Efficacy and Safety of Grass-SPIRE Registration Study

• Status: Withdrawn
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Circassia Limited

Criteria

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