Back to resultsStudy Immunology and Safety of 60-day Treatment of SQ Grass SLIT (Sublingual Immunotherapy)-Tablet in Adult Subjects With Grass Pollen-induced Allergic Rhinoconjunctivitis
Primary Purpose
Seasonal Allergic Rhinitis
Status
Completed
Phase
Phase 3
Locations
Russian Federation
Study Type
Interventional
Intervention
Phleum pratense grass pollen allergen extract
placebo
Sponsored by
About this trial
This is an interventional treatment trial for Seasonal Allergic Rhinitis focused on measuring GRAZAX
Eligibility Criteria
Inclusion Criteria:
- clinical history consistent with grass pollen-induced allergic rhinoconjunctivitis.
- Use of symptomatic treatment of grass pollen-induced allergic rhinoconjunctivitis.
- Positive skin prick test response (wheal diameter ≥3 mm) to Phleum pratense.
- If asthma, daily use of Inhaled corticosteroid (ICS) should be ≤400 microgram budesonide or equivalent
- Moderate or higher level of Phleum pratense specific IgE (Immunoglobulin E) (defined as ≥IgE Class 2; or ≥0.70 Kilo Units/liter (kU/L))
Exclusion Criteria:
- Reduced lung function (defined as FEV1 < 70% (FEV1=Forced Expiratory Volume in 1 second) of predicted value after adequate pharmacologic treatment) measured at Visit 1 and Visit 2
- Clinical history of uncontrolled asthma within 3 months prior to the screening visit
Sites / Locations
- Research facility ID ORG-001086
- Research facility ID ORG-001018
- Research facility ID ORG-001005
- Research facility ID ORG-001009
- Research facility ID ORG-001016
- Research facility ID ORG-001006
- Research facility ID ORG-001085
- Research facility ID ORG-001014
- Research facility ID ORG-001015
- Research facility ID ORG-001021
- Research facility ID ORG-001017
- Research facility ID ORG-001007
- Research facility ID ORG-001019
- Research facility ID ORG-001008
- Research facility ID ORG-001020
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Grass tablet 75,000 SQ-T
Placebo
Arm Description
Grass tablet 75,000 Standardized Quality units Tablet (SQ-T)
Placebo
Outcomes
Primary Outcome Measures
The Primary Efficacy Endpoint is Change From Baseline to End of Treatment of Phleum Pratense Specific Immunoglobulin G4 (IgG4) in Serum
measurement of IgG4 in serum
Secondary Outcome Measures
Change of Phleum Pratense Specific Immunoglobulin E (IgE) From Baseline to End of Treatment
measurement of IgE in serum
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02245360
Brief Title
Study Immunology and Safety of 60-day Treatment of SQ Grass SLIT (Sublingual Immunotherapy)-Tablet in Adult Subjects With Grass Pollen-induced Allergic Rhinoconjunctivitis
Official Title
A Randomized, Double-blind, Placebo-controlled Study Investigating the Immunologic Effects and Safety of 60-day Treatment of the SQ Grass SLIT-tablet in Adult Subjects With Grass Pollen-induced Allergic Rhinoconjunctivitis
Study Type
Interventional
2. Study Status
Record Verification Date
December 2015
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
March 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Abbott
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To investigate the immunologic effects and safety of 60-day treatment of the Standardized Quality units (SQ) grass Sublingual immunotherapy (SLIT)-tablet in adult subjects with grass pollen-induced allergic rhinoconjunctivitis in a double-blind, placebo-controlled study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Seasonal Allergic Rhinitis
Keywords
GRAZAX
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
107 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Grass tablet 75,000 SQ-T
Arm Type
Experimental
Arm Description
Grass tablet 75,000 Standardized Quality units Tablet (SQ-T)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
Phleum pratense grass pollen allergen extract
Other Intervention Name(s)
GRAZAX/GRASTEK
Intervention Description
Allergy Immunotherapy grass tablet 75,000 SQ-T given once daily over 60 days
Intervention Type
Drug
Intervention Name(s)
placebo
Intervention Description
placebo tablet given once daily over 60 days
Primary Outcome Measure Information:
Title
The Primary Efficacy Endpoint is Change From Baseline to End of Treatment of Phleum Pratense Specific Immunoglobulin G4 (IgG4) in Serum
Description
measurement of IgG4 in serum
Time Frame
baseline versus end of treatment (approx. 60 days)
Secondary Outcome Measure Information:
Title
Change of Phleum Pratense Specific Immunoglobulin E (IgE) From Baseline to End of Treatment
Description
measurement of IgE in serum
Time Frame
baseline versus end of treatment (approx. 60 days)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
clinical history consistent with grass pollen-induced allergic rhinoconjunctivitis.
Use of symptomatic treatment of grass pollen-induced allergic rhinoconjunctivitis.
Positive skin prick test response (wheal diameter ≥3 mm) to Phleum pratense.
If asthma, daily use of Inhaled corticosteroid (ICS) should be ≤400 microgram budesonide or equivalent
Moderate or higher level of Phleum pratense specific IgE (Immunoglobulin E) (defined as ≥IgE Class 2; or ≥0.70 Kilo Units/liter (kU/L))
Exclusion Criteria:
Reduced lung function (defined as FEV1 < 70% (FEV1=Forced Expiratory Volume in 1 second) of predicted value after adequate pharmacologic treatment) measured at Visit 1 and Visit 2
Clinical history of uncontrolled asthma within 3 months prior to the screening visit
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dmitri Kazei, MD PhD
Organizational Affiliation
Abbott
Official's Role
Study Director
Facility Information:
Facility Name
Research facility ID ORG-001086
City
Moscow
ZIP/Postal Code
105077
Country
Russian Federation
Facility Name
Research facility ID ORG-001018
City
Moscow
ZIP/Postal Code
115446
Country
Russian Federation
Facility Name
Research facility ID ORG-001005
City
Moscow
ZIP/Postal Code
115478
Country
Russian Federation
Facility Name
Research facility ID ORG-001009
City
Moscow
ZIP/Postal Code
119333
Country
Russian Federation
Facility Name
Research facility ID ORG-001016
City
Moscow
ZIP/Postal Code
119991
Country
Russian Federation
Facility Name
Research facility ID ORG-001006
City
Moscow
ZIP/Postal Code
123182
Country
Russian Federation
Facility Name
Research facility ID ORG-001085
City
Moscow
ZIP/Postal Code
123182
Country
Russian Federation
Facility Name
Research facility ID ORG-001014
City
Moscow
ZIP/Postal Code
142190
Country
Russian Federation
Facility Name
Research facility ID ORG-001015
City
Samara
ZIP/Postal Code
443099
Country
Russian Federation
Facility Name
Research facility ID ORG-001021
City
Saratov
ZIP/Postal Code
410028
Country
Russian Federation
Facility Name
Research facility ID ORG-001017
City
Smolensk
ZIP/Postal Code
214019
Country
Russian Federation
Facility Name
Research facility ID ORG-001007
City
St. Petersburg
ZIP/Postal Code
193231
Country
Russian Federation
Facility Name
Research facility ID ORG-001019
City
St. Petersburg
ZIP/Postal Code
195030
Country
Russian Federation
Facility Name
Research facility ID ORG-001008
City
St. Petersburg
ZIP/Postal Code
198216
Country
Russian Federation
Facility Name
Research facility ID ORG-001020
City
Ufa
ZIP/Postal Code
450000
Country
Russian Federation
12. IPD Sharing Statement
Learn more about this trial
Study Immunology and Safety of 60-day Treatment of SQ Grass SLIT (Sublingual Immunotherapy)-Tablet in Adult Subjects With Grass Pollen-induced Allergic Rhinoconjunctivitis
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