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Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn's Disease (SBCD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03046056
Recruitment Status : Recruiting
First Posted : February 8, 2017
Last Update Posted : November 7, 2019
Galapagos NV
Information provided by (Responsible Party):
Gilead Sciences

Brief Summary:
The primary objective of this study is to evaluate the efficacy of filgotinib, when compared to placebo, in establishing clinical remission in participants with Crohn's disease involving the small bowel. Participants will have the option to enter a separate long-term extension study if they meet eligibility requirements.

Condition or disease Intervention/treatment Phase
Small Bowel Crohn's Disease Drug: Filgotinib Drug: Placebo to match filgotinib Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn's Disease (SBCD)
Actual Study Start Date : April 11, 2017
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : July 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
Experimental: Filgotinib Dose A
Filgotinib dose A + placebo to match filgotinib dose B for 24 weeks
Drug: Filgotinib
Tablet(s) administered orally once daily
Other Names:
  • GS-6034
  • GLPG0634

Drug: Placebo to match filgotinib
Tablet(s) administered orally once daily

Experimental: Filgotinib Dose B
Filgotinib dose B + placebo to match filgotinib dose A for 24 weeks
Drug: Filgotinib
Tablet(s) administered orally once daily
Other Names:
  • GS-6034
  • GLPG0634

Drug: Placebo to match filgotinib
Tablet(s) administered orally once daily

Placebo Comparator: Placebo
Placebo to match filgotinib dose A + placebo to match filgotinib dose B for 24 weeks
Drug: Placebo to match filgotinib
Tablet(s) administered orally once daily

Primary Outcome Measures :
  1. Proportion of Participants Achieving Clinical Remission at Week 24 [ Time Frame: Week 24 ]

Secondary Outcome Measures :
  1. Change From Baseline in Magnetic Resonance Imaging (MRI) disease parameters at Week 24 [ Time Frame: Week 24 ]
  2. Proportion of Participants Achieving Small Bowel Remission Measured via MRI Disease Parameters at Week 24 [ Time Frame: Week 24 ]
  3. Proportion of Participants Achieving Remission in the Terminal Ileum Measured via MRI Disease Parameters at Week 24 [ Time Frame: Week 24 ]
  4. Proportion of Participants Achieving Remission in all Bowel Segments via MRI Disease Parameters at Week 24 [ Time Frame: Week 24 ]
  5. Change From Baseline in Patient Reported Symptoms of Abdominal Pain and Liquid Stool Frequency at Week 10 [ Time Frame: Week 10 ]
  6. Change from Baseline in Patient Reported Symptoms of Abdominal Pain and Liquid Stool Frequency at Week 24 [ Time Frame: Week 24 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Key Inclusion Criteria:

  • Males or non-pregnant, nonlactating females, ages 18 to 75 years, inclusive based on the date of screening visit
  • Moderately or severely active CD
  • Minimum duration of CD of at least 6 months
  • Presence of diseased SB segments in at least 1 of the following segments: terminal ileum, distal ileum, or jejunum
  • Patients with additional colonic involvement of CD are permitted in study as long as SBCD is present
  • Previously demonstrated an inadequate clinical response, loss of response to, or intolerance to at least 1 of the following agents (depending on current country treatment recommendations/guidelines):

    • Corticosteroids
    • Immunomodulators
    • Tumor necrosis factor-alpha (TNFα) antagonists
    • Vedolizumab
    • Ustekinumab
  • Willing and able to undergo magnetic resonance enterography (MRE) per protocol requirements

Key Exclusion Criteria:

  • Presence of symptomatic or clinically significant (eg, obstructive or symptomatic) strictures or stenosis.
  • Presence of fistulae
  • Evidence of short bowel syndrome
  • Presence of ulcerative colitis, indeterminate colitis, ischemic colitis, fulminant colitis, or toxic mega-colon
  • History of total colectomy, subtotal-colectomy, presence of ileostomy or colostomy, or likely requirement for surgery during the study
  • Use of any prohibited concomitant medications as described in the study protocol
  • Active tuberculosis (TB) or history of latent TB that has not been treated

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03046056

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Contact: Gilead Clinical Study Information Center 1-833-445-3230 (GILEAD-0)

