Status:
COMPLETED
Afamelanotide in Patients Suffering From Polymorphic Light Eruption (PLE)
Lead Sponsor:
Clinuvel Pharmaceuticals Limited
Conditions:
Polymorphic Light Eruption
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
This study was to evaluate the safety and efficacy of afamelanotide in patients suffering from polymorphic light eruption (PLE).
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 5 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT04704713
Start Date
May 5 2010
Last Update
March 19 2021
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