Crohn's DiseasePhase 3DIVERSITY1NCT02914561
Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Crohn's Disease
A Phase 3 study testing Filgotinib in people with Crohn's Disease, run by Lakefront Biotherapeutics NV at 513 sites in 41 countries.
Trial summary
The primary objectives of this study are to evaluate the safety and efficacy of filgotinib during induction and maintenance treatment of moderately to severely active Crohn's disease (CD) 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
- 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
- 1,372 participants
- Where
- 513 sitesin 41 countries
- Study dates
- 31 Oct 2016to 11 Nov 2022
- Phase
- Phase 3
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
- Documented diagnosis of CD with a minimum disease duration of 3 months with involvement of the ileum and/or colon at a minimum, as determined by histopathology and endoscopic assessment
- Moderately to severely active CD
- Cohort A (Biologic Naïve): 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 and immunomodulators
- Cohort A (Biologic Experienced): 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) or discontinuation of use of at least one of the following agents for reasons other than inadequate clinical response, loss of response or intolerance: tumor necrosis factor alpha (TNFa) antagonists, vedolizumab, and ustekinumab
- Cohort B (Biologic Experienced): 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): TNFa antagonists, vedolizumab, and ustekinumab
Who cannot join
- Current complications of CD such as symptomatic strictures, severe rectal/anal stenosis, fistulae other than perianal fistulae, short bowel syndrome, etc.
- Presence of ulcerative colitis, indeterminate colitis, ischemic colitis, fulminant colitis, or toxic mega-colon
- Active tuberculosis (TB) or history of latent TB that has not been treated
- Use of any prohibited concomitant medications as described in the study protocol
- NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.
Trial locations and contacts
513 sites in 41 countries.
513 sites in 41 countries
United States101 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
University of Chicago Medical Center
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
VVCRD Research
Garden Grove, California, 92845
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- Baylor Medical Center
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 Health University Hospital
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
UC San Diego Health System
La Jolla, California, 92037
Florida Research Institute
Lakewood Rch, Florida, 34211
Florida Center for Gastroenterology
Largo, Florida, 33777
Las Vegas Medical Research
Las Vegas, Nevada, 89113
Emeritas Research Group LLC
Leesburg, Virginia, 20176
South Denver Gastroenterology, PC
Lone Tree, Colorado, 80124
Cedars Sinai Medical Center
Los Angeles, California, 90048
University of Louisville, School of Medicine
Louisville, Kentucky, 40202
Gastroenterology Associates of Central Georgia, LLC
Macon, Georgia, 31201
University of Wisconsin Hospital & Clinics
Madison, Wisconsin, 53792
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
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
Gastroenterology Associates of Orangeburg
Orangeburg, South Carolina, 29118
Center for Interventional Endoscopy - AdventHealth Orlando
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, GI (111N)
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
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 (IP Shipment)
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 (Patient Exams)
Washington D.C., District of Columbia, 20007
Shafran Gastroenterology Center
Winter Park, Florida, 32789
Florida Medical Clinic, P.A.
Zephyrhills, Florida, 33540
India50 sites
Kaizen Hospital
Ahmedabad, 380052
Gastroplus Digestive Disease Centre Pvt Ltd
Ahmedabad, 380054
Sal Hospital and Medical Institute
Ahmedabad, 380054
Victoria Hospital, Bangalore Medical College and Research Institute
Bangalore, 560002
M S Ramaiah Medical College and Hospital
Bangalore, 560054
KLES Dr. Prabhakar Kore Hospital & MRC
Belagavi, 590010
BGS Global Hospital
Bengaluru, 560060
S.P. Medical College & AG of Hospitals
Bikaner, Rajasthan, 334003
Apollo Speciality Hospital
Chennai, 600035
VGM Hospital Institute of Gastroenterology
Coimbatore, 641005
Maharaja Agrasen Hospital
Delhi, 110026
Lourdes Hospital
Ernākulam, 682012
PVS Memorial Hospital Private Limited
Ernākulam, 682017
Fortis Medical Research Institute
Gūrgaon, 122002
Institute of Digestive & Liver Diseases
Guwahati, 781006
Gleneagles Global Hospitals
Hyderabad, 500004
Citizens Specialty Hospital
Hyderabad, 500019
Aware Gleneagles Global Hospitals
Hyderabad, 500035
Centre for Liver Research & Diagnostics
Hyderabad, 500058
Asian Institute of Gastroenterology Pvt Ltd
Hyderabad, 500082
S.R.Kalla Memorial Gastro.&General Hospital
Jaipur, 302001
S.M.S Medical College & Hospitals
Jaipur, 302004
GSVM Medical College
Kanpur, 208002
Lakeshore Hospital and Research Centre Ltd.
