NCT02245360CompletedPhase 3
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
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Abbott
- Enrollment
- 107
- Locations
- 15
- Primary Endpoint
- The Primary Efficacy Endpoint is Change From Baseline to End of Treatment of Phleum Pratense Specific Immunoglobulin G4 (IgG4) in Serum
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 18 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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
Arms & Interventions
Placebo
Placebo Comparator
Placebo
Intervention: placebo (Drug)
Grass tablet 75,000 SQ-T
Experimental
Grass tablet 75,000 Standardized Quality units Tablet (SQ-T)
Intervention: Phleum pratense grass pollen allergen extract (Drug)
Outcomes
Primary Outcomes
The Primary Efficacy Endpoint is Change From Baseline to End of Treatment of Phleum Pratense Specific Immunoglobulin G4 (IgG4) in Serum
Time Frame: baseline versus end of treatment (approx. 60 days)
measurement of IgG4 in serum
Secondary Outcomes
- Change of Phleum Pratense Specific Immunoglobulin E (IgE) From Baseline to End of Treatment(baseline versus end of treatment (approx. 60 days))
Investigators
Study Sites (15)
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