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NCT03931993: G104

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

Completed Phase 1 Last updated 30 April 2019
What this trial tests

Phase 1 trial testing Placebo comparator in Seasonal Allergic Rhinitis in 30 participants. Completed in 27 April 2017.

Timeline
16 January 2017
Primary endpoint
27 April 2017
27 April 2017

Quick facts

Lead sponsorAllergy Therapeutics
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment30
Start date16 January 2017
Primary completion27 April 2017
Estimated completion27 April 2017
Sites4 locations across United States

Drugs / interventions tested

Conditions studied

Sponsor

Allergy Therapeutics — full company profile →

Who can join

Adults 18 to 50, any sex, with Seasonal Allergic Rhinitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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Other trials of Grass MATA MPL

Trials testing the same drug.

Other recruiting trials for Seasonal Allergic Rhinitis

Currently open trials in the same condition.

Other Allergy Therapeutics trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03931993.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing