A Safety and Efficacy Study of BLI-1300 Ointment in Symptomatic Perianal Crohn's Disease

Inclusion Criteria:

- All subjects must give written informed consent.

- Male or female subjects, 18 years of age.

- Confirmed diagnosis of Crohn's Disease.

- Subject must have a 3 month documented history of perianal Crohn's Disease (PCD) and
with clinical evidence of active PCD.

- Subject must have a Crohn's Disease Activity Index (CDAI) total score of ≤ 350 at
Visit 2.

- Subjects must have a qualifying perianal pain score at Visits 1 and 2.

Exclusion Criteria:

- Women of childbearing potential who are not using adequate contraception.

- Women who are pregnant or breastfeeding.

- Subjects on unstable regimens of Crohn's therapy (e.g. tumor necrosis factor (TNF)
inhibitors, immunosuppressants, steroids).

- Subjects taking strong analgesics that could interfere with pain measurements.
Subjects with a perianal abscess requiring incision and drainage.

- Subjects with anal stenosis.

- Subjects with fistulae outside the immediate perianal area.

- Subjects who have had abdominal surgery for Crohn's disease within the past 12 weeks.

- Subjects who have had significant anorectal surgery for Crohns disease within the
past 8 weeks.