Efficacy and Safety of SUBLIVAC Phleum for Immunotherapy of Grass Pollen-Allergy

Allergic Rhinitis Clinical Trial

Official title: A Single-center, Randomized, Double Blind, Placebo-Controlled, Parallel Group Study to Investigate the Relative Efficacy and Safety of Immunotherapy With SUBLIVAC FIX Phleum Pratense in Grass Pollen-Allergic Subjects With IgE-Mediated Seasonal ARC

Status Completed

Clinical Trial Summary

The purpose of this study is to assess safety, tolerability and demonstrate a dose response signal using Total Symptom Score (TSS), based on challenges with grass pollen in an Environmental Exposure Chamber (EEC), followed by estimation of the minimum effective dose of SUBLIVAC FIX Phleum (SP) after 10 months of treatment compared to placebo.

The study has 4 treatment groups: 3 different doses of SP and placebo will be tested.

Clinical Trial Description

The current dose range finding study with SP has been designed to test three different concentrations of SUBLIVAC FIX Phleum (SP) that includes 3 doses (10,000 AUN/mL; 40,000 AUN/mL; 80,000 AUN/mL) and placebo to demonstrate a dose response signal and to estimate the minimal effective dose of SP. The study will be conducted in the target population of seasonal allergic subjects in a fully validated Environmental Exposure Chamber (EEC) system. The EEC system is a facility that has temporal uniformity of airborne allergen (pollen) exposure to subjects. Use of the EEC ensures exposure to relatively consistent levels of allergen. This facility has been used in a number of immunotherapy trials and is an improved challenge model of AR compared to the previously used nasal provocation test. Treatment duration of this study is extended to 10 months. ;

Related Conditions & MeSH terms

• Allergic Rhinitis
• Allergic Rhinoconjunctivitis
• Rhinitis
• Rhinitis, Allergic

• NCT number: NCT02556801
• Study type: Interventional
• Source: HAL Allergy
• Status: Completed
• Phase: Phase 2
• Start date: September 2015
• Completion date: October 2016