Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Crohn's Disease (DIVERSITY1)

November 24, 2023 updated by: Galapagos NV

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

1372

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Rosario, Argentina, S2000DEF
        • Fundacion Estudios Clinicos CiRec
  • Australia
    • New South Wales
      • Camperdown, New South Wales, Australia, 2050
        • Royal Prince Alfred Hospital
      • Clayton, New South Wales, Australia, 3168
        • Monash Medical Centre
      • Darlinghurst, New South Wales, Australia, 2010
        • St. Vincent's Hospital Sydney
      • Kingswood, New South Wales, Australia, 2747
        • Nepean Hospital
      • Wollongong, New South Wales, Australia, 2500
        • Wollongong Hospital
    • Queensland
      • Mountain Creek, Queensland, Australia, 4557
        • Coastal Digestive Health
      • North Mackay, Queensland, Australia, 4740
        • Coral Sea Clinical Research Institute (Mackay)
      • South Brisbane, Queensland, Australia, 4101
        • Mater Misericordiae Ltd
      • Woolloongabba, Queensland, Australia, 4102
        • Princess Alexandra Hospital
    • South Australia
      • Bedford Park, South Australia, Australia, 5042
        • Flinders Medical Centre
      • Woodville South, South Australia, Australia, 5011
        • The Queen Elizabeth Hospital
    • Victoria
      • Camberwell, Victoria, Australia, 3124
        • Emeritus Research
      • Footscray, Victoria, Australia, 3011
        • Footscray Hospital
      • Heidelberg, Victoria, Australia, 3084
        • Austin Health
      • Malvern, Victoria, Australia, 3144
        • Cabrini Hospital
      • Melbourne, Victoria, Australia, 3004
        • Alfred Hospital
      • Parkville, Victoria, Australia, 3050
        • Royal Melbourne Hospital
  • Austria
      • Innsbruck, Austria, 6020
        • Universitätsklinik Innsbruck
      • Wien, Austria, 1090
        • AKH-Medizinische Universitat Wien
  • Belgium
      • Antwerpen, Belgium, 2018
        • GZA Ziekenhuizen campus Sint-Vincentius
      • Bonheiden, Belgium, 2820
        • Imelda General Hospital
      • Brussel, Belgium, 1070
        • CUB Hôpital Erasme
      • Gent, Belgium, 9000
        • Universitair Ziekenhuis Gent
      • Leuven, Belgium, 3000
        • Universitair Ziekenhuis Leuven
      • Liege, Belgium, 4000
        • CHR Citadelle
      • Liège, Belgium, 4000
        • Centre Hospitalier Chretien (CHC) - Clinique Saint-Joseph
      • Roeselare, Belgium, 8800
        • AZ Delta Campus Wilgenstraat
  • Bulgaria
      • Samokov, Bulgaria, 2000
        • Medical Center - Complete Medical Solutions OOD
      • Sliven, Bulgaria, 8800
        • Medical Center - "Tsaritsa Yoanna" EOOD
      • Veliko Tarnovo, Bulgaria, 5000
        • "MDHAT Dr. St.Cherkezov" AD
      • Vidin, Bulgaria, 3700
        • MHAT "Sveta Petka" AD
  • Canada
      • Barrie, Canada, L4M 7G1
        • Barrie GI Associates
      • Calgary, Canada, T2N 4Z6
        • University of Calgary, Heritage Medical Research Clinic
      • Hamilton, Canada, L8S 4K1
        • Hamilton Health Sciences Corporation, McMaster University Medical Centre
      • London, Canada, N6A 5A5
        • London Health Sciences Centre - University Hospital
      • North York, Canada, M6A 3B4
        • TIDHI Innovation Inc.
      • Oakville, Canada, L6L 5L7
        • ABP Research Services
      • Saskatoon, Canada, S7N 0W8
        • Royal University Hospital
      • Vancouver, Canada, V5Z 1M9
        • The Gordon and Leslie Diamond Health Care Centre
      • Vaughan, Canada, L4L 4Y7
        • Toronto Digestive Disease Associates Inc.
      • Victoria, Canada, V8V 3M9
        • PerCuro Clinical Research Ltd.
  • Croatia
      • Osijek, Croatia, 31 000
        • University Hospital Center Osijek
      • Zagreb, Croatia, 10000
        • University hospital center Zagreb
      • Zagreb, Croatia, 10000
        • Clinical Hospital Dubrava
  • Czechia
      • Hradec Kralove, Czechia, 500 12
        • Hepato-Gastroenterologie HK, s.r.o.
      • Mlada Boleslav, Czechia, 293 01
        • Oblastni nemocnice Mlada Boleslav, a.s., nemocnice Stredoceskeho kraje, Gastroenterologicke oddeleni
      • Praha 3, Czechia, 130 00
        • G.E.P. Clinic, s r.o.
      • Praha 4, Czechia, 140 00
        • Thomayerova nemocnice, Interni klinika 3. LF UK a TN (Interni Oddeleni)
      • Praha 9, Czechia, 190 00
        • ISCARE a.s. (Klinicke centrum ISCARE), Klinicke a vyzkumne centrum pro strevni zanety
  • France
      • Amiens Cedex 1, France, 80054
        • CHU Amiens Picardie
      • Caen Cedex 9, France, 14033
        • CHU de Caen
      • Clermont-Ferrand, France, 63003
        • CHU de Clermont-Ferrand - Hôpital d'Estaing
      • Clichy, France, 92110
        • APHP - Hopital Beaujon - Clichy - Universite Paris VII
      • Créteil, France, 94010
        • Centre Hospitalier Intercommunal de Créteil
      • Dijon, France, 21079
        • CHU de Dijon Bourgogne - Hopital Francois Mitterand
      • La Tronche, France, 38700
        • CHU Grenoble Alpes
      • Le Kremlin Bicetre, France, 94270
        • Hopital Universitaire de Bicetre
      • Lille, France, 59000
        • Centre Hospitalier Regional Universitaire de Lille
      • Marseille, France, 13015
        • Hopital Nord
      • Marseille, France, 13285
        • Hôpital Saint Joseph
      • Montpellier, France, 34295
        • CHU de Montpellier-Hopital Saint Eloi
      • Nantes, France, 44093
        • Centre d'Investigation Clinique - CHU Hotel-Dieu
      • Nice, France, 06202
        • Hopital de l'archet 2
      • Pessac, France, 33600
        • CHU de Bordeaux - Hôpital Haut Leveque
      • Pierre-Benite, France, 69495
        • Centre Hospitalier Universitaire de Lyon Sud
      • Pringy Cedex, France, 74374
        • CH Annecy Genevois - Site d'Annecy
      • Rennes Cedex 9, France, 35033
        • Centre Hospitalier Universitaire de Rennes - Hôpital Pontchaillou
      • Saint Priest en Jarez, France, 42055
        • CHU de Saint-Etienne - Hôpital Nord
      • Strasbourg, France, 67091
        • Nouvel Hopital Civil
      • Strasbourg, France, 67098
        • Hôpitaux Universitaires de Strasbourg - Hôpital de Hautepierre
      • Toulouse, France, 31059
        • CHU de Toulouse - Hôpital Rangueil
      • Toulouse Cedex 9, France, 31059
        • CHU de Toulouse - Hôpital Rangueil
      • Vandoeuvre-les-Nancy Cedex, France, 54511
        • CHU de Nancy - Hopital Brabois Adultes
  • Georgia
      • Batumi, Georgia, 6010
        • Unimed Ajara LLC - Batumi Referral Hospital
      • Tbilisi, Georgia, 0160
        • Medi Club Georgia LLC
      • Telavi, Georgia, 2200
