Study to Evaluate the Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn's Disease (SBCD)
NCT ID: NCT03046056
Last Updated: 2021-08-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
78 participants
INTERVENTIONAL
2017-04-11
2020-07-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Filgotinib 200 mg
Filgotinib 200 mg tablet + placebo to match (PTM) filgotinib 100 mg tablet for up to 27 weeks.
Filgotinib
Tablet(s) administered orally once daily
Placebo to match filgotinib
Tablet(s) administered orally once daily
Filgotinib 100 mg
Filgotinib 100 mg tablet + PTM filgotinib 200 mg tablet for up to 26.3 weeks.
Filgotinib
Tablet(s) administered orally once daily
Placebo to match filgotinib
Tablet(s) administered orally once daily
Placebo
PTM filgotinib 200 mg tablet + PTM filgotinib 100 mg tablet for up to 28.7 weeks.
Placebo to match filgotinib
Tablet(s) administered orally once daily
Interventions
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Filgotinib
Tablet(s) administered orally once daily
Placebo to match filgotinib
Tablet(s) administered orally once daily
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Moderately or severely active CD
* Minimum duration of CD of at least 6 months
* Presence of diseased small bowel (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
Exclusion Criteria
* 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
18 Years
75 Years
ALL
No
Sponsors
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Galapagos NV
INDUSTRY
Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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Gastroenterology Research of San Antonio
San Antonio, Texas, United States
TDDC San Marcos
San Marcos, Texas, United States
Texas Digestive Disease Consultants
Southlake, Texas, United States
McGuire DVAMC
Richmond, Virginia, United States
Medical University of Innsbruck, Department of Internal Medicine I
Innsbruck, , Austria
University of Miami Crohn's and Colitis Center
Miami, Florida, United States
Center for lnterventional Endoscopy- Florida Hospital
Orlando, Florida, United States
University of South Florida South Tampa campus
Tampa, Florida, United States
Indiana University Health University Hospital
Indianapolis, Indiana, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
Gastro Center of Maryland
Columbia, Maryland, United States
Meritus Center for Clinical Research
Hagerstown, Maryland, United States
Clinical Research Institute of Michigan
Chesterfield, Michigan, United States
Fargo Gastroenterology and Hepatology Clinic
Fargo, North Dakota, United States
Gastro One
Germantown, Tennessee, United States
Texas Clinical Research Institute
Arlington, Texas, United States
Medical University of Vienna, Department of Internal Medicine III, Division Gastroenterology and Hepatology
Vienna, , Austria
Universitair Ziekenhuis Antwerpen
Edegem, , Belgium
Centre Hospitalier Chretien
Liège, , Belgium
Mount Sinai Hospital
Toronto, , Canada
PerCuro Clinical Research Ltd.
Victoria, , Canada
Hepato-Gastroenterologie HK, s.r.o.
Hradec Králové, , Czechia
CHU de Toulouse -Hopital Rangueil (Main Office)
Toulouse, Midi-Pyrenees, France
Gastroenterologie, Hepatologie und Endokrinologie
Hanover, , Germany
Universitatsklinikum Jena
Jena, , Germany
Bugát Pál Kórház, Gasztroenterológiai osztály
Gyöngyös, Heves County, Hungary
Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórháza
Békéscsaba, , Hungary
Azienda Ospedaliero - Universitaria Mater Domini
Catanzaro, , Italy
Gastroenterologia, Policlinico Universitario Campus Bio-Medico di Roma
Rome, , Italy
Hospital Universitario de Fuenlabrada
Fuenlabrada, Madrid, Spain
Hospital Universitario Gran Canaria Dr. Negrin
Las Palmas de Gran Canaria, , Spain
Ivano-Frankivsk Central City Clinical Hospital, Department of Therapy #1, SHEI Ivano-Frankivsk National Medical University
Ivano-Frankivsk, , Ukraine
Communal Healthcare Institution Regional Hospital of War Veterans, Department of Therapy #1
Kharkiv, , Ukraine
Communal Institution of Ternopil Regional Council Ternopil University Hospital. Regional Center of Gastroenterology
Ternopil, , Ukraine
Queen Elizabeth University Hospital
Glasgow, Scotland, United Kingdom
Royal Devon and Exeter Hospital, Department of Gastroenterology
Exeter, , United Kingdom
St Georges Clinical Research Facility
London, , United Kingdom
John Radcliffe Hospital
Oxford, , United Kingdom
Countries
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References
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Riviere P, D'Haens G, Peyrin-Biroulet L, Baert F, Lambrecht G, Pariente B, Bossuyt P, Buisson A, Oldenburg B, Vermeire S, Laharie D. Location but Not Severity of Endoscopic Lesions Influences Endoscopic Remission Rates in Crohn's Disease: A Post Hoc Analysis of TAILORIX. Am J Gastroenterol. 2021 Jan 1;116(1):134-141. doi: 10.14309/ajg.0000000000000834.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2016-003179-23
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-419-4015
Identifier Type: -
Identifier Source: org_study_id
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