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

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ClinicalTrials.gov Identifier: NCT03046056
Recruitment Status : Recruiting
First Posted : February 8, 2017
Last Update Posted : November 26, 2019
Sponsor:
Collaborator:
Galapagos NV
Information provided by (Responsible Party):
Gilead Sciences

Tracking Information
First Submitted Date  ICMJE February 6, 2017
First Posted Date  ICMJE February 8, 2017
Last Update Posted Date November 26, 2019
Actual Study Start Date  ICMJE April 11, 2017
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 6, 2017)
Proportion of Participants Achieving Clinical Remission at Week 24 [ Time Frame: Week 24 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03046056 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 6, 2017)
  • Change From Baseline in Magnetic Resonance Imaging (MRI) disease parameters at Week 24 [ Time Frame: Week 24 ]
  • Proportion of Participants Achieving Small Bowel Remission Measured via MRI Disease Parameters at Week 24 [ Time Frame: Week 24 ]
  • Proportion of Participants Achieving Remission in the Terminal Ileum Measured via MRI Disease Parameters at Week 24 [ Time Frame: Week 24 ]
  • Proportion of Participants Achieving Remission in all Bowel Segments via MRI Disease Parameters at Week 24 [ Time Frame: Week 24 ]
  • Change From Baseline in Patient Reported Symptoms of Abdominal Pain and Liquid Stool Frequency at Week 10 [ Time Frame: Week 10 ]
  • Change from Baseline in Patient Reported Symptoms of Abdominal Pain and Liquid Stool Frequency at Week 24 [ Time Frame: Week 24 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn's Disease (SBCD)
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Small Bowel Crohn's Disease
Intervention  ICMJE
  • Drug: Filgotinib
    Tablet(s) administered orally once daily
    Other Names:
    • GS-6034
    • GLPG0634
  • Drug: Placebo to match filgotinib
    Tablet(s) administered orally once daily
Study Arms  ICMJE
  • Experimental: Filgotinib Dose A
    Filgotinib dose A + placebo to match filgotinib dose B for 24 weeks
    Interventions:
    • Drug: Filgotinib
    • Drug: Placebo to match filgotinib
  • Experimental: Filgotinib Dose B
    Filgotinib dose B + placebo to match filgotinib dose A for 24 weeks
    Interventions:
    • Drug: Filgotinib
    • Drug: Placebo to match filgotinib
  • Placebo Comparator: Placebo
    Placebo to match filgotinib dose A + placebo to match filgotinib dose B for 24 weeks
    Intervention: Drug: Placebo to match filgotinib
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: February 6, 2017)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2020
Estimated Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Gilead Clinical Study Information Center 1-833-445-3230 (GILEAD-0) GileadClinicalTrials@gilead.com
Listed Location Countries  ICMJE Austria,   Belgium,   Canada,   Czechia,   France,   Germany,   Hungary,   Israel,   Italy,   Spain,   Ukraine,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03046056
Other Study ID Numbers  ICMJE GS-US-419-4015
2016-003179-23 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gilead Sciences
Study Sponsor  ICMJE Gilead Sciences
Collaborators  ICMJE Galapagos NV
Investigators  ICMJE
Study Director: Gilead Study Director Gilead Sciences
PRS Account Gilead Sciences
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP