EUCTR2016-005025-37-PL进行中（未招募）1 期
A randomized, double-blind, multi-center, parallel-group, placebo-controlled dose-ranging study to assess the efficacy and safety of nemolizumab (CD14152) in moderate-to-severe atopic dermatitis subjects with severe pruritus receiving topical corticosteroids - Dose-ranging study of nemolizumab in atopic dermatitis
GALDERMA R&D, SNC0 个研究点目标入组 351 人开始时间: 2017年9月22日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 351
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
- •- Male or female subjects = 18 years (or legal age when higher)
- •- Chronic AD (according to American Academy of Dermatology Consensus Criteria [Eichenfield 2014]), that has been present for at least 2 years before the visit
- •- Eczema Area and Severity Index (EASI) score = 12
- •- IGA score = 3 (based on the IGA scale ranging from 0 to 4, in which 3 is moderate and 4 is severe)
- •- AD involvement = 10% of BSA
- •- Severe pruritus, defined as average of pruritus Numeric Rating Score (NRS) for the maximum intensity = 7 during the 7 days prior to the visit.
- •NOTE: A minimum of 4 daily scores out of the 7 days is required to calculate the baseline average score.
- •- Documented recent history (within 6 months before the visit) of inadequate response to topical medications
- •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 166
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 84
排除标准
- •- Body weight < 45 kg
- •- Subjects with a medical history of asthma that fulfil any one or more of the scenarios below:
- •* Had an asthma exacerbation requiring hospitalization in the last 12 months before screening visit
- •* Whose asthma has not been well-controlled (i.e. symptoms >2 days per week, nighttime awakenings >1-3 times per week, or some interference with normal activities) during the last 3 months before the screening visit
- •* Peak Expiratory Flow (PEF) <80% of the predicted value
- •- Cutaneous bacterial or viral infection within 1 week before the screening visit or during the run-in period.
- •- Pregnant women (with a positive serum pregnancy test result at the screening visit), breastfeeding women, or women planning to become
- •pregnant during the clinical trial
- •- History of intolerance to low or mid potency TCS or for whom TCS is not advisable (e.g. hypersensitivity to TCS or to any other ingredient
- •contained in the TCSs to be used in the study, significant skin atrophy)
研究者
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