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

InMed Pharmaceuticals Inc.0 个研究点目标入组 20 人开始时间: 2021年4月19日最近更新: 2024年1月8日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: InMed Pharmaceuticals Inc.
入组人数: 20

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•Individuals must meet all of the following criteria to be included in the study:
•1. Male or female patients aged =18 years with documented diagnosis of any of the following types of inherited EB:
•EB simplex
•Junctional EB
•Dystrophic EB
•Kindler EB
•Enrolment will be extended to patients =12 years old and <18 years old after positive opinion of a DMC after their review of safety and tolerability data from at least 4 adult patients who have completed at least 2 weeks of study treatment.
•2. Presence of at least 1 pair of index areas that are well matched in terms of type(s) of EB sign or symptom, severity, and size. To be eligible, the pair of index areas must be either non-wound areas with symptom of itch or wounds (that may or may not have associated pain or itch). Up to 2 pairs of index areas (1 pair of non-wound and 1 pair of wound index areas) can be selected and treated in each individual patient.
•For non-wound itch index areas, both areas should meet the following criteria:
•Chronic itch, not associated with a wound, with a score =40 mm on a 100 mm VAS at the Screening Visit and with an average score =40 mm during the 7 days before the Baseline Visit, and present for the majority of time over the 6 weeks before to the Baseline Visit
•Absence of wounds at the Screening and Baseline Visits that could qualify as an index wound (see below) in the index areas or that require wound dressing.
•The area cannot also have a wound that has healed (re-epithelialised) within the past 3 weeks prior to Screening.
•Extension of each index area to be treated should not exceed 20% of BSA and should not be less than 1% of BSA
•A difference in the index areas to be treated not larger than 2-fold the area of the smallest index non-wound itch area at the Screening Visit
•Additional signs or symptoms of EB other than itch from selected index areas do not need to be matched.
•If the pair of index areas are wounds, both wounds should meet all following characteristics:
•Wounds with a surface area =5 cm2 and =50 cm2 inclusive at the Screening and Baseline Visits and aged =3 weeks at the Screening Visit
•At Baseline Visit, each index wound should not present a surface reduction =30% from the Screening Visit
•To be considered well-matched the index wounds must have:
•a. a difference in the surface area not larger than 2-fold the surface of the smallest index wound at the Screening Visit
•b. both must fit into the same duration window of either =3 weeks to 3 months before the Screening Visit or >3 months
•c. not located at anatomical sites with high likelihood of accidental trauma (e.g., knees, elbows)
•3. Female patients of childbearing potential or men whose sexual partners are women of childbearing potential (WOCBP) must be able and willing to use at least 1 method of contraception until the patient’s last study visit. The following are permitted contraceptive methods: intrauterine device, hormonal contraceptives (e.g., oral, patch, or injectable), male vasectomy (if vasectomy was medically confirmed). Abstinence from heterosexual intercourse is acceptable when this is the usual lifestyle of the patient. A female patient is considered not of childbearing potential when postmenopausal (at least 12 consecutive months without menses without an alternative medical cause) or otherwise permanently sterile (for which acceptable methods include hysterectomy, bilateral salpingectomy, or bilateral oophorectomy with or without hysterectomy).
•4. If the patient

排除标准

•Individuals meeting any of the following criteria at Screening or Baseline are ineligible to participate in this study:
•1. EB index areas have evidence of infection.
•2. Patient has evidence of a systemic infection or has used systemic antibiotics for EB-related infections within 7 days before the Baseline Visit.
•3. Administration of systemic corticosteroids within 30 days or of topical (except ophthalmic) corticosteroids on chosen index areas within 14 days before the Baseline Visit. Corticosteroids for inhalation or intranasal use are permitted provided they are taken at a stable dosing.
•4. Immunosuppressive therapy or cytotoxic chemotherapy within 60 days before the Baseline Visit.
•5. Use of any high potency opioid within 30 days prior to Baseline Visit.
•6. Use of cannabis, cannabis extracts, or any cannabinoid products for medical or recreational use by any route of administration within 2 weeks prior to the Baseline Visit. The patient can be using the cannabinoid-containing product at Screening but must commit to avoiding cannabinoid use in the prescribed timeframe.
•7. Patient has undergone stem cell transplant or gene therapy for the treatment of inherited EB.
•8. History of malignancy including basal cell carcinomas and squamous cell carcinomas.
•9. Arterial or venous disorder resulting in ulcerated wounds.
•10. Uncontrolled diabetes mellitus.
•11. Presence of chronic pruritus believed to be primarily attributable to concomitant pathologies or conditions other than EB (e.g., renal or cholestatic pathologies).
•12. Patient has received blood transfusion to treat anaemia within the past 3 months.
•13. Patient has received any investigational drug within 30 days or 5 half-lives (whichever is longer) before the Baseline Visit.
•14. Patient has an underlying condition which in the opinion of the investigator places the patient at unacceptable risk.
•15. Women who are pregnant, breastfeeding (lactating), or planning to become pregnant during the study.
•16. Patient is considered by the investigator, for any reason, to be an unsuitable candidate for the study.
•17. Patient is an inmate of a psychiatric ward, prison, or state institution by virtue of an order issued either by the judicial or the administrative authorities.

研究者

发起方

InMed Pharmaceuticals Inc.

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