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
Brief Title
Efficacy and Safety of Grass-SPIRE Registration Study
Categories
Conditions
Rhinitis
Conjunctivitis
Eligibility Criteria
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
* 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
Inclusion Criteria
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
* 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
Gender
All
Gender Based
false
Keywords
Rhinitis
Conjunctivitis
Grass
Allergy
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Estimated
Last Update Submit Date
Maximum Age
75 Years
Minimum Age
12 Years
NCT Id
NCT02795273
Org Class
Industry
Org Full Name
Circassia Limited
Org Study Id
TG005
Overall Status
Withdrawn
Phases
Phase 2
Phase 3
Primary Completion Date
Primary Completion Date Type
Estimated
Official Title
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
Primary Outcomes
Outcome Description
Measurement of subject allergy symptoms (eg sneezing, watery eyes) and use of allergy medication
Outcome Measure
Combined Score of symptoms and allergy medication
Outcome Time Frame
Approximately 66 weeks
Outcome Description
Measurement of adverse events
Outcome Measure
Safety of Grass-SPIRE
Outcome Time Frame
Approximately 66 weeks
Secondary Outcomes
Outcome Description
Categorical scores of allergy symptoms (eg sneezing, watery eyes) as assessed by subjects
Outcome Time Frame
Approximately 66 weeks
Outcome Measure
Symptom Scores
Outcome Description
Use of allergy medication to help allergy symptoms
Outcome Time Frame
Approximately 66 weeks
Outcome Measure
Rescue Medication Use
Outcome Description
Assessment of Quality of Life measured by responses to a questionnaire
Outcome Time Frame
Approximately 66 weeks
Outcome Measure
Quality of Life
Start Date
Status Verified Date
First Post Date
First Post Date Type
Estimated
First Submit Date
First Submit QC Date
Std Ages
Child
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
75
Minimum Age Number (converted to Years and rounded down)
12
Investigators
Investigator Type
Principal Investigator
Investigator Name
Golda Hudes
Investigator Email
ghudes@montefiore.org
Investigator Phone
646-229-9509