NCT01033097已完成2 期
A Multicenter, Randomized, Double-blinded, Placebo and Positive Controlled Study to Evaluate the Anti-pruritic Effect, Safety and Tolerability, Systemic and Skin Exposure, After 2 Weeks of Treatment With a Microemulsion Formulation of DNK333 in Atopic Dermatitis Patients
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Efficacy of DNK333 in reduction in pruritus in atopic dermatitis patients, as measured by actigraphy and visual analogue scale (VAS)
研究概览
简要总结
This study will assess the safety and efficacy of DNK333 in patients with atopic dermatitis suffering from pruritus, who require systemic treatment of the disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female atopic dermatitis patients,18 to 60 years of age inclusive, who fulfill the following criteria:
- •Requirement of systemic therapy
- •Itch VAS score higher than 50 mm
- •EASI score higher than 8
排除标准
- •Women of child-bearing potential who are not willing to use two highly effective methods of contraception are not allowed in the study. Similarly, men who are not willing to use two acceptable methods of contraception are not allowed in the study.
- •Any systemic immunosuppressive treatment and/or phototherapy within 4 weeks prior to the first dosing.
- •Use of any systemic antihistamines or topical corticosteroids within one week prior to first dosing and for the duration of the treatment period. Any other topical or oral treatment for atopic dermatitis (except emollients prescribed by the investigator) within 2 weeks prior to the first dosing will also be excluded.
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
DNK333 5 mg
Experimental
干预措施: DNK333 5 mg (Drug)
Placebo to DNK333 5mg
Placebo Comparator
干预措施: Placebo to 5 mg (Drug)
DNK333 25 mg
Experimental
干预措施: DNK333 25 mg (Drug)
Placebo to DNK333 25 mg
Placebo Comparator
干预措施: Placebo to 25 mg (Drug)
DNK333 100 mg
Experimental
干预措施: DNK333 100 mg (Drug)
Placebo to DNK333 100 mg
Placebo Comparator
干预措施: Placebo to 100 mg (Drug)
Betamethasone 4 mg
Active Comparator
干预措施: Betamethasone 4 mg (Drug)
DNK333 1 mg
Experimental
干预措施: DNK333 1mg (Drug)
placebo 1mg
Placebo Comparator
干预措施: Placebo to 1mg (Drug)
结局指标
主要结局
Efficacy of DNK333 in reduction in pruritus in atopic dermatitis patients, as measured by actigraphy and visual analogue scale (VAS)
时间窗: 2 weeks
次要结局
- Compare the pharmacokinetics of DNK333 administered as an oral microemulsion drinking solution to a solid dispersion tablet in steady state.(2 weeks)
- Evaluate the therapeutic benefit from the patient's perspective of DNK333 to reduce pruritus as assessed by the Patient Benefit Index for Pruritus (PBIfP)(2 weeks)
- Efficacy of DNK333 to reduce dermatitis as measured by the atopic dermatitis score and the Eczema Severity Index (EASI)(2 weeks)
- Safety and tolerability of DNK333 in atopic dermatitis patients(2 weeks)
- the plasma pharmacokinetics and skin exposure following treatment of atopic dermatitis patients with DNK333.(2 weeks)
- Assess the health-related quality of life by using the Quality of Life for Atopic Dermatitis (QoLIAD) score.(2 weeks)
研究者
研究点 (2)
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