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 safety and tolerability of CUV1647 •Evaluate the effect of CUV1647 on the use of rescue medication for the treatment of PLE symptoms •Evaluate the effect of CUV1647 on melanin density measured by skin reflectance
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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
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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 assessment and patient’s assessment at Days 60, 120 and 150. •Cumulative disease burden at Days 60, 120 and 150 in years 1 and 2. •Amount of rescue medication used •Changes in melanin density from baseline
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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 | 2 |
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 |