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

NCT01675791 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 637

Last updated 2014-01-22

No results posted yet for this study

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.

Conditions

  • Birch Pollen Allergy

Interventions

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

Sponsors & Collaborators

  • ALK-Abelló A/S

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-08-31
Primary Completion
2013-07-31
Completion
2013-09-30

Countries

  • Finland
  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01675791 on ClinicalTrials.gov