EUCTR2019-001517-16-HU进行中（未招募）1 期
A randomised, double-blind, placebo-controlled clinical trial to evaluate the efficacy and safety of PQ Grass in subjects with seasonal allergic rhinitis and/or rhinoconjunctivitis induced by grass pollen exposure
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,204
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Capable of giving signed informed consent
- •2. Subject who has signed and dated the ICF.
- •3. Subject must be 18 to 65 years of age inclusive, at the time of signing the ICF.
- •4. Male or female.
- •5. Female subjects who are not of childbearing potential or females of childbearing potential who agree to comply with the contraceptive requirements of the study protocol
- •6. Positive history of moderate to severe symptoms of seasonal allergic rhinitis and/or rhinoconjunctivitis ascribed to grass pollen of at least 2 seasons duration.
- •For Detailed list see the protocol
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 1084
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 120
排除标准
- •1. Pregnant or lactating subject.
- •2. Presence of any medical history of moderate to severe allergy symptoms (verified by a positive SPT or positive specific IgE [=2]* at screening) to any other seasonal allergen (other than grass) or perennial allergens.
- •*Please note: The specific IgE testing mentioned above is applicable only in EU for Cockroach and Ash allergens.
- •3. Subjects with a positive SPT at US sites in regions with relevant southern grass (Bahia grass, Bermuda grass or Johnson grass) exposure.
- •4. Moderate to severe symptoms during the 3 years prior to Visit 1 to any other seasonal or perennial allergen not tested in the SPT done at screening that cannot be avoided during the Period 1 to Period 3 of the clinical trial and the symptoms of which may interfere with administration of treatment and/or impact the data collected.
- •5. Presence of any medical condition that may reduce the ability to survive a serious allergic reaction.
- •6. Presence of active systemic autoimmune disorder, systemic autoimmune disorders in remission or active organ specific autoimmune disorder.
- •7. Presence of active malignant neoplasia, severe cardiovascular disease (e.g., coronary artery disease, cardiac insufficiency, etc.), pulmonary insufficiency, severe psychiatric disorders or primary and secondary immunodeficiencies.
- •8. History of any other immunological disorder or other diseases that in the opinion of the Investigator may pose a safety risk or compromise the interpretation of efficacy of the clinical trial treatment.
- •9. Presence of severe or poorly controlled or uncontrolled asthma as defined by at least 1 of the following criteria:
- •a. Severe asthma (as per the current GINA guidelines [GINA, 2021]).
- •b. Uncontrolled or poorly controlled asthma as per the current GINA guidelines (GINA, 2021).
- •c. Asthma that requires more than a daily dose above 800 µg of inhaled budesonide (or clinically comparable inhaled corticosteroid) as per the current GINA guidelines (GINA, 2021).
- •d. History of 2 or more systemic corticosteroid courses within 6 months of screening or Visit 2 or 1 course of systemic corticosteroids within 3 months of screening or Visit 2 to treat asthma.
- •e. Prior intubation/mechanical ventilation for asthma.
- •f. Emergency room visit or hospitalisation for asthma in the 12 months prior to screening or Visit 2.
- •g. Any history of a life-threatening asthma attack.
- •h. FEV1 <70% of predicted or FEV1/FVC =75% or PEFR <70% of predicted with or without controller medications at screening or Visit 2.
- •For Detailed List see the Protocol
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