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

NCT04908215 | Completed Phase 2 DMC

• 1 other identifier: 755-201-EB
• Study Type: interventional
• Target: 19
• Locations: 5 countries
• Sites: 7

Brief 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).

Conditions

Epidermolysis Bullosa Simplex; Epidermolysis Bullosa, Junctional; Epidermolysis Bullosa Dystrophica; Kindler Syndrome

Outcome Measures

Primary Outcomes (5)

• Change from Baseline in Non-Wound Itch by Visual Analogue Scale (VAS)

  Patients will report peak (maximal) pruritus intensity over the previous 24 hours using a 100 mm VAS (0 being "no itch" to 100 mm being "worst imaginable itch") recorded daily in the study diary. This outcome measure is applicable only for patients with non-wound index areas with eligible (moderate to severe) itch.

  Baseline to Day 29

• Change from Baseline in Wound Surface Area

  Wound surface area will be measured by digital photography at weekly intervals. This outcome measure is applicable only for patients with wound index areas.

  Baseline to Day 29

• Change from Baseline in Procedural Wound Pain by VAS

  Patients will report wound pain intensity using a 100 mm VAS (0 being "no pain" to 100 mm being "worst imaginable pain") and this will be recorded in the study diary. Procedural pain will be assessed immediately after each wound dressing, which may be every 1, 2, or 3 days according to an individual patient's schedule for dressing change. This outcome measure is applicable only for patients with wound index areas associated with eligible (moderate to severe) procedural pain.

  Baseline to Day 29

• Change from Baseline in Background Wound Pain by VAS

  Patients will report wound pain intensity using a 100 mm VAS (0 being "no pain" to 100 mm being "worst imaginable pain") and this will be recorded in the study diary. Peak (maximal) background pain will be assessed daily in the morning (done before the dressing change). This outcome measure is applicable only for patients with wound index areas associated with eligible (moderate to severe) background pain.

  Baseline to Day 29

• Change from Baseline in Wound Itch by VAS

  Patients will report peak (maximal) pruritus intensity over the previous 24 hours using a 100 mm VAS (0 being "no itch" to 100 mm being "worst imaginable itch") recorded daily in the study diary. This outcome measure is applicable only for patients with wound index areas associated with eligible (moderate to severe) itch.

  Baseline to Day 29

Study Arms (2)

INM-755 (cannabinol) cream

EXPERIMENTAL

Cannabinol cream, topically applied daily in thin layer on non-wound index areas and every 1, 2 or 3 days in thick layer on dressings for index wounds for a 28-day period.

Drug: INM-755 (cannabinol) cream

Vehicle cream

PLACEBO COMPARATOR

Vehicle cream, topically applied daily in thin layer on non-wound index areas and every 1, 2 or 3 days in thick layer on dressings for index wounds for a 28-day period.

Drug: Vehicle Cream

Interventions

INM-755 (cannabinol) cream DRUG

topical cream containing cannabinol for dermal application

INM-755 (cannabinol) cream

Vehicle Cream DRUG

topical cream base for dermal application containing no active agent

Vehicle cream

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Have chronic itch with a score ≥40 mm on a 100 mm VAS
• Not exceed 20 percent of body surface area (BSA) or be less than 1 percent of BSA
• Be similar size, up to twice the area of the smaller index area
• For wound index areas, both wounds should:
• Have a surface area ≥5 cm\^2 and ≤50 cm\^2 inclusive and be aged ≥3 weeks
• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• InMed Pharmaceuticals Inc.: lead

Study Sites (7)

Hopital Saint Louis APHP Paris

Paris, 75010, France

Location

CHU Toulouse - Hopital Larrey

Toulouse, 31059, France

Location

Universitaetsklinikum Freiburg

Freiburg im Breisgau, 79104, Germany

Location

Andreas Syggros Hospital of Cutaneous Venereal Diseases

Athens, 16121, Greece

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, 6423930, Israel

Location

Fondazione IRCCS Ca Granda. Ospedale Maggiore Policlinico

Milan, Milano, 20122, Italy

Location

Instituto Dermopatico dell'Immacolata, IDI-IRCCS

Rome, Roma, 00167, Italy

Location

MeSH Terms

Conditions

Epidermolysis Bullosa Simplex; Epidermolysis Bullosa, Junctional; Epidermolysis Bullosa Dystrophica; Poikiloderma of Kindler

Interventions

Cannabinol

Condition Hierarchy (Ancestors)

Epidermolysis Bullosa; Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Skin Diseases, Genetic; Genetic Diseases, Inborn; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Vesiculobullous; Collagen Diseases; Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Alexandra DJ Mancini, MSc

  InMed Pharmaceuticals Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: INM-755 (cannabinol cream) and vehicle cream (control) are identical in appearance and texture and packaged in kits labelled with unique blinded kit numbers.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Within-patient randomized, double-blind comparisons of INM-755 (cannabinol cream) versus vehicle cream (control) in matched, paired index areas

Study Record Dates

• First Submitted: May 26, 2021
• First Posted: June 1, 2021
• Study Start: December 28, 2021
• Primary Completion: April 3, 2023
• Study Completion: April 19, 2023
• Last Updated: July 3, 2023

Record last verified: 2023-06

Locations

GR (1); IT (2); FR (2); IL (1); DE (1)