Efficacy and Safety From a Recombinant Folding Variant of Bet v 1

Allergopharma

Status and phase: Completed; Phase 3

Conditions: Allergy

Treatments: Biological: placebo; Biological: recombinant birch pollen allergen

Study type: Interventional

Funder types: Industry

Identifiers

NCT00554983

2007-001029-84 (EudraCT Number)

AL0702rB

Details and patient eligibility

About

Efficacy and Safety from a recombinant folding variant of Bet v 1

Enrollment: 255 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
• Positive specific provocation test

Exclusion criteria

• Serious chronic diseases
• Other perennial allergies

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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255 participants in 2 patient groups, including a placebo group

2

Placebo Comparator group

Treatment:

Biological: placebo

1

Experimental group

Treatment:

Biological: recombinant birch pollen allergen