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United States, Colorado
Peak Gastroenterology Associates Recruiting
Colorado Springs, Colorado, United States, 80907
United States, Florida
Florida Center for Gastroenterology Recruiting
Largo, Florida, United States, 33777
University of Miami Crohn's and Colitis Center Recruiting
Miami, Florida, United States, 33136
Gastroenterology Group of Naples Withdrawn
Naples, Florida, United States, 34102
Center for lnterventional Endoscopy- Florida Hospital Recruiting
Orlando, Florida, United States, 32804
Gulf Region Clinical Research Institute Withdrawn
Pensacola, Florida, United States, 32514
University of South Florida South Tampa campus Recruiting
Tampa, Florida, United States, 33606
Shafran Gastroenterology Center Withdrawn
Winter Park, Florida, United States, 32789
United States, Illinois
Northwestern University Feinberg School of Medicine Recruiting
Chicago, Illinois, United States, 60611
United States, Indiana
Indiana University Health University Hospital Recruiting
Indianapolis, Indiana, United States, 46202
United States, Kansas
University of Kansas Medical Center, Research Institute Inc. Recruiting
Kansas City, Kansas, United States, 66160
United States, Kentucky
University of Louisville Clinical Trials Unit Withdrawn
Louisville, Kentucky, United States, 40202
United States, Louisiana
Louisiana Research Center, LLC Withdrawn
Shreveport, Louisiana, United States, 71105
United States, Maryland
Gastro Center of Maryland Recruiting
Columbia, Maryland, United States, 21045
Meritus Center for Clinical Research Recruiting
Hagerstown, Maryland, United States, 21742
United States, Michigan
Clinical Research Institute of Michigan Recruiting
Chesterfield, Michigan, United States, 48047
Gastroenterology Associates of Western Michican, PLC d.b.a. West Michigan Clinical Research Center Recruiting
Wyoming, Michigan, United States, 49519
United States, Nevada
Gastroenterology Consultants Recruiting
Reno, Nevada, United States, 89502
United States, North Carolina
Carolina's GI Research, LLC Withdrawn
Raleigh, North Carolina, United States, 27607
United States, North Dakota
Fargo Gastroenterology and Hepatology Clinic Recruiting
Fargo, North Dakota, United States, 58103
United States, Tennessee
Gastro One Recruiting
Germantown, Tennessee, United States, 38138
Vanderbilt University Medical Center - IBD Clinic Recruiting
Nashville, Tennessee, United States, 37212-1375
United States, Texas
Texas Clinical Research Institute Recruiting
Arlington, Texas, United States, 76012
San Antonio Military Medical Center Withdrawn
Fort Sam Houston, Texas, United States, 78234
DHAT Research Institute Recruiting
Richardson, Texas, United States, 75082
Gastroenterology Research of San Antonio Recruiting
San Antonio, Texas, United States, 78229
Texas Digestive Disease Consultants Recruiting
San Marcos, Texas, United States, 78666
Texas Digestive Disease Consultants Recruiting
Southlake, Texas, United States, 76092
United States, Utah
Val R. Hansen, M.D. Withdrawn
Bountiful, Utah, United States, 84010
United States, Virginia
Emeritas Research Group LLC Withdrawn
Lansdowne Town Center, Virginia, United States, 20176
McGuire DVAMC Recruiting
Richmond, Virginia, United States, 23249
Medical University of Innsbruck, Department of Internal Medicine I Recruiting
Innsbruck, Austria, 6020
Medical University of Vienna, Department of Internal Medicine III, Division Gastroenterology and Hepatology Recruiting
Vienna, Austria, 1090
Universitair Ziekenhuis Antwerpen Recruiting
Edegem, Belgium, 2650
Universitair Ziekenhuis Gent Recruiting
Gent, Belgium, 9000
Centre Hospitalier Chretien Recruiting
Liège, Belgium, 4000