Kochi, 682040
Amrita Institute of Medical Sciences and Research Centre
Kochi, 682041
School of Digestive & Liver Diseases
Kolkata, 700020
Apollo Gleneagles Hospitals
Kolkata, 700054
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
Lokmanya Tilak Municipal General Hospital
Mumbai, 400022
Midas Multispeciality Hospital Pvt. Ltd
Nagpur, 440010
Suretech Hospital & Research Centre Ltd
Nagpur, 440012
Max Smart Super Speciality Hospital
New Delhi, 110017
All India Institute of Medical Sciences
New Delhi, 110029
Dr. B.L. Kapur Memorial Hospital
New Delhi, 11005
Fortis Flt. Lt. Rajan Dhall Hospital
New Delhi, 110070
S.L Raheja Hospital
Parel, 400012
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
BAPS Pramukh Swami Hospital
Surat, 395009
Kasturba Hospital Medical College
Udupi, 576104
Sterling Hospital
Vadodara, 390007
Samvedna Hospital
Varanasi, 221005
Japan49 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
Medical corporation Ryowakai, Hamamatsu South Hospital
Hamamatsu, 430-0846
Hiroshima Prefectural Hospital
Hiroshima, 734-8530
Hiroshima University Hospital
Hiroshima, 734-8551
Fukuoka University Hospital
Jonan-ku, 814-0180
Nanpuh Hospital
Kagoshima, 892 -8512
Ofuna Chuo Hospital
Kamakura, 247-0056
Tsujinaka Hospital
Kashiwa, 277-0871
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
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
Yokohama Health Medicine Association Kannai Suzuki Clinic
Yokohama, 231-0012
Poland26 sites
Uniwersytecki Szpital Kliniczny w Bialymstoku, Klinika Gastroenterologii i Chorob Wewnetrznych
Bialystok, 15-276
VITAMED Galaj i Cichomski spolka 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
Centrum Medyczno-Diagnostyczne Prima-Med
Krakow, 30-015
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. Norbert Barlickiego
Lodz, 90-153
Trialmed Crs
Piotrkow Trybunalski, 97-300
Clinical Research Center Spolka z ograniczna 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, 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
Centrum Medyczne
Wroclaw, 54-204
Germany24 sites
Charite Universitaetsmedizin Berlin
Berlin, 10117
Gastro-Studien
Berlin, 10825
Charite - Universitatsmedizin Berlin
Berlin, 13353
DRK Kliniken Berlin - Westend - Klinik fuer Innere Medizin
Berlin, 14050
Stadtisches Klinikum Braunschweig gGmbH
Braunschweig, 38126
Universitatsklinik Koln
Cologne, 50937
Agaplesion Markus Krankenhaus
Frankfurt am Main, 60431
CED Studien UG, Interdisciplinary Crohn Colitis Center (iCCC) Rhein-Main
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
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
Centre d'Investigation Clinique - 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
Australia17 sites
Flinders Medical Centre
Bedford Park, South Australia, 5042
Emeritus Research
Camberwell, Victoria, 3124
Royal Prince Alfred Hospital
Camperdown, New South Wales, 2050
Monash Medical Centre
Clayton, New South Wales, 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
Ukraine16 sites
Bukovinian State Medical University
Chernivtsi, 58000
Municipal City Clinical Hospital of the Emergency Medical Care, 1 st Therapy Department. Danylo Halytsky Lviv National Medical
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 University 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
Medical Center LLC "Health Clinic"
Vinnytsia, 21009
M.I. Pyrogov Vinnytsia Regional Clinical Hospital, Gastroenterology Department
Vinnytsia, 21018
Municipal Institution "Zaporizhzhya Regional Clinical Hospital" of Zaporizhzhya Regional Council
Zaporizhzhya, 69600
United Kingdom15 sites
Queen Elizabeth Hospital
Birmingham, B15 2WB
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
Medical Outpatient Department
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
Hull Royal Infirmary
Hull, HU3 2JZ
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 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
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
Complejo Hospitalario Universitario de Pontevedra
Pontevedra, 36071
Hospital de Sagunto
Sagunto, 46520
Hospital Universitario Virgen del Rocio
