Summary

for people ages 18-75 (full criteria)
at La Jolla, California and other locations
study started
estimated completion

Description

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.

Official Title

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

Keywords

Fistulizing Crohn's Disease Crohn Disease Filgotinib Filgotinib Dose A Filgotinib Dose B

Eligibility

For people ages 18-75

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.

Locations

  • UC San Diego Health System accepting new patients
    La Jolla California 92037 United States
  • Las Vegas Medical Research withdrawn
    Las Vegas Nevada 89113 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Gilead Sciences
ID
NCT03077412
Phase
Phase 2
Study Type
Interventional
Last Updated