Birch-SPIRE Safety and Efficacy Study
A Double-Blind, Randomised, Placebo-Controlled, Escalating, Multiple Dose Study in to Assess the Safety, Tolerability and Pharmacodynamic Effects of Birch-SPIRE
1 other identifier
interventional
64
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 11, 2015
CompletedFirst Posted
Study publicly available on registry
June 23, 2015
CompletedStudy Start
First participant enrolled
July 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2016
CompletedNovember 8, 2016
November 1, 2016
1 year
June 11, 2015
November 7, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Safety of Birch-SPIRE administrations measured by Adverse Events
Up to 16 weeks after start of dosing
Secondary Outcomes (3)
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
Other Outcomes (1)
Allergy symptoms and allergy medication use during next Birch season
Up to 9 months after start of dosing
Study Arms (5)
Cohort 1
EXPERIMENTALBirch-SPIRE or placebo, 2 weeks apart
Cohort 2
EXPERIMENTALBirch-SPIRE or placebo, 2 weeks apart
Cohort 3
EXPERIMENTALBirch-SPIRE or placebo, 2 weeks apart
Cohort 4
EXPERIMENTALBirch-SPIRE or placebo, 2 weeks apart
Cohort 5
EXPERIMENTALBirch-SPIRE or placebo, 2 weeks apart
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Circassia Limitedlead
- Adiga Life Sciences, Inc.collaborator
- Quintiles, Inc.collaborator
Study Sites (1)
Centre de Recherche Appliqué en Allergie de Québec
Québec, Quebec, G1V 4M6, Canada
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 11, 2015
First Posted
June 23, 2015
Study Start
July 1, 2015
Primary Completion
July 1, 2016
Last Updated
November 8, 2016
Record last verified: 2016-11