Back to resultsEfficacy and Safety of Grass-SPIRE Registration Study
Primary Purpose
Rhinitis, Conjunctivitis
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Grass-SPIRE
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Rhinitis focused on measuring Rhinitis, Conjunctivitis, Grass, Allergy
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
Sites / Locations
- Bernstein Clinical Research Center, LLC
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Grass-SPIRE
Placebo
Arm Description
Eight intradermal injections of Grass-SPIRE
Eight intradermal injections of Placebo
Outcomes
Primary Outcome Measures
Combined Score of symptoms and allergy medication
Measurement of subject allergy symptoms (eg sneezing, watery eyes) and use of allergy medication
Safety of Grass-SPIRE
Measurement of adverse events
Secondary Outcome Measures
Symptom Scores
Categorical scores of allergy symptoms (eg sneezing, watery eyes) as assessed by subjects
Rescue Medication Use
Use of allergy medication to help allergy symptoms
Quality of Life
Assessment of Quality of Life measured by responses to a questionnaire
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02795273
Brief Title
Efficacy and Safety of Grass-SPIRE Registration Study
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
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Withdrawn
Why Stopped
Decision made to stop study following availability of results from another study
Study Start Date
May 2016 (undefined)
Primary Completion Date
October 2018 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Circassia Limited
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinitis, Conjunctivitis
Keywords
Rhinitis, Conjunctivitis, Grass, Allergy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Grass-SPIRE
Arm Type
Experimental
Arm Description
Eight intradermal injections of Grass-SPIRE
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Eight intradermal injections of Placebo
Intervention Type
Drug
Intervention Name(s)
Grass-SPIRE
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Combined Score of symptoms and allergy medication
Description
Measurement of subject allergy symptoms (eg sneezing, watery eyes) and use of allergy medication
Time Frame
Approximately 66 weeks
Title
Safety of Grass-SPIRE
Description
Measurement of adverse events
Time Frame
Approximately 66 weeks
Secondary Outcome Measure Information:
Title
Symptom Scores
Description
Categorical scores of allergy symptoms (eg sneezing, watery eyes) as assessed by subjects
Time Frame
Approximately 66 weeks
Title
Rescue Medication Use
Description
Use of allergy medication to help allergy symptoms
Time Frame
Approximately 66 weeks
Title
Quality of Life
Description
Assessment of Quality of Life measured by responses to a questionnaire
Time Frame
Approximately 66 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Bernstein, MD
Organizational Affiliation
University of Cincinnati
Official's Role
Principal Investigator
Facility Information:
City
Canton
State/Province
Ohio
Country
United States
Facility Name
Bernstein Clinical Research Center, LLC
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45231
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Efficacy and Safety of Grass-SPIRE Registration Study
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