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

Birch Pollen Allergy Clinical Trial

Official title:

A Dose-response Evaluation of ALK Tree AIT

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01675791
• Other study ID #: TT-02
• Status: Completed
• Phase: Phase 2
• First received: August 27, 2012
• Last updated: January 20, 2014
• Start date: August 2012
• Est. completion date: September 2013

Study information

• Verified date: January 2014
• Source: ALK-Abelló A/S
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Medicines AgencyFinland: Finnish Medicines AgencyLithuania: State Medicines Control AgencyThe Netherlands: Medicines Evaluation BoardNorway: Norwegian Medicines AgencyPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsSweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 637
• Est. completion date: September 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 65 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Birch Pollen Allergy
• Rhinitis, Allergic, Seasonal

Intervention

Biological:
• 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

Locations

Country	Name	City	State
Finland	Skin and Allergy Hospital, Helsinki University Central Hospital	Helsinki	HUS
Netherlands	Slotervaart Ziekenhuis	Amsterdam

Sponsors (1)

Lead Sponsor	Collaborator
ALK-Abelló A/S

Countries where clinical trial is conducted

Finland,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	During the birch pollen season 2013, an expected average of 3 weeks	No
Primary	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.	Throughout the trial, an expected average of 8 months	Yes
Secondary	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.	Throughout the trial, an expected average of 8 months	Yes