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

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.

Timeline

Start

2015-09

Primary completion

2016-10

Completion

2016-10

Outcome

Missed primary endpoint

registry analysis (superiority test); Placebo vs SP 10,000 AUN/ml vs SP 40,000 AUN/ml vs SP 80,000 AUN/ml; p = 0.057; Test statistic 1.823; MCP-Mod Method NCT02556801 ↗

Drugs

Indications