Seville, 41013
Hospital de Galdakao-Usandolo
Usansolo, 48960
Italy12 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
Endoscopia Digestiva Centralizzata
Milan, 20121
UO Gastroenterologia
Modena, 40124
UOC Gastroenterologia
Padova, 35128
Azienda Ospedaliero-Universitaria Pisana - Presidio Ospedaliero Cisanello
Pisa, 56124
UOC di Gastroenterologia ed Endoscopia Digestiva
Roma, 00133
Istituto Clinico Humanitas
Rozzano, 20089
A.O. Ordine Mauriziano di Torino
Torino, 10122
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, 13496
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
Israel11 sites
Emek Medical Center
Afula, 18101
Soroka Medical Center
Beersheba, 8410101
Bnai Zion Medical Center
Haifa, 31048
Rambam Health Care Campus
Haifa, 3109601
The Edith Wolfson Medical Center
Holon, 5822012
Shaare Zedek Medical Center
Jerusalem, 9103102
Hadassah Medical Center
Jerusalem, 91120
Meir Medical Center
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
Romania11 sites
SC MedLife SA, 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, 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
Russia11 sites
State Budgetary Healthcare Institute "Chelyabinsk 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 "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 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
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
Canada10 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
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 3M9
Netherlands9 sites
NZW Alkmaar (Noordwest Ziekenhuisgroep)
Alkmaar, 1815 JD
VU University Medical Centre
Amsterdam, 1081 HV
Academic Medical Center (AMC)
Amsterdam, 1100
Gelre Hospital
Apeldoorn, 7334
University Medical Center Groningen (UMCG)
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
Belgium8 sites
GZA Ziekenhuizen campus Sint-Vincentius
Antwerp, 2018
Imelda General Hospital
Bonheiden, 2820
CUB Hopital Erasme
Brussels, 1070
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 Campus Wilgenstraat
Roeselare, 8800
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
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 Saude do Alto Minho, EPE
Viana do Castelo, 4904-858
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
Czechia5 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
Thomayerova nemocnice, Interni klinika 3. LF UK a TN (Interni Oddeleni)
Prague, 140 00
ISCARE a.s. (Klinicke centrum ISCARE), Klinicke a vyzkumne centrum pro strevni zanety
Prague, 190 00
Greece5 sites
General Hospital of Athens "Hippokratio", 2nd Internal Medicine Clinic of Athens University, Hepato-gastroenterology Unit
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, 26500
General Hospital of Thessaloniki "Hippokratio", 4th Internal Medicine Department of Aristotle University of Thessaloniki
Thessaloniki, 54642
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
Serbia5 sites
Clinical Center of Serbia
Belgrade, 11000
Clinical Hospital Center Zemun
Belgrade, 11000
University Hospital Medical Center Bezanijska kosa
Belgrade, 3010-777
Zvezdara University Medical Center
Belgrade, 3810-969
Clinical Center of Vojvodina
Novi Sad, 21000
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
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
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
Singapore4 sites
National University Hospital
Singapore, 119074
Singapore General Hospital
Singapore, 169608
Tan Tock Seng Hospital
Singapore, 308433
Changi General Hospital
Singapore, 529889
Sri Lanka4 sites
National Hospital of Sri Lanka
Colombo, 00700
Teaching hospital Karapitiya
Galle, 80000
Kandy Teaching Hospital
Kandy, 20000
Colombo North Teaching Hospital
Ragama, 11010
Croatia3 sites
University Hospital Center Osijek
Osijek, 31 000
Clinical Hospital Dubrava
Zagreb, 10000
University Hospital Center Zagreb
Zagreb, 10000
Georgia3 sites
Unimed Ajara LLC - Batumi Referral Hospital
Batumi, 6010
Medi Club Georgia LLC
Tbilisi, 0160
Ltd. Unimed Kakheti - Telavi Referral Hospital
Telavi, 2200
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
South Africa3 sites
