Clinical trial NCT02481856: A Dose-response Evaluation of the SQ Tree SLIT-tablet Using an Environmental Exposure Chamber
Official title: A Dose-response Evaluation of the SQ Tree SLIT-tablet in Subjects With Moderate to Severe Allergic Rhinoconjunctivitis Induced by Pollens From the Birch Group During Controlled Exposure in an Environmental Exposure Chamber
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Allergic Rhinoconjunctivitis
Lead sponsor: ALK-Abelló A/S
Sponsor class: INDUSTRY
Collaborators: name: Inflamax Research Incorporated
First posted: 2015-06-25
Enrollment: 219
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The trial is a phase II, randomised, parallel-group, double-blind, placebo-controlled multi-site trial conducted in Canada. Before the start of treatment, the subjects will undergo baseline birch and oak Environmental Exposure Chamber sessions. The treatment duration is 24 weeks. The subjects will undergo birch Environmental Exposure Chamber sessions after 8, 16 and 24 weeks of treatment and an oak Environmental Exposure Chamber session after 24 weeks of treatment.


Eligibility criteria: Inclusion Criteria:

* Written informed consent obtained before any trial related procedures are performed
* Male or female aged 18 to 65 years
* Female subjects of child-bearing potential must have a negative urine pregnancy test and be willing to practise contraceptive methods
* History of moderate-to-severe rhinoconjunctivitis induced by pollens from the birch group with or without asthma despite having received treatment with symptom relieving medication during the previous 2 tree pollen seasons
* Positive SPT response (wheal diameter ≥ 3 mm) to Betula verrucosa
* Positive specific IgE against Bet v1 (≥ IgE Class 2; ≥0.70 kU/L)
* Willing and able to comply with the trial protocol
* Minimum level of rhinoconjunctivitis symptoms, defined as a TSS of at least 7 (of 18), at one timepoint during birch baseline EEC session.

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.

Primary outcomes:
measure: Average total rhinoconjunctivitis symptom score
timeFrame: After 24 weeks of treatment
Secondary outcomes:
measure: Average total rhinoconjunctivitis symptom score
timeFrame: After 8 and 16 weeks of treatment
measure: Average total rhinoconjunctivitis symptom score
timeFrame: After 24 weeks of treatment
measure: Adverse events
timeFrame: During the 24-weeks treatment period
measure: Vital signs
timeFrame: During the 24-weeks treatment period
measure: Lung function measures
timeFrame: During the 24-weeks treatment period
measure: Changes in significant clinical safety laboratory values
timeFrame: Before and after the 24-weeks treatment period
Other outcomes:
Locations:
city: Mississauga
country: Canada
facility: Inflamax Research Inc.
state: Ontario
Study officials:
affiliation: Inflamax Research Incorporated
name: Peter Couroux, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Biedermann T, Couroux P, Greve TM, Makela M. Safety of the standardized quality tree sublingual immunotherapy tablet: Pooled safety analysis of clinical trials. Allergy. 2021 Dec;76(12):3733-3742. doi: 10.1111/all.14882. Epub 2021 May 15.