Afamelanotide in Patients Suffering From Polymorphic Light Eruption (PLE)

Clinuvel

Status and phase

Completed

Phase 3

Conditions

Polymorphic Light Eruption

Treatments

Drug: Afamelanotide

Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT04704713

CUV032

Details and patient eligibility

About

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

Enrollment

31 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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