Efficacy and Safety of Filgotinib in the Treatment of Small Bowel Crohn's Disease (SBCD)

Key Inclusion Criteria:

- Males or non-pregnant, nonlactating females, ages 18 to 75 years, inclusive based on
the date of screening visit

- Moderately or severely active CD

- Minimum duration of CD of at least 6 months

- Presence of diseased SB segments in at least 1 of the following segments: terminal
ileum, distal ileum, or jejunum

- Patients with additional colonic involvement of CD are permitted in study as long as
SBCD is present

- Previously demonstrated an inadequate clinical response, loss of response to, or
intolerance to at least 1 of the following agents (depending on current country
treatment recommendations/guidelines):

- Corticosteroids

- Immunomodulators

- Tumor necrosis factor-alpha (TNFα) antagonists

- Vedolizumab

- Ustekinumab

- Willing and able to undergo magnetic resonance enterography (MRE) per protocol
requirements

Key Exclusion Criteria:

- Presence of symptomatic or clinically significant (eg, obstructive or symptomatic)
strictures or stenosis.

- Presence of fistulae

- Evidence of short bowel syndrome

- Presence of ulcerative colitis, indeterminate colitis, ischemic colitis, fulminant
colitis, or toxic mega-colon

- History of total colectomy, subtotal-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.