This trial is to test which dose of a dispersible tablet containing birch pollen allergens can improve hay fever symptoms and reduce the need for symptomatic allergy medication.

A dose-response evaluation of ALK tree AIT

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2012-000031-59-LT

Enrollment

600

Registered

2012-05-08

Start date

2012-09-12

Completion date

Unknown

Last updated

2013-10-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Subjects with a documented clinically relevant history of moderate to severe birch pollen induced allergic rhinoconjunctivitis (with or without asthma) with symptoms despite having received symptomatic medication. MedDRA version: 16.0 Level: LLT Classification code 10066093 Term: Birch pollen allergy System Organ Class: 100000004870

Interventions

Product Name: ALK tree AIT Pharmaceutical Form: Sublingual tablet Current Sponsor code: ALK Tree AIT Other descriptive name: Betula verrucosa birch pollen allergen extract Concentration unit: SQU Stan

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Male or females aged 12-65 (adolescents ages 12 - =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: A clinically relevant history of perennial allergic rhinitis and/or asthma having received regular medication due to an allergen to which the subject is regularly exposed. A clinical history of uncontrolled asthma within 3 month prior to randomisation Reduced lung function, defined as FEV-1 < 70% of predicted value after adequate pharmacological treatment. Previous treatment with immunotherapy with birch pollen allergen - or a cross-reacting allergen such as hazel or alder.

Design outcomes

Primary

Measure	Time frame
Main Objective: To identify an optimal dose interval with respect to efficacy and safety for the ALK tree AIT in adults and adolescents with moderate to severe birch pollen induced allergic rhinoconjunctivitis.;Secondary Objective: To evaluate the quality of life related to rhinoconjunctivitis during treatment with the ALK tree AIT. To investigate the immunological response to the ALK tree AIT;Primary end point(s): The primary efficacy endpoint is the avarage rhinoconjunctivitis daily symptom score during the birch pollen season, calculated for each subject as the sum of the rhinoconjunctivitis daily symptom score during the birch pollen season divided by the number of days with diary records in the birch pollen season.;Timepoint(s) of evaluation of this end point: By the end of trial - there are no interim analyses planned.	—

Measure

Time frame

Main Objective: To identify an optimal dose interval with respect to efficacy and safety for the ALK tree AIT in adults and adolescents with moderate to severe birch pollen induced allergic rhinoconjunctivitis.;Secondary Objective: To evaluate the quality of life related to rhinoconjunctivitis during treatment with the ALK tree AIT. To investigate the immunological response to the ALK tree AIT;Primary end point(s): The primary efficacy endpoint is the avarage rhinoconjunctivitis daily symptom score during the birch pollen season, calculated for each subject as the sum of the rhinoconjunctivitis daily symptom score during the birch pollen season divided by the number of days with diary records in the birch pollen season.;Timepoint(s) of evaluation of this end point: By the end of trial - there are no interim analyses planned.

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Secondary

Measure	Time frame
Secondary end point(s): The secondary efficacy endpoints comprises of: The average rhinoconjunctivitis daily medication score during the birch pollen season calculated for each subject as the sum of rhinoconjunctivitis daily symptom score during the birch pollen season divided by the number of days with diary records in the birch pollen season. The combined rhinoconjunctivitis symptom and medication score during the entire birch pollen season. The average rhinoconjunctivitis daily symptom score, average rhinoconjunctivitis daily medication score during the entire tree pollen season.;Timepoint(s) of evaluation of this end point: By the end of trial - there are no interim analyses planned.	—

Measure

Time frame

Secondary end point(s): The secondary efficacy endpoints comprises of: The average rhinoconjunctivitis daily medication score during the birch pollen season calculated for each subject as the sum of rhinoconjunctivitis daily symptom score during the birch pollen season divided by the number of days with diary records in the birch pollen season. The combined rhinoconjunctivitis symptom and medication score during the entire birch pollen season. The average rhinoconjunctivitis daily symptom score, average rhinoconjunctivitis daily medication score during the entire tree pollen season.;Timepoint(s) of evaluation of this end point: By the end of trial - there are no interim analyses planned.

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Countries

Denmark, Finland, Lithuania, Netherlands, Norway, Poland, Sweden

Contacts

Public ContactGlobal Clinical Development

ALK-Abelló A/S

bmtdk@alk-abello.com+4545747576

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026