A Dose-response Evaluation of the SQ Tree SLIT-tablet Using an Environmental Exposure Chamber

Exclusion Criteria

• •Symptoms induced by interfering allergens that are expected to be present during the periods where the subject attends the EEC sessions
• •Rhinoconjunctivitis caused by animal hair and dander to which the subject is regularly exposed.
• •Allergic symptoms induced by perennial allergens such as house dust mites, and moulds
• •A clinical history of uncontrolled asthma within 3 months prior to screening
• •Reduced lung function FEV1 (\< 70% of predicted value after adequate pharmacological treatment)
• •Asthma requiring treatment with inhaled corticosteroid within the past 3 months prior to screening
• •Previous treatment with any allergy immunotherapy product with tree pollen allergens or a cross-reacting allergen within the past 5 years
• •Ongoing treatment with any allergy immunotherapy product
• •Immunosuppressive treatment within 3 months prior to the screening visit
• •Treatment with tricyclic antidepressants, catecholamine-O-methyltransferase inhibitors, mono amine oxidase inhibitors and beta-blockers
• •Treatment with antidepressant medication with antihistaminic effect
• •Treatment with antipsychotic medications with antihistaminic effect
• •Treatment with anti-IgE drugs within 130 days/5 half-lives of the drug (which ever longest)
• •Treatment with an investigational drug within 30 days/5 half-lives of the drug (which ever longest) prior to screening
• •Severe oral inflammation or oral wounds at randomisation
• •Symptoms of or treatment for upper respiratory tract infection, acute sinusitis, acute otitis media or other relevant infections that have not resolved 1-week prior to the baseline birch and oak Environmental Exposure Chamber sessions and at the randomisation visit
• •Clinically relevant nasal polyps
• •A history of paranasal sinus surgery
• •A history of surgery of nasal turbinates
• •A history of anaphylaxis with cardiorespiratory symptoms
• •A history of recurrent (defined as two or more episodes) generalised urticaria during the last 2 years
• •A history of drug-induced (incl. Allergy Immunotherapy) facial angioedema or a family (parents and siblings) history of hereditary angioedema
• •Any clinically relevant chronic disease (≥3 months duration) that in the opinion of the investigator would interfere with the trial assessments or the safety of the subject
• •An uncontrolled systemic disease affecting the immune system (e.g. insulin-dependent diabetes, autoimmune disease, immune complex disease, or immune deficiency disease whether acquired or not)
• •A history of allergy, hypersensitivity or intolerance to the investigational medicinal product (except Betula verrucosa) or any of the symptomatic medications provided in this trial
• •Being immediate family of the investigator or trial staff, defined as the investigator's/staff's spouse, parent, child, grandparent or grandchild.