A Phase III, multicentre, double–blind, placebo controlled, cross over study to evaluate the safety and efficacy of subcutaneous bioresorbable implants of afamelanotide in the treatment of solar urticaria (SU) - Multicentre Phase III SU Study

• Conditions: Solar urticaria (SU); MedDRA version: 12.0Level: LLTClassification code 10041307Term: Solar urticaria

• Registration Number: EUCTR2008-002143-16-GB
• Lead Sponsor: Clinuvel Pharmaceuticals Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03-15
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

To be eligible to enter the study, subjects must meet the following inclusion criteria:
- Male or female subjects with confirmed diagnosis of SU who phototest positive by producing a wheal (oedema) and flare (diffuse erythema);
- Aged 18 years or older; and
- Written informed consent prior to the performance of any study-specific procedure.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

To be eligible to enter the study, subjects must not meet any of the following exclusion criteria:
- Known allergy or hypersensitivity to afamelanotide or the polymer contained in the implant;
- Personal history of melanoma, lentigo maligna or dysplastic nevus cell syndrome;
- History of basal cell carcinoma, current Bowen’s disease, squamous cell carcinoma or other malignant skin lesions;
- Any evidence of clinically significant organ dysfunction or any clinically significant deviation from normal in the clinical or laboratory evaluations;
- Undergone PUVA or UVB therapy within the last three months prior to Screening;
- Subjects requiring depot corticosteroids, chronic systemic corticosteroids or immunosuppressants who in the opinion of the investigator are not able to discontinue such treatment;
- Any other photodermatosis such as PLE, EPP or DLE;
- Major medical or psychiatric illness which in the opinion of the investigator would interfere with the study outcome;
- Subject assessed as not suitable for the study in the opinion of the investigator (e.g. noncompliance history, allergic to local anaesthetics, known alcohol and/or drug abuse:;
- Female who is pregnant (confirmed by positive serum ß-HCG pregnancy test prior to baseline) or lactating;
- Females of child-bearing potential (pre-menopausal, not surgically sterile) not using adequate contraceptive measures (i.e. oral contraceptives, diaphragm plus spermicide, intrauterine device); and
- Participation in a clinical trial for an investigational agent within 30 days prior to the screening visit.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified