Afamelanotide in Patients Suffering From Polymorphic Light Eruption (PLE)
Condition: Polymorphic Light Eruption
MeSH terms: Exanthema; Dermatitis, Contact
Intervention: Afamelanotide; Placebo
Intervention MeSH terms: Afamelanotide
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 31.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

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

Eligibility 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