Safety Study of Ragweed-SPIRE in Subjects With Ragweed Allergies and Asthma

Study Overview
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Brief Summary
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The purpose of this study is to determine whether it is safe to administer Ragweed-SPIRE to subjects suffering from both ragweed allergy and asthma.

Official Title
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A Multi-Centre, Double-Blind, Randomised, Placebo-Controlled Parallel-Group Study to Assess the Safety and Tolerability of Ragweed-SPIRE in Subjects With Asthma and Ragweed-Induced Rhinoconjunctivitis

Conditions
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Seasonal Allergic Rhinitis, Asthma

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, aged 18-65 years. Asthma treated by inhaled SABA or inhaled SABA plus low-medium dose ICS in 6 weeks prior to randomisation. A reliable history consistent with moderate to severe rhinoconjunctivitis on exposure to ragweed for at least the previous two ragweed seasons. Positive skin prick test to ragweed Ragweed-specific Immunoglobulin E (IgE) ≥ 0.35 kU/L. Exclusion Criteria: History of life-threatening asthma. Uncontrolled asthma according to GINA FEV1 of < 70 % of predicted, regardless of the cause. Administration of adrenaline (epinephrine) is contraindicated (e.g. subjects with acute or chronic symptomatic coronary heart disease or severe hypertension). History of severe drug allergy or anaphylactic reaction to food. A history of any significant disease or disorder (e.g. immune system, pulmonary, cardiovascular, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ragweed-SPIRE 1<br>Ragweed-SPIRE regimen 1 given 2 weeks apart | Biological: Ragweed-SPIRE<br>* Intradermal injection<br>|
| Experimental: Ragweed-SPIRE 2<br>Ragweed-SPIRE regimen 2 given 2 weeks apart | Biological: Ragweed-SPIRE<br>* Intradermal injection<br>|
| Placebo Comparator: Placebo<br>Placebo given 2 weeks apart | Biological: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with adverse events as a measure of safety and tolerability |  | Throughout subjects participation in the study, approximately 22 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with asthma exacerbations as a measure of safety and tolerability |  | Throughout subjects participation in the study, approximately 22 weeks | 
| Evaluation of change in lung function as a measure of safety and tolerability |  | Throughout subjects participation in the study, approximately 22 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Ragweed, Allergy, rhinoconjunctivitis, rhinitis, asthma