Evaluating the Efficacy of Ragweed-SPIRE Following Exposure to Ragweed Allergen in an Environmental Exposure Chamber

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

280 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2014-10-31

Brief Summary

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The purpose of this study is to determine whether Ragweed-SPIRE is safe and effective at reducing allergy symptoms in people who suffer from allergy to Ragweed pollen

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Detailed Description

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Conditions

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Seasonal Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Ragweed-SPIRE 1

Ragweed SPIRE regimen 1 given 2 weeks apart

Group Type EXPERIMENTAL

Ragweed-SPIRE

Intervention Type BIOLOGICAL

Ragweed-SPIRE 2

Ragweed-SPIRE regimen 2 given 2 weeks apart

Group Type EXPERIMENTAL

Ragweed-SPIRE

Intervention Type BIOLOGICAL

Ragweed-SPIRE 3

Ragweed-SPIRE regimen 3 given 2 weeks apart

Group Type EXPERIMENTAL

Ragweed-SPIRE

Intervention Type BIOLOGICAL

Placebo

Placebo given 2 weeks apart

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Interventions

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Ragweed-SPIRE

Intervention Type BIOLOGICAL

Placebo

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Male or female, aged 18-65 years.
* Reliable history consistent with moderate to severe rhinoconjunctivitis on exposure to ragweed for at least the previous two seasons.
* Minimum qualifying rhinoconjunctivitis symptom scores
* Ragweed-specific Immunoglobulin E (IgE) \> 0.70 kU/L.

Exclusion Criteria

* Subjects with a history of ragweed pollen induced asthma
* A history of anaphylaxis to ragweed allergen.
* FEV1 \< 80 % of predicted.
* Subjects who cannot tolerate Baseline Challenge in the EEC.
* Subjects for whom administration of epinephrine is contraindicated (e.g. subjects with acute or chronic symptomatic coronary heart disease or severe hypertension).
* History of immunopathological diseases (e.g. multiple sclerosis) that in the opinion of the Investigator or the Sponsor could interfere with the results obtained from the study.
* A history of severe drug allergy, severe angioedema or anaphylactic reaction to food.
* A history of any significant disease or disorder (e.g. cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, neoplastic/malignant, psychiatric, major physical impairment)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No