Phase 3 N=107 Randomized Triple-blind Treatment

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

Seasonal Allergic Rhinitis

Bottom Line

View on ClinicalTrials.gov: NCT02245360 ↗

Enrolled (actual)

107

Serious AEs

0.0%

Results posted

Dec 2015

Primary outcome: Primary: The Primary Efficacy Endpoint is Change From Baseline to End of Treatment of Phleum Pratense Specific Immunoglobulin G4 (IgG4) in Serum — 0.684; 0.050 mgA/L

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Phleum pratense grass pollen allergen extract (Drug); placebo (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Abbott
Primary completion: Mar 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY The Primary Efficacy Endpoint is Change From Baseline to End of Treatment of Phleum Pratense Specific Immunoglobulin G4 (IgG4) in Serum	0.684; 0.050	—
SECONDARY Change of Phleum Pratense Specific Immunoglobulin E (IgE) From Baseline to End of Treatment	22.751; -2.756	—

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.

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

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Data sourced from ClinicalTrials.gov (NCT02245360). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.