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

Phase 2

Completed

• Conditions: Birch Pollen Allergy
• Interventions: Biological: ALK tree AIT Placebo; Biological: ALK tree AIT 0.5 DU; Biological: ALK tree AIT 1 DU; Biological: ALK tree AIT 4 DU; Biological: ALK tree AIT 2 DU; Biological: ALK tree AIT 7 DU; Biological: ALK tree AIT 12 DU

• Registration Number: NCT01675791
• Lead Sponsor: ALK-Abelló A/S

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-08-27
• Study First Submitted QC: 2012-08-29
• Study First Posted: 2012-08-30
• Primary Completion: 2013-07
• Study Completion: 2013-09
• Status Verified: 2014-01
• Last Update Submitted: 2014-01-20
• Last Update Posted: 2014-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 637

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ALK tree AIT Placebo	ALK tree AIT Placebo	1 AIT administered sublingually every day
ALK tree AIT 0.5 DU	ALK tree AIT 0.5 DU	1 AIT administered sublingually every day
ALK tree AIT 1 DU	ALK tree AIT 1 DU	1 AIT administered sublingually every day
ALK tree AIT 4 DU	ALK tree AIT 4 DU	1 AIT administered sublingually every day
ALK tree AIT 2 DU	ALK tree AIT 2 DU	1 AIT administered sublingually every day
ALK tree AIT 7 DU	ALK tree AIT 7 DU	1 AIT administered sublingually every day
ALK tree AIT 12 DU	ALK tree AIT 12 DU	1 AIT administered sublingually every day

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (2)

Slotervaart Ziekenhuis; 🇳🇱 Amsterdam, Netherlands

Skin and Allergy Hospital, Helsinki University Central Hospital; 🇫🇮 Helsinki, HUS, Finland