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

Allergy Therapeutics (UK) Ltd.0 sites1,342 target enrollmentJune 14, 2022

ConditionsSeasonal allergic rhinitis and/or rhinoconjunctivitis induced by grass pollen exposure MedDRA version: 20.0Level: LLTClassification code 10001728Term: Allergic rhinoconjunctivitisSystem Organ Class: 10015919 - Eye disorders Therapeutic area: Body processes [G] - Immune system processes [G12]

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Seasonal allergic rhinitis and/or rhinoconjunctivitis induced by grass pollen exposure
Sponsor: Allergy Therapeutics (UK) Ltd.
Enrollment: 1342
Status: Active, not recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

June 14, 2022

End Date

TBD

Last Updated

2 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Allergy Therapeutics (UK) Ltd.

Eligibility 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\. 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

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 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) 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.
•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 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.