| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Male and female patients, 18 to 70 years of age, with a diagnosis of chronic plaque psoriasis. |
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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 | 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 |
| To assess the efficacy, safety, and tolerability of LAS37779 1% cream applied twice daily for 8 weeks, compared to 8 weeks of twice daily applications of LAS37779 vehicle cream. |
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| E.2.2 | Secondary objectives of the trial |
• To assess the relative efficacy, safety, and tolerability of LAS37779 1% cream applied twice daily for 8 weeks to calcipotriol 0.005% cream applied twice daily.
• To investigate the systemic drug levels of LAS37779 and its main metabolites after single and multiple cutaneous applications of LAS37779 1% cream in psoriasis patients.
• To evaluate the cosmetic acceptability of study creams in patients.
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|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
Patients eligible to be enrolled as subjects in this study:
1. are male or female, 18 to 70 years of age;
2. if female of childbearing potential, use of a highly effective method of birth control defined as those which result in a low failure rate (i.e., less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomy of the partner. In addition these female patients will have to have a negative pregnancy test at screening and agrees to submit to a pregnancy test at the end of study;
3. have clinical diagnosis of chronic plaque psoriasis, characterized at screening visit by:
• an Investigator’s Global Assessment of Disease Severity (IGA static) score of 2 (=mild) or 3 (=moderate).
• two target lesions, one located in the elbow or knee and the other on trunk or limbs of similar size (minimum size of 2 cm in diameter) and severity with score of at least 2 (=moderate) for induration and 2 (=moderate) for erythema.
• at least 2% but no more than 20% of body surface area (BSA) affected by the disease
• have lesions in at least two anatomical regions (trunk, legs or arms)
4. are free of any systemic and dermatologic disorders, which, in the opinion of the investigator, will interfere with the study results or increase the risk of adverse events;
5. may read, understand and provide signed informed consent;
6. are willing to follow the study procedures for treatment application and dosing regimen and complete the study.
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| E.4 | Principal exclusion criteria |
Patients may not be enrolled as subjects in this study who:
1. are females who are pregnant, plan to become pregnant during the study, or are nursing a child;
2. have inverse or palmoplantar psoriasis; acute guttate, erythrodermic, exfoliative or pustular psoriasis; atopic dermatitis, seborrheic dermatitis; or any inflammatory skin disease other than the primary diagnosis of chronic plaque psoriasis;
3. have markedly improving or worsening psoriasis during the wash-out period (e.g. ≥ 1 point in IGA static) or before study entry.
4. have an Investigator’s Global Assessment of Disease Severity (IGA static) score of 4 (=severe) or 5 (=very severe) and/or are eligible for systemic or ultraviolet light therapy at the investigator’s criteria;
5. have lesions with very severe (= 4) scaling
6. are known to be non-responders to topical treatments;
7. are known to be immuno-compromised, to have an auto-immune disorder, or to have a history of non-cured malignancy;
8. have active Hepatitis B or C, or Acquired Immunodeficiency Syndrome (AIDS);
9. have a history of opportunistic infections, including skin infections within 3 months prior to the Baseline Visit;
10. have any unstable concomitant disease or any significant disease, or any gross physical impairment, which may, in the opinion of the investigator, interfere with the performance of the study, or with the interpretation of study outcomes, or place the subject at undue risk;
11. have a clinically significant laboratory test abnormality at the Screening Visit;
12. have QTcB >430 msec (males) or >450 msec (females) or clinically significant ECG abnormalities at the Screening Visit as determined by a general physician or cardiologist;
13. have not undergone a washout period of 2 weeks for topical corticosteroids, retinoids, calcipotriol, coal tar, anthralin, salicylic acid, or any other topical treatment indicated for psoriasis by the time of Baseline Visit;
14. have not undergone a washout period of 4 weeks for any systemic treatment indicated for psoriasis (including corticosteroids and retinoids), any immunosuppressive or cytostatic agent (including methotrexate and cyclosporin), and prolonged sun exposure or ultraviolet light therapy (UVB, PUVA) by the time of Baseline Visit;
15. are using drugs that may worsen psoriasis, such as lithium, beta-adrenergic antagonists, antimalarials and ACE-inhibitors (patients in stable doses without interruption for at least 2 months throughout the study can be included);
16. have received biologics for treatment of psoriasis, psoriatic arthritis, rheumatoid arthritis or any other immune-related disease within 3 months (6 months for alefacept) by the time of Baseline Visit.
17. intend to use other concomitant therapies during the study for the treatment of their psoriasis (emollient creams without specific pharmacologically active components are permitted no more than once per day; keratolytic or tar shampoos for the scalp are allowed) or plan prolonged sun exposure during the study;
18. are using or intend to use any other medication or therapy (radiation, cytostatic, immunosuppressive) which, in the opinion of the investigator, may interfere with the performance of the study, or with the interpretation of study outcomes, or place the subject at undue risk;
19. have a known sensitivity to any constituents of any of the study drugs;
20. have a history of drug abuse or continuous alcohol consumption;
21. have received any investigational treatment(s) within the 30 days by the time of Screening Visit.
22. have a known disorder of calcium metabolism.
23. are taking calcium, vitamin D supplement or vitamin D-like medicines.
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| E.5 End points |
| E.5.1 | Primary end point(s) |
Primary efficacy end-point:
Change from baseline in the average Total Sign Score (TSS) of two target lesions to the end of treatment (Visit 6 - Day 56).
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| E.6 and E.7 Scope of the trial |
| E.6 | Scope of the trial |
| E.6.1 | Diagnosis | Information not present in EudraCT |
| E.6.2 | Prophylaxis | Information not present in EudraCT |
| E.6.3 | Therapy | Information not present in EudraCT |
| E.6.4 | Safety | Yes |
| E.6.5 | Efficacy | Yes |
| E.6.6 | Pharmacokinetic | Yes |
| E.6.7 | Pharmacodynamic | Information not present in EudraCT |
| E.6.8 | Bioequivalence | Information not present in EudraCT |
| E.6.9 | Dose response | Information not present in EudraCT |
| E.6.10 | Pharmacogenetic | Information not present in EudraCT |
| E.6.11 | Pharmacogenomic | Information not present in EudraCT |
| E.6.12 | Pharmacoeconomic | Information not present in EudraCT |
| E.6.13 | Others | Information not present in EudraCT |
| 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) | 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 | Yes |
| E.8.5.1 | Number of sites anticipated in the EEA | 12 |
| 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
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| The last visit of the last subject undergoing the trial will be considered the end of 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 | |
| E.8.9.1 | In the Member State concerned months | 7 |
| E.8.9.1 | In the Member State concerned days | |
| E.8.9.2 | In all countries concerned by the trial months | 7 |
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