Efficacy and Safety of Grass-SPIRE Registration Study

Phase 2

Withdrawn

• Conditions: Conjunctivitis; Rhinitis
• Interventions: Drug: Placebo; Drug: Grass-SPIRE

• Registration Number: NCT02795273
• Lead Sponsor: Circassia Limited

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

Detailed Description

Not available

Study Timeline

• Study Start: 2016-05
• Study First Submitted: 2016-05-05
• Status Verified: 2016-06
• Study First Submitted QC: 2016-06-06
• Study First Posted: 2016-06-10
• Last Update Submitted: 2016-06-21
• Last Update Posted: 2016-06-23
• Primary Completion: 2018-10

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	Eight intradermal injections of Placebo
Grass-SPIRE	Grass-SPIRE	Eight intradermal injections of Grass-SPIRE

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Bernstein Clinical Research Center, LLC; 🇺🇸 Cincinnati, Ohio, United States