Phase I/IIa Clinical Evaluation of AllerT vs Placebo in Subjects Allergic to Birch Pollen
Status:
Terminated
Trial end date:
2012-07-01
Target enrollment:
Participant gender:
Summary
Birch pollen allergic patients are currently treated by subcutaneous injections of pollen
extracts either by standard allergen specific immunotherapy (SIT) or ultra-rush
immunotherapy. Such treatment is prone to side effects and has to be performed in a hospital
environment due to the risk of potential anaphylactic reactions. The aim of this study is to
test the new product AllerT expected to show widely reduced side effects. AllerT will be
injected via two different routes, subcutaneous versus intradermal. The primary endpoint of
the study is the local and systemic safety of repeated injections of the product. Since
AllerT should provide patients with a pre-seasonal treatment to decrease seasonal allergic
symptoms, we will also evaluate the potential efficacy of the approach using a nasal
provocation test (NPT) with birch pollen