drugset / Trial / NCT01353755

2nd Pivotal Study rPhleum - Adults and Adolescents With Rhinoconjunctivitis +/-Controlled Asthma

NCT01353755 ↗

Phase 3 Completed 195 enrolled Allergopharma GmbH & Co. KG
RandomizedParallel-groupQuadruple-blindTreatment

Summary

To evaluate efficacy and tolerability of specific subcutaneous immunotherapy with a cocktail of recombinant major allergens of Timothy Grass Pollen (Phleum pratense) in subjects with rhinoconjunctivitis caused by grass pollen with/without controlled asthma.

Timeline

Start
2009-10
Primary completion
2012-08
Completion
2014-09

Drugs

EvaluationDrugModalityDoseRoute
Subject rPhleum Protein / enzyme biologic 0.78 ug/ml Subcutaneous
Subject rPhleum Protein / enzyme biologic 6.25 ug/ml Subcutaneous
Subject rPhleum Protein / enzyme biologic 50 ug/ml Subcutaneous
Subject rPhleum Protein / enzyme biologic 200 ug/ml Subcutaneous