E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 12.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10041307 |
E.1.2 | Term | Solar urticaria |
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E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Primary objective: To determine if afamelanotide increases the minimal urticarial dose (MUD) in subjects with solar urticaria (SU). |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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.
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E.4 | Principal 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 β-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.
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E.5 End points |
E.5.1 | 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
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | Yes |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 5 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The end of the trial is defined by the last visit of the last subject undergoing the trial. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 8 |
E.8.9.2 | In all countries concerned by the trial days | 0 |