Dr MJ Prins
Cape Town, 7500
Dr John P Wright
Cape Town, 7708
Peermed Clinical Trial Centre
Johannesburg, 1619
Austria2 sites
Universitatsklinik Innsbruck
Innsbruck, 6020
AKH-Medizinische Universitat Wien
Vienna, 1090
Sweden2 sites
Danderyds Sjukhus AB
Danderyd, SE-18288
Akademiska Sjukhuset
Uppsala, 75185
Switzerland2 sites
Gastroenterologische Praxis Balsiger, Seibold und Partner
Bern, 3012
Universitatsspital Zurich
Zurich, 8091
About this study
Official title: Combined Phase 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 Crohn's Disease
The primary objectives of this study are to evaluate the safety and efficacy of filgotinib during induction and maintenance treatment of moderately to severely active Crohn's disease (CD) in participants who are biologic-naive and biologic-experienced.
Participants who complete the study, or do not meet protocol response or remission criteria at Week 10 will have the option to enter a separate long-term extension (LTE) study (Study GS-US-419-3896).
- 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
Filgotinib tablets administered orally once daily.
PlaceboOther
Placebo administered orally once daily.
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: Filgotinib 200 (mg) (Induction Study) | Experimental | Biologic naïve and biologic experienced participants received filgotinib 200 milligram (mg) with placebo-to-match (PTM) filgotinib 100 mg tablet orally once daily, for a period of 10 weeks. Receives: Drug: Filgotinib; Other: Placebo |
| Cohort A: Filgotinib 100 mg (Induction Study) | Experimental | Biologic naïve and biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks. Receives: Drug: Filgotinib; Other: Placebo |
| Cohort A: Placebo (Induction Study) | Placebo comparator | Biologic naïve and biologic experienced participants received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks. Receives: Drug: Filgotinib; Other: Placebo |
| Cohort B: Filgotinib 200 mg (Induction Study) | Experimental | Biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks. Receives: Drug: Filgotinib; Other: Placebo |
| Cohort B: Filgotinib 100 mg (Induction Study) | Experimental | Biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks. Receives: Drug: Filgotinib; Other: Placebo |
| Cohort B: Placebo (Induction Study) | Placebo comparator | Biologic experienced participants received PTM filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks. Receives: Drug: Filgotinib; Other: Placebo |
| Filgotinib 200 mg to Filgotinib 200 mg (Maintenance Study) | Experimental | Participants who received filgotinib 200 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, up to Week 58. Receives: Drug: Filgotinib |
| Filgotinib 200 mg to Placebo (Maintenance Study) | Experimental | Participants who received filgotinib 200 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58. Receives: Drug: Filgotinib; Other: Placebo |
| Filgotinib 100 mg to Filgotinib 100 mg (Maintenance Study) | Experimental | Participants who received filgotinib 100 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58. Receives: Drug: Filgotinib |
| Filgotinib 100 mg to Placebo (Maintenance Study) | Experimental | Participants who received filgotinib 100 mg in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib 200 mg and PTM filgotinib 100 mg tablet orally once daily, up to Week 58. Receives: Drug: Filgotinib; Other: Placebo |
| Placebo to Placebo (Maintenance Study) | Placebo comparator | Participants who received placebo in induction study and who achieved either clinical remission by PRO2 or endoscopic response at Week 10 were re-randomized to the maintenance study and received PTM filgotinib 100 mg and PTM filgotinib 200 mg tablet orally once daily, up to Week 58. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Induction Study: Percentage of Participants Who Achieved Clinical Remission by Crohn's Disease Activity Index (CDAI) at Week 10
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 subscores of abdominal pain (0-3), general well-being (0-4), 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.
