- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01675791
A Dose-response Evaluation of ALK (the Sponsor) Tree Allergy Immunotherapy Tablet
January 20, 2014 updated by: ALK-Abelló A/S
A Dose-response Evaluation of ALK Tree AIT
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
637
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
HUS
-
Helsinki, HUS, Finland, 00029
- Skin and Allergy Hospital, Helsinki University Central Hospital
-
-
-
-
-
Amsterdam, Netherlands, 1066EC
- Slotervaart Ziekenhuis
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years to 65 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: ALK tree AIT Placebo
1 AIT administered sublingually every day
|
|
Experimental: ALK tree AIT 0.5 DU
1 AIT administered sublingually every day
|
|
Experimental: ALK tree AIT 1 DU
1 AIT administered sublingually every day
|
|
Experimental: ALK tree AIT 2 DU
1 AIT administered sublingually every day
|
|
Experimental: ALK tree AIT 4 DU
1 AIT administered sublingually every day
|
|
Experimental: ALK tree AIT 7 DU
1 AIT administered sublingually every day
|
|
Experimental: ALK tree AIT 12 DU
1 AIT administered sublingually every day
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
During the birch pollen season 2013, an expected average of 3 weeks
|
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.
|
Throughout the trial, an expected average of 8 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Throughout the trial, an expected average of 8 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2012
Primary Completion (Actual)
July 1, 2013
Study Completion (Actual)
September 1, 2013
Study Registration Dates
First Submitted
August 27, 2012
First Submitted That Met QC Criteria
August 29, 2012
First Posted (Estimate)
August 30, 2012
Study Record Updates
Last Update Posted (Estimate)
January 22, 2014
Last Update Submitted That Met QC Criteria
January 20, 2014
Last Verified
January 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TT-02
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Birch Pollen Allergy
-
Medical University of ViennaAustrian Science Fund (FWF)CompletedBirch Pollen Allergy | Birch Pollen Related Apple AllergyAustria
-
MacroArray Diagnostics GmbHCompletedCat Allergy | Grass Pollen Allergy | Birch Pollen Allergy | House Dust Mite Allergy | Bee Venom Allergy | Vespid Venom AllergyAustria
-
Desentum OyCompletedBirch Pollen AllergyFinland
-
Desentum OyCompleted
-
AnergisCompletedBirch Pollen AllergySweden, France, Lithuania, Denmark, Latvia, Poland, Switzerland
-
Assistance Publique - Hôpitaux de ParisIltoo PharmaCompletedAllergic Rhinoconjunctivitis to Birch Pollen | With a Positive Skin Prick Test to Birch PollenFrance
-
Allergopharma GmbH & Co. KGCompletedBirch Pollen AllergyGermany
-
Allergopharma GmbH & Co. KGCompletedBirch Pollen AllergyGermany
-
Regeneron PharmaceuticalsCompletedHealthy Volunteers | Birch Pollen AllergyBelgium
-
Odense University HospitalAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA); European... and other collaboratorsCompletedAllergic Rhinoconjunctivitis | Birch Pollen AllergyDenmark
Clinical Trials on ALK tree AIT Placebo
-
ALK-Abelló A/SErgomed; ACM Pivotal Global Central LaboratoryCompleted
-
Allergy TherapeuticsCompleted
-
ALK-Abelló A/SInflamax Research IncorporatedCompletedAllergic RhinoconjunctivitisCanada
-
Beijing Tongren HospitalZhejiang Wolwo Bio-Pharmaceutical Co., Ltd.CompletedAllergic RhinitisChina
-
AbbottDatamap; Linical Co., Ltd.CompletedAsthma | Allergy | RhinitisBelarus, Russian Federation
-
ALK-Abelló A/SParexelCompletedAllergyHungary, Canada, Belgium, Poland, Austria, Germany, Denmark, Lithuania, Netherlands, Russian Federation, Slovakia
-
Poznan University of Life SciencesPoznan University of Medical SciencesCompleted
-
Odense University HospitalAcademisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA); European... and other collaboratorsCompletedAllergic Rhinoconjunctivitis | Birch Pollen AllergyDenmark
-
University of SouthamptonIsle of Wight NHS TrustCompletedAsthma | Immunotherapy | Allergy and ImmunologyUnited Kingdom
-
Jose Luis Quiles MoralesRecruiting