A randomised, double-blind, placebo-controlled exploratory study to explore the efficacy and safety of PQ Grass 27600 SU in subjects with seasonal allergic rhinitis and/or rhinoconjunctivitis induced by grass pollen exposure - An exploratory study of PQ Grass 27600 S

Allergy Therapeutics (UK) Ltd.0 个研究点目标入组 150 人开始时间: 2020年4月28日最近更新: 2022年3月2日

试验速览

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•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.
•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 135
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 15

•1. Pregnant or lactating subject.
•2. Moderate to severe allergy symptoms during the screening and treatment periods, and/or GPS caused by perennial allergens or seasonal allergens (other than grass).
•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 another seasonal or perennial allergen not tested in the SPT that cannot be avoided during the study and the symptoms of which may interfere with administration of treatment and/or impact the data collected, as determined by the investigator.
•5. Presence of any medical condition that may reduce the ability to survive a serious allergic reaction.
•6. History of autoimmune disease including Hashimoto’s thyroiditis or 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 study treatment.
•7. Presence of severe or uncontrolled or partly controlled Asthma.
•8. History of any allergen SIT.
•For Detailed List see the Protocol

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