Birch Pollen AllergyPhase 2NCT01675791
A Dose-response Evaluation of ALK (the Sponsor) Tree Allergy Immunotherapy Tablet
A Phase 2 study testing ALK tree AIT 0.5 DU, ALK tree AIT 1 DU and ALK tree AIT 2 DU in people with Birch Pollen Allergy, run by ALK-Abelló A/S at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 65 years
- Conditions the study is for
- Birch Pollen Allergy
- What is being tested?
- ALK tree AIT 0.5 DU, ALK tree AIT 1 DU and ALK tree AIT 2 DU
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 637 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Aug 2012to Sep 2013
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
Finland1 site
Skin and Allergy Hospital, Helsinki University Central Hospital
Helsinki, HUS, 00029
About this study
Official title: 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.
- Conditions
- Birch Pollen Allergy
- Being tested
- 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALK tree AIT 0.5 DUBiological
ALK tree AIT 1 DUBiological
ALK tree AIT 2 DUBiological
ALK tree AIT 4 DUBiological
ALK tree AIT 7 DUBiological
ALK tree AIT 12 DUBiological
ALK tree AIT PlaceboBiological
| Study group | Role | What they receive |
|---|---|---|
| ALK tree AIT Placebo | Placebo comparator | 1 AIT administered sublingually every day Receives: Biological: ALK tree AIT Placebo |
| ALK tree AIT 0.5 DU | Experimental | 1 AIT administered sublingually every day Receives: Biological: ALK tree AIT 0.5 DU |
| ALK tree AIT 1 DU | Experimental | 1 AIT administered sublingually every day Receives: Biological: ALK tree AIT 1 DU |
| ALK tree AIT 2 DU | Experimental | 1 AIT administered sublingually every day Receives: Biological: ALK tree AIT 2 DU |
| ALK tree AIT 4 DU | Experimental | 1 AIT administered sublingually every day Receives: Biological: ALK tree AIT 4 DU |
| ALK tree AIT 7 DU | Experimental | 1 AIT administered sublingually every day Receives: Biological: ALK tree AIT 7 DU |
| ALK tree AIT 12 DU | Experimental | 1 AIT administered sublingually every day Receives: Biological: ALK tree AIT 12 DU |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Throughout the trial, an expected average of 8 months
Secondary outcomes (1)
Adverse events severity
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.
Measured: Throughout the trial, an expected average of 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2012 (estimated)
- Study startAug 2012
- Primary completionJul 2013
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Birch Pollen AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 637 participants (actual)
Sponsor and investigators
- Lead sponsor
- ALK-Abelló A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01675791
- Sponsor's protocol ID
- TT-02
- Status last verified
- Jan 2014
- First submitted
- 27 Aug 2012
- Last updated
- 22 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Dose-response Evaluation of ALK Tree AIT
- ClinicalTrials.gov ID
- NCT01675791
- Acronym / sponsor ID
- TT-02
- Conditions
- Birch Pollen Allergy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 637 participants (actual)
- Lead sponsor
- ALK-Abelló A/SIndustry (pharma, biotech, devices)
- Study start
- Aug 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 30 Aug 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| ALK tree AIT Placebo | Placebo comparator | Biological: ALK tree AIT Placebo1 AIT administered sublingually every day |
| ALK tree AIT 0.5 DU | Experimental | Biological: ALK tree AIT 0.5 DU1 AIT administered sublingually every day |
| ALK tree AIT 1 DU | Experimental | Biological: ALK tree AIT 1 DU1 AIT administered sublingually every day |
| ALK tree AIT 2 DU | Experimental | Biological: ALK tree AIT 2 DU1 AIT administered sublingually every day |
| ALK tree AIT 4 DU | Experimental | Biological: ALK tree AIT 4 DU1 AIT administered sublingually every day |
| ALK tree AIT 7 DU | Experimental | Biological: ALK tree AIT 7 DU1 AIT administered sublingually every day |
| ALK tree AIT 12 DU | Experimental | Biological: ALK tree AIT 12 DU1 AIT administered sublingually every day |
Who may qualify
- Ages
- 12 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALK tree AIT 0.5 DU | Biological | ALK tree AIT 0.5 DU |
| ALK tree AIT 1 DU | Biological | ALK tree AIT 1 DU |
| ALK tree AIT 2 DU | Biological | ALK tree AIT 2 DU |
| ALK tree AIT 4 DU | Biological | ALK tree AIT 4 DU |
| ALK tree AIT 7 DU | Biological | ALK tree AIT 7 DU |
| ALK tree AIT 12 DU | Biological | ALK tree AIT 12 DU |
| ALK tree AIT Placebo | Biological | ALK tree AIT Placebo |
Primary outcome
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.
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.
1 secondary outcome
Adverse events severity
Time frame: Throughout the trial, an expected average of 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jan 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ALK tree AIT 0.5 DU, ALK tree AIT 1 DU and ALK tree AIT 2 DU in people with Birch Pollen Allergy, run by ALK-Abelló A/S at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Finland, Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Allergy symptom severity scores on a scale from 0-3 (time frame: During the birch pollen season 2013, an expected average of 3 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jan 2014.