Efficacy and Safety of Grass-SPIRE Registration Study

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

WITHDRAWN

Clinical Phase

PHASE2/PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Brief Summary

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The purpose of this study is to evaluate the safety of Grass-SPIRE compared with placebo and to evaluate the treatment effect of Grass-SPIRE on symptoms and use of rescue medication during the grass pollen season

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Detailed Description

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Conditions

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Rhinitis Conjunctivitis

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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Grass-SPIRE

Eight intradermal injections of Grass-SPIRE

Group Type EXPERIMENTAL

Grass-SPIRE

Intervention Type DRUG

Placebo

Eight intradermal injections of Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Grass-SPIRE

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Clinical history of grass pollen-induced allergic rhinitis with or without conjunctivitis for at least 2 years
* Score of ≤ 21 on RCAT questionnaire
* Rye grass specific IgE of ≥ 0.7 kU/L
* Positive skin prick test to Rye grass whole allergen extract

Exclusion Criteria

* History or findings of significant disease
* Asthma requiring GINA Step 3 or higher treatment
* History of severe drug allergy, severe angioedema or systemic allergic reaction
* Course of short-duration allergy-specific immunotherapy or more than 3 months treatment with long-duration allergen immunotherapy within 5 years
* Contraindications for administration of epinephrine

Minimum Eligible Age

12 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No