        • Ltd. Unimed Kakheti - Telavi Referral Hospital
  • Germany
      • Berlin, Germany, 13353
        • Charité - Universitätsmedizin Berlin
      • Berlin, Germany, 10825
        • GASTRO-Studien
      • Berlin, Germany, 10117
        • Charite Universitaetsmedizin Berlin
      • Berlin, Germany, 14050
        • DRK Kliniken Berlin - Westend - Klinik fuer Innere Medizin
      • Braunschweig, Germany, 38126
        • Städtisches Klinikum Braunschweig gGmbH
      • Frankfurt am Main, Germany, 60431
        • Agaplesion Markus Krankenhaus
      • Frankfurt am Main, Germany, 60594
        • CED Studien UG, Interdisciplinary Crohn Colitis Center (iCCC) Rhein-Main
      • Freiburg, Germany, 79106
        • Universitätsklinikum Freiburg
      • Hamburg, Germany, 22559
        • Asklepios Westklinikum Hamburg
      • Hannover, Germany, 30625
        • Medizinische Hochschule Hannover
      • Heidelberg, Germany, 69120
        • Universitätsklinikum Heidelberg
      • Heidelberg, Germany, 69121
        • Praxis fur Gastroenterologie
      • Herne, Germany, 44623
        • Gastroenterologische Gemeinschaftspraxis Herne
      • Jena, Germany, 07747
        • Universitätsklinikum Jena
      • Kiel, Germany, 24105
        • Universitätsklinikum Schleswig-Holstein
      • Koln, Germany, 50937
        • Universitätsklinik Köln
      • Leipzig, Germany, 04103
        • Universitätsklinikum Leipzig
      • Leipzig, Germany, 04103
        • Eugastro GmbH
      • Lüneburg, Germany, 21339
        • Klinikum Luneburg
      • Minden, Germany, 32423
        • Gastroenterologische Gemeinschaftspraxis Minden
      • Muenchen, Germany, 81377
        • Klinikum der Universität München - Großhadern
      • Rostock, Germany, 18057
        • Universitaetsmedizin Rostock, Zentrum fuer Innere Medizin
      • Tuebingen, Germany, 72074
        • Universitaetsklinikum Tuebingen
      • Ulm, Germany, 89081
        • Universitatsklinikum Ulm, Zentrum Fur Innere Medizin
  • Greece
      • Athens, Greece, 11527
        • General Hospital of Athens "Hippokratio", 2nd Internal Medicine Clinic of Athens University, Hepato-gastroenterology Unit
      • Athens, Greece, 12462
        • University General Hospital "Attikon", 2nd Propaedeutic Internal Medicine Dept. and Research Unit, Hepatogastroenterology Unit
      • Ioannina, Greece, 45332
        • University General Hospital of Ioannina, Gastroenterology Department, Internal Medicine Division
      • Patras, Greece, 26500
        • University General Hospital of Patras "Panagia I Voithia", Gastroenterology Department, Internal Medicine Division
      • Thessaloniki, Greece, 54642
        • General Hospital of Thessaloniki "Hippokratio", 4th Internal Medicine Department of Aristotle University of Thessaloniki
  • Hong Kong
      • Hong Kong, Hong Kong
        • Queen Mary Hospital
      • Hong Kong, Hong Kong
        • Princess Margaret Hospital
      • Shatin, Hong Kong
        • Department of Medicine & Therapeutics, The Chinese University of Hong Kong, Prince of Wales Hospital
      • Tuen Mun, Hong Kong
        • Tuen Mun Hospital
  • Hungary
      • Bekescsaba, Hungary, 5600
        • Bekes Megyei Kosponti Korhaz, Dr. Rethy Pal Tagkorhaz, IV. Belgyogyaszat - 2. Gasztroenterologia
      • Budapest, Hungary, 1032
        • Szent Margit Korhaz, Gasztroenterológiai Osztály
      • Budapest, Hungary, 1033
        • Clinexpert Egészségügyi Szolgáltató és Kereskedelmi Kft.
      • Budapest, Hungary, 1097
        • Del-pesti Centrumkorhaz - Orszagos Hematologiai es Infektologiai Intezet, Kozponti Felnott Szakrendelo
      • Budapest, Hungary, 1125
        • Szent Janos Korhaz es Eszak-budai Egitett Korhazak, I. Belgyogyaszati - Gasztroenterologiai Osztaly
      • Debrecen, Hungary, 4032
        • Debreceni Egyetem Klinikai Kozpont, II. sz. Belgyogyaszati Klinika, Gasztroenterologia
      • Gyöngyös, Hungary, 3200
        • Bugat Pal Korhaz, Belgyogyaszat
      • Mosonmagyarovar, Hungary, 9200
        • Karolina Korhaz es Rendelointezet, Altalanos Belgyogyaszat-Gasztroenterologia
  • Iceland
      • Reykjavik, Iceland, 101
        • Landspitali University Hospital
  • India
      • Ahmedabad, India, 380052
        • Kaizen Hospital
      • Ahmedabad, India, 380054
        • Gastroplus Digestive Disease Centre Pvt Ltd
      • Ahmedabad, India, 380054
        • Sal Hospital and Medical Institute
      • Bangalore, India, 560002
        • Victoria Hospital, Bangalore Medical College And Research Institute
      • Bangalore, India, 560054
        • M S Ramaiah Medical College and Hospital
      • Belgaum, India, 590010
        • KLES Dr. Prabhakar Kore Hospital & MRC
      • Bengaluru, India, 560060
        • BGS Global Hospital
      • Chennai, India, 600035
        • Apollo Speciality Hospital
      • Coimbatore, India, 641005
        • VGM Hospital Institute of Gastroenterology
      • Delhi, India, 110026
        • Maharaja Agrasen Hospital
      • Ernakulam, India, 682012
        • Lourdes Hospital
      • Ernakulam, India, 682017
        • PVS Memorial Hospital Private Limited
      • Gurgaon, India, 122002
        • Fortis Medical Research Institute
      • Guwahati, India, 781006
        • Institute of Digestive & Liver Diseases
      • Hyderabad, India, 500004
        • Gleneagles Global Hospitals
      • Hyderabad, India, 500019
        • Citizens Specialty Hospital
      • Hyderabad, India, 500035
        • Aware Gleneagles Global Hospitals
      • Hyderabad, India, 500058
        • Centre for Liver Research & Diagnostics
      • Hyderabad, India, 500082
        • Asian Institute of Gastroenterology Pvt Ltd
      • Jaipur, India, 302001
        • S.R.Kalla Memorial Gastro.&General Hospital
      • Jaipur, India, 302004
        • S.M.S Medical College & Hospitals
      • Kanpur, India, 208002
        • GSVM Medical College
      • Kochi, India, 682040
        • Lakeshore Hospital and Research Centre Ltd.
      • Kochi, India, 682041
        • Amrita Institute of Medical Sciences and Research Centre
      • Kolkata, India, 700020
        • School of Digestive & Liver Diseases
      • Kolkata, India, 700054
        • Apollo Gleneagles Hospitals
      • Lucknow, India, 226003
        • King George's Medical University
      • Ludhiana, India, 141001
        • Dayanand Medical College & Hospital
      • Mangaluru, India, 575001
        • Kasturba Medical College (KMC) Hospital
      • Mumbai, India, 400012
        • Seth G.S Medical College & KEM Hospital
      • Mumbai, India, 400022
        • Lokmanya Tilak Municipal General Hospital
      • Nagpur, India, 440010
        • Midas Multispeciality Hospital Pvt. Ltd
      • Nagpur, India, 440012
