E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Polymorphic light eruption (PLE) |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | PT |
E.1.2 | Classification code | 10036087 |
E.1.2 | Term | Polymorphic light eruption |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
• Evaluate whether CUV1647 prevents episodes or reduces the severity of symptoms in patients with PLE • Evaluate the effect of CUV1647 on the use of rescue medication for the treatment of PLE symptoms
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E.2.2 | Secondary objectives of the trial |
• Determine whether CUV1647 has a beneficial effect on the quality of life of PLE sufferers • Determine if there are any confounding factors that may influence the severity of PLE symptoms • Evaluate the effect of CUV1647 on melanin density measured by skin reflectance • Evaluate the safety and tolerability of CUV1647
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
• Documented history of moderate/severe PLE as diagnosed/confirmed by a photodermatologist/photobiologist • Patients have recurrent episodes that occur at least once per year in their local environment
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E.4 | Principal exclusion criteria |
• PLE requiring treatment with systemic immunosuppressive agents • Documented history of other photosensitivity conditions eg. Solar urticaria • Documented presence of anti nuclear antibody and/or positive extractable nuclear antibody • Evidence of clinically significant organ dysfunction or clinically significant deviation from normal in clinical or laboratory parameters • Females who are pregnant, lactating or of childbearing potential and not using adequate form(s) of contraception • Personal history of melanoma, lentigo maligma or multiple dysplastic nevi.
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E.5 End points |
E.5.1 | Primary end point(s) |
• Physician’s global severity at Day 120 (defined as the sum of the maximum severity for each episode experienced during the 120 days following the date of the first implant). • A reduction in the use of rescue medication in the CUV1647 treated group compared with placebo (Days 0 to 120).
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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 | Yes |
E.8.1.6 | Cross over | No |
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
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 4 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 9 |
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 | Yes |
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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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 8 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 8 |