A Phase II, Randomized, Double-Blind, Placebo-Controlled Multicenter Study to Assess the Efficacy and Safety of MSTT1041A in Patients With Moderate to Severe Atopic Dermatitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 21
- 主要终点
- Percent Change of Total Eczema Area and Severity Index (EASI) Score
研究概览
简要总结
This study will assess the efficacy and safety of MSTT1041A (astegolimab) in participants with moderate to severe atopic dermatitis (AD). The study consists of a screening period, a 16-week treatment period, and an 8-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 75 Years（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
Treatment
Participants will receive MSTT1041A
干预措施: MSTT1041A (Drug)
Placebo
Participants will receive placebo matched to MSTT1041A
干预措施: Placebo (Drug)
结局指标
主要结局
Percent Change of Total Eczema Area and Severity Index (EASI) Score
时间窗: Baseline, Week 16
The Eczema Area and Severity Index (EASI) is a standardized instrument to evaluate the extent and severity of atopic dermatitis. An area score comprised of the percentage of skin affected by eczema for each of 4 body regions (head/neck, trunk, upper extremities, and lower extremities) is calculated with 0 = none, 1 = 1-9%, 2 = 10-29%, 3 = 30-49%, 4 = 50-69%, 5 = 70-89%, and 6 = 90-100%. Severity is scored for each of the 4 body regions by the summation of the intensity scores for 4 signs (redness, thickness, scratching, and lichenification), with 0 = none/absent, 1 = mild, 2 = moderate, and 3 = severe. The minimum final EASI score is 0 and the maximum score is 72.
次要结局
- Proportion of Participants Who Achieve >/=75% Reduction From Baseline in Eczema Area and Severity Index (EASI-75) Score(Baseline, Week 16)
- Percent Change in Body Surface Area (BSA) With Atopic Dermatitis (AD) Involvement(Baseline, Week 16)
- Percent Change in Disease Severity as Assessed by SCORing Atopic Dermatitis (SCORAD)(Baseline, Week 16)
- Percentage of Participants With Adverse Events (AE)(Up to Week 24)
- Serum Concentrations of MSTT1041A(At pre-defined intervals from baseline up to Week 24)
- Proportion of Participants Who Achieve Investigator's Global Assessment (IGA) Response of 0 or 1(Baseline, Week 16)
- Percent Change in Pruritus as Assessed by a Numeric Rating Scale (NRS)(Baseline, Week 16)
- Incidence of Treatment-Emergent Anti-Drug Antibodies (ADAs)(Up to Week 24)