Specific Immunotherapy With Recombinant Birch Pollen Allergen rBet v1-FV

NCT00266526 ↗

Phase 2 Completed Allergopharma GmbH & Co. KG

RandomizedParallel-groupOpen-labelTreatment

Summary

Specific immunotherapy with recombinant birch pollen allergen rBet v1-FV

Timeline

Start: 2003-07
Primary completion: 2004-07
Completion: 2005-07

Outcome

Missed primary endpoint

paper In this first in man, proof of concept phase II trial no statistical difference between rBet v 1-FV and an established natural pollen extract could be observed. PMID 26328056 ↗

Publications

Klimek L, Bachert C, Lukat KF, Pfaar O, Meyer H, Narkus A. Allergy immunotherapy with a hypoallergenic recombinant birch pollen allergen rBet v 1-FV in a randomized controlled trial. Clin Transl Allergy. 2015 Aug 3;5:28. doi: 10.1186/s13601-015-0071-x. eCollection 2015.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	rBet v1-FV	Protein / enzyme biologic	—	Subcutaneous