Allergic Rhinoconjunctivitis
Conditions
Keywords
House Dust Mite, Allergic rhinitis, