally once a day until unblinding of the parent study (up to 308 weeks).
Receives: Drug: Placebo

What is being measured

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

  1. Number of Participants With Treatment Emergent Adverse Events (TEAEs)

    An AE was defined as any untoward medical occurrence in a participant administered a study drug, and which did not necessarily have a causal relationship with this treatment. An AE could therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug whether or not considered related to the study drug. Treatment-emergent adverse events (TEAEs) were defined as 1 or both of the following:

    • Any AEs with an onset date on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug
    • Any AEs leading to premature discontinuation of study drug.

    Measured: From the First Dose to Week 312

Secondary outcomes (3)

  1. Change From Baseline in Patient Reported Outcomes 2 (PRO2) Scores for Liquid or Very Soft Stools

    The PRO2 was a composite score based on 2 components of CDAI, the number of liquid or soft stools/day for 7 days, stool frequency and abdominal pain (rated on a scale of 0-3, higher values mean greater abdominal pain) assessed for 7 days. The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The sub scores of abdominal pain (0-3), general well-being (0-4, higher values mean worse well-being), and number of liquid or very soft stools were summed over the 7 days prior to each visit. The remaining predictors were also weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome. Change from baseline for number of liquid or very soft stool per day was reported.

    Measured: Baseline, Week 12, Week 24, Week 48, Week 96, Week 156, Week 216, Week 264, and Week 300

  2. Change From Baseline in Patient Reported Outcomes (PRO2) Scores for Abdominal Pain

    The PRO2 was a composite score based on 2 components of CDAI, the number of liquid or soft stools/day for 7 days, stool frequency and abdominal pain (rated on a scale of 0-3, higher values mean greater abdominal pain) assessed for 7 days. The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The sub scores of abdominal pain (0-3), general well-being (0-4, higher values mean worse well-being), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome. Change from baseline in abdominal pain was reported.

    Measured: Baseline, Week 12, Week 24, Week 48, Week 96, Week 156, Week 216, Week 264, and Week 300

  3. Change From Baseline in CDAI Scores

    The CDAI system was a composite index of 8 disease activity variables: severity of abdominal pain, general well-being, very soft/liquid stool frequency, extra-intestinal symptoms, need for antidiarrheal drugs, presence of an abdominal mass, body weight and hematocrit. Participants reported information regarding symptoms using a diary. The sub scores of abdominal pain (rated on a scale of 0-3, higher values mean greater abdominal pain), general well-being (0-4, higher values mean worse well-being), and number of very soft or liquid stools were then summed over the 7 days prior to each visit. Additionally, the remaining predictors were also noted and weighted to create the total CDAI score which ranged from 0-600 with a higher score indicating a worse outcome.

    Measured: Baseline, Week 12, Week 24, Week 48, Week 96, Week 156, Week 216, Week 264, and Week 300

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 start17 Mar 2017
  3. Primary completion1 Aug 2023
  4. Study completion1 Aug 2023

Why it stopped: development program for filgotinib for participants with Crohn's disease has been stopped

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
Non-randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
1,188 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02914600
Sponsor's protocol ID
GS-US-419-3896
Other IDs
2016-002763-34, 2016
Acronym
DIVERSITY LTE
Status last verified
May 2024
First submitted
22 Sep 2016
Last updated
10 Jul 2024
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Filgotinib in people with Crohn's Disease, run by Lakefront Biotherapeutics NV at 486 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 6 inclusion and 5 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: stopped early, as of the sponsor's last update on 10 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 486 sites in United States, Japan, India, Germany, Poland 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 10 Jul 2024). 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?

Number of Participants With Treatment Emergent Adverse Events (TEAEs) (time frame: From the First Dose to Week 312). 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 NCT02914600.

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 10 Jul 2024.

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