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

Phase 3

Completed

• Conditions: Seasonal Allergic Rhinitis
• Interventions: Drug: placebo; Drug: Phleum pratense grass pollen allergen extract

• Registration Number: NCT02245360
• Lead Sponsor: Abbott

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-09-17
• Study First Submitted QC: 2014-09-17
• Study First Posted: 2014-09-19
• Study Start: 2014-10
• Primary Completion: 2015-03
• Study Completion: 2015-03
• Results First Submitted: 2015-11-03
• Results First Submitted QC: 2015-11-03
• Status Verified: 2015-12
• Results First Posted: 2015-12-08
• Last Update Submitted: 2015-12-09
• Last Update Posted: 2016-01-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 107

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	placebo	Placebo
Grass tablet 75,000 SQ-T	Phleum pratense grass pollen allergen extract	Grass tablet 75,000 Standardized Quality units Tablet (SQ-T)

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (15)

Research facility ID ORG-001014; 🇷🇺 Moscow, Russian Federation

Research facility ID ORG-001006; 🇷🇺 Moscow, Russian Federation

Research facility ID ORG-001016; 🇷🇺 Moscow, Russian Federation

Research facility ID ORG-001007; 🇷🇺 St. Petersburg, Russian Federation

Research facility ID ORG-001018; 🇷🇺 Moscow, Russian Federation

Research facility ID ORG-001085; 🇷🇺 Moscow, Russian Federation

Research facility ID ORG-001008; 🇷🇺 St. Petersburg, Russian Federation

Research facility ID ORG-001005; 🇷🇺 Moscow, Russian Federation

Research facility ID ORG-001009; 🇷🇺 Moscow, Russian Federation

Research facility ID ORG-001015; 🇷🇺 Samara, Russian Federation

Research facility ID ORG-001086; 🇷🇺 Moscow, Russian Federation

Research facility ID ORG-001021; 🇷🇺 Saratov, Russian Federation

Research facility ID ORG-001017; 🇷🇺 Smolensk, Russian Federation

Research facility ID ORG-001020; 🇷🇺 Ufa, Russian Federation

Research facility ID ORG-001019; 🇷🇺 St. Petersburg, Russian Federation