Mount Sinai Hospital Recruiting
Toronto, Canada, M5T 3L9
PerCuro Clinical Research Ltd. Recruiting
Victoria, Canada, V8V 3M9
Hepato-Gastroenterologie HK, s.r.o. Recruiting
Hradec Králové, Czechia, 500 12
CHU de Toulouse -Hopital Rangueil (Main Office) Recruiting
Toulouse Cedex 9, Midi-Pyrenees, France, 31059
Service de Gastro-Entérologie Recruiting
Saint-Étienne, Rhone-Alps, France, 42055
AP-HP - Hôpital Bicêtre (Main Office) Recruiting
Le Kremlin-Bicêtre, France, 94270
CHU de Strasbourg - Nouvel Hopital Civil (Main Office) Recruiting
Strasbourg, France, 67091
Hopitaux Universitaires de Strasbourg- Hopital Hautepierre (Main Office) Withdrawn
Strasbourg, France
Asklepios Westklinikum Withdrawn
Hamburg, Germany, 22559
Gastroenterologie, Hepatologie und Endokrinologie Recruiting
Hannover, Germany, 30625
Universitatsklinikum Jena Recruiting
Jena, Germany, 07747
Universitatsklinikum Schleswig-Holstein Recruiting
Kiel, Germany, 24105
Bugát Pál Kórház, Gasztroenterológiai osztály Recruiting
Gyöngyös, Heves, Hungary, 3200
Egyesitett Szent Istvan es Szent Laszlo K6rbaz - Rendelointezet Withdrawn
Budapest, Hungary, 1097
Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórháza Recruiting
Békéscsaba, Hungary, 5600
Rambam Health Care Campus Recruiting
Haifa, Israel, 3109601
Rabin Medical Center, Beilinson Hospital Recruiting
Petah Tikva, Israel, 49100
Azienda Ospedaliero - Universitaria Mater Domini Recruiting
Catanzaro, Italy, 88100
AOU Policlinico Di Modena - U.O Gastroenterologia Withdrawn
Modena, Italy, 41124
Gastroenterologia, Policlinico Universitario Campus Bio-Medico di Roma Recruiting
Rome, Italy, 00128
Istituto Clinico Humanitas Recruiting
Rozzano, Italy, 20089
Complejo Hospitalario Universitario de Ferrol Recruiting
Ferrol, A Coruña, Spain, 15405
Hospital Universitario de Fuenlabrada Recruiting
Fuenlabrada, Madrid, Spain, 28942
Hospital de Sagunto Withdrawn
Sagunto, Valencia, Spain, 46520
Hospital Universitario Gran Canaria Dr. Negrin Recruiting
Las Palmas De Gran Canaria, Spain, 35016
Hospital General Universitario Gregorio Maranon Withdrawn
Madrid, Spain, 28007
SI Institute of Gastroenterology of NAMS of Ukraine. Department of Diseases of Stomach and Duodenum Recruiting
Dnipropetrovsk, Ukraine, 49074
Ivano-Frankivsk Central City Clinical Hospital, Department of Therapy #1, SHEI Ivano-Frankivsk National Medical University Recruiting
Ivano-Frankivsk, Ukraine, 76018
Communal Healthcare Institution Regional Hospital of War Veterans, Department of Therapy #1 Recruiting
Kharkiv, Ukraine, 61137
Treatment and Diagnostic Center of Private Enterprise of Private Production Company ' Atsynus Recruiting
Kirovohrad, Ukraine, 25006
Communal Institution of Ternopil Regional Council Ternopil University Hospital. Regional Center of Gastroenterology Recruiting
Ternopil, Ukraine, 46002
United Kingdom
John Radcliffe Hospital Recruiting
Oxford, Oxfordshire, United Kingdom, OX3 9DU
Royal Devon and Exeter Hospital, Department of Gastroenterology Recruiting
Exeter, United Kingdom, EX2 5DW
Queen Elizabeth University Hospital Recruiting
Glasgow, United Kingdom, G51 4TF
St Georges Clinical Research Facility Recruiting
London, United Kingdom, SW17 0QT
Sponsors and Collaborators
Gilead Sciences
Galapagos NV
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Study Director: Gilead Study Director Gilead Sciences

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Responsible Party: Gilead Sciences Identifier: NCT03046056     History of Changes
Other Study ID Numbers: GS-US-419-4015
2016-003179-23 ( EudraCT Number )
First Posted: February 8, 2017    Key Record Dates
Last Update Posted: November 7, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases