EUCTR2019-001517-16-PL
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
- 1342
- Status
- Active, not recruiting
- Last Updated
- last year
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\. 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]
Outcomes
Primary Outcomes
Not specified
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