Back to resultsBirch-SPIRE Safety and Efficacy Study
Primary Purpose
Rhinitis
Status
Completed
Phase
Phase 2
Locations
Canada
Study Type
Interventional
Intervention
Birch-SPIRE
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Rhinitis focused on measuring Allergy, Birch, Rhinitis, Rhinoconjuntivitis, SPIRE, Toleromune
Eligibility Criteria
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)
Sites / Locations
- Centre de Recherche Appliqué en Allergie de Québec
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
Cohort 1
Cohort 2
Cohort 3
Cohort 4
Cohort 5
Arm Description
Birch-SPIRE or placebo, 2 weeks apart
Birch-SPIRE or placebo, 2 weeks apart
Birch-SPIRE or placebo, 2 weeks apart
Birch-SPIRE or placebo, 2 weeks apart
Birch-SPIRE or placebo, 2 weeks apart
Outcomes
Primary Outcome Measures
Safety of Birch-SPIRE administrations measured by Adverse Events
Secondary Outcome Measures
Measurement of IgE as a Pharmacodynamic parameter
Conjunctival Provocation Test as a Pharmacodynamic parameter
Skin Prick Testing as a Pharmacodynamic parameter
Full Information
NCT ID
NCT02478060
First Posted
June 11, 2015
Last Updated
November 7, 2016
Sponsor
Circassia Limited
Collaborators
Adiga Life Sciences, Inc., Quintiles, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT02478060
Brief Title
Birch-SPIRE Safety and Efficacy Study
Official Title
A Double-Blind, Randomised, Placebo-Controlled, Escalating, Multiple Dose Study in to Assess the Safety, Tolerability and Pharmacodynamic Effects of Birch-SPIRE
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
July 2015 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Circassia Limited
Collaborators
Adiga Life Sciences, Inc., Quintiles, Inc.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinitis
Keywords
Allergy, Birch, Rhinitis, Rhinoconjuntivitis, SPIRE, Toleromune
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
64 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
Birch-SPIRE or placebo, 2 weeks apart
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
Birch-SPIRE or placebo, 2 weeks apart
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
Birch-SPIRE or placebo, 2 weeks apart
Arm Title
Cohort 4
Arm Type
Experimental
Arm Description
Birch-SPIRE or placebo, 2 weeks apart
Arm Title
Cohort 5
Arm Type
Experimental
Arm Description
Birch-SPIRE or placebo, 2 weeks apart
Intervention Type
Biological
Intervention Name(s)
Birch-SPIRE
Intervention Type
Biological
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Safety of Birch-SPIRE administrations measured by Adverse Events
Time Frame
Up to 16 weeks after start of dosing
Secondary Outcome Measure Information:
Title
Measurement of IgE as a Pharmacodynamic parameter
Time Frame
Up to 9 months after start of dosing
Title
Conjunctival Provocation Test as a Pharmacodynamic parameter
Time Frame
Up to 9 months after start of dosing
Title
Skin Prick Testing as a Pharmacodynamic parameter
Time Frame
Up to 9 months after start of dosing
Other Pre-specified Outcome Measures:
Title
Allergy symptoms and allergy medication use during next Birch season
Time Frame
Up to 9 months after start of dosing
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Facility Information:
Facility Name
Centre de Recherche Appliqué en Allergie de Québec
City
Quebec
ZIP/Postal Code
G1V 4M6
Country
Canada
12. IPD Sharing Statement
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Birch-SPIRE Safety and Efficacy Study
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