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

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.