Study to Evaluate the Efficacy and Safety of Filgotinib in the Treatment of Perianal Fistulizing Crohn's Disease

Purpose

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 (LTE) study (GS-US-419-3896; NCT02914600) if they meet eligibility requirements.

Condition

  • Fistulizing Crohn's Disease

Eligibility

Eligible Ages
Between 18 Years and 75 Years
Eligible Genders
All
Accepts Healthy Volunteers
No

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 magnetic resonance imaging (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 - Tumor necrosis factor α (TNFα) Antagonist - Is willing and able to undergo MRI per protocol requirements - Is willing and able to undergo flexible sigmoidoscopy per protocol requirements

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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Filgotinib 200 mg 		Filgotinib 200 mg + placebo to match filgotinib 100 mg 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 100 mg 		Filgotinib 100 mg + placebo to match filgotinib 200 mg 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
Placebo 		Placebo to match filgotinib 200 mg + placebo to match filgotinib 100 mg for 24 weeks
  • Drug: Placebo to match filgotinib
    Tablet(s) administered orally once daily

More Details

Status
Completed
Sponsor
Gilead Sciences

Study Contact