drugset / Trial / NCT03931993

A Study of Tolerability and Safety of a New Cumulative Dose of Grass MATA MPL

NCT03931993 ↗

RandomizedParallel-groupSingle-blindTreatment

Summary

There is increasing evidence that the effectiveness of allergy immunotherapy to control symptoms of rhinoconjunctivitis is related to the cumulative dose of allergen or allergoid administered during a single regimen of subcutaneous (SC) injections or of sublingual administration. Previously, high cumulative doses of the Grass MATA MPL 10200 and 18200 SU (Standardized Units) were compared with the marketed dose of 5100 SU and were found to have acceptable tolerability and safety. The purpose of this study is to evaluate the tolerability and safety of an even higher cumulative dose regimen of 35600 SU. of Grass MATA MPL compared with placebo in patients with seasonal allergic rhinoconjunctivitis (SAR) due to grass pollen, to enable selection of the best dose to take forward for further development.

Timeline

Start
2017-01-16
Primary completion
2017-04-27
Completion
2017-04-27

Drugs

EvaluationDrugModalityDoseRoute
Subject Grass MATA MPL Vaccine 8000 unknown Subcutaneous