A Randomized Double-blind, Placebo-controlled Study Evaluating the Effect of Dupilumab on Sleep in Adult Patients With Moderate to Severe Atopic Dermatitis (AD)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 188
- 试验地点
- 42
- 主要终点
- DB Period: Percent Change From Baseline in Sleep Quality Numerical Rating Scale (NRS) at Week 12
研究概览
简要总结
Primary Objective:
To evaluate the effect of dupilumab on sleep quality in adult participants with moderate to severe atopic dermatitis (AD).
Secondary Objectives:
To evaluate the effect of dupilumab on objective and subjective quantitative sleep parameters, AD related outcomes, and daytime consequences of sleep deprivation.
To continue to assess the safety and tolerability throughout the study.
详细描述
Duration per participant was up to 28 weeks.
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
Dupilumab/Dupilumab
Participants received dupilumab 600 milligrams (mg) (loading dose) injection subcutaneously (SC) on Day 1 followed by dupilumab 300 mg injection SC every 2 weeks (q2w) up to Week 10 in the double-blind (DB) period of 12 weeks. After completion of DB period, participants entered in the open-label extension (OLE) period (Week 12 to 24) and continued to receive dupilumab 300 mg injection SC q2w from Week 12 up to Week 22.
干预措施: Dupilumab (Drug)
Placebo/Dupilumab
Participants received placebo matching to dupilumab injection SC on Day 1 then followed by placebo injection SC q2w up to Week 10 in the DB period of 12 weeks. After completion of DB period, participants entered in the OLE period (Week 12 to 24) and received dupilumab 600 mg (loading dose) at Week 12 followed by dupilumab 300 mg injection SC q2w up to Week 22.
干预措施: Dupilumab (Drug)
Placebo/Dupilumab
Participants received placebo matching to dupilumab injection SC on Day 1 then followed by placebo injection SC q2w up to Week 10 in the DB period of 12 weeks. After completion of DB period, participants entered in the OLE period (Week 12 to 24) and received dupilumab 600 mg (loading dose) at Week 12 followed by dupilumab 300 mg injection SC q2w up to Week 22.
干预措施: Placebo (Drug)
结局指标
主要结局
DB Period: Percent Change From Baseline in Sleep Quality Numerical Rating Scale (NRS) at Week 12
时间窗: Baseline, Week 12
Sleep quality NRS was used to assess the quality of the participant's previous night's sleep. It was collected on a 11-point scale ranged from 0 (worst possible sleep) to 10 (best possible sleep), where higher score indicated better outcome. Percent change from Baseline in sleep quality NRS at Week 12 was reported in this outcome measure.
次要结局
- DB Period: Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Related Impairment Short Form 8a (SF8a) Total T-Score at Week 12(Baseline, Week 12)
- DB Period: Percent Change From Baseline in Peak Pruritus NRS at Week 12(Baseline, Week 12)
- DB Period: Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Total Score at Week 12(Baseline, Week 12)
- DB Period: Percentage of Participants With Eczema Area Severity Index-50 (EASI-50) (Greater Than or Equal to [>=] 50% Improvement From Baseline) at Week 12(Baseline, Week 12)
- DB Period: Percentage of Participants With Eczema Area Severity Index-75 (EASI-75) (>= 75% Improvement From Baseline) at Week 12(Baseline, Week 12)
- DB Period: Change From Baseline in Patient Oriented Eczema Measure (POEM) Total Score at Week 12(Baseline, Week 12)
- DB Period: Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score at Week 12(Baseline, Week 12)
- DB Period: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)(Baseline up to 14 days after last IMP administration (i.e., up to Week 12))
- Entire Study Duration: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs)(Baseline up to 14 days after last IMP administration (i.e., up to Week 24))
- DB Period: Change From Baseline in SCORAD Sleep Loss Visual Analog Scale (VAS) Score at Week 12(Baseline, Week 12)
- DB Period: Change From Baseline in Weekly Average Sleep Efficiency (SE) at Week 12(Baseline, Week 12)
- DB Period: Change From Baseline in Weekly Average Wake After Sleep Onset (WASO) at Week 12(Baseline, Week 12)
- DB Period: Change From Baseline in Weekly Average Total Sleep Time (TST) at Week 12(Baseline, Week 12)
- DB Period: Change From Baseline in Weekly Average Sleep Onset Latency (SOL) at Week 12(Baseline, Week 12)