Solar urticaria (SU) MedDRA version: 12.0 Level: LLT Classification code 10041307 Term: Solar urticaria
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: - Male or female subjects with confirmed diagnosis of SU who phototest positive by producing a wheal (oedema) and flare (diffuse erythema); - Aged 18 years or older; and - Written informed consent prior to the performance of any study-specific procedure. 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: - Known allergy or hypersensitivity to afamelanotide or the polymer contained in the implant; - Personal history of melanoma, lentigo maligna or dysplastic nevus cell syndrome; - History of basal cell carcinoma, current Bowen’s disease, squamous cell carcinoma or other malignant skin lesions; - Any evidence of clinically significant organ dysfunction or any clinically significant deviation from normal in the clinical or laboratory evaluations; - Undergone PUVA or UVB therapy within the last three months prior to Screening; - Subjects requiring depot corticosteroids, chronic systemic corticosteroids or immunosuppressants who in the opinion of the investigator are not able to discontinue such treatment; - Any other photodermatosis such as PLE, EPP or DLE; - Major medical or psychiatric illness which in the opinion of the investigator would interfere with the study outcome; - Subject assessed as not suitable for the study in the opinion of the investigator (e.g. noncompliance history, allergic to local anaesthetics, known alcohol and/or drug abuse:; - 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) not using adequate contraceptive measures (i.e. oral contraceptives, diaphragm plus spermicide, intrauterine device); and - Participation in a clinical trial for an investigational agent within 30 days prior to the screening visit.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Primary objective: To determine if afamelanotide increases the minimal urticarial dose (MUD) in subjects with solar urticaria (SU).;Secondary Objective: Secondary objectives: - To determine if afamelanotide reduces the incidence and severity of naturally occurring urticarial episodes and the use of rescue medication; - To determine if afamelanotide can improve the quality of life of SU patients; and - To evaluate the safety and tolerability of afamelanotide in the treatment of SU.;Primary end point(s): Endpoints: Primary endpoint will be assessed by: - MUD determined by phototesting at Screening, Day 30, 90 and 120 Secondary endpoints will be assessed by: - Quality of life measured by DLQI and Skindex-29 questionnaires at Screening and Study Days 30, 90 and 120 - The frequency of use of rescue medication between Days 0 to 30 and Days 90 to 120 - The incidence of urticarial episodes between Days 0 to 30 and Days 90 to 120 - The treatment-emergent adverse events (TEAEs), including clinically significant changes in laboratory parameters occurring in the 30 day period following treatment | — |
Countries
United Kingdom
Outcome results
None listed