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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase III, Randomised, Double-Blind, Placebo Controlled Study to Evaluate the Safety and Efficacy of Subcutaneous Implants of CUV1647 in Patients Suffering From Polymorphic Light Eruption (PLE).

Conditions
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Polymorphic Light Eruption (PLE)

Intervention / Treatment
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* Drug: Afamelanotide (CUV1647)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Afamelanotide (CUV1647)|16mg implant|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate whether afamelanotide (CUV1647) prevents episodes or reduces the severity of PLE symptoms in patients with a well documented history of PLE |  | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety and tolerability of afamelanotide (CUV1647) in this specific clinical setting |  | 18 months | 
| To evaluate the effect of afamelanotide (CUV1647) on melanin density levels as measured by skin reflectance |  | 18 months | 
| To evaluate whether afamelanotide (CUV1647) has a beneficial effect on the quality of life of patients with a documented history of PLE |  | 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 |  | 18 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Polymorphic Light Eruption (PLE), Afamelanotide, CUV1647, photoprotection, sun poisoning