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

January 20, 2014 updated by: ALK-Abelló A/S

A Dose-response Evaluation of ALK Tree AIT

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.

Study Overview

Study Type

Interventional

Enrollment (Actual)

637

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • HUS
      • Helsinki, HUS, Finland, 00029
        • Skin and Allergy Hospital, Helsinki University Central Hospital
      • Amsterdam, Netherlands, 1066EC
        • Slotervaart Ziekenhuis

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: ALK tree AIT Placebo
1 AIT administered sublingually every day
Experimental: ALK tree AIT 0.5 DU
1 AIT administered sublingually every day
Experimental: ALK tree AIT 1 DU
1 AIT administered sublingually every day
Experimental: ALK tree AIT 2 DU
1 AIT administered sublingually every day
Experimental: ALK tree AIT 4 DU
1 AIT administered sublingually every day
Experimental: ALK tree AIT 7 DU
1 AIT administered sublingually every day
Experimental: ALK tree AIT 12 DU
1 AIT administered sublingually every day

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Allergy symptom severity scores on a scale from 0-3
Time Frame: 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.
During the birch pollen season 2013, an expected average of 3 weeks
Adverse events frequency
Time Frame: 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.
Throughout the trial, an expected average of 8 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adverse events severity
Time Frame: 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.
Throughout the trial, an expected average of 8 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

August 27, 2012

First Submitted That Met QC Criteria

August 29, 2012

First Posted (Estimate)

August 30, 2012

Study Record Updates

Last Update Posted (Estimate)

January 22, 2014

Last Update Submitted That Met QC Criteria

January 20, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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