Afamelanotide in Patients Suffering From Polymorphic Light Eruption (PLE)

Polymorphic Light Eruption Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04704713
• Other study ID #: CUV032
• Status: Completed
• Phase: Phase 3
• Start date: May 5, 2010

Study information

• Verified date: February 2021
• Source: Clinuvel Pharmaceuticals Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. primary completion date: December 9, 2010
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 (ß-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

Related Conditions & MeSH terms

• Dermatitis, Contact
• Exanthema
• Polymorphic Light Eruption

Intervention

Drug:
• Afamelanotide

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Clinuvel Pharmaceuticals Limited

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Frequency (Number) of Documented PLE Episodes Recorded in Paper Patient Diaries		From Day 0 to Day 120
Secondary	Duration of PLE Episodes Recorded in Paper Patient Diaries		From Day 0 to Day 120
Secondary	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