        • Suretech Hospital & Research Centre Ltd
      • New Delhi, India, 110029
        • All India Institute of Medical Sciences
      • New Delhi, India, 110070
        • Fortis Flt. Lt. Rajan Dhall Hospital
      • New Delhi, India, 110017
        • Max Smart Super Speciality Hospital
      • New Delhi, India, 11005
        • Dr. B.L. Kapur Memorial Hospital
      • Parel, India, 400012
        • S.L Raheja Hospital
      • Pune, India, 411001
        • Department of Surgery, B.J. Government Medical College & Sassoon General Hospital
      • Pune, India, 411001
        • Grant Medical Foundation Ruby Hall Clinic
      • Pune, India, 411011
        • Universal Hospital
      • Rajkot, India, 360002
        • Shree Giriraj Multispeciality Hospital
      • Secunderabad, India, 500003
        • Gandhi Hospital
      • Secunderabad, India, 500003
        • Institute of Gastroenterology & Liver Disease. Sunshine Hospitals
      • Surat, India, 395002
        • Surat Institute of Digestive Sciences
      • Surat, India, 395009
        • BAPS Pramukh Swami Hospital
      • Udupi, India, 576104
        • Kasturba Hospital Medical College
      • Vadodara, India, 390007
        • Sterling Hospital
      • Varanasi, India, 221005
        • Samvedna Hospital
    • Rajasthan
      • Bīkaner, Rajasthan, India, 334003
        • S.P. Medical College & AG of Hospitals
  • Ireland
      • Dublin, Ireland, 9
        • Beaumont Hospital
      • Dublin, Ireland, 4
        • St. Vincent's University Hospital
      • Dublin, Ireland, DUBLIN 8
        • Wellcome Trust HRB Clinical Research Facility
      • Galway, Ireland, H91 YR71
        • University Hospital Galway
  • Israel
      • Afula, Israel, 18101
        • Emek Medical Center
      • Be'er Sheva, Israel, 8410101
        • Soroka Medical Center
      • Haifa, Israel, 3109601
        • Rambam Health Care Campus
      • Haifa, Israel, 31048
        • Bnai Zion Medical Center
      • Holon, Israel, 5822012
        • The Edith Wolfson Medical Center
      • Jerusalem, Israel, 9103102
        • Shaare Zedek Medical Center
      • Jerusalem, Israel, 91120
        • Hadassah Medical Center
      • Kefar Sava, Israel, 4428164
        • Meir Medical Center
      • Petah Tikva, Israel, 4941492
        • Rabin Medical Center
      • Ramat Gan, Israel, 5265601
        • The Chaim Sheba Medical Center
      • Tel Aviv-Yafo, Israel, 64239
        • Tel Aviv Sourasky Medical Center
  • Italy
      • Castellana Grotte, Italy, 70013
        • UOC Gastroenterologia II
      • Catanzaro, Italy, 88100
        • U.O. Fisiopatologia Digestiva
      • Cento, Italy, 44042
        • UOC Medicina Interna
      • Chieti, Italy, 66100
        • Ospedale Clinicizzato SS. Annunziata - Dipartimento di Medicina
      • Firenze, Italy, 50134
        • Gastroenterologia clinica - Azienda Ospedaliero-Universitaria Careggi
      • Milano, Italy, 20121
        • Endoscopia Digestiva Centralizzata
      • Modena, Italy, 40124
        • UO Gastroenterologia
      • Padova, Italy, 35128
        • UOC Gastroenterologia
      • Pisa, Italy, 56124
        • Azienda Ospedaliero-Universitaria Pisana - Presidio Ospedaliero Cisanello
      • Roma, Italy, 00133
        • UOC di Gastroenterologia ed Endoscopia Digestiva
      • Rozzano, Italy, 20089
        • Istituto Clinico Humanitas
      • Torino, Italy, 10122
        • A.O. Ordine Mauriziano di Torino
  • Japan
      • Ageo-shi, Japan, 362-0075
        • Ohmori Toshihide gastro-intestinal Clinic
      • Bunkyo-ku, Japan, 113-8519
        • Tokyo Medical and Dental University Hospital
      • Chuo-ku, Japan, 060-0033
        • Hokkaido P.W.F.A.C Sapporo-Kosei General Hospital
      • Fukuoka-shi, Japan, 815-8555
        • Japanese Red Cross Fukuoka Hospital
      • Hachioji, Japan, 192-0032
        • Tokai University Hachioji Hospital
      • Hamamatsu-shi, Japan, 430-0846
        • Medical corporation Ryowakai, Hamamatsu South Hospital
      • Hiroshima, Japan, 734-8551
        • Hiroshima University Hospital
      • Hiroshima-shi, Japan, 734-8530
        • Hiroshima Prefectural Hospital
      • Jonan-ku, Japan, 814-0180
        • Fukuoka University Hospital
      • Kagoshima-shi, Japan, 892 -8512
        • Nanpuh Hospital
      • Kamakura, Japan, 247-0056
        • Ofuna Chuo Hospital
      • Kashiwa-city, Japan, 277-0871
        • Tsujinaka Hospital
      • Kawagoe, Japan, 350-8550
        • Saitama Medical Center, Saitama Medical University
      • Kitakyushu-shi, Japan, 802-0077
        • Kitakyushu City Hospital Organization Kitakyushu Municipal Medical Center
      • Kofu-shi, Japan, 400-8506
        • Yamanashi Prefectural Central Hospital
      • Kurume-shi, Japan, 839-0809
        • Hidaka Coloproctology Clinic
      • Kurume-shi, Japan, 830-0011
        • Kurume University Hospital
      • Kyoto-shi, Japan, 602-8566
        • University Hospital, Kyoto Prefectural University of Medicine
      • Minato-ku, Japan, 108-8642
        • Kitasato University Kitasato Institute Hospital
      • Minato-ku, Japan, 105-8471
        • The Jikei University Hospital
      • Mitaka-shi, Japan, 181-8611
        • Kyorin University Hospital
      • Morioka-shi, Japan, 020-8505
        • Iwate Medical University Hospital
      • Nagakute-shi, Japan, 480-1195
        • Aichi Medical University Hospital
      • Nagasaki-shi, Japan, 8528501
        • Nagasaki University Hospital
      • Nagoya, Japan, 467-8602
        • Nagoya City University Hospital
      • Nishi-ku, Japan, 950-1104
        • Saiseikai Niigata Daini Hospital
      • Nishinomiya, Japan, 663-8501
        • Hyogo College of Medicine College Hospital
      • Oita-shi, Japan, 870-0823
        • Ishida IBD Clinic
      • Okayama-city, Japan, 700-8558
        • Okayama University Hospital
      • Osaka, Japan, 545-8586
        • Osaka City University Hospital
      • Osaka, Japan, 579-8056
        • Wakakusa-Daiichi Hospital
      • Osaka-City, Japan, 530-0011
        • Kinshukai Infusion Clinic
      • Otsu, Japan, 520-2192
        • Shiga University Of Medical Science Hospital
      • Saga, Japan, 849-8501
        • Saga University Hospital
      • Saga-shi, Japan, 840-8571
        • Saga-Ken Medical Centre Koseikan
      • Sagamihara, Japan, 252-0375
        • Kitasato University Hospital, THE KITASATO INSTITUTE
      • Saitama, Japan, 336-0963
        • Tokito Clinic
      • Sakura, Japan, 285-8741
        • Toho University Sakura Medical Center
      • Sapporo, Japan, 004-0041
        • Sapporo Tokushukai Hospital
      • Sapporo-shi, Japan, 065-0033
        • Sapporo Higashi Tokushukai Hospital
      • Sendai, Japan, 983-8520
