Efficacy and Safety of Grass-SPIRE Registration Study

A Combined Phase 2b/3, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Centre Study to Assess the Efficacy and Safety of Grass-SPIRE in Subjects With Grass Pollen-Induced Allergic Rhinitis, With or Without Conjunctivitis

The purpose of this study is to evaluate the safety of Grass-SPIRE compared with placebo and to evaluate the treatment effect of Grass-SPIRE on symptoms and use of rescue medication during the grass pollen season

Inclusion Criteria:

• Clinical history of grass pollen-induced allergic rhinitis with or without conjunctivitis for at least 2 years
• Score of ≤ 21 on RCAT questionnaire
• Rye grass specific IgE of ≥ 0.7 kU/L
• Positive skin prick test to Rye grass whole allergen extract

Exclusion Criteria:

• History or findings of significant disease
• Asthma requiring GINA Step 3 or higher treatment
• History of severe drug allergy, severe angioedema or systemic allergic reaction
• Course of short-duration allergy-specific immunotherapy or more than 3 months treatment with long-duration allergen immunotherapy within 5 years
• Contraindications for administration of epinephrine