Tree pollen induced allergic rhinitis and/or conjuctivitis. MedDRA version: 20.0 Level: LLT Classification code 10001726 Term: Allergic rhinitis due to pollen System Organ Class: 100000004870 MedDRA version: 20.0 Level: LLT Classification code 10001709 Term: Allergic conjunctivitis System Organ Class: 100000004853
Conditions
Interventions
Trade Name: ITULAZAX
Product Name: SQ tree SLIT-tablet
Pharmaceutical Form: Oral lyophilisate
INN or Proposed INN: BETULA VERRUCOSA (108) POLLEN EXTRACT
Other descriptive name: BETULA VERRUCOSA (108)
Sponsors
ALK-Abelló A/S
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects are eligible to be included in the trial only if all the following criteria apply: •Male or female of any race/ethnicity aged =4 to =65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Subjects are excluded from the trial if any of the following criteria apply: •A clinically relevant history of symptomatic seasonal AR/C caused by an allergen source, other than tree pollen from the birch homologous group, with a season overlapping the TPS •A clinically relevant history of symptomatic perennial AR/C caused by an allergen source such as animal hair and dander to which the subject is exposed during the TPS •Any clinical deterioration of asthma (i.e. asthma exacerbation) that resulted in emergency treatment, hospitalisation or treatment with systemic corticosteroids within 3 months prior to randomisation •Reduced lung function at randomisation defined as forced expiratory volume in 1 second (FEV1) <70% of predicted value. For subjects with asthma, this is assessed on subject’s usual asthma medication following at least a 6-hour wash-out of SABA. This criterion does not need to be fulfilled if the subject is <7 years old, cannot perform reproducible FEV1 manoeuvres despite coaching and is not considered as having a diagnosis of asthma •Ongoing treatment with any allergy immunotherapy product •Severe chronic oral inflammation •A diagnosis of eosinophilic oesophagitis •A relevant history of systemic allergic reaction e.g. anaphylaxis with cardiorespiratory symptoms, generalised urticaria or severe facial angioedema that in the opinion of the investigator may constitute an increased safety concern •Immunosuppressive treatment (ATC code L04 or L01) within 3 months prior to the screening visit
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: Key secondary objectives: To compare the efficacy of the SQ tree SLIT-tablet to placebo based on: •The average TCS during the tree pollen season (TPS) •The average allergic rhinoconjunctivitis daily symptom score (average DSS) during the BPS and TPS •The average allergic rhinoconjunctivitis daily medication score (average DMS) during the BPS and TPS Secondary objectives: •To compare the safety and tolerability of the SQ tree SLIT-tablet to placebo •To compare the efficacy of the SQ tree SLIT-tablet to placebo using additional endpoints based on daily allergic rhinoconjunctivitis symptoms and rescue medication use •To compare the efficacy of the SQ tree SLIT-tablet to placebo based on assessments of quality of life •To compare the efficacy of the SQ tree SLIT-tablet to placebo based on patient treatment satisfaction •To compare the effect of the SQ tree SLIT-tablet to placebo on immunological parameters to birch, alder, hazel and oak pollen ;Primary end point(s): Average TCS during the BPS;Timepoint(s) of evaluation of this end point: During the Birch Pollen Season (BPS);Main Objective: To compare the efficacy of the SQ tree SLIT-tablet to placebo in the treatment of moderate to severe allergic rhinitis and/or conjunctivitis induced by pollen from birch and trees belonging to the birch homologous group in children and adolescents (5 through 17 years of age) based on the average allergic rhinoconjunctivitis daily total combined score (average TCS) during the birch pollen season (BPS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): •Average TCS during the TPS •Average DSS during the BPS •Average DSS during the TPS •Average DMS during the BPS •Average DMS during the TPS ;Timepoint(s) of evaluation of this end point: During either Birch Pollen Season (BPS) or Tree Pollen Season (TPS), respectively. | — |
Countries
Austria, Belgium, Canada, Denmark, Germany, Hungary, Lithuania, Netherlands, Poland, Russian Federation, Slovakia
Contacts
Public ContactHead of Clinical Project Management
ALK-Abelló A/S
Outcome results
None listed