EUCTR2019-001517-16-HU
Active, not recruiting
Phase 1
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
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
- 1204
- Status
- Active, not recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
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\. 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
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:
Outcomes
Primary Outcomes
Not specified
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