        • National Hospital Organization Sendai Medical Center
      • Shinjuku-ku, Japan, 169-0073
        • Tokyo Yamate Medical Center
      • Suita, Japan, 565-0871
        • Osaka University Hospital
      • Takamatsu-shi, Japan, 760-8557
        • Kagawa Prefectural Central Hospital
      • Takasaki-shi, Japan, 3700829
        • National Hospital Organization Takasaki General Medical Center
      • Takatsuki, Japan, 569-8686
        • Osaka Medical College Hospital
      • Toyota-shi, Japan, 470-1219
        • Ieda Hospital
      • Wakayama-shi, Japan, 641-8509
        • Wakayama Medical University Hospital
      • Yokohama-shi, Japan, 231-0012
        • Yokohama Health Medicine Association Kannai Suzuki Clinic
  • Korea, Republic of
      • Busan, Korea, Republic of, 49241
        • Pusan National University Hospital
      • Daegu, Korea, Republic of, 42415
        • Yeungnam University Hospital
      • Guri-Si, Korea, Republic of, 471-701
        • Kyung Hee University Hospital
      • Gyeonggi-do, Korea, Republic of, 11923
        • Hanyang University Guri Hospital
      • Seongnam-si, Korea, Republic of, 13496
        • CHA Bundang Medical Center, CHA University
      • Seoul, Korea, Republic of, 03080
        • Seoul National University Hospital
      • Seoul, Korea, Republic of, 05505
        • Asan Medical Center
      • Seoul, Korea, Republic of, 03181
        • Kangbuk Samsung Hospital
      • Seoul, Korea, Republic of, 03722
        • Yonsei University Health System, Severance Hospital
      • Seoul, Korea, Republic of, 06351
        • Division of Gastroenterology, Department of Medicine, Samsung Medical Center
      • Suwon-si, Korea, Republic of, 16247
        • The Catholic University of Korea, St. Vincent's Hospital
      • Wonju, Korea, Republic of, 220-701
        • Yonsei University Wonju Severance Christian Hospital
  • Malaysia
      • Cheras, Malaysia, 56000
        • Universiti Kebangsaan Malaysia Medical Center
      • George Town, Malaysia, 10990
        • Hospital Pulau Pinang
      • Kota Kinabalu, Malaysia, 88586
        • Hospital Queen Elizabeth
      • Kuala Lumpur, Malaysia, 59100
        • University Malaya Medical Centre
      • Kuantan, Malaysia, 25100
        • Hospital Tengku Ampuan Afzan
  • Netherlands
      • Alkmaar, Netherlands, 1815 JD
        • NZW Alkmaar (Noordwest Ziekenhuisgroep)
      • Amsterdam, Netherlands, 1081 HV
        • VU University Medical Centre
      • Amsterdam, Netherlands, 1100
        • Academic Medical Center (AMC)
      • Apeldoorn, Netherlands, 7334
        • Gelre Hospital
      • Groningen, Netherlands, 9700 RB
        • University Medical Center Groningen (UMCG)
      • Maastricht, Netherlands, 6229 HX
        • Maastricht University Medical Centre
      • Rotterdam, Netherlands, 3015 CE
        • Erasmus University Medical Center
      • Tilburg, Netherlands, 5022
        • Elisabeth-TweeSteden hospital
      • Utrecht, Netherlands, 3584 CX
        • University Medical Center Utrecht
  • New Zealand
      • Christchurch, New Zealand, 8011
        • Christchurch Hospital
      • Dunedin, New Zealand, 9016
        • Southern District Health Board - Dunedin Hospital
      • Grafton, New Zealand, 1023
        • Auckland City Hospital
      • Hamilton, New Zealand, 3240
        • Waikato Hospital
      • Newtown, New Zealand, 6021
        • Wellington Hospital
      • Tauranga, New Zealand, 3112
        • Bay of Plenty District Health Board - Tauranga Hospital
      • Wellington, New Zealand, 5010
        • Hutt Valley District Health Board - Hutt Valley Hospital
  • Norway
      • Drammen, Norway, 3004
        • Vestre Viken Hospital Trust, Baerum Hospital
  • Poland
      • Bialystok, Poland, 15-276
        • Uniwersytecki Szpital Kliniczny w Bialymstoku, Klinika Gastroenterologii i Chorob Wewnetrznych
      • Bydgoszcz, Poland, 85-681
        • Gabinet Lekarski Janusz Rudzinski
      • Bydgoszcz, Poland, 85-079
        • VITAMED Galaj i Cichomski spolka jawna
      • Bydgoszcz, Poland, 85-168
        • Szpital Uniwersytecki nr 2 im. Dr. Jana Biziela w Bydgoszczy, Centrum Endoskopii Zabiegowej, Poradnia Chorob Jelitowych
      • Czestochowa, Poland, 42-217
        • NZOZ INTER-MED, Centrum Endoskopowe
      • Katowice, Poland, 40-659
        • Niepubliczny Zaklad Opieki Zdrowotnej All-Medicus
      • Krakow, Poland, 31-009
        • Gabinet Endoskopii Przewodu Pokarmowego
      • Kraków, Poland, 31-501
        • Krakowskie Centrum Medyczne Sp. z o.o.
      • Kraków, Poland, 30-015
        • Centrum Medyczno-Diagnostyczne Prima-Med
      • Lodz, Poland, 90-153
        • Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwerstyeckiego Szpitala Klinicznego nr 1 im. Norbert Barlickiego
      • Piotrków Trybunalski, Poland, 97-300
        • Trialmed CRS
      • Poznan, Poland, 60-848
        • Clinical Research Center Spolka z ograniczna odpowiedzialnoscia Medic-R Sp. k.
      • Rzeszów, Poland, 35-301
        • Gabinet Lekarski Dr. Hab. N. Med. Bartosz Korczowski
      • Sopot, Poland, 81-756
        • ENDOSKOPIA Sp. z o.o.
      • Szczecin, Poland, 71-434
        • Twoja Przychodnia-Szczecinskie Centrum Medyczne
      • Torun, Poland, 87-100
        • GASTROMED Kopon, Zmudzkinski i Wspolnicy Sp. j. Specjalistyczne Centrum Gastrologii i Endoskopii
      • Tychy, Poland, 43-100
        • H-T.Centrum Medyczne Spolka z Ograniczona Odpowiedzialnoscia Sp.K.
      • Warsaw, Poland, 02-781
        • Centrum Onkologii - Instytut im. Marii Sklodowskiej-Curie
      • Warszawa, Poland, 00-728
        • WIP Warsaw IBD Point Profesor Kierkus
      • Warszawa, Poland, 00-635
        • Centrum Zdrowia MDM
      • Warszawa, Poland, 02-798
        • Medical Concierge Centrum Medyczne
      • Warszawa, Poland, 02-507
        • Centralny Szpital Kliniczny Ministerstwa Spraw Wewnetrznych i Administacji w Warszawie
      • Warszawa, Poland, 03-580
        • Niepubliczny Zaklad Opieki Zrodotnej VIVAMED Jadwige Miecz
      • Warszawa, Poland, 03-712
        • BodyClinic
      • Wroclaw, Poland, 52-416
        • Centrum Medyczne Oporów
      • Wroclaw, Poland, 54-204
        • Centrum Medyczne
  • Portugal
      • Braga, Portugal, 4710-243
        • Hospital de Braga
      • Coimbra, Portugal, 3000-075
        • Centro Hospitalar e Universitário de Coimbra, E.P.E.
      • Covilhã, Portugal, 6200-251
        • Centro Hospitalar Cova de Beira, EPE
      • Faro, Portugal, 8000-386
        • Centro Hospitalar do Algarve EPE
      • Guimaraes, Portugal, 4835-044
        • Hospital da Senhora da Oliveira Guimaraes, E.P.E.
      • Loures, Portugal, 2674-514
        • Hospital Beatriz Angelo
      • Porto, Portugal, 4200-319
