A Study of Tolerability & Safety of Two New Doses of Grass MATA MPL

Status Completed

Clinical Trial 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.

Two new cumulative doses of the Grass MATA MPL 10200 and 18200 SU (Standardized Units) are being developed to compare with the current dose of 5100 SU. The purpose of this study is to evaluate the tolerability and safety of these two new cumulative dose regimens 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 go into a larger scale study to assess the efficacy and safety of the higher cumulative doses.

Clinical Trial Description

Structure: Single center, parallel group, single-blind, randomized study There will be three treatment groups, two groups receiving a different, cumulative dose of Grass MATA MPL and the third group receiving placebo only.

Duration: The duration of the study from screening to final visit after treatment is expected to be approximately 7 weeks. There will be a telephone follow up at 1, 3, 6 and 12 months after treatment. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02557633
Study type	Interventional
Source	Allergy Therapeutics
Contact
Status	Completed
Phase	Phase 1
Start date	August 2015
Completion date	October 2016

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A Study of Tolerability and Safety of Two New Doses of Grass MATA MPL

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms