An Optional Follow-Up Study to Evaluate the Continued Efficacy of ToleroMune Grass in Grass Allergic Subjects Following Challenge With Grass Allergen in an Environmental Exposure Unit.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 84
- 主要终点
- Total Rhinoconjunctivitis Symptom Scores
研究概览
简要总结
Grass pollen allergens are recognised as a major cause of allergic diseases in humans and animals. Worldwide, at least 40% of allergic patients are sensitised to grass pollen allergens and between 50-90% of hayfever or seasonal allergy sufferers are allergic to grass pollen. ToleroMune Grass is a novel, synthetic, allergen-derived peptide desensitising vaccine, currently being developed for the treatment of grass allergy.
The purpose of this optional observational follow-on study is to further evaluate rhinoconjunctivitis symptoms on exposure to Grass in the EEU among subjects who completed all dosing visits in study TG002 approximately two years after the start of treatment.
详细描述
This is a follow-up study to a multi-centre, randomised, double-blind, placebo controlled, parallel group clinical study (TG002) which evaluated the efficacy, safety and tolerability of three doses of ToleroMune Grass versus placebo in grass allergic subjects. Subjects who completed TG002 in calendar year 2012 will undergo a further single exposure to grass allergens in an EEU.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Previously randomised into study TG002, and completed all treatment visits and PTC during calendar year 2012
排除标准
- •"Partly controlled" and "uncontrolled" asthama
- •History of anaphylaxis to grass allergen
- •FEV1 <80% of predicted
- •Treatment with beta-blockers, alpha-adrenoreceptor blockers, tranquilizers or psychoactuve drugs
- •Symptoms of a clinically relevant illness
- •Subjects who cannot tolerate allergen challenge in the EEU
结局指标
主要结局
Total Rhinoconjunctivitis Symptom Scores
时间窗: 32 months post first dose in TG002
次要结局
- Grass Specific Immunoglobulin E (IgE)(32 months post first dose in TG002)
- Grass Specific Immunoglobulin A (IgA)(32 months post first dose in TG002)
- Grass Specific Immunoglobulin G Isotype 4 (IgG4)(32 months post first dose in TG002)
- Skin Prick Weal Diameter(32 months post first dose in TG002)
- Adverse Events(32 months post first dose in TG002)