A Dose-response Evaluation of ALK (the Sponsor) Tree Allergy Immunotherapy Tablet

ALK-Abelló

Status and phase

Completed

Phase 2

Conditions

Birch Pollen Allergy

Treatments

Biological: ALK tree AIT 1 DU

Biological: ALK tree AIT 2 DU

Biological: ALK tree AIT 4 DU

Biological: ALK tree AIT 0.5 DU

Biological: ALK tree AIT Placebo

Biological: ALK tree AIT 12 DU

Biological: ALK tree AIT 7 DU

Study type

Interventional

Funder types

Industry

Identifiers

NCT01675791

TT-02

Details and patient eligibility

About

The primary aim of this trial is to evaluate the dose-response relationship for the ALK tree AIT administered once daily in order to define a dose-range that would be suitable for at-home administration.

Enrollment

637 patients

Sex

All

Ages

12 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

A history of moderate to severe birch pollen allergy
Use of symptomatic medication for treatment of birch pollen allergy
Positive skin prick test to birch extract
Positive specific IgE against Bet v 1

Exclusion criteria

Overlapping perennial allergies
History of uncontrolled asthma within the last 3 months
FEV1 < 70% of predicted value in adults or FEV1 < 80% of predicted value in adolescents
Previous or ongoing treatment with immunotherapy

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

637 participants in 7 patient groups, including a placebo group

ALK tree AIT Placebo

Placebo Comparator group

Description: