NCT01728519

Phase I/IIa Clinical Evaluation of AllerT vs Placebo in Subjects Allergic to Birch Pollen

Phase I/IIa Study to Assess the Safety, Immunogenicity and Efficacy of AllerT, a Combination of Peptides Derived From Bet v 1, Administered Via the Subcutaneous or Intradermal Route to Volunteers Allergic to Birch Pollen

• Status: Terminated
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: Anergis · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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

Detailed description

In addition to the initial protocol, post hoc evaluations were conducted, after new ethics committee reviews, to assess quality of life during the birch pollen season following the trial (April 2009) and to obtain blood samples for evaluation of immunology markers IgG4 and IgE after the season 2010 (July 2010) and after the season 2012 (July 2012),

Conditions

• Allergic Rhinitis
• Allergy

Interventions

Type	Name	Description
DRUG	AllerT SC	AllerT subcutaneous injections on days 1, 7, 14, 21 and 56 - cumulative dose 440 microgram)
DRUG	AllerT ID	AllerT intra-dermal injections on days 1, 7, 14, 21 and 56 - cumulative dose 440 microgram)
DRUG	Placebo SC	Placebo subcutaneous injections on days 1, 7, 14, 21 and 56
DRUG	Placebo ID	Placebo intra-dermal injections on days 1, 7, 14, 21 and 56

Timeline

• Start date: 2008-08-01
• Primary completion: 2009-03-01
• Completion: 2012-07-01
• First posted: 2012-11-20
• Last updated: 2012-11-20

Locations

1 site across 1 country: Switzerland