Seasonal Allergic Rhinitis
Conditions
Keywords
GRAZAX
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.
Interventions
DRUGPhleum pratense grass pollen allergen extract
Allergy Immunotherapy grass tablet 75,000 SQ-T given once daily over 60 days
DRUGplacebo
placebo tablet given once daily over 60 days
Sponsors
Abbott
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Primary Efficacy Endpoint is Change From Baseline to End of Treatment of Phleum Pratense Specific Immunoglobulin G4 (IgG4) in Serum | baseline versus end of treatment (approx. 60 days) | measurement of IgG4 in serum |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of Phleum Pratense Specific Immunoglobulin E (IgE) From Baseline to End of Treatment | baseline versus end of treatment (approx. 60 days) | measurement of IgE in serum |
Countries
Russia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Grass Tablet 75,000 SQ-T Grass tablet 75,000 Standardized Quality units Tablet (SQ-T)
Phleum pratense grass pollen allergen extract: Allergy Immunotherapy grass tablet 75,000 SQ-T given once daily over 60 days | 53 |
| Placebo Placebo
placebo: placebo tablet given once daily over 60 days | 54 |
| Total | 107 |
Baseline characteristics
| Characteristic | Placebo | Grass Tablet 75,000 SQ-T | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 54 Participants | 53 Participants | 107 Participants |
| Age, Continuous | 34.1 years STANDARD_DEVIATION 10.1 | 35.8 years STANDARD_DEVIATION 11.2 | 34.9 years STANDARD_DEVIATION 10.6 |
| Region of Enrollment Russian Federation | 54 participants | 53 participants | 107 participants |
| Sex: Female, Male Female | 21 Participants | 27 Participants | 48 Participants |
| Sex: Female, Male Male | 33 Participants | 26 Participants | 59 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 26 / 53 | 12 / 54 |
| serious Total, serious adverse events | 0 / 53 | 0 / 54 |
Outcome results
Primary
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
Time frame: baseline versus end of treatment (approx. 60 days)
Population: In each treatment arm/group 1 subject was excluded from the analyzed sample due to missing post-baseline efficacy data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Grass Tablet 75,000 SQ-T | The Primary Efficacy Endpoint is Change From Baseline to End of Treatment of Phleum Pratense Specific Immunoglobulin G4 (IgG4) in Serum | 0.684 mgA/L | Standard Deviation 1.691 |
| Placebo | The Primary Efficacy Endpoint is Change From Baseline to End of Treatment of Phleum Pratense Specific Immunoglobulin G4 (IgG4) in Serum | 0.050 mgA/L | Standard Deviation 0.588 |
Secondary
Change of Phleum Pratense Specific Immunoglobulin E (IgE) From Baseline to End of Treatment
measurement of IgE in serum
Time frame: baseline versus end of treatment (approx. 60 days)
Population: In each treatment arm/group 1 subject was excluded from the analyzed sample due to missing post-baseline efficacy data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Grass Tablet 75,000 SQ-T | Change of Phleum Pratense Specific Immunoglobulin E (IgE) From Baseline to End of Treatment | 22.751 UA/ml | Standard Deviation 29.364 |
| Placebo | Change of Phleum Pratense Specific Immunoglobulin E (IgE) From Baseline to End of Treatment | -2.756 UA/ml | Standard Deviation 16.933 |