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Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn's Disease (Divergence2)

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ClinicalTrials.gov Identifier: NCT03077412
Recruitment Status : Completed
First Posted : March 13, 2017
Last Update Posted : March 19, 2021
Sponsor:
Collaborator:
Galapagos NV
Information provided by (Responsible Party):
Gilead Sciences

Tracking Information
First Submitted Date  ICMJE March 8, 2017
First Posted Date  ICMJE March 13, 2017
Last Update Posted Date March 19, 2021
Actual Study Start Date  ICMJE April 6, 2017
Actual Primary Completion Date January 20, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 8, 2017)
Proportion of Participants Establishing Combined Fistula Response at Week 24 [ Time Frame: Week 24 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 25, 2017)
  • Proportion of Participants Establishing Combined Fistula Remission at Week 24 [ Time Frame: Week 24 ]
  • Time to Clinical Fistula Response [ Time Frame: Up to 24 weeks ]
  • Time to Clinical Fistula Remission [ Time Frame: Up to 24 weeks ]
  • Proportion of Participants Achieving Proctitis Remission at Week 24 [ Time Frame: Week 24 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: March 8, 2017)
  • Proportion of Participants Establishing Combined Fistula Remission at Week 24 [ Time Frame: Week 24 ]
  • Time to Clinical Fistula Response [ Time Frame: Up to 24 weeks ]
  • Time to Clinical Fistula Remission [ Time Frame: Up to 24 weeks ]
  • Time to First Complete Perianal Fistula Closure [ Time Frame: Up to 24 weeks ]
  • Proportion of Participants Achieving Proctitis Remission at Week 24 [ Time Frame: Week 24 ]
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 Perianal Fistulizing Crohn's Disease
Official Title  ICMJE A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study Evaluating the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn's Disease
Brief Summary The primary objective of this study is to evaluate the efficacy of filgotinib as compared to placebo in establishing combined fistula response at Week 24. 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 Fistulizing 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 200 mg
    Filgotinib 200 mg + placebo to match filgotinib 100 mg for 24 weeks
    Interventions:
    • Drug: Filgotinib
    • Drug: Placebo to match filgotinib
  • Experimental: Filgotinib 100 mg
    Filgotinib 100 mg + placebo to match filgotinib 200 mg for 24 weeks
    Interventions:
    • Drug: Filgotinib
    • Drug: Placebo to match filgotinib
  • Experimental: Placebo
    Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg 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 Completed
Actual Enrollment  ICMJE
 (submitted: August 26, 2020)
57
Original Estimated Enrollment  ICMJE
 (submitted: March 8, 2017)
75
Actual Study Completion Date  ICMJE February 17, 2021
Actual Primary Completion Date January 20, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Key Inclusion Criteria:

  • Males or non-pregnant, non-lactating females, ages 18 to 75 years, inclusive based on the date of screening visit
  • Diagnosis of Crohn's disease (CD) with a minimum duration of CD of at least 3 months
  • Has draining perianal fistulae as a complication of CD, confirmed by MRI at screening
  • Previously demonstrated an inadequate clinical response, loss of response to, or intolerance of at least 1 of the following agents (depending on current country treatment recommendations/guidelines):

    • Antibiotics AND/OR
    • Immunomodulators AND/OR
    • TNFα Antagonist
  • Is willing and able to undergo MRI per protocol requirements
  • Is willing and able to undergo flexible sigmoidoscopy per protocol requirements

Key Exclusion Criteria:

  • Presence of current rectovaginal anovaginal or enterovesicular fistulae
  • Presence of ulcerative colitis (UC), indeterminate colitis, ischemic colitis, fulminant colitis, or toxic mega-colon
  • History of total proctocolectomy, total 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 information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Austria,   Belgium,   Canada,   France,   Germany,   Hungary,   Italy,   United Kingdom,   United States
Removed Location Countries Czechia,   Israel,   Poland,   Spain
 
Administrative Information
NCT Number  ICMJE NCT03077412
Other Study ID Numbers  ICMJE GS-US-419-4016
2016-003153-15 ( 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
Plan to Share IPD: No
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 March 2021

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