A Randomised, Double-Blind, Vehicle-Controlled Phase 2 Study of Topically Applied INM-755 (Cannabinol) Cream in Patients With Epidermolysis Bullosa

Who is this study for? Patients with epidermolysis bullosa
What treatments are being studied? INM-755
Status: Completed
Location: See all (7) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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).

Eligibility
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: f
View:

• 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)

Locations
Other Locations
France
Hopital Saint Louis APHP Paris
Paris
CHU Toulouse - Hopital Larrey
Toulouse
Germany
Universitaetsklinikum Freiburg
Freiburg Im Breisgau
Greece
Andreas Syggros Hospital of Cutaneous Venereal Diseases
Athens
Israel
Tel Aviv Sourasky Medical Center
Tel Aviv
Italy
Fondazione IRCCS Ca Granda. Ospedale Maggiore Policlinico
Milan
Instituto Dermopatico dell'Immacolata, IDI-IRCCS
Rome
Time Frame
Start Date: 2021-12-28
Completion Date: 2023-04-19
Participants
Target number of participants: 19
Treatments
Experimental: INM-755 (cannabinol) cream
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.
Placebo_comparator: Vehicle cream
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.
Sponsors
Leads: InMed Pharmaceuticals Inc.

This content was sourced from clinicaltrials.gov