Molecular and Cellular Mechanism in the Course of Immunotherapy With a Phleum Pratense Oral Lyophilisate

Overview

This trial is an exploratory randomised, parallel-group, double-blind, placebo- controlled, national, single-centre trial. The trial will be initiated before 2013 grass pollen season and subjects will be randomised in September 2013 to receive active treatment (Grazax®) or placebo during 2 years. Placebo group will be treated 2 years with placebo and a third year with active therapy (Grazax®) and active group will continue the active treatment in the third year. In the last year, all placebo patients will be changed to active group and active and placebo patients will be informed about, but the trial will not be unblinded until the end of the third year and patients won´t know what treatment they were assigned to during the first 2 years.

There is a first stage of clinical trial (GT-20) in which ALK- Abelló is directly working into the MEICA project to explore human immunological mechanisms of SIT (observed after Grazax® treatment). In this trial, different potential biomarkers of early and sustained effect of specific immunotherapy have been identified. Therefore, for a further research, it was necessary to carry on a new clinical double blind placebo control trial to evaluate a selected panel of biomarkers that can be applied in the selection and monitoring of patients during immunotherapy. They can be of value in the evaluation of future product candidates for specific immunotherapy. For this purpose, it is necessary that the Biomarkers selected, clearly differentiate between active and placebo treated groups. Moreover, specific immunological changes differences between active and placebo patients during pollen seasons are unknown. This first study allowed us identifying a potential set of biomarkers and time points for each of them that might correlate with treatment effect. This second study is needed to evaluate the potential of these biomarkers to discriminate placebo treated patients and it is a necessary step before incorporating them in big prospective efficacy studies. A third year in an active IMP design after the two years in a double blind placebo setup is included as a way to validate the differences observed intergroup during the first year of therapy. This is needed as pollen seasons significantly differ in strength and duration. Moreover, there is a unique opportunity of analysing immunological changes of the intervention before a careful baseline monitoring of patients undergoing placebo treatment, with the opportunity of understanding immunological clues in the natural evolution of allergy disease.