| E.1 Medical condition or disease under investigation |
| E.1.1 | Medical condition(s) being investigated |
| Psoriasis is a common inherited autoimmune disease that affects 2-3% of the world-wide population. There are several recognized forms of psoriasis, such as plaque psoriasis, which is also known as psoriasis vulgaris and guttate, inverse, erythrodermic and pustular psoriasis, which can coexist within the same patient. The most common form is the plaque psoriasis. |
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| MedDRA Classification |
| E.1.2 Medical condition or disease under investigation |
| E.1.2 | Version | 8.1 |
| E.1.2 | Level | LLT |
| E.1.2 | Classification code | 10037153 |
| E.1.2 | Term | Psoriasis |
|
| 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 of a 3% cream formulation of P32/98 compared to placebo
|
|
| E.2.2 | Secondary objectives of the trial |
· To assess the local and systemic tolerability and safety of a 3% cream formulation of P32/98
· To assess the pharmacokinetics of a 3% cream formulation of P32/98
|
|
| E.2.3 | Trial contains a sub-study | No |
| E.3 | Principal inclusion criteria |
1. Male and female patients with stable plaque-type psoriasis aged between 18 and 60 years (inclusive)
2. PASI (psoriasis area and severity index) score </= 15 calculated by the dermatologist
3. At least three psoriasis plaques of >/= 2.5 cm in diameter being suitable as target-lesions, as determined by the dermatologist. These target plaques may not be located on elbow, knee, back or scalp.
4. Normal body weight, as determined by a body mass index ranging between 20-30 kg/m2.
5. Good health, except psoriasis; evidenced by uneventful medical history and the absence of clinically significant abnormal physical findings at screening (minor deviations of laboratory values from the normal range may be accepted, if these are judged by the investigator to have no clinical relevance and do not interfere with study objectives)
6. Negative HIV 1/2 Ab, HBsAg and HCV-Ab test
7. Negative urine alcohol test and urine drug screening at screening
8. Drinking ≤6 cups of xanthine-containing beverages (coffee, tea, cola) per day
9. Females participating in the study must be either
(1) of non-childbearing potential (e.g. surgically sterilized or postmenopausal with no menstrual bleeding for at least 2 years prior the study), or
(2) using one of the following contraceptive methods plus condom:
– Implants of levonorgestrel or injectable progestogen
– Oral contraceptive - combined or progestogen only
– Intrauterine device (IUD) during the course of the study and up to one month (i.e. one complete menstrual cycle) after the last administration of the study drug (whichever is longer)
– Any IUD with published data showing that the lowest expected failure rate is less than 1% per year (not all IUDs meet this criteria)
– Any other methods with published data showing that the lowest expected failure rate for birth control is less than 1% per year, or
(3) Abstinence from intercourse for 2 weeks before exposure to the study drug, throughout the clinical trial until after follow up, or
(4) have a male partner who is sterile prior to the female patient’s entry into the study and is the sole sexual partner for that female during the study period.
10. If the patient is a sexually active man and not surgically sterilized, he must be willing to abstain from sexual intercourse, or use a condom plus another form of contraception (e.g., spermicide, IUD, birth control pills taken by female partner, diaphragm with spermicide) if engaging in sexual intercourse with a woman who could become pregnant. This will avoid pregnancy caused by possibly damaged sperm. Males must use a condom during sexual intercourse with pregnant or lactating females. Male patients must not father a child from administration of the first dose and up to one month after the last dose of study medication
11. Non-smokers or mild smokers of ≤10 cigarettes per day
12. Able to understand and willing to sign the Informed consent form
13. Able to communicate well with the investigator and willing to comply with the requirements of the entire trial
|
|
| E.4 | Principal exclusion criteria |
1. Patients who fail to meet any of the inclusion criteria
2. Any clinically significant abnormalities from the screening examinations of any of the hematology or biochemistry tests, as judged by the investigator
3. Any history or clinical finding, which may interfere with the pharmacokinetics of drugs
4. Any patient who had received any medication within two weeks prior to the first day of dosing or who receives any non-study drug during the study which might interfere with the study procedures, e.g. which might have an influence on psoriasis. Exceptions can be made, if the patients has received the medication as stable therapy for at least 3 months, e.g. beta-blocker against hypertension
5. Systemic treatment with biological therapies (marketed or not marketed) with a possible effect on psoriasis (e.g. alefacept, efalizumab, etanercept, infliximab) within 6 months prior to initial phase of the study or during the study
6. Systemic treatment with all other therapies than biological, with a possible effect on psoriasis (e.g., vitamin D analogues, retinoids, immunosuppressants) within 4 weeks prior to first study drug administration and during the study
7. PUVA within 12 weeks prior to first study drug administration and during the study. UVB therapy within 8 weeks prior to first study drug administration and during the study
8. Any patient who had received any investigational medication within three months prior to the start of this study or who is scheduled to receive another investigational drug during the course of this study
9. Blood donation or comparable blood losses during the last three months
10. Patients with any history of chronic abuse of analgesics, alcohol, tranquillizers, opioids or known drug dependence or a positive result in the urine drug screen or urine alcohol test
11. History of more than moderate alcohol consumption (more than 200 g alcohol per week, equivalent to 3 - 4 liters of normal beer of 5 vol. %)
12. History or suspicion of inability to cooperate adequately
13. Known sensitivity reactions to aluminium and Scanpor
14. Patients who suffer or have suffered from a severe allergy (anaphylaxis, angioneurotic edema) or from svere chronic seasonal allergy (e.g. asthma, urticaria)
15. History of serious adverse reactions or hypersensitivity to any drug or contraindication to drugs pharmacologically related to the investigational medicinal product
16. Patients suffering or having suffered from any cutaneous or systemic disease (e.g. viral lesions of the skin, skin infections, active dermatosis, photosensitivity reactions, abnormal skin pigmentation, diabetes) or concurrent therapy that may interfere with the evaluation of the study results
17. Foreseeable intensive solar exposure during the study (UV radiation, etc.)
18. Tattoos, use of self-tanning lotions or creams, topical or systemic treatments for psoriasis which may interfere with the study objectives as determined by the investigator. This includes local therapy of the target lesions within 2 weeks prior to the first administration
19. The patient is not able to understand and comply with protocol requirements, instructions and protocol-stated restrictions
20. Vulnerable patients (e.g. persons kept in detention). |
|
| E.5 End points |
| E.5.1 | Primary end point(s) |
· Thickness of epidermis assessed by high-frequency ultrasound
|
|
| 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 | 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) | 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 | Yes |
| 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 | Information not present in EudraCT |
| E.8.1.7 | Other | Information not present in EudraCT |
| E.8.1.7.1 | Other trial design description |
| Study is open with respect to comparator and double blind with respect to IMP/placebo |
|
| 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
| Yes |
| E.8.4 | The trial involves multiple sites in the Member State concerned | No |
| 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
|
| End of trial is last visit of last patient. |
|
| 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 | 6 |
| E.8.9.1 | In the Member State concerned days | |
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