EUCTR2019-001517-16-PL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
- 1,342
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
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. For female subjects only: 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 exposure 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 1142
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 200
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 Europe for Cockroach and Ash allergens. Class =2 by an ImmunoCAP
- •test implies specific IgE =0.71 kUA/L. Furthermore, in Europe if SPTs are
- •not available in Year 2 of the trial (as detailed in Section 10.10, Appendix
- •10 of the protocol), all the listed allergens [apart from the 12-grass mix]
- •for the European panel will be tested using specific IgE measurements
- •for same or similar allergens; i.e., Class =2 by an ImmunoCAP test.
- •3. Subjects with a positive SPT at US sites in regions with relevant
- •southern grass (Bahia grass, Bermuda grass or Johnson grass)
- •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.
- •Please note: In countries in Europe where Johnson grass or Bahia grass
- •is present, any medical history of moderate to severe symptoms to
- •Johnson grass and/or Bahia grass will represent a reason for exclusion
- •as it will not be possible to conduct Period 1, Period 2 and Period 3 of
- •the entire clinical trial outside of their pollen seasons. Albeit Johnson
- •grass and Bahia grass are being commonly defined as grasses, they
- •belong to the Poaceae family.
- •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
- •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, 2022]).
- •b. Uncontrolled or poorly controlled asthma as per the current GINA
- •guidelines (GINA, 2022).
- •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, 2022).
- •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
- 另有 5 项未显示
研究者
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