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Completed

NCT Number: NCT01675791

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

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.

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Key information

Conditions

Birch Pollen Allergy

Age range

12 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Skin and Allergy Hospital, Helsinki University Central Hospital, Helsinki, HUS, Finland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Biological

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

ALK-Abelló A/S

Industry

Registry information

Official study title

A Dose-response Evaluation of ALK Tree AIT

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Aug 30, 2012
Registry last updated
Jan 22, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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