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

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

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 Overview

• Status: Completed
• Conditions: Seasonal Allergic Rhinitis
• Intervention / Treatment: Drug: Phleum pratense grass pollen allergen extract; Drug: placebo

• Study Type: Interventional
• Enrollment (Actual): 107
• Phase: Phase 3

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation, 105077
    • Research facility ID ORG-001086
  • Moscow, Russian Federation, 115446
    • Research facility ID ORG-001018
  • Moscow, Russian Federation, 115478
    • Research facility ID ORG-001005
  • Moscow, Russian Federation, 119333
    • Research facility ID ORG-001009
  • Moscow, Russian Federation, 119991
    • Research facility ID ORG-001016
  • Moscow, Russian Federation, 123182
    • Research facility ID ORG-001006
  • Moscow, Russian Federation, 123182
    • Research facility ID ORG-001085
  • Moscow, Russian Federation, 142190
    • Research facility ID ORG-001014
  • Samara, Russian Federation, 443099
    • Research facility ID ORG-001015
  • Saratov, Russian Federation, 410028
    • Research facility ID ORG-001021
  • Smolensk, Russian Federation, 214019
    • Research facility ID ORG-001017
  • St. Petersburg, Russian Federation, 193231
    • Research facility ID ORG-001007
  • St. Petersburg, Russian Federation, 195030
    • Research facility ID ORG-001019
  • St. Petersburg, Russian Federation, 198216
    • Research facility ID ORG-001008
  • Ufa, Russian Federation, 450000
    • Research facility ID ORG-001020

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: Abbott
• Investigators: Study Director: Dmitri Kazei, MD PhD, Abbott

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): March 1, 2015
• Study Completion (Actual): March 1, 2015

Study Registration Dates

• First Submitted: September 17, 2014
• First Submitted That Met QC Criteria: September 17, 2014
• First Posted (Estimate): September 19, 2014

Study Record Updates

• Last Update Posted (Estimate): January 11, 2016
• Last Update Submitted That Met QC Criteria: December 9, 2015
• Last Verified: December 1, 2015

More Information

Terms related to this study

• Keywords: GRAZAX
• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Seasonal
• Other Study ID Numbers: GRAS3001