Phase III Trial of CUV1647 in Polymorphic Light Eruption (PLE)

Clinuvel Pharmaceuticals Limited18 enrolled

Overview

The purpose of this study is to determine whether the afamelanotide (CUV1647) formulation is effective in preventing PLE episodes or reducing the severity of PLE symptoms in patients with a well documented history of the disease. The study also aims to determine whether treatment with afamelanotide (CUV1647) can reduce the use of rescue medication in this group.

Polymorphic Light Eruption (PLE) is a prevalent photosensitivity disorder, occurring in up to 20% of the European and US populations and up to 5% of the Australian population. The disease is characterised by a rash that is intensely itchy with blisters, bumps and patches presenting on areas of the skin that have been exposed to the sun. There is a lack of effective treatment available for the condition but the most common available forms of therapy include sun avoidance and the use of the use of steroids and/or phototherapy.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Polymorphic Light Eruption (PLE)

Interventions

Afamelanotide (CUV1647)DRUG

16mg implant

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Aged 18 - 70 years at inclusion. * Well documented history of moderate/severe PLE as diagnosed/confirmed by a photodermatologist or photobiologist. Newly diagnosed patients with moderate/severe PLE can be included if numbers of established patients are limited provided their diagnosis is confirmed by a photodermatologist or photobiologist. * Recurrent episodes that occur at least once a year, developing in own country (to exclude patients affected only when traveling to sunnier climates). * Have given written informed consent to participate in the study. Exclusion Criteria: * Personal history of melanoma, lentigo maligna or multiple (3 or more) dysplastic nevi. * Current Bowen's Disease, basal cell carcinoma, squamous cell carcinoma or other malignant skin lesions. * Documented history of other photosensitive conditions. * Female who is pregnant (confirmed by positive serum β-HCG pregnancy test prior to baseline) or lactating. * Females of child-bearing potential that are not using adequate contraceptive measures.

Locations (3)

St Vincents Hospital

Melbourne, Australia

Medical University of Vienna

Vienna, Austria

Hope Hospital

Manchester, United Kingdom

Outcomes

Primary Outcomes

To evaluate whether afamelanotide (CUV1647) prevents episodes or reduces the severity of PLE symptoms in patients with a well documented history of PLE

Time frame: 18 months

Secondary Outcomes

To evaluate the safety and tolerability of afamelanotide (CUV1647) in this specific clinical setting

Time frame: 18 months

To evaluate the effect of afamelanotide (CUV1647) on melanin density levels as measured by skin reflectance

Time frame: 18 months

To evaluate whether afamelanotide (CUV1647) has a beneficial effect on the quality of life of patients with a documented history of PLE

Time frame: 18 months

To determine if there are other factors that may influence the severity of PLE symptoms eg. sun exposure and use of sun protection methods

Time frame: 18 months

Data from ClinicalTrials.gov

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