Study 205050: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Investigate the Efficacy and Safety of Mepolizumab Administered Subcutaneously in Subjects With Moderate to Severe Atopic Dermatitis
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Number of Participants With an Investigator's Global Assessment (IGA) Score of 0 or 1 and at Least a 2- Grade Improvement at Week 16
研究概览
简要总结
Mepolizumab is a humanized Immunoglobulin G1 (IgG1) monoclonal antibody (mAb) that acts on Interleukin-5 (IL-5), which is responsible for the growth and differentiation, recruitment, activation, and survival of eosinophils; thereby reducing the production and survival of eosinophils which may be therapeutic in subjects with atopic dermatitis (AD). This study will investigate the efficacy and safety of mepolizumab (100 milligram [mg] subcutaneous [SC] administered every 4 weeks) compared with placebo in adult subjects with moderate to severe atopic dermatitis (AD). Subjects will be randomized 1:1 to either placebo SC or mepolizumab SC. The study will comprise of a pre-screening period of up to approximately 4 weeks, a screening period of up to 2 weeks, followed by a 16-Week study treatment period (16 weeks with the last dose of study treatment at Week 12) and follow-up period of up to 4-week. The total duration of subject participation will be approximately 26 weeks. (Note: For subjects, who may need to stop treatment with a biologic, the total Pre-Screening and Screening period may last up to 20 weeks and total duration of participation in the study may be up to 40 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 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
Mepolizumab
Eligible subjects will receive mepolizumab 100 mg subcutaneously every 4 weeks on Day 1, Week 4, Week 8, and Week 12
干预措施: Mepolizumab 100 mg (Drug)
Placebo
Eligible subjects will receive matching placebo subcutaneously every 4 weeks on Day 1, Week 4, Week 8, and Week 12
干预措施: Placebo matching mepolizumab (Drug)
结局指标
主要结局
Number of Participants With an Investigator's Global Assessment (IGA) Score of 0 or 1 and at Least a 2- Grade Improvement at Week 16
时间窗: Week 16
The IGA is a clinical tool for assessing the current state/severity of a participant's atopic dermatitis . It is a static 5-point morphological assessment of overall disease severity determined by the investigator, sub-investigator, or trained healthcare professional with required qualifications on a scale of 0 to 4 where, 0-clear, 1-almost clear, 2-mild, 3-moderate, and 4- severe. Higher score indicates severity of disease. A responder is defined as a participant who had an IGA score of 0 or 1 and a minimum 2-grade improvement from Baseline. Number of participants with IGA score of 0 or 1 and at least a 2- grade improvement at Week 16 was presented.
次要结局
- Change From Baseline in Hematology Parameter: Erythrocytes(Baseline (Day 1) and Weeks 4, 8, 12, 16 and 20)
- Mean Percentage Change in Eczema Area and Severity Index (EASI) Score From Baseline to Each Study Visit(Baseline (Day 1) and Weeks 4, 8, 12, 16 and 20)
- Number of Participants With an IGA Score of 0 or 1 and at Least a 2-grade Improvement at Each Study Visit(Weeks 4, 8, 12, 16 and 20)
- Number of Participants With On-treatment Adverse Events (AEs), Serious Adverse Events (SAEs) and Non-serious Adverse Events (nSAEs)(Up to Week 20)
- Number of Participants With On-treatment AEs of Special Interest Reported as Local Site Injection Reaction and Systemic Reactions(Up to Week 20)
- Change From Baseline in Hematology Parameters: Basophils, Eosinophils, Leukocytes, Lymphocytes, Monocytes, Neutrophils and Platelets(Baseline (Day 1) and Weeks 4, 8, 12, 16 and 20)
- Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Hemoglobin(Baseline (Day 1) and Weeks 4, 8, 12, 16 and 20)
- Change From Baseline in Hematology Parameter: Erythrocytes Mean Corpuscular Volume(Baseline (Day 1) and Weeks 4, 8, 12, 16 and 20)
- Change From Baseline in Hematology Parameter: Hematocrit(Baseline (Day 1) and Weeks 4, 8, 12, 16 and 20)
- Change From Baseline in Hematology Parameter: Hemoglobin(Baseline (Day 1) and Weeks 4, 8, 12, 16 and 20)
- Change From Baseline in Chemistry Parameters: Alanine Aminotransferase (ALT), Alkaline Phosphatase (ALP), Aspartate Aminotransferase (AST)(Baseline (Day 1) and Weeks 4, 8, 12, and 16)
- Change From Baseline in Chemistry Parameters: Albumin and Protein(Baseline (Day 1) and Weeks 4, 8, 12, and 16)
- Change From Baseline in Chemistry Parameters: Bilirubin, Creatinine, Direct Bilirubin(Baseline (Day 1) and Weeks 4, 8, 12, and 16)
- Change From Baseline in Chemistry Parameters: Calcium, Glucose, Potassium, Sodium and Urea(Baseline (Day 1) and Weeks 4, 8, 12, and 16)
- Number of Participants With Worst Post Baseline Potential Clinical Importance (PCI) Value for Hematology Parameters(Up to Week 20)
- Number of Participants With Worst Post Baseline PCI Value for Chemistry Parameters(Up to Week 16)
- Change From Baseline in PR Interval, QRS Duration, QT Interval and QT Interval Corrected for Heart Rate According to Fridericia's Formula (QTcF)(Baseline (Screening) and Weeks 4, 16)
- Change From Baseline in Vital Signs: Diastolic Blood Pressure (DBP) and Systolic Blood Pressure (SBP)(Baseline (Day 1) and Weeks 4, 8, 12, 16 and 20)
- Number of Participants With Worst Post Baseline PCI Value for Vital Signs(Up to Week 20)
- Change From Baseline in Vital Signs: Pulse Rate(Baseline (Day 1) and Weeks 4, 8, 12, 16 and 20)
- Change From Baseline in Vital Signs: Temperature(Baseline (Day 1) and Weeks 4, 8, 12, 16 and 20)
- Number of Participants With Abnormal Findings for ECG Parameters(Week 4 and Week 16)
- Number of Participants With Any Time Post Baseline Anti-mepolizumab Binding Antibodies and Neutralizing Antibodies Response(Up to Week 20)