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 | 10037153 |
E.1.2 | Term | Psoriasis |
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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 |
The Objective of this study is to demonstrate an anti-inflammatory effect of Rosuvastatin therapy in patients affected by Psoriasis in term of: 1) significant reduction in one or more systemic inflammatory markers (CRP plasma levels, IL-6, Hs-Interleukin-6 , IFN and TNF-alpha, Myeloperoxidase) or 2) significant reduction in levels of circulated CD4-CD28 null and inflammatory infiltration in the skin biopsy |
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E.2.2 | Secondary objectives of the trial |
The secondary Objectives are to demonstrate an higher presence of initial stigmata of atherosclerosis (IMT) in patients with more severe manifestations of skin disease compared with patients with mild form, also evaluating IMT modifications after 30 days treatment with 20 mg of Rosuvastatin/die to demonstrate an higher systemic inflammatory state in patients with moderate-severe psoriasis compared with patients with mild form. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
The following inclusion criteria will have to be met: 1. age >18 years 2. active but clinically stable plaque psoriasis 3. involvement of at least 10 percent of the body surface area for the moderate-severe group and < 10% for the group with mild psoriasi 4. minimal psoriasis area-and-severity index of <10 or >10 for the two groups respectively during the screening period |
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E.4 | Principal exclusion criteria |
The following criteria will preclude participation to the study: 1. pregnancy and nursing 2. guttate, erythrodernic, or pustular psoriasis at the time of screening 3. previous treatment with etanercept or anti-TNF antibodies 4. previous treatment with anti-CD4 antibodies or interleukin-2-diphtheria-toxin fusion protein within the previous six months 5. previous treatment with biologic or investigational drug, psoralen-ultaviolet A phototherapy, systemic corticosteroids, or systemic psoriasis therapy within the previous four weeks 6. previous treatment with ultraviolet B phototherapy, topical corticosteroids, vitamin A or D analogues, or anthralin within the previous two weeks antibiotic treatment within the previous week 7. other inflammatory, tumoral, systemic or skin disease 8. recent vaccination 9. previous or current use of lipid-lowering therapy 10. current use of post menopausal hormone replacement therapy 11. evidence of hepatic disfunction (alanine amino transferase levels> twice the upper limits of the normal range) 12. a CK level more than three times the upper limits of the normal range 13. a Creatinine level higher than 2 mg/dl 14. a recent history of alcohol or drug abuse. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Primary end-point is the demonstration of a significant reduction in one or more inflammatory markers (CRP, IL-6, IL-2, TNFalpha, INF gamma, MPO and of circulated CD4-CD28 null and inflammatory infiltration in the skin biopsy) after 30 days treatment with Rosuvastatin in patients with Psoriasis. |
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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 | No |
E.6.3 | Therapy | Yes |
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 | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Controllo pre e post trattamento |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Information not present in EudraCT |
E.8.2.2 | Placebo | Information not present in EudraCT |
E.8.2.3 | Other | Information not present in EudraCT |
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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
E.8.5 | The trial involves multiple Member States | No |
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
| |
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 | 6 |
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 | 6 |