Birch-SPIRE Safety and Efficacy Study

Study Overview
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Brief Summary
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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.

Official Title
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A Double-Blind, Randomised, Placebo-Controlled, Escalating, Multiple Dose Study in to Assess the Safety, Tolerability and Pharmacodynamic Effects of Birch-SPIRE

Conditions
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Rhinitis

Intervention / Treatment
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* Biological: Birch-SPIRE
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>Birch-SPIRE or placebo, 2 weeks apart | Biological: Birch-SPIRE<br> <br> Biological: Placebo<br> <br> |
| Experimental: Cohort 2<br>Birch-SPIRE or placebo, 2 weeks apart | Biological: Birch-SPIRE<br> <br> Biological: Placebo<br> <br> |
| Experimental: Cohort 3<br>Birch-SPIRE or placebo, 2 weeks apart | Biological: Birch-SPIRE<br> <br> Biological: Placebo<br> <br> |
| Experimental: Cohort 4<br>Birch-SPIRE or placebo, 2 weeks apart | Biological: Birch-SPIRE<br> <br> Biological: Placebo<br> <br> |
| Experimental: Cohort 5<br>Birch-SPIRE or placebo, 2 weeks apart | Biological: Birch-SPIRE<br> <br> Biological: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of Birch-SPIRE administrations measured by Adverse Events |  | Up to 16 weeks after start of dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Allergy, Birch, Rhinitis, Rhinoconjuntivitis, SPIRE, Toleromune