A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study Investigating the Efficacy, Safety, Serum Concentration and Biomarker Profile of Dupilumab Administered to Adult Patients With Moderate-to-Severe Atopic Dermatitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 54
- 主要终点
- Percent Change From Baseline in the Eczema Area Severity Index Score (EASI) to Week 16
研究概览
简要总结
The primary objective of the study was to assess the efficacy of Dupilumab, compared to placebo, in adult patients with moderate-to-severe atopic dermatitis (AD).
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, 18 years or older;
- •Chronic AD that had been present for at least 3 years before the screening visit;
- •Patients with documented recent history (within 6 months before the screening visit) of inadequate response to out-patient treatment with topical medications, or for whom topical treatments were otherwise inadvisable;
- •Willing and able to comply with all clinic visits and study-related procedures.
排除标准
- •Prior participation in a Dupilumab clinical trial;
- •Treatment with an investigational drug within 8 weeks or within 5 half-lives before the baseline visit;
- •The following treatments within 4 weeks before the baseline visit, or any condition that, in the opinion of the investigator, will likely require such treatment(s) during the first 4 weeks of study treatment:
- •Systemic corticosteroids;
- •Immunosuppressive/immunomodulating drugs;
- •Phototherapy for AD;
- •Treatment with topical corticosteroids, tacrolimus and/or pimecrolimus within 1 week before the baseline visit;
- •Treatment with certain biologics;
- •Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks before the baseline visit;
- •Planned major surgical procedure during the participant's participation in this study;
- •Participant was a member of the investigational team or his/her immediate family;
- •Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit
- •Pregnant or breast-feeding women or women planning to become pregnant or breastfeed during the study;
- •Note: The information listed above is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial therefore not all inclusion/exclusion criteria are listed.
研究组 & 干预措施
Placebo qw
Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection once weekly (qw) from Week 1 to Week 15.
干预措施: Placebo (Drug)
Placebo qw
Two subcutaneous injections of Placebo (for Dupilumab) as a loading dose on Day 1 followed by a single injection once weekly (qw) from Week 1 to Week 15.
干预措施: Background treatment (Other)
Dupilumab 200 mg qw
Two subcutaneous injections of Dupilumab 200 milligram (mg) (for a total of 400 mg) as a loading dose on Day 1, followed by a single 200 mg injection qw from Week 1 to Week 15.
干预措施: Dupilumab (Drug)
Dupilumab 200 mg qw
Two subcutaneous injections of Dupilumab 200 milligram (mg) (for a total of 400 mg) as a loading dose on Day 1, followed by a single 200 mg injection qw from Week 1 to Week 15.
干预措施: Background treatment (Other)
结局指标
主要结局
Percent Change From Baseline in the Eczema Area Severity Index Score (EASI) to Week 16
时间窗: Baseline to Week 16
The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema (E), infiltration (I), excoriation (Ex) and lichenification (L) on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. Values after first rescue medication use were set to missing and missing values imputed by last observation carried forward (LOCF).
次要结局
- Percentage of Participants With Investigator's Global Assessment (IGA) Score of "0" or "1" at Week 16(Week 16)
- Percentage of Participants Who Achieved IGA Score Reduction From Baseline of ≥2 Points at Week 16(Baseline to Week 16)
- Absolute Change From Baseline in Pruritus Numeric Rating Scale (NRS) at Week 16(Baseline to Week 16)
- Percent Change From Baseline in Pruritus Numeric Rating Scale (NRS) at Week 16(Baseline to Week 16)
- Absolute Change From Baseline in EASI Score to Week 16(Baseline to Week 16)
- Absolute Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score to Week 16(Baseline to Week 16)
- Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score to Week 16(Baseline to Week 16)
- Percentage of Participants Who Achieved 50%, 75% and 90% Reduction From Baseline in EASI Score ( EASI-50, EASI-75, and EASI-90 Respectively) at Week 16(Baseline to Week 16)
- Percentage of Participants Who Achieved 50%, 75% and 90% Reduction From Baseline in SCORAD Score (SCORAD-50, SCORAD-75 and SCORAD-90 Respectively) at Week 16(Baseline to Week 16)
- Absolute Change From Baseline in Participant's Oriented Eczema Measure (POEM) Score to Week 16(Baseline to Week 16)
- Percent Change From Baseline in Participant's Oriented Eczema Measure (POEM) Score to Week 16(Baseline to Week 16)
- Change From Baseline in Global Individual Signs Score (GISS) Components (Erythema, Infiltration/Papulation, Excoriations, and Lichenification) to Week 16(Baseline to Week 16)
- Changes From Baseline in GISS Cumulative Score to Week 16(Baseline to Week 16)