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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

637

participants targeted

Target at P75+ for phase_2

Timeline

Completed

Started Aug 2012

Shorter than P25 for phase_2

Geographic Reach

2 countries

2 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

1.1 years study duration

Study Start

First participant enrolled

August 1, 2012

Completed

26 days until next milestone

First Submitted

Initial submission to the registry

August 27, 2012

Completed

3 days until next milestone

First Posted

Study publicly available on registry

August 30, 2012

Completed

10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed

2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed

Last Updated

January 22, 2014

Status Verified

January 1, 2014

Enrollment Period

11 months

First QC Date

August 27, 2012

Last Update Submit

January 20, 2014

Conditions

Birch Pollen Allergy

Outcome Measures

Primary Outcomes (2)

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
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

Secondary Outcomes (1)

Adverse events severity
Throughout the trial, an expected average of 8 months