        • Centro Hospitalar de Sao Joao, EPE
      • Viana do Castelo, Portugal, 4904-858
        • Unidade Local de Saude do Alto Minho, EPE
  • Romania
      • Bucharest, Romania, 011025
        • S.C. Centrul Medical Sana S.R.L., Gastroenterologie
      • Bucharest, Romania, 050098
        • Spitalul Universitar de Urgenta Bucuresti - Sectia Medicina Interna II
      • Bucuresti, Romania, 010719
        • SC MedLife SA, Gastroenterologie
      • Bucuresti, Romania, 010825
        • Spitalul Universitar de Urgenta Militar Central Dr. Carol Davila - Sectia Clinica de Gastroenterologie
      • Bucuresti, Romania, 014142
        • Delta Health Care/ Ponderas Academic Hospital
      • Bucuresti, Romania, 020125
        • Spitalul Clinic Colentina, Gastroenterologie
      • Bucuresti, Romania, 031784
        • MedLife, Gastroenterologie
      • Iasi, Romania, 700506
        • Gastromedica SRL, Gastroenterologie
      • Timisoara, Romania, 300002
        • Cabinet Particular Policlinic Algomed SRL
      • Timisoara, Romania, 300168
        • Centrul Medical Tuculanu, Gastroenterologie
      • Timisoara, Romania, 300594
        • S.C. Policlinica Dr. Citu S.R.L.- Gastroenterologie
  • Russian Federation
      • Chelyabinsk, Russian Federation, 454076
        • State Budgetary Healthcare Institute "Chelyabinsk Regional Clinical Hospital"
      • Irkutsk, Russian Federation, 669079
        • State Budgetary Institution of Health Irkustsk Order "Badge of Honor" Regional Clinical Hospital
      • Moscow, Russian Federation, 127015
        • State Budgetary Healthcare Institution of Moscow "City Clinical Hospital # 24 of Healthcare Department of Moscow"
      • Moscow, Russian Federation, 129110
        • State Budgetary Healthcare Institution of Moscow Region "Moscow Regional Clinical Research Institute n.a. M.F. Vladimirskiy"
      • Nizhniy Novgorod, Russian Federation, 603126
        • State Budgetary Healthcare Institution of Nizhny Novgorod Region "Nizhny Novgorod Regional Clinical Hospital n.a. N.A.
      • Novosibirsk, Russian Federation, 630087
        • State Budgetary Healthcare Institution of the Novosibirsk Region "State Novosibirsk Regional Clinical Hospital"
      • Novosibirsk, Russian Federation, 630091
        • State Budgetary Institution of Health of Novosibirsk Region "City Clinical Hospital #12"
      • Saint-Petersburg, Russian Federation, 191015
        • Saint Petersburg State Budgetary Healthcare Institution "City Polyclinic #38"
      • Saint-Petersburg, Russian Federation, 196143
        • "Scientific Research Centre ECO-safety" LLC
      • Saint-Petersburg, Russian Federation, 197110
        • "PolyClinic EXPERT" LLC
      • Saratov, Russian Federation, 410053
        • State Healthcare Institution "Regional Clinical Hospital"
  • Serbia
      • Belgrade, Serbia, 11000
        • Clinical Center of Serbia
      • Belgrade, Serbia, 11000
        • Clinical Hospital Center Zemun
      • Belgrade, Serbia, 3010-777
        • University Hospital Medical Center Bezanijska kosa
      • Belgrade, Serbia, 3810-969
        • Zvezdara University Medical Center
      • Novi Sad, Serbia, 21000
        • Clinical Center of Vojvodina
  • Singapore
      • Singapore, Singapore, 169608
        • Singapore General Hospital
      • Singapore, Singapore, 119074
        • National University Hospital
      • Singapore, Singapore, 308433
        • Tan Tock Seng Hospital
      • Singapore, Singapore, 529889
        • Changi General Hospital
  • Slovakia
      • Bratislava, Slovakia, 82007
        • Cliniq s. r. o., Gastroenterologicke centrum Ruzinov
      • Nitra, Slovakia, 950 01
        • KM Management, s.r.o., Gastroenterologicke a hepatologicke centrum Nitra
      • Presov, Slovakia, 8001
        • Gastro I., s.r.o.
  • South Africa
      • Cape Town, South Africa, 7500
        • Dr MJ Prins
      • Cape Town, South Africa, 7708
        • Dr John P Wright
      • Johannesburg, South Africa, 1619
        • Peermed Clinical Trial Centre
  • Spain
      • Badalona, Spain, 08916
        • Hospital Universitari Germans Trias I Pujol
      • Barcelona, Spain, 8003
        • Hospital del Mar
      • Barcelona, Spain, 08022
        • Centro Médico Teknon
      • Ferrol, Spain, 15405
        • Complejo Hospitalario Universitario de Ferrol
      • Las Palmas de Gran Canaria, Spain, 35010
        • Hospital Universitario de Gran Canaria "Dr. Negrin"
      • Madrid, Spain, 28040
        • Hospital Clinico San Carlos
      • Madrid, Spain, 28007
        • Hospital General Universitario Gregorio Maranon
      • Madrid, Spain, 28942
        • Hospital Universitario de Fuenlabrada
      • Oviedo, Spain, 33006
        • Hospital Universitario Central de Asturias
      • Pontevedra, Spain, 36071
        • Complejo Hospitalario Universitario de Pontevedra
      • Sagunto, Spain, 46520
        • Hospital de Sagunto
      • Sevilla, Spain, 41013
        • Hospital Universitario Virgen del Rocío
      • Usansolo, Spain, 48960
        • Hospital de Galdakao-Usandolo
  • Sri Lanka
      • Colombo, Sri Lanka, 00700
        • National Hospital of Sri Lanka
      • Galle, Sri Lanka, 80000
        • Teaching hospital Karapitiya
      • Kandy, Sri Lanka, 20000
        • Kandy Teaching Hospital
      • Ragama, Sri Lanka, 11010
        • Colombo North Teaching Hospital
  • Sweden
      • Danderyd, Sweden, SE-18288
        • Danderyds sjukhus AB
      • Uppsala, Sweden, 75185
        • Akademiska sjukhuset
  • Switzerland
      • Bern, Switzerland, 3012
        • Gastroenterologische Praxis Balsiger, Seibold und Partner
      • Zurich, Switzerland, 8091
        • Universitätsspital Zürich
  • Taiwan
      • Changhua, Taiwan, 500
        • Changhua Christian Hospital
      • Kaohsiung, Taiwan, 807
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
      • New Taipei City, Taiwan, 220
        • Far Eastern Memorial Hospital
      • Taichung, Taiwan, 40447
        • China Medical University Hospital
      • Taichung, Taiwan, 40201
        • Chang Shan Medical University Hospital
      • Tainan City, Taiwan, 7428
        • National Cheng Kung University Hospital
      • Taipei, Taiwan, 100
        • National Taiwan University Hospital
      • Taipei, Taiwan, 114
        • Tri-Service General Hospital
      • Taipei, Taiwan, 112
        • Taipei Veterans General Hospital
      • Taipei, Taiwan, 104
        • Mackay Memorial Hospital, Taipei
      • Taoyuan, Taiwan, 33305
        • Chang Gung Medical Foundation, Chang Gung Memorial Hospital, Linkou Branch
  • Ukraine
      • Chernivtsi, Ukraine, 58000
        • Bukovinian State Medical University
      • Chernivtsi, Ukraine, 58000
