NCT01018693已完成2 期
Randomized, Double-blind, Placebo-controlled Trial to Determine the Capacity of VAK694 to Elicit Long Term Immune Tolerance When Combined With Subcutaneous Allergen Immunotherapy for the Treatment of Seasonal Allergic Rhinitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Intra-dermal late phase response to allergen Measure: Wheal diameter
研究概览
简要总结
The purpose of the study is to determine whether VAK694 when combined with subcutaneous immunotherapy leads to long term immune tolerance to allergen in individuals with seasonal allergic rhinitis.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of atopy, defined as a history of seasonal allergic rhinitis for at least 2 years (in relation to the grass pollen allergy season), and evidence of atopy, defined as a positive skin prick test (wheal difference allergen - negative control at least 3 mm) to grass pollen allergen at screening.
- •Male or female subjects aged between 18 and 60 years (inclusive)
- •Female subjects must be of non-childbearing potential
- •Subjects must weigh at least 50 kg with a body mass index (BMI) within the range of 18 to 32 kg/m2 (inclusive)
- •Informed consent
排除标准
- •Treatment with intranasal corticosteroids within 28 days prior to the first dose.
- •History of asthma with treatment with inhaled or systemic corticosteroids within 6 months of the first dose.
- •History of COPD.
- •Any exposure to human monoclonal or polyclonal antibodies.
- •Any allergy immunotherapy within 3 years prior to screening.
- •Any prior grass pollen allergy immunotherapy.
- •FEV1 < 70% of predicted at screening or baseline.
- •Other protocol-defined inclusion/exclusion criteria may apply
研究组 & 干预措施
VAK694 placebo AND Immunotherapy (alutard) placebo
Experimental
干预措施: VAK694 placebo infusion; Saline (Drug)
: VAK694 placebo AND Immunotherapy (alutard)
Experimental
干预措施: VAK694 placebo infusion; Alutard Avanz SQ (Drug)
VAK694 AND Immunotherapy (alutard)
Experimental
干预措施: VAK694; Alutard Avanz SQ (Drug)
结局指标
主要结局
Intra-dermal late phase response to allergen Measure: Wheal diameter
时间窗: 10-12 months
次要结局
- To evaluate the immunomodulatory activity of VAK694 Measure: IgE/IgG, Th1/Th2 cytokine expression, Treg induction(10-12 months)
- To assess the effects of VAK694 combined with SCIT on the symptoms of seasonal allergic rhinitis Measure: mini-Respiratory Quality of Life Questionnaire (RQLQm) and visual analogue scale (VAS)(10-12 months)
- To preliminarily assess the ability of VAK694 to reduce the side-effects of subcutaneous immunotherapy Measure: Frequency and severity of local and systemic reactions to immunotherapy(10-12 months)
研究者
研究点 (1)
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