Afamelanotide in Patients Suffering From Polymorphic Light Eruption (PLE)

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
• Are willing and able to comply with the conditions specified in the protocol and study procedures in the opinion of the Investigator

Exclusion criteria

• Currently requiring treatment with systemic immunosuppressive agents
• Documented history of other photosensitivity 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 beta-Human chorionic gonadotropin (β-HCG) pregnancy test prior to baseline) or lactating
• Female of child-bearing potential (pre-menopausal, not surgically sterile) that is not using or is 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 thereafter
• Participation in a clinical trial with another Investigational Medicinal Product (IMP) within 30 days prior to the Screening visit or during the study
• Hypersensitivity to afamelanotide or any of its components