Afamelanotide in Patients Suffering From Polymorphic Light Eruption (PLE)

Phase 3

Completed

• Conditions: Polymorphic Light Eruption
• Interventions: Drug: Afamelanotide; Drug: Placebo

• Registration Number: NCT04704713
• Lead Sponsor: Clinuvel Pharmaceuticals Limited

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2010-05-05
• Primary Completion: 2010-12-09
• Study First Submitted: 2021-01-08
• Study First Submitted QC: 2021-01-08
• Study First Posted: 2021-01-12
• Results First Submitted: 2021-01-26
• Status Verified: 2021-02
• Results First Submitted QC: 2021-02-25
• Last Update Submitted: 2021-02-25
• Results First Posted: 2021-03-19
• Last Update Posted: 2021-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Afamelanotide	Afamelanotide	Afamelanotide implants were administered on Days 0 and 60. Patients returned to the clinic on Day 120 for the final visit.
Placebo	Placebo	Placebo implants were administered on Days 0 and 60. Patients returned to the clinic on Day 120 for the final visit.

Primary Outcome Measures

Name	Time	Method
Severity of PLE Related Pruritus Recorded Using an 11-point Likert Scale	From Day 0 to Day 120	PLE related pruritus was recorded in paper patient diaries commencing using an 11-point Likert scale from 0 (no pruritus) to 10 (most severe pruritus).

Secondary Outcome Measures

Name	Time	Method
Duration of PLE Episodes Recorded in Paper Patient Diaries	From Day 0 to Day 120
Frequency (Number) of Documented PLE Episodes Recorded in Paper Patient Diaries	From Day 0 to Day 120
Quality of Life Using the Dermatology Life Quality Index (DLQI)	At Day 0, Day 60 and Day 120	The DLQI questionnaire consists of 10 questions, each answered on a categorical scale. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.