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

A Dose-response Evaluation of ALK Tree AIT

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01675791

Enrollment

637

Registered

2012-08-30

Start date

2012-08-31

Completion date

2013-09-30

Last updated

2014-01-22

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

Conditions

Birch Pollen Allergy

Brief summary

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.

Interventions

BIOLOGICALALK tree AIT 2 DU

BIOLOGICALALK tree AIT 0.5 DU

BIOLOGICALALK tree AIT 1 DU

BIOLOGICALALK tree AIT 4 DU

BIOLOGICALALK tree AIT 7 DU

BIOLOGICALALK tree AIT 12 DU

BIOLOGICALALK tree AIT Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

12 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame	Description
Allergy symptom severity scores on a scale from 0-3	During the birch pollen season 2013, an expected average of 3 weeks	Determine the dose-efficacy response relationship of the ALK tree AIT. This information will, in combination with the evaluation of the frequency and severity of adverse events, form the basis of the conclusion on the primary endpoint.
Adverse events frequency	Throughout the trial, an expected average of 8 months	Determine the dose-safety response relationship of the ALK tree AIT. This information will, in combination with the evaluation of the allergy symptoms, form the basis of the conclusion on the primary endpoint.

Secondary

Measure	Time frame	Description
Adverse events severity	Throughout the trial, an expected average of 8 months	Determine the dose-safety response relationship of the ALK tree AIT. This information will, in combination with the evaluation of the allergy symptoms, form the basis of the conclusion on the primary endpoint.

Countries

Finland, Netherlands

Outcome results

None listed

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