E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
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 investigate the efficacy of CT 327, when administered twice daily as a topical cream to lesions of Psoriasis Vulgaris (PV) in comparison to placebo in terms of improvements from baseline in study group (within patient comparison by McNemar test) on: Proportion of lesions with a reduction in m-PASI-score of > 50% for CT 327 vs placebo treated lesions at Week 8
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E.2.2 | Secondary objectives of the trial |
To investigate the efficacy and safety of CT 327, when administered twice daily as a topical cream to lesions of Psoriasis Vulgaris (PV) in comparison to placebo in terms of: EFFICACY: 1) Proportion of lesions with a reduction in mPASI-score of > 75% at week 8 compared to baseline values. 2) Time to onset of effect: At each visit and for each patient, reduction in m-PASI-score compared to baseline values will be determined. 3)IGA (Investigator Global Assessment) will be assessed at week 8 SAFETY: 1) local tolerability 2) systemic safety and tolerability 3) absorption of CT 327 to the systemic circulation (Blood levels of CT 327 and K252a) |
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E.2.3 | Trial contains a sub-study | Yes |
E.2.3.1 | Full title, date and version of each sub-study and their related objectives |
Within the main protocol there is the option for the subjects to have a pre-treatment biopsy taken from one of their target lesions. If the patient's condition in either target lesion improves, according to mPASI score, during the treatment period, a post-treatment biopsy would be taken from both target lesions. All biopsy samples will be centrally read for various cytokines and immune system cell types that are implicated in the pathophysiology of psoriasis vulgaris. |
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E.3 | Principal inclusion criteria |
•Age > 18 and < 71 years of age •Able to give informed consent •Diagnosis of mild (affecting < 3% BSA) to moderate (affecting < 10% BSA) Psoriasis Vulgaris, including, at baseline visit, two symmetrical,similar sized, target plaques, comparable in severity, on either side, of at least 10 cm2 each
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E.4 | Principal exclusion criteria |
•Subject or partner of subject not using an adequate and appropriate form of contraception such as condom (male) or oral contraceptive; intra-uterine device (IUD); contraceptive injection, implant or patch (female) •Subject or partner of subject are pregnant or lactating, or intend to become pregnant during the study period and one month thereafter •Allergy to test drug or any other ingredient •Usage of topical corticosteroids or other topical treatments for PV within the last two weeks prior to study entry (including calcineurin inhibitor, topical H1 antihistamines, topical antimicrobials, other medicated topical agents) or herbal preparation to the area selected for treatment Within 4 weeks prior to study entry, have received systemic treatment for psoriasis (including systemic corticosteroids, nonsteroidals, immune-suppressants, or immune-modulating drugs, or treatment with light). •Received treatment with systemic or locally acting medications which might counter or influence the study aim •Clinical diagnosis of bacterial infection of the skin including impetigo and abscesses •Have concomitant dermatologic or medical condition(s) which may interfere with the investigator's ability to evaluate the patient's response to the study drug •Have immune-compromised status (such as known human immunodeficiency virus infection) •Have a history of malignancy, excluding basal cell carcinoma of the skin •Have an active intercurrent infection •Suffer from erythrodermic psoriasis, psoriasis punctata and pustular psoriasis or extended chronic stationary forms of psoriasis
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E.5 End points |
E.5.1 | Primary end point(s) |
To assess the efficacy of an 8-week treatment of CT 327 vs Placebo in terms of improvements from baseline in study group (within patient comparison by McNemar test) on: Proportion of lesions with a reduction in m-PASI-score of > 50% for CT 327 vs placebo treated lesions at Week 8 |
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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 | Yes |
E.6.7 | Pharmacodynamic | Yes |
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 | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
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 | No |
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 | 3 |
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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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 | 4 |
E.8.9.1 | In the Member State concerned days | 15 |
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 | 10 |
E.8.9.2 | In all countries concerned by the trial days | 6 |