drugset / Trial / NCT01567306

Phase II Trial With Subcutaneous Immunotherapy in Patients Sensitized to Phleum Pratense

NCT01567306 ↗

Phase 2 Completed 151 enrolled Roxall Medicina España S.A
RandomizedParallel-groupQuadruple-blindTreatment

Summary

Based on EMA (European Medicines Agency) new guidelines on the clinical development of products for immunotherapy for the treatment of allergic diseases the aim of this study is to establish a dose-response relationship for clinical efficacy of Phleum pratense pollen extract subcutaneous vaccine.

Timeline

Start
2011-10
Primary completion
2013-04
Completion
2013-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Allergovac Depot Vaccine 0.25 unknown Subcutaneous
Subject Allergovac Depot Vaccine 0.5 unknown Subcutaneous
Subject Allergovac Depot Vaccine 1 unknown Subcutaneous
Subject Allergovac Depot Vaccine 2 unknown Subcutaneous
Subject Allergovac Depot Vaccine 4 unknown Subcutaneous

Indications