Who is sponsoring NCT01675791?

NCT01675791 is sponsored by ALK-Abelló A/S.

What condition does NCT01675791 study?

NCT01675791 studies Birch Pollen Allergy.

What drugs are being tested in NCT01675791?

Interventions: 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.

What is the status of NCT01675791?

NCT01675791 is currently COMPLETED.

Last reviewed 2014-01-20 · How we verify

A Dose-response Evaluation of ALK Tree AIT

NCT01675791 Phase 2 COMPLETED

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.

Details

Lead sponsor	ALK-Abelló A/S
Phase	Phase 2
Status	COMPLETED
Enrolment	637
Start date	2012-08
Completion	2013-09

Conditions

Birch Pollen Allergy

Interventions

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

Primary outcomes

Allergy symptom severity scores on a scale from 0-3 — 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.
Adverse events frequency — 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.

Countries

Finland, Netherlands