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 | 12.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10050576 |
E.1.2 | Term | Psoriasis vulgaris |
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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 |
To compare LEO 90110 20.0 mg/g ointment to LEO 90110 ointment vehicle with respect to efficacy when administered twice daily for 8 weeks to patients with psoriasis vulgaris
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E.2.2 | Secondary objectives of the trial |
To compare LEO 29102 2.5 mg/g cream to LEO 29102 cream vehicle with respect to efficacy when administered twice daily for 8 weeks to patients with psoriasis vulgaris
To compare LEO 90110 20.0 mg/g ointment to LEO 29102 2.5 mg/g cream with respect to efficacy when administered twice daily for 8 weeks to patients with psoriasis vulgaris
To investigate the safety of LEO 90110 20.0 mg/g ointment and LEO 29102 2.5 mg/g cream when administered twice daily for 8 weeks to patients with psoriasis vulgaris
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
1. Following verbal and written information about the trial, the subject has provided signed and dated in-formed consent before any study related activity is carried out, including activities relating to the wash-out period 2. Clinical diagnosis of psoriasis vulgaris with lesions located on arms, legs or trunk amenable for topical treatment 3. Two symmetrically distributed lesions, one on each side of the body, located on arms, legs or trunk, fulfilling the following criteria: a. Size Each lesion of minimum 0.5% and maximum 1% of total body surface area. The two lesions should be of similar size according to the Investigator’s judge-ment. b. Total Clinical Score Each lesion with a Total Clinical Score of at least 5. Any difference in Total Clinical Score between the two lesions should be of maximum ‘1’. c. Severity Severity of each lesion at least mild according to Investigator’s Global Assessment. Severity score must be the same for both lesions. 4. Aged 18 years or above |
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E.4 | Principal exclusion criteria |
1. Systemic treatment with biological therapies directed against or with a potential effect on psoriasis vulgaris, within the following time period: - etanercept: within 4 weeks prior to randomisation - adalimumab, infliximab: within 2 months prior to randomisation - alefacept, ustekinumab: within 4 months prior to randomisation 2. Systemic treatment with all other than biological therapies with a potential effect on psoriasis vulgaris (e.g. corticosteroids, retinoids, immunosuppressants, salazopyrin) within 4 weeks prior to randomisation 3. PUVA therapy or Grenz ray therapy within 4 weeks prior to randomisation 4. UVB therapy within 2 weeks prior to randomisation 5. Topical treatment with potent or very potent WHO group III and IV corticosteroids within 2 weeks prior to randomisation 6. Any topical treatment (except for emollients) of the two selected target lesions within 2 weeks prior to randomisation 7. Planned initiation of, or planned changes to, concomitant medication that may affect psoriasis vulgaris (e.g., beta blockers, chloroquine, lithium and ACE inhibitors) within 2 weeks prior to randomisation and during the study 8. Treatment with drugs sensitive to CYP3A4 or CYP2D6 metabolism within 5 half lives prior to randomisation 9. Current diagnosis of guttate, erythrodermic, exfoliative or pustular psoriasis 10. Any of the following conditions present on the two selected target lesions: Infectious skin disorder, eczematous skin, atopic dermatitis, ulcers or wounds 11. Skin disease on the two selected target lesions that may confound the evaluation of psoriasis vulgaris (e.g., seborrhoiec dermatitis, contact dermatitis or fungal infection) as judged by the Investigator 12. Planned exposure to the sun during the study that may affect psoriasis vulgaris (i.e., normal lifestyle outdoor activities are permitted but deliberate exposure to sunlight or artificial ultraviolet light to the two selected target lesions should be avoided) 13. Clinically significant cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, haematologic, malignant or gastrointestinal disease, immunologic insufficiency, or other major diseases or current condition which, in the opinion of the Investigator, would put the subject at risk by participating in the study or would interfere with the evaluation of study results 14. History of immune deficiency condition (e.g., lymphoma, HIV or Wiskott-Aldrich Syndrome) 15. Chronic or ongoing infectious disease requiring systemic treatment such as, but not limited to, chronic renal infection, chronic chest infection with bronchiectasis, tuberculosis, active hepatitis B, active hepatitis C, HIV positive 16. Known or suspected hypersensitivity to component( s) of the investigational products 17. Current participation in any other interventional clinical trial 18. Treatment with any non-marketed drug substance (i.e., an agent which has not yet been made available for clinical use following registration) within the last 4 weeks prior to randomisation, or for biologics, within the last 12 weeks prior to randomisation 19. Previously randomised in this trial 20. Known or suspected to be unlikely to comply with the Clinical Study Protocol (e.g., due to alcoholism, drug dependency or psychotic state) 21. Female subjects who are pregnant, of child-bearing potential and wishing to become pregnant during the trial, or are breast feeding 22. Female subjects of childbearing potential1 expected not using an adequate method of contraception during the study and during 4 weeks after last administration of investigational product. Adequate methods of contraception are defined as - abstinence (when this is in line with the preferred and usual lifestyle of the subject) - vasectomised partner (partner should be the sole partner for the subject) - an intrauterine device - double barrier method defined as two distinct methods (either two actual barrier methods or one actual barrier method and one hormonal method) - hormonal contraceptive (oral hormonal birth control, estrogenic vaginal ring, percutaneous contraceptive patches, implants and injectables) for at least one menstrual cycle prior to randomisation (Visit 1)
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E.5 End points |
E.5.1 | Primary end point(s) |
The absolute change in Total Clinical Score from baseline (Visit 1) to 8 weeks of treatment (end of treatment, Visit 7) for the selected target lesion on the left and right side of the body |
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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 | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
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 | Yes |
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) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
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) | Yes |
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 | 8 |
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 | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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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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Please refer to Protocol Version 29-Oct-2010 |
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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 |