Open Label Safety Study of a Birch Pollen Allergen Extract

Allergopharma

Status and phase: Completed; Phase 2

Conditions: Rhinoconjunctivitis

Treatments: Drug: Biological: AL0206st

Study type: Interventional

Funder types: Industry

Identifiers

NCT00818181

AL0206st

2007-006053-24 (EudraCT Number)

Details and patient eligibility

About

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

Enrollment: 73 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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73 participants in 1 patient group

Solution of birch pollen allergen extract

Experimental group

Description:

In total up to 4 drops (dose for maintainace therapy)are administered under the tongue.

Treatment:

Drug: Biological: AL0206st