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 clinical efficacy of 3% GW842470X cream applied to involved skin of adult patients with moderate atopic dermatitis using the Eczema Area Severity Index (EASI) |
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E.2.2 | Secondary objectives of the trial |
To investigate the safety and tolerability of 3% GW842470X cream on diseased skin of adult patients with moderate atopic dermatitis To investigate the clinical efficacy of 3% GW842470X cream applied to involved skin of adult patients with moderate atopic dermatitis using the SCORing Atopic Dermatitis score (SCORAD) and the Investigators Global Assessment scale (IGA) for Atopic Dermatitis To characterise the systemic exposure to GW842470X following 21 day dosing of 3% GW842470X cream on diseased skin of adult patients with atopic dermatitis To investigate histological biomarkers in a subgroup of adult patients with moderate atopic dermatitis Endpoint(s) |
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E.2.3 | Trial contains a sub-study | Information not present in EudraCT |
E.3 | Principal inclusion criteria |
1. Adult men or women. Women will be eligible to enter the study if they are: -Not pregnant or nursing. -Of non-child-bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is post-menopausal or surgically sterile). -Of child-bearing potential and using an appropriate method of contraception with a documented failure rate of less than 1% per year for the duration of the study and for 1 month after the last administration of investigational product 2. Aged 18 to 65 years. 3. Body weight ≥ 50 kg (110 lbs) and BMI within the range of 17.5-32 kg/m2 inclusive where BMI =(weight in kg)/(height in meters)*2 4. Subjects with a diagnosis of atopic dermatitis but who are otherwise healthy. Healthy is defined as individuals who are free from significant cardiac, pulmonary, gastrointestinal, hepatic, renal, haematological, neurological and psychiatric disease as determined by history, physical examination and screening investigations. 5. Subjects must have body surface area (BSA) disease involvement of >5% as assessed by the rule of nines method. 6. Patients must be willing to wash out from current active therapy for at least 10 days prior to Day 1. 7. Capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the consent form 8. A signed and dated written informed consent is obtained from the subject. |
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E.4 | Principal exclusion criteria |
1. The subject presents with any systemic disorder or active skin disease (other than atopic dermatitis) (e.g. psoriasis) that would in any way confound interpretation of the study results or subjects who present with scars, moles, tattoos, body piercings, sunburn in the test area which could interfere with the assessment of lesions at screening. 2. The subject has atopic dermatitis restricted to the face, the feet or the hands only. 3. The subject has a current complication of atopic dermatitis such as erythroderma or overt bacterial or viral infection for which treatment with anti-infectives are indicated. 4. History of recent (<1 month) active or presence of current superficial skin infections of viral aetiology such as herpes simplex, or varicella. 5. The subject has been diagnosed as having contact dermatitis in area of target lesions, seborrheic dermatitis and/or occupational eczema at predilection sites of atopic dermatitis. 6. The subject has had topical or transdermal treatments, such as but not limited to retinoids, nicotine or hormone replacement therapies, on or near the intended site of application within 14 days prior to first application of study medication. Use of other topical preparations such as those containing vitamins, supplements or herbal within 14 days prior to application. 7. The subject has had systemic treatment for atopic dermatitis (including PUVA or UVB) within 14 days of the first dose of study medication. 8. Foreseeable intensive UV exposure during the study (solar or artificial). Subjects must not be exposed to intense direct sunlight for long periods, and must not use skin tanning devices (e.g. sunbed) for the duration of the study. 9. The subject has used topical treatment with tar or any corticosteroid or oral treatment with any corticosteroids within 10 days of the first dose of study medication. Additionally, subjects who have taken oral immunosuppressants (e.g. cyclosporine azathioprine) within 1 month of the first dose of study medication. 10. History of cutaneous photodisorder, such as photoallergic reaction or polymorphic light eruption. 11. History of allergy to components of test medications, including vaseline, emollient or specific soap and adhesives to be used in the study.12. History of clinically significant cardiovascular, neurological, renal, endocrine or haematological abnormalities. 13. Subjects with a history of diaphoresis/excessive sweating not restricted to palms or face. 14. Subjects with a smoking history of >10 cigarettes per day in the last 3 months. 15. Subjects taking dietary and herbal supplements, high strength mineral supplements (specifically Selenium (>75ug per day) and Zinc (>15mg per day)) or antiinflammatory drugs (e.g. corticosteroids, immunosuppressive drugs, or antihistamines). The use of stable therapy for 6 months for subjects with well controlled chronic disease (eg. hypertension, depression, anxiety, acid reflux, etc) and the use of multi-vitamin supplements are permitted at the discretion of the Principal Investigator/physician designee in consultation with the Medical Monitor where there is a question. 16. As a result of the medical interview, physical examination or screening investigations, the physician responsible (Principal Investigator or delegated physician) considers the subject unfit for the study. 17. The subject has plasma concentrations of aspartate-, alanine aminotransferase, total bilirubin, or alkaline phosphatases higher than the upper limit of normal at screening that are considered to be clinically significant. 18. The subject has been exposed to more than 3 new chemical entities within 12 months prior to the first application day. 19. The subject has received an investigational drug or participated in any other research trial within 30 days or within 5 half-lives of the previous investigational product, or twice the duration of the biological effect of any drug (whichever is longer) prior to the first dose of current study medication. 20. The subject has donated in excess of 500 mL of blood within 56 days prior to the study or intends to donate in the month after completing the study. 21. The subject has an average weekly intake of alcohol defined as greater than 21 units or an average daily intake of greater than 3 units (males) or defined as an average weekly intake of greater than 14 units or an average daily intake of greater than 2 units (females). 22. The subject has tested positive for HIV, hepatitis B surface antigen, hepatitis C antibody result at pre-study screening. 23. The subject has a past history of drug abuse or the subject's urine has tested positive for drugs of abuse at pre-study screening or at pre-dose. 24. Pregnant women, nursing women. 25. Any subject who the investigator considers is unlikely to tolerate the washout, treatment regimen or for whom the rescue regimen in the washout period is not appropriate. |
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E.5 End points |
E.5.1 | Primary end point(s) |
Difference in change from baseline EASI scores between GW842470X Cohort vs. placebo (vehicle) Cohort |
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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 | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | Yes |
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 | 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) | 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.8.5 | The trial involves multiple Member States | Yes |
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 | Information not present in EudraCT |
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 | |
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 months | 6 |