EUCTR2014-005057-39-BE进行中（未招募）1 期
A RANDOMIZED, DOUBLE-BLIND, PLACEBO CONTROLLED, PARALLEL GROUP STUDY TO DETERMINE THE EFFECTS OF 8 WEEKS TREATMENT WITH ORAL ZPL-3893787 (30 MG OD X 56 DAYS) ON PRURITUS IN ADULT SUBJECTS WITH MODERATE TO SEVERE ATOPIC DERMATITIS.
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 90
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
- •* Males and females aged 18-65 years inclusive with physician documented history or diagnosis of atopic dermatitis for at least 12 months prior to screening. Chronic AD should be diagnosed by the Eichenfield revised criteria of Hanifin and Rajka (Eichenfield, 2004).
- •*Females should be either of non child-bearing potential or must agree to use highly effective methods of contraception. Males with partners who are WOCBP must also use contraception
- •* Eczema Area and Severity Index (EASI) of =12 and <48.
- •* An Investigator’s Global Assessment (IGA) score = 3 at both Screening and Day 0.
- •* A mean pruritus score of = 5 on a 0-10 scale over the 7 day Run In (Days -7 to -1)
- •* Atopic dermatitis affecting =10% BSA
- •* Patients must be willing to apply stable amounts of an additive-free, basic, bland emollient, twice daily for at least 7 days before the baseline visit.
- •* Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of the study.
- •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 90
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects presenting with any of the following will not be included in the study:
- •1 AD of such severity (EASI >48) that the subject could not comply with the demands of the study and/or the subject is not a suitable candidate for a placebo-controlled study
- •2 Have concurrent skin disease (e.g. acne) of such severity in the study area that it could interfere with the study evaluation or presence of skin comorbidities that may interfere with study assessments.
- •3 Have an active skin infection or any other clinically apparent infections.
- •4 Hypersensitivity to mometasone or to any other ingredients contained by the topical corticosteroid product used as rescue medication in the study.
- •5 Have received phototherapy (e.g. UVA, UVB), or systemic therapy (e.g. immunosuppressants, cytostatics) known or suspected to have an effect on AD, within 4 weeks of the start of the Run In.
- •6 Have received systemic corticosteroids ([CS] e.g. oral, intravenous, intraarticular, rectal) within 4 weeks of the start of the Run in. Subjects on a stable maintenance dose (over the preceding 3 months) of inhaled or intranasal CS may participate.
- •7 Were treated with oral antihistamines or topical calcineurin inhibitors or topical steroids within 7 days of starting Run In; intranasal antihistamines for the treatment of allergic rhinitis are acceptable.
- •8Use of a tanning booth/parlour within 4 weeks before start of the Run In.
- •9 Have used antiseptic treatments (e.g. bleach baths, potassium permanganate etc.) within 4 weeks before the start of the Run In. (Patients who have recently used antiseptic treatment may be rescreened at a later date if they wish to participate in the study and agree to stop antiseptic treatment.)
- •10 Evidence of significant concomitant clinical disease that may need a change in management during the study or could interfere with the conduct or safety of this study (Stable well-controlled chronic conditions such as controlled hypertension (BP<140/90 mmHg) thyroid disease, well-controlled Type 1 or Type 2 diabetes (HbA1c< 8%), hypercholesterolemia, gastroesophageal reflux, or depression under control with medication (other than tricyclic antidepressants), are acceptable provided the symptoms and medications would not be predicted to compromise safety or interfere with the tests and interpretations of this study).
- •11 Clinically significant cardiac disease or ECG abnormalities, including:
- •? Predominant heart rhythm other than normal sinus rhythm
- •? AV block greater than first degree
- •? Resting heart rate >100 or <50 bpm
- •? Electrocardiographic evidence or a history of myocardial infarction
- •? Electrocardiographic evidence of conduction system abnormality
- •? Subjects with pre-randomization evidence of QTc prolongation (defined as >450 msec).
研究者
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