An Exploratory Study of PQ Grass 27600 SU

Inclusion Criteria

• Informed Consent
• Capable of giving signed informed consent and demonstrates willingness to comply with the requirements and restrictions listed in the ICF and study protocol and to attend required study visits.
• Subject who has signed and dated the ICF.
• Age:
• 18 to 65 years of age inclusive, at the time of signing the ICF.
• Sex / Contraceptive requirements:
• Male or female.
• Female subjects who are not of childbearing potential (defined as at least 12 months natural spontaneous amenorrhoea, or at least 6 weeks following surgical menopause) or females of childbearing potential who agree to comply with the contraceptive requirements of the study protocol.
• Subjects and general health characteristics:
• Good general health, as determined by the investigator, based on a medical evaluation, including medical history, physical examination, and laboratory tests. A subject with a clinical abnormality or laboratory parameters outside the reference range for the population being studied may be included only if the investigator agrees that the finding is unlikely to introduce additional risk factors and will not interfere with the study procedures.
• Positive history of moderate to severe symptoms of seasonal allergic rhinitis and/or rhinoconjunctivitis ascribed to grass (Pooideae) pollen exposure that required repeated use of antihistamines, nasal corticosteroids, and/or leukotriene modifiers for relief of symptoms during the last 2 consecutive seasons prior to the study, confirmed by subject records.

Please note: Subjects with asthma may be included, but the asthma must be well controlled (according to current Global Initiative for Asthma {GINA} guidelines [GINA, 2020]).

• A positive SPT for grass pollen (wheals [longest diameter] ≥3 mm and histamine ≥3 mm) and a negative SPT to the negative control (wheal diameter =0) at screening.
• Grass specific IgE class ≥2 as documented by an ImmunoCAP test at screening.
• FEV1 ≥80% of predicted, with a FEV1/FVC ratio ≥70% and (PEFR) ≥75% predicted at screening.
• Subjects who have no suspicion or symptoms of SARS-CoV-2 infection (as assessed by the investigator) or who have had no contact with a confirmed case of COVID-19 in the past 2 weeks prior to screening and randomisation.

Exclusion Criteria (include amongst others):

• Medical conditions:
• Pregnant or lactating subject.
• Moderate to severe allergy symptoms during the screening and treatment periods, and/or GPS caused by perennial allergens or seasonal allergens (other than grass) as verified by medical history and positive SPT.

Exception: screening, treatment and collection of eDiary data can be conducted outside of the pollen season(s) of concern or perennial allergies are irrelevant due to avoidance measures (e.g., cats and dog allergy).

• Subjects with a positive SPT at US and EU sites in regions with relevant southern grass (Bahia grass, Bermuda grass or Johnson grass) exposure.
• 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.
• Presence of any medical condition that may reduce the ability to survive a serious allergic reaction.
• History of autoimmune disease including Hashimoto's thyroiditis or other immunological disorder or other diseases (including, but not limited to, malignancy, cardiovascular, gastro-intestinal, hepatic, renal, hematological, neurological, endocrine or pulmonary disease) that in the opinion of the investigator may pose a safety risk or compromise the interpretation of efficacy of the study treatment.
• Presence of severe or uncontrolled or partly controlled asthma as defined in the GINA guidelines (GINA 2020) or asthma that requires more than a daily dose above 400 mcg of inhaled budesonid