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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
ALK-Abelló A/S
ClinicalTrials.gov Identifier:
NCT01675791
First received: August 27, 2012
Last updated: January 20, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention Phase
Birch Pollen Allergy
Biological: ALK tree AIT 0.5 DU
Biological: ALK tree AIT 1 DU
Biological: ALK tree AIT 2 DU
Biological: ALK tree AIT 4 DU
Biological: ALK tree AIT 7 DU
Biological: ALK tree AIT 12 DU
Biological: ALK tree AIT Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Dose-response Evaluation of ALK Tree AIT

Resource links provided by NLM:


Further study details as provided by ALK-Abelló A/S:

Primary Outcome Measures:
  • Allergy symptom severity scores on a scale from 0-3 [ Time Frame: During the birch pollen season 2013, an expected average of 3 weeks ] [ Designated as safety issue: No ]
    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 [ Time Frame: Throughout the trial, an expected average of 8 months ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: Throughout the trial, an expected average of 8 months ] [ Designated as safety issue: Yes ]
    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.


Enrollment: 637
Study Start Date: August 2012
Study Completion Date: September 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: ALK tree AIT Placebo
1 AIT administered sublingually every day
Biological: ALK tree AIT Placebo
Experimental: ALK tree AIT 0.5 DU
1 AIT administered sublingually every day
Biological: ALK tree AIT 0.5 DU
Experimental: ALK tree AIT 1 DU
1 AIT administered sublingually every day
Biological: ALK tree AIT 1 DU
Experimental: ALK tree AIT 2 DU
1 AIT administered sublingually every day
Biological: ALK tree AIT 2 DU
Experimental: ALK tree AIT 4 DU
1 AIT administered sublingually every day
Biological: ALK tree AIT 4 DU
Experimental: ALK tree AIT 7 DU
1 AIT administered sublingually every day
Biological: ALK tree AIT 7 DU
Experimental: ALK tree AIT 12 DU
1 AIT administered sublingually every day
Biological: ALK tree AIT 12 DU

  Eligibility

Ages Eligible for Study:   12 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01675791

Locations
Finland
Skin and Allergy Hospital, Helsinki University Central Hospital
Helsinki, HUS, Finland, 00029
Netherlands
Slotervaart Ziekenhuis
Amsterdam, Netherlands, 1066EC
Sponsors and Collaborators
ALK-Abelló A/S
  More Information

No publications provided

Responsible Party: ALK-Abelló A/S
ClinicalTrials.gov Identifier: NCT01675791     History of Changes
Other Study ID Numbers: TT-02
Study First Received: August 27, 2012
Last Updated: January 20, 2014
Health Authority: Denmark: Danish Medicines Agency
Finland: Finnish Medicines Agency
Lithuania: State Medicines Control Agency
The Netherlands: Medicines Evaluation Board
Norway: Norwegian Medicines Agency
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Sweden: Medical Products Agency

Additional relevant MeSH terms:
Hypersensitivity
Rhinitis, Allergic, Seasonal
Immune System Diseases
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate

ClinicalTrials.gov processed this record on August 18, 2014