NCT02532179已完成1 期
A Biomarker-Based Pilot Study of Mouse Subcutaneous Immunotherapy in Mouse Sensitive Adults With Asthma and/or Perennial Allergic Rhinitis (ICAC-26)
National Institute of Allergy and Infectious Diseases (NIAID)4 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2015年10月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 4
- 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
- •Participants who meet any of the following criteria are not eligible for enrollment but may be reassessed. Participants are ineligible if they:
- •Are pregnant or lactating. Females must be abstinent or use a medically acceptable birth control method throughout the study (e.g. oral, subcutaneous, mechanical, or surgical contraception);
- •Cannot perform spirometry at Screening;
- •Have an asthma severity classification at Recruitment of severe persistent, using the NAEPP classification, as evidenced by at least one of the following:
- •Requires a dose of greater than 500 mcg of fluticasone per day or the equivalent of another inhaled corticosteroid;
- •Have received more than 2 courses of oral or parenteral corticosteroids within the last 12 months;
- •Have been treated with depot steroids within the last 12 months;
- •Have been hospitalized for asthma within the 6 months prior to recruitment;
- •Have had a life-threatening asthma exacerbation that required intubation, mechanical ventilation, or that resulted in a hypoxic seizure within 2 years prior to recruitment.
- •Do not have access to a phone (needed for scheduling appointments);
- •Have received allergen immunotherapy (SLIT or SCIT) in the last 12 months prior to recruitment or who plan to initiate or resume allergen immunotherapy during the study;
- •Have previously been treated with anti-IgE therapy within 1 year of recruitment;
- •Have received an investigational drug in the 30 days prior to recruitment or who plan to use an investigational drug during the study;
- •Refuses to sign the Epinephrine Auto-injector Training Form.
排除标准
- •Participants who meet any of the following criteria are not eligible for enrollment and may not be reassessed. Participants are ineligible if they:
- •Do not primarily speak English;
- •Plan to move from the area during the study period;
- •Have a history of idiopathic anaphylaxis or anaphylaxis grade 2 or higher as defined per protocol;
- •Have unstable angina, significant arrhythmia, uncontrolled hypertension, history of autoimmune disease, or other chronic or immunological diseases that in the opinion of the investigator might interfere with the evaluation of the investigational agent or pose additional risk to the participant;
- •Are using tricyclic antidepressants or beta-adrenergic blocker drugs (both oral and topical);
- •Have not received the seasonal Flu (Influenza) Vaccine if enrolling December through March.
研究组 & 干预措施
Mouse Allergenic Extract
Experimental
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)
研究者
研究点 (4)
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