A Biomarker-Based Pilot Study of Mouse Subcutaneous Immunotherapy in Mouse Sensitive Adults With Asthma and/or Perennial Allergic Rhinitis (ICAC-26)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 8
- 主要终点
- Number of Reported Serious Adverse Events (SAEs)
研究概览
简要总结
This is an open label trial of mouse allergenic extract administered by subcutaneous injection in adults with asthma and mouse sensitivity. The study is designed to evaluate:
- the safety of this therapy when given by injection
- biomarkers of the immune response and
- whether the therapy would be effective in treating allergic asthma.
详细描述
The primary objective of the study is to assess if treatment with mouse subcutaneous immunotherapy (SCIT), using the per protocol allergenic extract doses, is safe. This will be done by determining the rate of related adverse events and serious adverse events in the course of treatment.
Secondary objectives include:
- determination of whether a 24 week treatment with mouse SCIT, using the per protocol allergenic extract doses, will induce a 3-fold increase in mouse-specific serum immunoglobulin E (IgE)
- determination of whether a 24 week treatment with mouse SCIT, using the per protocol allergenic extract doses, will induce changes in the serum levels of mouse-specific immunoglobulin G (IgG) and immunoglobulin subclass 4 (IgG4).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（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
Mouse Allergenic Extract
Participants will receive escalating doses of glycerinated mouse allergenic extract administered via the subcutaneous route up to a Maximum Study Dose (MSD) of 0.4 mL of extract at a concentration of 1:10 wt/vol.
干预措施: Mouse Allergenic Extract (Biological)
结局指标
主要结局
Number of Reported Serious Adverse Events (SAEs)
时间窗: Baseline (Pre-Treatment) through 24 Weeks of Treatment
Frequency of any Serious Adverse Events (SAEs) throughout the duration of study participation.
Number of Reported Adverse Events (AEs)
时间窗: Baseline (Pre-Treatment) through 24 Weeks of Treatment
Frequency of any AEs tabulated by preferred event term.
次要结局
- Change in Mouse-Specific IgG4 Antibodies(Baseline (Pre-Treatment) to Week 24)
- Change in Mouse-Specific IgE Antibodies(Baseline (Pre-Treatment) through Week 24)
- Change in Mouse-Specific IgG Antibodies(Baseline (Pre-Treatment) to Week 24)
- Change in In-vitro Mouse Antigen Binding to B-cells(Baseline (Pre-Treatment) to Week 24)