A Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Dupilumab in Chinese Adult Patients With Moderate-to-severe Atopic Dermatitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 165
- 试验地点
- 27
- 主要终点
- Number of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" and Reduction From Baseline of Greater Than or Equal to (>=) 2 Points at Week 16
研究概览
简要总结
Primary Objective:
To evaluate the efficacy of dupilumab monotherapy compared to placebo treatment in adult participants with moderate-to-severe atopic dermatitis (AD).
Secondary Objectives:
- To evaluate the safety of dupilumab monotherapy compared to placebo treatment in adult participants with moderate-to-severe AD.
- To evaluate the effect of dupilumab on improving patient reported outcomes (PROs).
- To evaluate dupilumab immunogenicity.
详细描述
The maximum study duration was 33 weeks per participants, including a screening period of up to 5 weeks, a 16-week randomized treatment period, and a 12-week follow-up period.
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Placebo Q2W
Placebo matched to dupilumab 600 milligrams (mg) (loading dose), subcutaneously (SC) on Day 1 followed by placebo matched to dupilumab 300 mg once every 2 weeks (Q2W) for 16 weeks.
干预措施: Placebo (Drug)
Placebo Q2W
Placebo matched to dupilumab 600 milligrams (mg) (loading dose), subcutaneously (SC) on Day 1 followed by placebo matched to dupilumab 300 mg once every 2 weeks (Q2W) for 16 weeks.
干预措施: Emollient (moisturizer) (Drug)
Dupilumab 300 mg Q2W
Dupilumab at a loading dose of 600 mg, SC on Day 1 followed by 300 mg, Q2W for 16 weeks.
干预措施: Dupilumab (Drug)
Dupilumab 300 mg Q2W
Dupilumab at a loading dose of 600 mg, SC on Day 1 followed by 300 mg, Q2W for 16 weeks.
干预措施: Emollient (moisturizer) (Drug)
结局指标
主要结局
Number of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" and Reduction From Baseline of Greater Than or Equal to (>=) 2 Points at Week 16
时间窗: Baseline, Week 16
The IGA is an assessment instrument used to rate the severity of AD globally based on a 5-point scale ranging from (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe), higher score indicated higher severity.
次要结局
- Change From Baseline to Week 16 in Percent Body Surface Area (BSA) of AD Involvement(Baseline to Week 16)
- Absolute Change From Baseline to Week 16 in EQ-5D Index Scores(Baseline to Week 16)
- Number of Participants With Eczema Area and Severity Index (EASI) - 75 Response (>= 75% Reduction in Score From Baseline) at Week 16(Baseline, Week 16)
- Number of Participants Who Achieved >=4 Points With Reduction From Baseline in Weekly Average of Peak Daily Pruritus Numerical Rating Scale (NRS) Score at Week 16(Baseline, Week 16)
- Number of Participants Who Achieved >=3 Points With Reduction From Baseline in Weekly Average of Peak Daily Pruritus Numerical Rating Scale Score at Week 16(Baseline, Week 16)
- Percentage Change From Baseline to Week 16 in EuroQoL Five Dimensions Questionnaire Visual Analog Scale Scores(Baseline to Week 16)
- Absolute Change From Baseline to Week 16 in EuroQoL Five Dimensions Questionnaire Visual Analog Scale Scores(Baseline to Week 16)
- Number of Participants Who Achieve Reduction of IGA Score by >=2 From Baseline to Week 16(Baseline to Week 16)
- Percentage Change From Baseline at Week 16 in Weekly Average of Peak Daily Pruritus NRS(Baseline, Week 16)
- Change From Baseline at Week 16 in Weekly Average of Peak Daily Pruritus NRS(Baseline, Week 16)
- Change From Baseline to Week 16 in Dermatology Life Quality Index (DLQI) Total Score(Baseline to Week 16)
- Change From Baseline to Week 16 in Patient Oriented Eczema Measure (POEM)(Baseline to Week 16)
- Percentage Change From Baseline to Week 2 in Weekly Average of Peak Daily Pruritus NRS(Baseline to Week 2)
- Percentage Change From Baseline to Week 16 in EuroQoL Five Dimensions Questionnaire (EQ-5D) Index Scores(Baseline to Week 16)
- Number of Participants Achieving IGA 0 to 1 and a Reduction of >=2 Points From Baseline Through Week 16(Baseline, Week 2, Week 4, Week 8, Week 12, Week 16)
- Number of Participants With EASI-90 (>=90% Improvement From Baseline) at Week 16(Baseline, Week 16)
- Percentage Change From Baseline to Week 16 in EASI Score(Baseline to Week 16)
- Absolute Change in EASI Score From Baseline at Weeks 2, 4, 8, 12 and 16(Baseline, Week 2, Week 4, Week 8, Week 12, Week 16)
- Number of Participants With EASI-50 (>=50% Improvement From Baseline) at Week 16(Baseline, Week 16)
- Percentage Change in EASI Score From Baseline at Weeks 2, 4, 8, 12 and 16(Baseline, Week 2, Week 4, Week 8, Week 12, Week 16)
- Absolute Change in Weekly Average of Peak Daily Pruritus NRS Score From Baseline Through Week 16(From Baseline Through Week 16)
- Percentage Change in Weekly Average of Peak Daily Pruritus NRS Score From Baseline Through Week 16(From Baseline Through Week 16)
- Number of Participants Who Responded "Absence of Pruritus" or "Mild Pruritus" in the Pruritus Categorical Scale at Week 16(Week 16)
- Percentage of Participants With at Least One Day Sick Leave/Missed School Days(Week 16)
- Number of Days of Sick Leave/Missed School Days(Week 16)