- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02481856
A Dose-response Evaluation of the SQ Tree SLIT-tablet Using an Environmental Exposure Chamber
January 18, 2017 updated by: ALK-Abelló A/S
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
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
219
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Ontario
-
Mississauga, Ontario, Canada, ON, L4W 1A4
- Inflamax Research Inc.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 65 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 12 DU SQ tree SLIT-tablet
Betula verrucosa, allergen extract, Oral lyophilisate
|
|
Experimental: 7 DU SQ tree SLIT-tablet
Betula verrucosa, allergen extract, Oral lyophilisate
|
|
Experimental: 2 DU SQ tree SLIT-tablet
Betula verrucosa, allergen extract, Oral lyophilisate
|
|
Placebo Comparator: Placebo
No active ingredient, Oral lyophilisate
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Average total rhinoconjunctivitis symptom score
Time Frame: After 24 weeks of treatment
|
The total rhinoconjunctivitis symptom score will measured during a birch pollen challenge in the Inflamax Environmental Exposure Chamber
|
After 24 weeks of treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Average total rhinoconjunctivitis symptom score
Time Frame: After 8 and 16 weeks of treatment
|
The total rhinoconjunctivitis symptom score will measured during a birch pollen challenge in the Inflamax Environmental Exposure Chamber
|
After 8 and 16 weeks of treatment
|
Average total rhinoconjunctivitis symptom score
Time Frame: After 24 weeks of treatment
|
The total rhinoconjunctivitis symptom score will measured during an oak pollen challenge in the Inflamax Environmental Exposure Chamber
|
After 24 weeks of treatment
|
Adverse events
Time Frame: During the 24-weeks treatment period
|
Adverse events will be grouped by number of treatment-emergent AEs and IMP-related AEs and will further summarised by treatment group and MedDRA SOC, MedDRA PT and broken down by severity, seriousness, action taken, time from first intake to AE and re-occurence after IMP administration
|
During the 24-weeks treatment period
|
Vital signs
Time Frame: During the 24-weeks treatment period
|
During the 24-weeks treatment period
|
|
Lung function measures
Time Frame: During the 24-weeks treatment period
|
Forced expiratory volume in 1 second and peak flow measurements will be performed.
|
During the 24-weeks treatment period
|
Changes in significant clinical safety laboratory values
Time Frame: Before and after the 24-weeks treatment period
|
Standard haematology, biochemistry, urinalysis analysis will be performed for each subject before and after the 24-weeks treatment period.
|
Before and after the 24-weeks treatment period
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
June 1, 2015
Primary Completion (Actual)
April 1, 2016
Study Completion (Actual)
April 1, 2016
Study Registration Dates
First Submitted
April 30, 2015
First Submitted That Met QC Criteria
June 23, 2015
First Posted (Estimate)
June 25, 2015
Study Record Updates
Last Update Posted (Estimate)
January 19, 2017
Last Update Submitted That Met QC Criteria
January 18, 2017
Last Verified
January 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- TT-03
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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