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Completed

NCT Number: NCT02245360

Study Immunology and Safety of 60-day Treatment of SQ Grass SLIT (Sublingual Immunotherapy)-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.

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Key information

Conditions

Seasonal Allergic Rhinitis Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Nose Diseases Otorhinolaryngologic Diseases Respiratory Hypersensitivity Respiratory Tract Diseases Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Seasonal

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Research facility ID ORG-001005, Moscow, Russia

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Phleum pratense grass pollen allergen extract

Drug

Allergy Immunotherapy grass tablet 75,000 SQ-T given once daily over 60 days

Other names: GRAZAX/GRASTEK

Placebo

Drug

placebo tablet given once daily over 60 days

Primary outcomes

  1. 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

  1. Change of Phleum Pratense Specific Immunoglobulin E (IgE) From Baseline to End of Treatment

    Time frame: baseline versus end of treatment (approx. 60 days)

    measurement of IgE in serum

Sponsors and collaborators

Lead sponsor

Abbott

Industry

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 19, 2014
Registry last updated
Jan 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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