        • Municipal City Clinical Hospital of the Emergency Medical Care, 1 st Therapy Department. Danylo Halytsky Lviv National Medical
      • Dnipropetrovsk, Ukraine, 49000
        • State Institution "Institute of Gastroenterology of National Academy of Medical Sciences of Ukraine"
      • Ivano-Frankivsk, Ukraine, 76018
        • Ivanto-Frankivsk Central City Clinic Hospital, Therapy Department #1. State Higher Education Institution Ivano-Frankivsk National
      • Kharkiv, Ukraine, 61037
        • Municipal Health Care Institution "Kharkiv City Clinical Hospital #2 named after prof. O. O. Shalimov", Proctology Department
      • Kharkiv, Ukraine, 63101
        • Municipal Institution of Health Care "Regional Hospital of War Veterans", Therapeutic Department No1
      • Kropyvnytskyi, Ukraine, 25006
        • Treatment and Diagnostic Center of Private Enterprise of Private Production Company "Acinus"
      • Kyiv, Ukraine, 01030
        • Kyiv City Clinical Hospital No. 18, Proctology Department
      • Kyiv, Ukraine, 1103
        • Municipal Non-profit Enterprise "Consultative and Diagnostic Center" of Pechersk District of Kyiv, Therapy Department
      • Odessa, Ukraine, 65025
        • Municipal Institution "Odesa Regional Clinical Hospital", Regional Gastroenterology Center based on Surgery Department
      • Ternopil, Ukraine, 46002
        • Ternopil University Hospital, Regional Center of Gastroenterology with Hepatology
      • Uzhgorod, Ukraine, 88009
        • Municipal Institution "Uzhgorod District Hospital", Therapy Department
      • Vinnytsia, Ukraine, 21005
        • Vinnytsia Regional Clinical Hospital of War Veterans, Therapy Department #1
      • Vinnytsia, Ukraine, 21009
        • Medical Center LLC "Health Clinic"
      • Vinnytsia, Ukraine, 21018
        • M.I. Pyrogov Vinnytsia Regional Clinical Hospital, Gastroenterology Department
      • Zaporizhzhya, Ukraine, 69600
        • Municipal Institution "Zaporizhzhya Regional Clinical Hospital" of Zaporizhzhya Regional Council
  • United Kingdom
      • Birmingham, United Kingdom, B15 2WB
        • Queen Elizabeth Hospital
      • Bury, United Kingdom, BL9 7TD
        • The Pennine Acute Hospitals NHS Trust
      • Cambridge, United Kingdom, CB2 0QQ
        • Cambridge University Hospital NHS Foundation Trust
      • Derby, United Kingdom, DE22 3NE
        • Royal Derby Hospital
      • Edinburgh, United Kingdom, EH4 2XU
        • NHS Lothian
      • Exeter, United Kingdom, EX2 5DW
        • Medical Outpatient Department
      • Glasgow, United Kingdom, G51 4TF
        • Glasgow Clinical Research Facility - Queen Elizabeth University Hospital
      • Glasgow, United Kingdom, G52 3NQ
        • NHS Greater Glasgow and Clyde
      • High Wycombe, United Kingdom, HP11 2TT
        • Wycombe Hospital
      • Hull, United Kingdom, HU3 2JZ
        • Hull Royal Infirmary
      • London, United Kingdom, W2 1NY
        • Imperial College Healthcare NHS Trust, St Mary's Hospital
      • Oxford, United Kingdom, OX3 9DU
        • Oxford University Hospitals NHS Foundation Trust
      • Prescot, United Kingdom, L35 5DR
        • St Helens and Knowsley Teaching Hospitals NHS Trust
      • Southampton, United Kingdom, SO16 6YD
        • Southampton National Institute for Health Research, Wellcome Trust Clinical Research Facility
    • Norfolk
      • Norwich, Norfolk, United Kingdom, NR4 7UY
        • Norfolk and Norwich University Hospital Nhs Foundation Trust
  • United States
    • Alabama
      • Dothan, Alabama, United States, 36305
        • Digestive Health Specialists of the Southeast
    • Arizona
      • Sun City, Arizona, United States, 85351
        • Arizona Digestive Health - Sun City
    • California
      • Coronado, California, United States, 92118
        • Southern California Research Center, Inc.
      • Garden Grove, California, United States, 92845
        • VVCRD Research
      • La Jolla, California, United States, 92037
        • UC San Diego Health System
      • Los Angeles, California, United States, 90048
        • Cedars Sinai Medical Center
      • Rialto, California, United States, 92377
        • Inland Empire Clinical Trials, LLC
      • San Francisco, California, United States, 94118
        • Kaiser Permanente
      • Santa Clarita, California, United States, 91351
        • Clearview Medical Research, LLC
    • Colorado
      • Aurora, Colorado, United States, 80045
        • University of Colorado Denver and Hospital
      • Lone Tree, Colorado, United States, 80124
        • South Denver Gastroenterology, PC
    • Connecticut
      • Farmington, Connecticut, United States, 06032
        • Connecticut GI, PC-Research Division
    • District of Columbia
      • Washington, District of Columbia, United States, 20007
        • Medstar Georgetown University Hospital (Patient Exams)
    • Florida
      • Coral Springs, Florida, United States, 33067
        • Advanced Research, LLC
      • Gainesville, Florida, United States, 32610
        • UF Clinical Research Center
      • Lakewood Ranch, Florida, United States, 34211
        • Florida Research Institute
      • Largo, Florida, United States, 33777
        • Florida Center for Gastroenterology
      • Miami, Florida, United States, 33136
        • University of Miami Crohn's and Colitis Center
      • Miami, Florida, United States, 33147
        • Advanced Pharma Cr
      • Miami, Florida, United States, 33155
        • Cordova Research Institute
      • Miami, Florida, United States, 33176
        • Vista Health Research, LLC
      • Naples, Florida, United States, 34102
        • Gastroenterology Group of Naples
      • Orlando, Florida, United States, 32803
        • Center for Interventional Endoscopy - AdventHealth Orlando
      • Pensacola, Florida, United States, 32514
        • Gulf Region Clinical Research Institute
      • Port Orange, Florida, United States, 32127
        • Advanced Medical Research Center
      • Tampa, Florida, United States, 33606
        • Tampa General Hospital
      • Winter Park, Florida, United States, 32789
        • Shafran Gastroenterology Center
      • Zephyrhills, Florida, United States, 33540
        • Florida Medical Clinic, P.A.
    • Georgia
      • Macon, Georgia, United States, 31201
        • Gastroenterology Associates of Central Georgia, LLC
      • Marietta, Georgia, United States, 30060
        • Gastrointestinal Specialists of Georgia
      • Suwanee, Georgia, United States, 30024
        • Atlanta Gastroenterology Specialist, PC
    • Illinois
      • Arlington Heights, Illinois, United States, 60005
        • Illinois Gastroenterology Group - Arlington Heights
      • Chicago, Illinois, United States, 60637