Clinical remission was defined as a CDAI of < 150 points.
Measured: Week 10
Induction Study: Percentage of Participants Who Achieved Endoscopic Response at Week 10
The Simple Endoscopic Score for Crohn's Disease (SES-CD) assessed the degree of inflammation on the basis of 4 components: size of ulcers, ulcerated surface, affected surface, and presence of narrowing. Each of these components was scored on a scale of 0 to 3 (worst). In the SES-CD, each of these 4 components are assessed in the five segments: ileum, right colon, transverse colon, left colon, and rectum. The SES-CD was the sum of the individual scores of each of the components across the five segments. The range of SES-CD scores was 0 - 12 for each segment, and 0 - 60 for the overall SES-CD score, with larger scores indicating greater severity of disease. Endoscopic response was defined as ≥ 50% reduction from baseline in total SES-CD score.
Measured: Week 10
Maintenance Study: Percentage of Participants Who Achieved Clinical Remission by CDAI at Week 58
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), 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.
Clinical remission was defined as a CDAI of < 150 points.
Measured: Week 58
Maintenance Study: Percentage of Participants Who Achieved Endoscopic Response at Week 58
The SES-CD assessed the degree of inflammation on the basis of 4 components: size of ulcers, ulcerated surface, affected surface, and presence of narrowing. Each of these components was scored on a scale of 0 to 3 (worst). In the SES-CD, each of these 4 components are assessed in the five segments: ileum, right colon, transverse colon, left colon, and rectum. The SES-CD was the sum of the individual scores of each of the components across the five segments. The range of SES-CD scores was 0 - 12 for each segment, and 0 - 60 for the overall SES-CD score, with larger scores indicating greater severity of disease. Endoscopic response was defined as ≥ 50% reduction from baseline in total SES-CD score.
Measured: Week 58
Secondary outcomes (16)
Induction Study: Percentage of Participants Who Achieved Clinical Remission by PRO2 at Week 10
The PRO2 was a composite score based on 2 components of the CDAI, the number of liquid or soft stools/day for 7 days, stool frequency and abdominal pain (rated on a scale of 0-3) assessed for 7 days. Clinical Remission was defined as the average daily stool score ≤3 points AND average daily abdominal pain score ≤1 point.
Measured: Week 10
Induction Study: Percentage of Participants Who Achieved Clinical Response by CDAI at Week 10
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 subscores of abdominal pain (0-3), general well-being (0-4), 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.
Clinical response was defined as reduction in CDAI score from Induction baseline by at least 100 points or CDAI score < 150 points.
Measured: Week 10
Maintenance Study: Percentage of Participants Who Achieved Clinical Remission by PRO2 at Week 58
The PRO2 was a composite score based on 2 components of the CDAI, the number of liquid or soft stools/day for 7 days, stool frequency and abdominal pain (rated on a scale of 0-3) assessed for 7 days. Clinical Remission was defined as the average daily stool score ≤3 points AND average daily abdominal pain score ≤1 point.
Measured: Week 58
Maintenance Study: Percentage of Participants Who Achieved Clinical Response by CDAI at Week 58
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), 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.
Clinical response was defined as reduction in CDAI score from Induction baseline by at least 100 points or CDAI score < 150 points.
Measured: Week 58
Maintenance Study: Percentage of Participants Who Achieved Sustained Clinical Remission by CDAI at Both Weeks 10 and 58
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), 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.
Sustained Clinical Remission by CDAI: CDAI <150 combined at both Week 10 and Week 58.
Measured: Weeks 10 and 58
Maintenance Study: Percentage of Participants Who Achieved 6 Month Corticosteroid-Free Remission by CDAI at Week 58
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 subscores of abdominal pain (0-3), general well-being (0-4), 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.
6-Month Corticosteroid-Free Clinical remission by CDAI: CDAI <150 with no corticosteroid use for indication of Crohn's disease for at least 6 months prior to Week 58.
