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INM-755 · 1 trial · 4 indications
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.
Wound surface area will be measured by digital photography at weekly intervals. This outcome measure is applicable only for patients with wound index areas.
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.
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.
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.
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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. |
| Name | Type | Description |
|---|---|---|
| INM-755 (cannabinol) cream | DRUG | topical cream containing cannabinol for dermal application |
| Vehicle Cream | DRUG | topical cream base for dermal application containing no active agent |
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 com...
INM-755 is an investigational small molecule being developed for Epidermolysis Bullosa Simplex, a rare genetic skin disorder. It is formulated as a cream and is being studied for its potential to treat this condition. The drug is currently in clinical development and has not been approved by regulatory authorities.
INM-755 is a small molecule that contains cannabinol (CBN) as its active ingredient. It is being studied for its effects on skin conditions, specifically Epidermolysis Bullosa Simplex. The exact molecular target of INM-755 has not been disclosed in available information.
INM-755 is being developed by InMed Pharmaceuticals Inc., a biopharmaceutical company. The company is publicly traded under the ticker symbol INM. InMed Pharmaceuticals is focused on developing cannabinoid-based therapies for various medical conditions.
INM-755 is in Phase 2 clinical development. It has completed a Phase 2 clinical trial, which was a randomized, double-blind, placebo-controlled study. The drug is still investigational and has not received regulatory approval for any indication.
INM-755 has been studied in one clinical trial, identified as NCT04908215, titled 'INM-755 (Cannabinol) Cream for Treatment of Epidermolysis Bullosa'. This Phase 2 trial was completed and enrolled 19 participants. The study was conducted in France, Germany, Greece, Israel, and Italy.
INM-755 is a cream formulation that contains Cannabinol (CBN) as its active ingredient. While INM-755 is the drug product being developed by InMed Pharmaceuticals, Cannabinol is the specific cannabinoid compound within it. They are related but not identical, as INM-755 is the proprietary formulation.