        • University of Chicago Medical Center
      • Chicago, Illinois, United States, 60611
        • Northwestern University, Feinberg School of Medicine
      • Gurnee, Illinois, United States, 60031
        • Illinois Gastroenterology Group - Gurnee
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Indiana University Health University Hospital
    • Iowa
      • Iowa City, Iowa, United States, 52242
        • University of Iowa Hospitals and Clinics
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • University of Kansas Medical Center
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville, School of Medicine
    • Louisiana
      • Monroe, Louisiana, United States, 71201
        • Delta Research Partners, LLC
      • Shreveport, Louisiana, United States, 71105
        • Louisiana Research Center, LLC
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Investigative Clinical Research
      • Baltimore, Maryland, United States, 21201
        • University of Maryland Medical Center
      • Chevy Chase, Maryland, United States, 20815
        • MGG Group Co., Inc., Chevy Chase Clinical Research
      • Columbia, Maryland, United States, 21045
        • Gastro Center of Maryland
      • Hagerstown, Maryland, United States, 21742
        • Meritus Center for Clinical Research
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital - Crohn's and Colitis Center
    • Michigan
      • Chesterfield, Michigan, United States, 48047
        • Clinical Research Institute of Michigan, LLC
      • Grand Rapids, Michigan, United States, 49546
        • Spectrum Health Butterworth Hospital
    • Minnesota
      • Rochester, Minnesota, United States, 55902
        • Mayo Clinic
    • Mississippi
      • Jackson, Mississippi, United States, 39216
        • University of Mississippi Medical Center
    • Missouri
      • Kansas City, Missouri, United States, 64131
        • Kansas City Research Institute
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine
    • Nevada
      • Las Vegas, Nevada, United States, 89113
        • Las Vegas Medical Research
    • New Jersey
      • Egg Harbor Township, New Jersey, United States, 08234
        • AGA Clinical Research Associates, LLC
    • New York
      • Brooklyn, New York, United States, 11235
        • NY Scientific
      • Great Neck, New York, United States, 11021
        • NYU Langone Long Island Clinical Research Associates
      • New York, New York, United States, 10016
        • New York University School of Medicine/NYU Gastroenterology Associates
      • New York, New York, United States, 10028
        • Lenox Hill Hospital
      • Poughkeepsie, New York, United States, 12601
        • Premier Medical Group of the Hudson Valley
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Charlotte Gastroenterology & Hepatology, PLLC
      • Raleigh, North Carolina, United States, 27607
        • Carolina's GI Research, LLC
    • North Dakota
      • Fargo, North Dakota, United States, 58103
        • Fargo Gastroenterology and Hepatology Clinic
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Consultants for Clinical Research
      • Cincinnati, Ohio, United States, 45219
        • UC Health Physicians Clifton
      • Mentor, Ohio, United States, 44060
        • Great Lakes Gastroenterology Research, LLC,
      • Middleburg Heights, Ohio, United States, 44130
        • Paramount Medical Research & Consulting, LLC
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
        • Options Health Research LLC
    • Pennsylvania
      • Harrisburg, Pennsylvania, United States, 17110
        • Great Lakes Medical Research, LLC
    • South Carolina
      • Orangeburg, South Carolina, United States, 29118
        • Gastroenterology Associates of Orangeburg
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • WR-ClinSearch, LLC
      • Germantown, Tennessee, United States, 38138
        • Gastro One
      • Nashville, Tennessee, United States, 37211
        • Quality Medical Research
      • Nashville, Tennessee, United States, 37212
        • Vanderbilt University Medical Center - IBD Clinic
    • Texas
      • Arlington, Texas, United States, 76012
        • Texas Clinical Research Institute
      • Austin, Texas, United States, 78757
        • Pinnacle Clinical Research
      • Baytown, Texas, United States, 77521
        • Inquest Clinical Research
      • Fort Sam Houston, Texas, United States, 78219
        • San Antonio Military Medical Center
      • Garland, Texas, United States, 75044
        • DHAT Research Institute
      • Houston, Texas, United States, 77030
        • The Methodist Hospital
      • Houston, Texas, United States, 77030
        • The University of Texas Health Science Center at Houston
      • Houston, Texas, United States, 77025
        • Kelsey-Seybold Clinic
      • Houston, Texas, United States, 77058
        • Centex Studies, Inc.
      • Houston, Texas, United States, 77030
        • Baylor College of Medicine- Baylor Medical Center
      • Houston, Texas, United States, 77098
        • Gulf Coast Research Group
      • San Antonio, Texas, United States, 78212
        • Clinical Associates in Research Therapeutics of America, LLC
      • San Antonio, Texas, United States, 78229
        • Pinnacle Clinical Research
      • San Antonio, Texas, United States, 78229
        • Gastroenterology Research of San Antonio
      • San Marcos, Texas, United States, 78666
        • TDDC San Marcos
      • Southlake, Texas, United States, 76092
        • Texas Digestive Disease Consultants (IP Shipment)
      • The Woodlands, Texas, United States, 77380
        • Spring Gastroenterology
      • Tyler, Texas, United States, 75701
        • Tyler Research Institute, LLC
    • Utah
      • Bountiful, Utah, United States, 84010
        • HP Clinical Research
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • University Of Virginia Health System
      • Charlottesville, Virginia, United States, 22911
        • Charlottesville Medical Research Center, LLC
      • Chesapeake, Virginia, United States, 23320
        • Gastroenterology Associates of Tidewater
      • Leesburg, Virginia, United States, 20176
        • Emeritas Research Group LLC
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University
      • Richmond, Virginia, United States, 23249
        • McGuire DVAMC, GI (111N)
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University of Wisconsin Hospital & Clinics
      • Milwaukee, Wisconsin, United States, 53215
        • Wisconsin Center for Advanced Research, a division of GI Associates, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Key Inclusion Criteria:

