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

Phase 2

Terminated

Interventions: Drug: placebo
Drug: BLI-1300 low dose
Drug: BLI-1300 high dose

Brief Summary: This randomized, placebo-controlled, parallel, multi-center, double-blind pilot study is designed to determine the effects of BLI-1300 ointment on perianal pain associated with active Perianal Crohn's Disease (PCD).

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
placebo	placebo	Placebo Ointment
BLI-1300 (low dose)	BLI-1300 low dose	Investigational Product (10%) Ointment
BLI-1300 (high dose)	BLI-1300 high dose	Investigational Product (20%) Ointment

Primary Outcome Measures

Name	Time	Method
Percentage of Perianal Pain Responders	12 weeks	Percent of responders during Week 12. Response is defined as ≥30% decrease in mean NRS score for perianal pain (for the 7 treatment days immediately preceding the Week 12 visit) compared to the screening period.

Secondary Outcome Measures

Name	Time	Method

Locations (17): Penn State Hershey Medical Center
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Hershey, Pennsylvania, United States
South Jersey Gastroenterology
🇺🇸
Marlton, New Jersey, United States
New York Center for Clinical Research
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Lake Success, New York, United States
Asheville Gastroenterology
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Asheville, North Carolina, United States
Borland Groover Clinic
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Jacksonville, Florida, United States
ACRI - Phase I
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Anaheim, California, United States
Mount Sinai Medical Center
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New York, New York, United States
Long Island Clinical Research Associates
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Great Neck, New York, United States
University Hospitals Case Medical Center
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Cleveland, Ohio, United States
University of California - San Francisco
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San Francisco, California, United States
UNC School of Medical
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Chapel Hill, North Carolina, United States
Consultants for Clinical Research
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Cincinnati, Ohio, United States
Medical University of South Carolina
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Charleston, South Carolina, United States
Vanderbilt University Medical Center
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Nashville, Tennessee, United States
Mayo Clinic
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Rochester, Minnesota, United States
University of Maryland
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Baltimore, Maryland, United States
Chevy Chase Clinical Research
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Chevy Chase, Maryland, United States