Measured: Week 58
Maintenance Study: Percentage of Participants Who Achieved Sustained Clinical Remission by PRO2 at Both Weeks 10 and 58
The PRO2 was a composite score based on 2 components of the CDAI, the number of liquid or soft stools/day for 7 days, stool frequency and abdominal pain (rated on a scale of 0-3) assessed for 7 days.
Sustained Clinical Remission by PRO2: liquid or very soft stool ≤3 and abdominal pain ≤1 combined at both Week 10 and Week 58.
Measured: Weeks 10 and 58
Maintenance Study: Percentage of Participants Who Achieved 6 Month Corticosteroid-Free Remission by PRO2 at Week 58
The PRO2 was a composite score based on 2 components of the CDAI, the number of liquid or soft stools/day for 7 days, stool frequency and abdominal pain (rated on a scale of 0-3) assessed for 7 days.
6-month Corticosteroid-Free Clinical Remission by PRO2: liquid or very soft stool ≤3 and abdominal pain ≤1 with no corticosteroid use for at least 6 months prior to Week 58.
Measured: Week 58
Induction Study:Pharmacokinetic Plasma Concentrations of Filgotinib at Week 4
Plasma concentrations of filgotinib [nanogram/milliliters (ng/mL)].
Measured: Week 4: 0.5, 1, 2, and 3 hours (hrs) post dose
Induction Study: Pharmacokinetic Plasma Concentrations of Filgotinib at Week 10
Plasma concentrations of filgotinib (ng/mL).
Measured: Week 10: Predose
Maintenance Study: Pharmacokinetic Plasma Concentrations of Filgotinib at Week 26
Plasma concentrations of filgotinib (ng/mL).
Measured: Week 26: At any timepoint
Maintenance Study: Pharmacokinetic Plasma Concentrations of Filgotinib at Week 58
Plasma concentrations of filgotinib (ng/mL).
Measured: Week 58: Pre-dose
Induction Study: Pharmacokinetic Plasma Concentrations of Filgotinib's Metabolite GS-829845 at Week 4
Plasma concentrations of GS-829845 (ng/mL).
Measured: Week 4: 0.5, 1, 2, and 3 hrs post dose
Induction Study: Pharmacokinetic Plasma Concentrations of Filgotinib's Metabolite GS-829845 at Week 10
Plasma concentrations of GS-829845 (ng/mL).
Measured: Week 10: Predose
Maintenance Study: Pharmacokinetic Plasma Concentrations of Filgotinib's Metabolite GS-829845 at Week 26
Plasma concentrations of GS-829845 (ng/mL).
Measured: Week 26: At any timepoint
Maintenance Study: Pharmacokinetic Plasma Concentrations of Filgotinib's Metabolite GS-829845 at Week 58
Plasma concentrations of GS-829845 (ng/mL).
Measured: Week 58: Pre-dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2016 (estimated)
- Study start31 Oct 2016
- Primary completion11 Nov 2022
- Study completion11 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- 1,372 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lakefront Biotherapeutics NV
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Gilead Sciences
- Responsible party
- Sponsor
- Investigators
- Galapagos Study Director, Study director, Lakefront Biotherapeutics NV
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02914561
- Sponsor's protocol ID
- GS-US-419-3895
- Other IDs
- 2016-001367-36, 2016
- Acronym
- DIVERSITY1
- Status last verified
- Nov 2023
- First submitted
- 22 Sep 2016
- Last updated
- 18 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vermeire S, Schreiber S, Rubin DT, D'Haens G, Reinisch W, Watanabe M, Mehta R, Roblin X, Beales I, Gietka P, Hibi T, Hospodarskyy I, Ritter T, Genovese MC, Kwon P, Santermans E, Le Brun FO, Barron R, Masior T, Danese S. Efficacy and safety of filgotinib as induction and maintenance therapy for Crohn's disease (DIVERSITY): a phase 3, double-blind, randomised, placebo-controlled trial. Lancet Gastroenterol Hepatol. 2025 Feb;10(2):138-153. doi: 10.1016/S2468-1253(24)00272-3. Epub 2024 Dec 2.
PubMed 39637881