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Dose Selection Study of Efficacy and Safety of Different Doses of Grass MATA MPL and Grass MATA Using mEECs™

NCT02582073 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 265

Last updated 2021-01-29

No results posted yet for this study

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. The current therapeutic dose regimen for Grass MATA MPL is a course of four injections of 300, 800, 2000 and 2000 SU (Standardized Units), administered at weekly intervals (cumulative dose 5100 SU). Two new cumulative doses of the Grass MATA MPL 10200 SU and 18200 SU are being developed to compare with the current dose. The study is designed to explore the benefit/risk of increasing the cumulative allergen dose of the Grass MATA MPL immunotherapy comparing these doses with the current dose of Grass MATA MPL, Grass MATA (without MPL) and placebo.

Conditions

  • Seasonal Allergic Rhinitis

Interventions

BIOLOGICAL

Placebo (0.5ml)

BIOLOGICAL

Placebo (1.0ml)

BIOLOGICAL

Grass MATA MPL (0.5ml) 5100SU

BIOLOGICAL

Grass MATA MPL (1.0ml) 10200SU

BIOLOGICAL

Grass MATA MPL (1.0ml) 18200SU

BIOLOGICAL

Grass MATA (0.5ml) 5100SU

Sponsors & Collaborators

  • Allergy Therapeutics

    lead INDUSTRY

Principal Investigators

  • Tim Higenbottam, DSc MD FRCP · Allergy Therapeutics

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-07
Primary Completion
2016-05-05
Completion
2017-04-28

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02582073 on ClinicalTrials.gov