Study Immunology and Safety of 60-day Treatment of SQ Grass SLIT (Sublingual Immunotherapy)-Tablet in Adult Subjects With Grass Pollen-induced Allergic Rhinoconjunctivitis

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Seasonal Allergic Rhinitis

Intervention / Treatment
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* Drug: Phleum pratense grass pollen allergen extract
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Grass tablet 75,000 SQ-T<br>Grass tablet 75,000 Standardized Quality units Tablet (SQ-T) | Drug: Phleum pratense grass pollen allergen extract<br>* Allergy Immunotherapy grass tablet 75,000 SQ-T given once daily over 60 days<br>* Other names: GRAZAX/GRASTEK;|
| Placebo Comparator: Placebo<br>Placebo | Drug: placebo<br>* placebo tablet given once daily over 60 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | baseline versus end of treatment (approx. 60 days) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Phleum Pratense Specific Immunoglobulin E (IgE) From Baseline to End of Treatment | measurement of IgE in serum | baseline versus end of treatment (approx. 60 days) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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GRAZAX