Allergic rhinoconjunctivitis MedDRA version: 9.1 Level: LLT Classification code 10001728 Term: Allergic rhinoconjunctivitis
Conditions
Interventions
Product Name: Oralgen Birch Pollen
Pharmaceutical Form: Oral solution
Current Sponsor code: Oralgen Birch pollen extract
Concentration unit: BAU/ml Bioequivalent Allergy Unit(s)/millilitre
Concentrati
Sponsors
Artu Biologicals Europe B.V.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Male and female between 18 and 60 years of age (inclusive). - History of birch pollen induced allergy with moderate to severe rhinoconjunctivitis symptoms for at least two seasons. - RRTSS of greater than or equal to 10 out of a maximal score of 18 - Birch pollen specific RAST of at least class 2. - Positive skin prick test (i.e. wheal diameter equal to or more than (=) 3 mm larger than the diluent control) for birch pollen. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Other clinically relevant allergies (perennial or seasonal) that could potentially interfere with the patient's study treatment schedule or assessments. Patients with allergic rhinoconjunctivitis due to allergens to which the patient is not exposed to during the study are allowed into the study. - Use of oral steroids within 12 weeks before the screening visit. - Treatment with beta-blockers or continuous inhalsed or systemic corticosteroid therapy. - Previous immunotherapy treatment with tree pollen extracts within the last five years or immunotherapy with any other allergen extract within the last two years.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate the safety and tolerability of Oralgen Birch Pollen in patients with allergic rhinoconjunctivitis.;Secondary Objective: ;Primary end point(s): safety and tolerability assessed as adverse events, hematology and biochemistry laboratory parameters, urinalysis, 12-Lead ECG, vital signs (blood pressure, pulse and respiration rate) and physical examination. | — |
Countries
Sweden
Outcome results
None listed