INM-755 (Cannabinol) Cream for Treatment of Epidermolysis Bullosa

• Status: Not yet recruiting
• Trial end date: 2022-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the safety of INM-755 (cannabinol) cream and obtain preliminary evidence of efficacy in treating symptoms and healing wounds over a 28-day period in patients with epidermolysis bullosa (EB).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: InMed Pharmaceuticals Inc.

Criteria

Key Inclusion Criteria:

• Male or female patients aged ≥18 years with documented diagnosis of any of the following types of inherited EB: Simplex, Junctional, Dystrophic, Kindler. Enrolment will be extended to patients ≥12 years old and <18 years old after positive opinion of a data monitoring committee after at least 4 adult patients have completed study.

• Presence of at least 1 pair of well-matched index areas. Up to 2 pairs of index areas (1 pair of non-wound and 1 pair of wound index areas) can be selected in each patient

• For non-wound itch index areas, both areas should:

1. Have chronic itch with a score ≥40 mm on a 100 mm VAS

2. Not exceed 20 percent of body surface area (BSA) or be less than 1 percent of BSA

3. Be similar size, up to twice the area of the smaller index area

• For wound index areas, both wounds should:

1. Have a surface area ≥5 cm^2 and ≤50 cm^2 inclusive and be aged ≥3 weeks

2. Be well matched for size (up to twice the area of the smaller index area) and age (both either ≥3 weeks to 3 months or >3 months)

• Female patients of childbearing potential or men whose sexual partners are women of childbearing potential (WOCBP) must use highly effective birth control

• WOCBP must have a negative urine pregnancy test result at baseline

• Must provide written consent (or assent for patients aged <18 years with parental/guardian consent)

Key Exclusion Criteria:

• EB index areas have evidence of infection

• Patient has a systemic infection or used systemic antibiotics for EB-related infections within 7 days

• Use of systemic corticosteroids within 30 days or of topical corticosteroids on chosen index areas within 14 days

• Immunosuppressive therapy or cytotoxic chemotherapy within 60 days

• Use of any high potency opioid within 30 days

• Use of cannabis, cannabis extracts, or any cannabinoid products for medical or recreational use by any route of administration within 2 weeks

• Prior stem cell transplant or gene therapy for EB

• History of malignancy including basal cell and squamous cell carcinomas

• Arterial or venous disorder resulting in ulcerated wounds

• Uncontrolled diabetes mellitus

• Chronic pruritus primarily attributable to pathologies or conditions other than EB

• Blood transfusion to treat anemia within the past 3 months

• Use of any investigational drug within 30 days or 5 half-lives (whichever is longer)

• An underlying condition which places the patient at unacceptable risk

• Women who are pregnant, breastfeeding (lactating), or planning to become pregnant during the study