Seasonal allergic rhinitis and/or rhinoconjunctivitis induced by grass pollen exposure MedDRA version: 20.0 Level: LLT Classification code 10001728 Term: Allergic rhinoconjunctivitis System Organ Class: 100000004853
Conditions
Sponsors
Allergy Therapeutics (UK) Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Efficacy: To evaluate the efficacy of PQ Grass 27600 SU in subjects with grass pollen induced SAR and/or rhinoconjunctivitis based on symptoms and medications. Safety: To evaluate the safety and tolerability of PQ Grass in subjects with grass pollen induced SAR and/or rhinoconjunctivitis. ;Secondary Objective: To evaluate the effect of PQ Grass 27600 SU on IgG4. To evaluate the potential of PQ Grass 27600 SU to eliminate symptom burden and the need for medication use. To evaluate the quality of life. ;Primary end point(s): Efficacy: CSMS averaged over the peak GPS Safety: Frequency, severity and relationship of AEs to treatment. Frequency of AEs leading to premature discontinuation from treatment or clinical trial. Frequency of AESI. Changes in clinical laboratory values (serum chemistry, haematology and urinalysis) between screening and Visit 11. Changes in vital signs at all treatment visits ;Timepoint(s) of evaluation of this end point: daily / during the GPS / during the course of the study as indicated in the protocol | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Efficacy: Serum grass specific IgG4 at Visit 7 compared to baseline. The number of well days during the peak GPS. RQLQ(S) measured within the peak GPS. Safety: Frequency, severity and relationship of AEs to treatment. Frequency of AEs leading to premature discontinuation from treatment or clinical trial. Frequency of AESI. Changes in clinical laboratory values (serum chemistry, haematology and urinalysis) between screening and Visit 11. Changes in vital signs at all treatment visits ;Timepoint(s) of evaluation of this end point: daily / during the GPS / during the course of the study as indicated in the protocol | — |
Countries
Austria, Czechia, Czech Republic, Germany, Hungary, Poland, United States
Contacts
Public ContactClinical Research Management
Bencard Allergie GmbH
Outcome results
None listed