  • 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

Key Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohort A: Filgotinib 200 (mg) (Induction Study)
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.
Drug: Filgotinib
Filgotinib tablets administered orally once daily.
Other Names:
  • GS-6034
  • GLPG0634
Other: Placebo
Placebo administered orally once daily.
Experimental: Cohort A: Filgotinib 100 mg (Induction Study)
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.
Drug: Filgotinib
Filgotinib tablets administered orally once daily.
Other Names:
  • GS-6034
  • GLPG0634
Other: Placebo
Placebo administered orally once daily.
Placebo Comparator: Cohort A: Placebo (Induction Study)
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.
Drug: Filgotinib
Filgotinib tablets administered orally once daily.
Other Names:
  • GS-6034
  • GLPG0634
Other: Placebo
Placebo administered orally once daily.
Experimental: Cohort B: Filgotinib 200 mg (Induction Study)
Biologic experienced participants received filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
Drug: Filgotinib
Filgotinib tablets administered orally once daily.
Other Names:
  • GS-6034
  • GLPG0634
Other: Placebo
Placebo administered orally once daily.
Experimental: Cohort B: Filgotinib 100 mg (Induction Study)
Biologic experienced participants received filgotinib 100 mg with PTM filgotinib 200 mg tablet orally once daily, for a period of 10 weeks.
Drug: Filgotinib
Filgotinib tablets administered orally once daily.
Other Names:
  • GS-6034
  • GLPG0634
Other: Placebo
Placebo administered orally once daily.
Placebo Comparator: Cohort B: Placebo (Induction Study)
Biologic experienced participants received PTM filgotinib 200 mg with PTM filgotinib 100 mg tablet orally once daily, for a period of 10 weeks.
Drug: Filgotinib
Filgotinib tablets administered orally once daily.
Other Names:
  • GS-6034
  • GLPG0634
Other: Placebo
Placebo administered orally once daily.
Experimental: Filgotinib 200 mg to Filgotinib 200 mg (Maintenance Study)
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.
Drug: Filgotinib
Filgotinib tablets administered orally once daily.
Other Names:
  • GS-6034
  • GLPG0634
Experimental: Filgotinib 200 mg to Placebo (Maintenance Study)
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.
Drug: Filgotinib
Filgotinib tablets administered orally once daily.
Other Names:
  • GS-6034
  • GLPG0634
Other: Placebo
Placebo administered orally once daily.
Experimental: Filgotinib 100 mg to Filgotinib 100 mg (Maintenance Study)
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.
Drug: Filgotinib
Filgotinib tablets administered orally once daily.
Other Names:
  • GS-6034
  • GLPG0634
Experimental: Filgotinib 100 mg to Placebo (Maintenance Study)
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.
Drug: Filgotinib
Filgotinib tablets administered orally once daily.
Other Names:
  • GS-6034
  • GLPG0634
Other: Placebo
Placebo administered orally once daily.
Placebo Comparator: Placebo to Placebo (Maintenance Study)
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.
Other: Placebo
Placebo administered orally once daily.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Induction Study: Percentage of Participants Who Achieved Clinical Remission by Crohn's Disease Activity Index (CDAI) at Week 10
Time Frame: 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.
Week 10
Induction Study: Percentage of Participants Who Achieved Endoscopic Response at Week 10
Time Frame: 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.
Week 10
Maintenance Study: Percentage of Participants Who Achieved Clinical Remission by CDAI at Week 58
Time Frame: 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.
Week 58
Maintenance Study: Percentage of Participants Who Achieved Endoscopic Response at Week 58
Time Frame: 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.
Week 58

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Induction Study: Percentage of Participants Who Achieved Clinical Remission by PRO2 at Week 10
Time Frame: 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.
Week 10
Induction Study: Percentage of Participants Who Achieved Clinical Response by CDAI at Week 10
Time Frame: 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.
Week 10
Maintenance Study: Percentage of Participants Who Achieved Clinical Remission by PRO2 at Week 58
Time Frame: 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.
Week 58
Maintenance Study: Percentage of Participants Who Achieved Clinical Response by CDAI at Week 58
Time Frame: 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.
Week 58
Maintenance Study: Percentage of Participants Who Achieved Sustained Clinical Remission by CDAI at Both Weeks 10 and 58
Time Frame: 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.
Weeks 10 and 58
Maintenance Study: Percentage of Participants Who Achieved 6 Month Corticosteroid-Free Remission by CDAI at Week 58
Time Frame: 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.
Week 58
Maintenance Study: Percentage of Participants Who Achieved Sustained Clinical Remission by PRO2 at Both Weeks 10 and 58
Time Frame: 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.
Weeks 10 and 58
Maintenance Study: Percentage of Participants Who Achieved 6 Month Corticosteroid-Free Remission by PRO2 at Week 58
Time Frame: 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.
Week 58
Induction Study:Pharmacokinetic Plasma Concentrations of Filgotinib at Week 4
Time Frame: Week 4: 0.5, 1, 2, and 3 hours (hrs) post dose
Plasma concentrations of filgotinib [nanogram/milliliters (ng/mL)].
Week 4: 0.5, 1, 2, and 3 hours (hrs) post dose
Induction Study: Pharmacokinetic Plasma Concentrations of Filgotinib at Week 10
Time Frame: Week 10: Predose
Plasma concentrations of filgotinib (ng/mL).
Week 10: Predose
Maintenance Study: Pharmacokinetic Plasma Concentrations of Filgotinib at Week 26
Time Frame: Week 26: At any timepoint
Plasma concentrations of filgotinib (ng/mL).
Week 26: At any timepoint
Maintenance Study: Pharmacokinetic Plasma Concentrations of Filgotinib at Week 58
Time Frame: Week 58: Pre-dose
Plasma concentrations of filgotinib (ng/mL).
Week 58: Pre-dose
Induction Study: Pharmacokinetic Plasma Concentrations of Filgotinib's Metabolite GS-829845 at Week 4
Time Frame: Week 4: 0.5, 1, 2, and 3 hrs post dose
Plasma concentrations of GS-829845 (ng/mL).
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
Time Frame: Week 10: Predose
Plasma concentrations of GS-829845 (ng/mL).
Week 10: Predose
Maintenance Study: Pharmacokinetic Plasma Concentrations of Filgotinib's Metabolite GS-829845 at Week 26
Time Frame: Week 26: At any timepoint
Plasma concentrations of GS-829845 (ng/mL).
Week 26: At any timepoint
Maintenance Study: Pharmacokinetic Plasma Concentrations of Filgotinib's Metabolite GS-829845 at Week 58
Time Frame: Week 58: Pre-dose
Plasma concentrations of GS-829845 (ng/mL).
Week 58: Pre-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Galapagos NV

Collaborators

Gilead Sciences

Investigators

  • Study Director: Galapagos Study Director, Galapagos NV

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 31, 2016

Primary Completion (Actual)

November 11, 2022

Study Completion (Actual)

November 11, 2022

Study Registration Dates

First Submitted

September 22, 2016

First Submitted That Met QC Criteria

September 22, 2016

First Posted (Estimated)

September 26, 2016

Study Record Updates

Last Update Posted (Actual)

December 18, 2023

Last Update Submitted That Met QC Criteria

November 24, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • GS-US-419-3895
  • 2016-001367-36 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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