NCT03100344已完成2 期
Randomized, Double-blind, Multi-center, Parallel-group, Placebo-controlled Dose-ranging Study to Assess the Efficacy and Safety of Nemolizumab in Moderate-to-severe Atopic Dermatitis Subjects With Severe Pruritus Receiving Topical Corticosteroids (TCS)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 226
- 试验地点
- 2
- 主要终点
- Percent Change From Baseline in Eczema Area and Severity Index (EASI) at Week 24
研究概览
简要总结
Assess the efficacy of several subcutaneous doses of nemolizumab in moderate-to-severe atopic dermatitis (AD) subjects with severe pruritus receiving TCS, who were not adequately controlled with topical treatments.
详细描述
The aim of the study is to assess the efficacy of several subcutaneous doses of nemolizumab in moderate-to-severe atopic dermatitis (AD) subjects with severe pruritus receiving topical corticosteroids, who were not adequately controlled with topical treatments.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects ≥ 18 years (or legal age when higher)
- •Chronic AD, that has been present for at least 2 years before the visit
- •Eczema Area and Severity Index (EASI) score ≥12
- •Investigator Global Assessment (IGA) score ≥ 3
- •AD involvement ≥ 10% of Body Surface Area (BSA)
- •Severe pruritus on at least 3 of the last 7 days before the visit
- •Documented recent history (within 6 months before the visit) of inadequate response to topical medications
- •Female subjects must fulfill one of the criteria below:
- •Female subjects of non-childbearing potential
- •Female subjects of childbearing potential who agree to a true abstinence or to use an effective or highly effective method of contraception throughout the clinical trial and for 120 days after the last study drug administration
排除标准
- •Body weight < 45 kg
- •subjects with a medical history of asthma requiring hospitalization in the last 12 months before screening visit and/or whose asthma has not been well-controlled during the last 3 months before the screening visit and/or 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
- •Infection requiring treatment with oral or parenteral antibiotics, antivirals, antiparasitics or antifungals within 1 week before the screening visit or during the run-in period
- •History of intolerance to low or mid potency TCS or for whom TCS is not advisable
研究组 & 干预措施
Group 3
Experimental
Nemolizumab (high dose)
干预措施: Nemolizumab (Drug)
Group 1
Experimental
Nemolizumab (low dose)
干预措施: Nemolizumab (Drug)
Group 2
Experimental
Nemolizumab (medium dose)
干预措施: Nemolizumab (Drug)
Group 4
Placebo Comparator
Nemolizumab placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Percent Change From Baseline in Eczema Area and Severity Index (EASI) at Week 24
时间窗: From Baseline to Week 24
EASI is a composite score ranging from 0 to 72.The severity of erythema, induration/papulation, excoriation, and lichenification was assessed on a scale of 0 (absent) to 3 (severe) for each of the 4 body areas: head/neck, trunk, upper limbs, and lower limbs, with half points allowed. Higher scores indicate worse outcome.
次要结局
- Percentage Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24(At baseline and Week 24)
- Number of Participants With Adverse Events(From screening to Follow-up visit (Week 32)/Early termination visit)
- Absolute Change From Baseline in SCORing Atopic Dermatitis (SCORAD) at Week 24(Baseline, Week 24)
- Percent Change From Baseline in Weekly Average Sleep Disturbance Numeric Rating Scale (NRS) at Week 24(Baseline, Week 24)
- Absolute Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24(Baseline to Week 24)
- Number of Participants Achieving Pruritus Categorical Scale (PCS) Success (Defined as a Weekly Prorated Rounded Average PCS ≤1 [None - Mild]) at Week 24(Week 24)
- Number of Participants With an Improvement of Weekly Average Peak Pruritus Numeric Rating Scale (NRS) ≥4 at Each Timepoint up to Week 24(From Week 1 to Week 24)
- Number of Participants Achieving Investigator's Global Assessment (IGA) Success (Defined as IGA 0 [Clear] or 1 [Almost Clear]) at Each Timepoint up to Week 24(From Week 1 to Week 24)
- Number of Participants With Eczema Area and Severity Index (EASI)-90 (Defined as Achieving 90% Reduction From Baseline in EASI Score) at Each Visit up to Week 24(From Week 1 to Week 24)
- Number of Participants Achieving Investigator Global Assessment (IGA) Success (Defined as IGA 0 [Clear] or 1 [Almost Clear]) and a Reduction of ≥2 Points at Each Visit up to Week 24(Week 1 to Week 24)
- Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) at Week 24(Baseline, Week 24)
- Absolute Change From Baseline in Weekly Average of the Peak Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24(Baseline to Week 24)
- Absolute Change From Baseline in Weekly Average Sleep Disturbance Numeric Rating Scale (NRS) at Week 24(Baseline, Week 24)
- Number of Participants With Eczema Area and Severity Index (EASI)-50 (Defined as Achieving 50% Reduction From Baseline in EASI Score) at Each Visit up to Week 24(From Week 1 to Week 24)
- Number of Participants With Eczema Area and Severity Index (EASI)-75 (Defined as Achieving 75% Reduction From Baseline in EASI Score) at Each Visit up to Week 24(From Week 1 to Week 24)
- Percentage Change From Baseline in Eczema Area and Severity Index (EASI) at Each Visit up to Week 24(From Baseline to Week 24)
- Percentage Change From Baseline in Weekly Average of the Average Pruritus Numeric Rating Scale (NRS) at Each Visit up to Week 24(Baseline to Week 24)
研究者
研究点 (2)
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