Birch-SPIRE Safety and Efficacy Study
Phase 2
Completed
- Conditions
- Rhinitis
- Interventions
- Biological: Birch-SPIREBiological: Placebo
- Registration Number
- NCT02478060
- Lead Sponsor
- Circassia Limited
- Brief Summary
The purpose of this study is to evaluate the safety and tolerability of multiple administrations of Birch-SPIRE. To make a preliminary assessment on pharmacodynamic parameters and clinical outcomes.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 64
Inclusion Criteria
- Male or female, aged 18 to 65 years;
- Minimum 1 year history of rhinitis with or without conjunctivitis on exposure to birch pollen
- Birch IgE ≥ 0.35 kU/L
- Positive skin prick test to whole birch allergen
Exclusion Criteria
- Any past history of asthma
- FEV1 < 80% of predicted
- History of severe allergic reaction to birch allergen, severe drug allergy, severe angioedema or severe allergic reactions to food
- Acute phase skin response to whole birch allergen with a mean wheal diameter > 50mm
- Administration of adrenaline (epinephrine) is contraindicated
- History of severe drug allergy or anaphylactic reaction to food.
- History of any significant disease or disorder (e.g. immune system, pulmonary, cardiovascular, gastrointestinal, liver, renal, neurological, metabolic, malignant, psychiatric, major physical impairment, history of alcohol or drug abuse)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Cohort 1 Birch-SPIRE Birch-SPIRE or placebo, 2 weeks apart Cohort 2 Placebo Birch-SPIRE or placebo, 2 weeks apart Cohort 3 Birch-SPIRE Birch-SPIRE or placebo, 2 weeks apart Cohort 3 Placebo Birch-SPIRE or placebo, 2 weeks apart Cohort 4 Birch-SPIRE Birch-SPIRE or placebo, 2 weeks apart Cohort 5 Birch-SPIRE Birch-SPIRE or placebo, 2 weeks apart Cohort 5 Placebo Birch-SPIRE or placebo, 2 weeks apart Cohort 1 Placebo Birch-SPIRE or placebo, 2 weeks apart Cohort 2 Birch-SPIRE Birch-SPIRE or placebo, 2 weeks apart Cohort 4 Placebo Birch-SPIRE or placebo, 2 weeks apart
- Primary Outcome Measures
Name Time Method Safety of Birch-SPIRE administrations measured by Adverse Events Up to 16 weeks after start of dosing
- Secondary Outcome Measures
Name Time Method Measurement of IgE as a Pharmacodynamic parameter Up to 9 months after start of dosing Conjunctival Provocation Test as a Pharmacodynamic parameter Up to 9 months after start of dosing Skin Prick Testing as a Pharmacodynamic parameter Up to 9 months after start of dosing
Trial Locations
- Locations (1)
Centre de Recherche Appliqué en Allergie de Québec
🇨🇦Quebec, Canada