Allergic Rhinoconjunctivitis induced by birch pollen MedDRA version: 19.0 Level: LLT Classification code 10066093 Term: Birch pollen allergy System Organ Class: 100000004870
Conditions
Sponsors
ALK Abello A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Moderate-to-severe allergic rhinitis and/or conjunctivitis induced by birch pollen with or without asthma (controlled/partly-controlled) despite having received treatment with symptom-relieving medication during the 2 previous TPS - An appropriate minimum level of allergic rhinoconjunctivitis symptoms induced by birch pollen during the BPS of 2016. - Presence of one or more of the following ARIA quality of life items due to allergic rhinitis and/or conjunctivitis during the previous BPS. - Positive SPT response (wheal diameter = 3 mm) to Betula verrucosa at screening - Positive specific IgE against species Bet v1 (= IgE Class 2; 0.7 kU/L) at screening Are the trial subjects under 18? yes Number of subjects for this age range: 60 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 540 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - A clinically relevant history of symptomatic (seasonal or perennial) allergic rhinitis and /or conjunctivitis caused by an allergen source, other than tree pollen from the birch group overlapping the tree pollen season - A subject with rhinitis and/or conjunctivitis caused by animal hair and dander to which the subject is regularly exposed is not eligible for the trial. - Severe asthma exacerbation or uncontrolled asthma within the last 3 months - Reduced lung function (FEV1 < 70% of predicted value after adequate pharmacological treatment) - Allergy immunotherapy treatment with birch pollen or a cross-reacting allergen within the last 5 years. - Ongoing treatment with any allergy immunotherapy product
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective is to demonstrate superiority of the SQ tree SLIT-tablet given once daily compared to placebo in the treatment of allergic rhinoconjunctivitis induced by birch pollen.;Secondary Objective: Key-secondary objectives are to demonstrate superiority of the SQ tree SLIT-tablet versus placebo on the rhinoconjunctivitis symptoms induced by birch pollen and pollen from the birch group and in the treatment of allergic rhinoconjunctivitis induced by pollen from the birch group. Secondary objectives are to demonstrate superiority of the SQ tree SLIT-tablet versus placebo on the use symptom-relieving medication in the birch pollen season and tree pollen season on immunological parameters (including Immunoglobulin Eand Immunoglobulin G, subtype 4) to Betula verrucosa, on rhinoconjunctivitis quality of life, mild and severe days induced by birch pollen and by pollen from birch group, global evaluation and on a rhinoconjunctivitis visual analogue scale. Further the safety profile versus placebo will be evaluated. ;Primary end point(s): The primary endpoint of the trial is combined rhinoconjunctivitis symptom and deciation score. ;Timepoint(s) of evaluation of this end point: During the birch pollen season. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - The average allergic rhinoconjunctivitis symptom score - The average allergic rhinoconjunctivitis daily medication score - Average number of mild and severe days - Average changes during treatment in immunological parameters - Average RQLQ(S) score - Average rhinoconjunctivitis symptom VAS - Patient-rated global evaluation - Treatment-emergent AEs - Investigational medicinal product related AEs - Time from start to resolution of recurrent AEs - Daily duration of recurrent AEs - Proportion of subjects with local administration site reactions - Clinical laboratory values before and after treatment - Changes in vital signs - Forced expiratory volume in 1 second - Physical examination before and after treatment;Timepoint(s) of evaluation of this end point: During the tree pollen seasons. | — |
Countries
Czech Republic, Denmark, Finland, France, Germany, Poland, Russian Federation, Sweden
Contacts
Public ContactMikkel Walmar
ALK Abello A/S
Outcome results
None listed