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

  • Interventional
  • Recruiting
  • NCT03077412
Eligibility Details Visit Clinicaltrials.gov

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

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.

Gender
All

Age Group
18 Years to 75 Years

Accepting Healthy Volunteers?
No

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.

At a Glance

National Government IDNCT03077412

IRB#IRB18-1368

Lead SponsorGilead Sciences

Lead PhysicianDavid T. Rubin

Collaborator(s)N/A

EligibilityAll
18 Years to 75 Years
Recruiting