Open Label Safety Study of a Birch Pollen Allergen Extract

A Multicentre Open Label Safety Study of a Sublingual Specific Immunotherapy With a Solution of Birch Pollen Allergen Extract in Patients With Clinically Relevant Birch Pollen Allergy

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00818181

Enrollment

Registered

2009-01-07

Start date

2008-06-30

Completion date

2010-08-31

Last updated

2013-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rhinoconjunctivitis

Keywords

Type I - Allergy, rhinoconjunctivitis

Brief summary

This trial is performed to assess safety of a sublingual birch pollen extract.

Interventions

DRUGBiological: AL0206st

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

* Allergic rhinoconjunctivitis attributable to birch pollen * Positive SPT * Positive EAST

Exclusion criteria

* Serious chronic diseases * Other perennial allergies * Partly controlled asthma

Design outcomes

Primary

Measure	Time frame	Description
number of patients with at least one adverse event	8 months	Between Visit 03 and Visit 05 (June 2008 - January 2009)

Secondary

Measure	Time frame	Description
Systemic reactions	Entire treatment period	The occurrence of systemic reactions during the entire treatment period: For this purpose patients completed a diary covering the treatment phase.

Other

Measure	Time frame	Description
Immunologic parameters	during the course of the study	Immunologic parameters (IgE, IgG1 and IgG4) were evaluated during the course of the study in order to obtain evidence of the immunologic effects.

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026