Polymorphic light eruption (PLE) MedDRA version: 12.1 Level: LLT Classification code 10036087 Term: Polymorphic light eruption
Conditions
Sponsors
Clinuvel Pharmaceuticals Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: To be eligible to enter the study, subjects must meet the following inclusion criteria: - Aged greater than 18 years; - Male or female patients with a documented history of PLE diagnosed or confirmed by a photodermatologist or photobiologist, with a history of PLE related pruritus symptoms; - Recurrent PLE episodes that occur at least once a year (as evidenced by PLE related pruritus symptoms) developing in their own country (to exclude patients affected only when traveling to sunnier climates); - Written informed consent prior to the performance of any study-specific procedure; and - Are willing and able to comply with the conditions specified in this protocol and study procedures in the opinion of the Investigator. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: To be eligible to enter the study, subjects must not meet any of the following exclusion criteria: - Personal history of melanoma, lentigo maligna or multiple (3 or more) dysplastic nevi; - Current Bowen’s Disease, basal cell carcinoma, squamous cell carcinoma or other malignant skin lesions; - Patients currently requiring treatment with systemic immunosuppressive agents; - Documented history of other photosensitive conditions which may be confused with PLE or interfere with the assessment of PLE episodes; - Solarium use in the three months prior to study involvement and throughout the duration of the study; - Use of immunosuppressive medications, drugs that cause hyperpigmentation or any other treatment that in the opinion of the investigator may interfere with this study; - Documented presence (> 1 in 320) of Anti Nuclear Antibody (ANA) and/or positive Extractable Nuclear Antibody (ENA); historical results from the 3 years prior to randomisation are acceptable if available; - In the opinion of the investigator, any evidence of clinically significant organ dysfunction, or any clinically significant deviation from normal in clinical or laboratory parameters; - History of drug or alcohol abuse (in the last 1 year); - Female who is pregnant (confirmed by positive serum ß-HCG pregnancy test prior to baseline) or lactating; - Females of child-bearing potential (pre-menopausal, not surgically sterile) that are not using or are not willing to use adequate contraceptive measures (e.g. oral contraceptives, condoms, diaphragm plus spermicide, intrauterine device); - Sexually active men with partners of child bearing potential not willing to use barrier contraception during the trial and for a period of three months hereafter; - Participation in a clinical trial with another IMP within 30 days prior to the screening visit or during the study; - Hypersensitivity to afamelanotide or any of its components; - Hyperpigmentary disorders; and - Use of therapeutic doses of ß-carotene and other excluded medicines, as described in the study protocol (in the last 3 months).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objectives - To determine if afamelanotide can reduce the severity of PLE related pruritis. ;Secondary Objective: Secondary objectives - To determine if afamelanotide can reduce the frequency of PLE episodes; - To determine if afamelanotide can reduce the duration of PLE episodes; - To evaluate the effect of afamelanotide on the use of rescue medication for the treatment of PLE episodes; - To evaluate the effect of afamelanotide on the quality of life of PLE patients; and - To evaluate the safety and tolerability of afamelanotide by measuring treatment-emergent adverse events. ;Primary end point(s): Assessment of primary endpoint of this study will be conducted using: - The mean pruritus (Likert scale) for each treatment arm (active or placebo) will be compared using a one-tailed, two-sample (un-paired) t-test or, if the assumptions of normality are not met, a non-parametric test, such as the Kruskal-Wallis test will be used instead. H0: there is no difference between patients treated with active and placebo. H1: there is more pruritus with patients treated with placebo than active. Logarithmic transform or normalization will be performed if indicated by the distribution of the data (with zero scores assigned a value less than the lowest recorded score). Baseline-correction will be applied, either as difference from pre-dose values or as percentage of pre-dose values, as indicated by the distribution of these changes in PLE related pruritus. | — |
Countries
Belgium, Germany, Netherlands
Outcome results
None listed