Randomized, Double-blind, Placebo-controlled, Parallel Group, Phase 2 Study Conducted Sequentially With 3 Doses Of Ima-638 Administered Sc.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 159
- 试验地点
- 162
- 主要终点
- Change From Baseline in Morning (Ante Meridiem) Peak Expiratory Flow Rate (AM PEFR) at Day 112 - Stage 2/3
研究概览
简要总结
Primary purpose is to assess if IMA-638 is safe and improves asthma in subjects with persistent asthma.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Generally healthy men and women with persistent asthma, 18 to 70 years of age, with body weight between 50 kg and 115 kg.
- •History of treatment with a medium to high dose of inhaled corticosteroids (ICS), with or without long-acting beta-agonists (LABA), for at least 2 months prior to the screening visit and must remain constant during the study.
- •FEV1 ≥ 55% to ≤ 80% predicted and demonstrated improvement in FEV1 (L) with inhaled albuterol (salbutamol) (reversibility) of ≥ 12%.
排除标准
- 未提供
研究组 & 干预措施
3
干预措施: placebo (Other)
结局指标
主要结局
Change From Baseline in Morning (Ante Meridiem) Peak Expiratory Flow Rate (AM PEFR) at Day 112 - Stage 2/3
时间窗: Baseline, Day 112
The PEFR is a participant's maximum speed of expiration, as measured with a peak flow meter. All participants were issued with the peak flow meter and instructed to perform the activity in triplicate in the morning prior to taking bronchodilator. The best among the 3 readings was selected.
Change From Baseline in Morning (Ante Meridiem) Peak Expiratory Flow Rate (AM PEFR) at Day 112 - Stage 1
时间窗: Baseline, Day 112
The PEFR is a participant's maximum speed of expiration, as measured with a peak flow meter. All participants were issued with the peak flow meter and instructed to perform the activity in triplicate in the morning prior to taking bronchodilator. The best among the 3 readings was selected.
次要结局
- Blood Eosinophils Levels - Stage 1(Baseline, Day 8, 28, 56, 84, 112)
- Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score at Day 8, 28, 56, 84 and 112 - Stage 1(Baseline, Day 8, 28, 56, 84, 112)
- Forced Mid-Expiratory Flow Rate 25 Percent (%) to 75% (FEF25-75) - Stage 2/3(Baseline, Day 8, 28, 56, 84, 112)
- Change From Baseline in Pre-beta-agonist Forced Expiratory Volume in 1 Second (FEV1) at Day 8, 28, 56, 84 and 112 - Stage 1(Baseline, Day 8, 28, 56, 84, 112)
- Change From Baseline in Pre-beta-agonist Forced Expiratory Volume in 1 Second (FEV1) at Day 8, 28, 56, 84 and 112 - Stage 2/3(Baseline, Day 8, 28, 56, 84, 112)
- Change From Baseline in Airway Hyper-reactivity at Day 28 and 112(Baseline, Day 28, 112)
- Change From Baseline in Asthma Control Questionnaire-5 (ACQ-5) Score at Day 8, 28, 56, 84 and 112 - Stage 2/3(Baseline, Day 8, 28, 56, 84, 112)
- Forced Vital Capacity (FVC) - Stage 1(Baseline, Day 8, 28, 56, 84, 112)
- Serum Interleukin-13 (IL-13) Level - Stage 1(Baseline, Day 8, 28, 56, 84, 112)
- Serum Interleukin-13 (IL-13) Level - Stage 2/3(Baseline, Day 8, 28, 56, 84, 112)
- Forced Vital Capacity (FVC) - Stage 2/3(Baseline, Day 8, 28, 56, 84, 112)
- Forced Mid-Expiratory Flow Rate 25 Percent (%) to 75% (FEF25-75) - Stage 1(Baseline, Day 8, 28, 56, 84, 112)
- Blood Eosinophils Levels - Stage 2/3(Baseline, Day 8, 28, 56, 84, 112)
- Percentage of Participants Who Required Treatment With Systemic Steroids for Clinical Exacerbation of Asthma - Stage 1(Baseline up to Day 112)
- Mean Number of Puffs of Rescue Medication Used - Stage 1(Day 8, 28, 56, 84, 89, 91, 94, 98, 112)
- Mean Number of Puffs of Rescue Medication Used - Stage 2/3(Day 8, 28, 56, 84, 89, 91, 94, 98, 112)
- Percentage of Participants Who Required Treatment With Systemic Steroids for Clinical Exacerbation of Asthma - Stage 2/3(Baseline up to Day 112)
- Log 10-transformed Serum Total Immunoglobulin E (IgE) Levels - Stage 1(Baseline, Day 28, 56, 84, 112)
- Log 10-transformed Serum Total Immunoglobulin E (IgE) Levels - Stage 2/3(Baseline, Day 28, 56, 84, 112)