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

• Register: EUCTR
• Last refreshed on: 19 March 2012
• Main ID: EUCTR2008-002143-16-GB
• Date of registration: 15/03/2010
• Prospective Registration: No
• Primary sponsor: Clinuvel Pharmaceuticals Limited
• Public title: 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
• Scientific title: 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
• Date of first enrolment: 04/02/2010
• Target sample size: 50
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2008-002143-16
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: no Single blind: no Double blind: yes Parallel group: no Cross over: yes Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no

Countries of recruitment

United Kingdom

Key inclusion & exclusion criteria

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.



Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Solar urticaria (SU)
MedDRA version: 12.0 Level: LLT Classification code 10041307 Term: Solar urticaria

Intervention(s)

Product Name: afamelanotide
Product Code: CUV1647
Pharmaceutical Form: Implant
Pharmaceutical form of the placebo: Implant
Route of administration of the placebo: Subcutaneous use

Primary Outcome(s)

Main Objective: Primary objective:
To determine if afamelanotide increases the minimal urticarial dose (MUD) in subjects with solar urticaria (SU).

Secondary Objective: Secondary objectives:
- To determine if afamelanotide reduces the incidence and severity of naturally occurring urticarial episodes and the use of rescue medication;
- To determine if afamelanotide can improve the quality of life of SU patients; and
- To evaluate the safety and tolerability of afamelanotide in the treatment of SU.

Primary end point(s): Endpoints:

Primary endpoint will be assessed by:
- MUD determined by phototesting at Screening, Day 30, 90 and 120

Secondary endpoints will be assessed by:
- Quality of life measured by DLQI and Skindex-29 questionnaires at Screening and Study Days 30, 90 and 120
- The frequency of use of rescue medication between Days 0 to 30 and Days 90 to 120
- The incidence of urticarial episodes between Days 0 to 30 and Days 90 to 120
- The treatment-emergent adverse events (TEAEs), including clinically significant changes in laboratory parameters occurring in the 30 day period following treatment

Secondary ID(s)

CUV023