Afamelanotide in Patients Suffering From Polymorphic Light Eruption (PLE)

A Phase III, Randomised, Double Blind, Placebo Controlled, Parallel Group Study, to Evaluate the Safety and Efficacy of Subcutaneous Implants of Afamelanotide (16 mg) in Patients Suffering From Polymorphic Light Eruption (PLE)

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

Study Overview

• Status: Completed
• Conditions: Polymorphic Light Eruption
• Intervention / Treatment: Drug: Placebo; Drug: Afamelanotide

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Afamelanotide; Afamelanotide implants were administered on Days 0 and 60. Patients returned to the clinic on Day 120 for the final visit.	Drug: Afamelanotide
Placebo Comparator: Placebo; Placebo implants were administered on Days 0 and 60. Patients returned to the clinic on Day 120 for the final visit.	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Severity of PLE Related Pruritus Recorded Using an 11-point Likert Scale	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).	From Day 0 to Day 120

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency (Number) of Documented PLE Episodes Recorded in Paper Patient Diaries		From Day 0 to Day 120
Duration of PLE Episodes Recorded in Paper Patient Diaries		From Day 0 to Day 120
Quality of Life Using the Dermatology Life Quality Index (DLQI)	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.	At Day 0, Day 60 and Day 120

Collaborators and Investigators

• Sponsor: Clinuvel Pharmaceuticals Limited

Study record dates

Study Major Dates

• Study Start (Actual): May 5, 2010
• Primary Completion (Actual): December 9, 2010

Study Registration Dates

• First Submitted: January 8, 2021
• First Submitted That Met QC Criteria: January 8, 2021
• First Posted (Actual): January 12, 2021

Study Record Updates

• Last Update Posted (Actual): March 19, 2021
• Last Update Submitted That Met QC Criteria: February 25, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Dermatitis; Skin Diseases, Eczematous; Exanthema; Dermatitis, Contact; Dermatologic Agents; Afamelanotide
• Other Study ID Numbers: CUV032