Afamelanotide in Patients Suffering From Polymorphic Light Eruption (PLE)

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

This study was to evaluate the safety and efficacy of afamelanotide in patients suffering from polymorphic light eruption (PLE).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Clinuvel Pharmaceuticals Limited
• Treatments: Afamelanotide

Criteria

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