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

Primary Purpose

Birch Pollen Allergy

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
ALK tree AIT 0.5 DU
ALK tree AIT 1 DU
ALK tree AIT 2 DU
ALK tree AIT 4 DU
ALK tree AIT 7 DU
ALK tree AIT 12 DU
ALK tree AIT Placebo
Sponsored by
ALK-Abelló A/S
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Birch Pollen Allergy

Eligibility Criteria

12 Years - 65 Years (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Skin and Allergy Hospital, Helsinki University Central Hospital
  • Slotervaart Ziekenhuis

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

ALK tree AIT Placebo

ALK tree AIT 0.5 DU

ALK tree AIT 1 DU

ALK tree AIT 2 DU

ALK tree AIT 4 DU

ALK tree AIT 7 DU

ALK tree AIT 12 DU

Arm Description

1 AIT administered sublingually every day

1 AIT administered sublingually every day

1 AIT administered sublingually every day

1 AIT administered sublingually every day

1 AIT administered sublingually every day

1 AIT administered sublingually every day

1 AIT administered sublingually every day

Outcomes

Primary Outcome Measures

Allergy symptom severity scores on a scale from 0-3
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
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

Adverse events severity
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.

Full Information

First Posted
August 27, 2012
Last Updated
January 20, 2014
Sponsor
ALK-Abelló A/S
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1. Study Identification

Unique Protocol Identification Number
NCT01675791
Brief Title
A Dose-response Evaluation of ALK (the Sponsor) Tree Allergy Immunotherapy Tablet
Official Title
A Dose-response Evaluation of ALK Tree AIT
Study Type
Interventional

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
September 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
ALK-Abelló A/S

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Birch Pollen Allergy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
637 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ALK tree AIT Placebo
Arm Type
Placebo Comparator
Arm Description
1 AIT administered sublingually every day
Arm Title
ALK tree AIT 0.5 DU
Arm Type
Experimental
Arm Description
1 AIT administered sublingually every day
Arm Title
ALK tree AIT 1 DU
Arm Type
Experimental
Arm Description
1 AIT administered sublingually every day
Arm Title
ALK tree AIT 2 DU
Arm Type
Experimental
Arm Description
1 AIT administered sublingually every day
Arm Title
ALK tree AIT 4 DU
Arm Type
Experimental
Arm Description
1 AIT administered sublingually every day
Arm Title
ALK tree AIT 7 DU
Arm Type
Experimental
Arm Description
1 AIT administered sublingually every day
Arm Title
ALK tree AIT 12 DU
Arm Type
Experimental
Arm Description
1 AIT administered sublingually every day
Intervention Type
Biological
Intervention Name(s)
ALK tree AIT 0.5 DU
Intervention Type
Biological
Intervention Name(s)
ALK tree AIT 1 DU
Intervention Type
Biological
Intervention Name(s)
ALK tree AIT 2 DU
Intervention Type
Biological
Intervention Name(s)
ALK tree AIT 4 DU
Intervention Type
Biological
Intervention Name(s)
ALK tree AIT 7 DU
Intervention Type
Biological
Intervention Name(s)
ALK tree AIT 12 DU
Intervention Type
Biological
Intervention Name(s)
ALK tree AIT Placebo
Primary Outcome Measure Information:
Title
Allergy symptom severity scores on a scale from 0-3
Description
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.
Time Frame
During the birch pollen season 2013, an expected average of 3 weeks
Title
Adverse events frequency
Description
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.
Time Frame
Throughout the trial, an expected average of 8 months
Secondary Outcome Measure Information:
Title
Adverse events severity
Description
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.
Time Frame
Throughout the trial, an expected average of 8 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
Skin and Allergy Hospital, Helsinki University Central Hospital
City
Helsinki
State/Province
HUS
ZIP/Postal Code
00029
Country
Finland
Facility Name
Slotervaart Ziekenhuis
City
Amsterdam
ZIP/Postal Code
1066EC
Country
Netherlands

12. IPD Sharing Statement

Learn more about this trial

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

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