EUCTR2013-001924-20-FI进行中（未招募）不适用
A study of the effect of OC000459 on signs & symptoms in subjects with moderate to severe atopic dermatitis: A randomised double blind placebo controlled parallel group study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 140
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Atopic dermatitis as defined by a score of at least 9 on the Nottingham Eczema Severity Score, stratified into moderate (score 9 to 11 inclusive) and severe (score 12 to 15 inclusive) disease.
- •2. Well documented history of AD over the past 2 years in the patient notes, including the use of topical corticosteroids (TCS) and/or topical calcineurin inhibitors (TCI) and any investigator severity scores (EASI/SCORAD). Subjects without a well documented history will be excluded from the study.
- •3. Male and female subjects with moderate to severe atopic dermatitis treated with TCS and/or TCI ONLY (with or without emollients) at the time of screening and over the previous month.
- •4. Subjects must have had at least one flare in the previous 6 months.
- •5. Any racial group.
- •6. Females of childbearing potential (i.e. having had a menstrual period within two years prior to the date of screening) must practise two forms of contraception (i.e. two of the following – oral contraception, barrier contraception, spermicide, intrauterine device) and must have a negative pregnancy test (blood or urine) at screening. Men whose partners could be of child bearing potential should routinely use a condom during the study and for three months thereafter. The partner, if not pregnant, should also use a reliable form of contraception such as the oral contraceptive pill or an intrauterine device.
- •7.Aged 18 to 48 years inclusive, stratified into subjects aged 18 to 30 inclusive and over 30 to 48 inclusive. The aim will be to recruit 50% of subjects into each group.
- •8. Documented history of atopy– subjects without a fully documented history will be excluded from the study.
- •9. Eosinophils > 0.25 x 109/L blood at visit 1 (screening)
- •10. Total Serum IgE = 1000kU/L at the screening visit.
- •11. Capable of giving written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- •12. Available to complete the study.
- •13. Subjects with health insurance coverage (France only).
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 140
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Clinically significant abnormality in clinical laboratory tests at screening (visit 1) as determined by the Principal Investigator or designee.
- •2. Subjects with chronic conditions requiring daily medication will be excluded from the study except those subjects with asthma and/or allergic rhinitis, depression, hypertension, migraine, epilepsy and thyroid conditions.
- •3. Subjects testing positive for hepatitis C antibody, hepatitis B surface antigen or HIV.
- •4. Receipt of any forbidden medication including over the counter preparations and herbal medicines within 14 days of the first dosing day with the exception of paracetamol up to a maximum of 2 g daily, antidepressants, anti-hypertensives, anti-migraine, anti-epileptics, oral
- •contraceptives, hormone replacement therapies and thyroid medications (see section 5.4.1).
- •5. Use of systemic steroids 4 weeks prior to the screening visit, light therapy or immunosuppressants 4 weeks prior to the screening visit.
- •6. Chronic use of NSAIDs (see section 5.4.1)
- •7. Subjects with contact dermatitis will be excluded.
- •8. Subjects with acute skin infection or acute disease flares. Subjects with active flares during the screening to randomisation period (visits 1 to 2) may be managed according to normal clinical practice and be rescreened once their flares are no longer active.
- •9. Subjects with a known allergy to hydrocortisone, hydrocortisone butyrate 0.1% cream (Locoid® cream, Alfason® creme) or hydrocortisone acetate will be excluded.
- •10. Participation in a study of an unlicensed drug or blood donation in the 3 months prior to the study.
- •11. The subject regularly, or on average, drinks more than four units of alcohol per day and/or uses drugs of abuse.
- •12. Females of child bearing potential who are unwilling to use two forms of contraception during the study and for a week after the last exposure to study medication.
- •13. Females who are pregnant or breastfeeding.
研究者
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