Efficacy and Safety of Grass-SPIRE Registration Study

A Combined Phase 2b/3, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Multi-Centre Study to Assess the Efficacy and Safety of Grass-SPIRE in Subjects With Grass Pollen-Induced Allergic Rhinitis, With or Without Conjunctivitis

Status

Withdrawn

Phases

Phase 2Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02795273

Enrollment

Registered

2016-06-10

Start date

2016-05-31

Completion date

Unknown

Last updated

2016-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Conjunctivitis, Rhinitis

Keywords

Rhinitis, Conjunctivitis, Grass, Allergy

Brief summary

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

Interventions

DRUGGrass-SPIRE

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

12 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Combined Score of symptoms and allergy medication	Approximately 66 weeks	Measurement of subject allergy symptoms (eg sneezing, watery eyes) and use of allergy medication
Safety of Grass-SPIRE	Approximately 66 weeks	Measurement of adverse events

Secondary

Measure	Time frame	Description
Symptom Scores	Approximately 66 weeks	Categorical scores of allergy symptoms (eg sneezing, watery eyes) as assessed by subjects
Rescue Medication Use	Approximately 66 weeks	Use of allergy medication to help allergy symptoms
Quality of Life	Approximately 66 weeks	Assessment of Quality of Life measured by responses to a questionnaire

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026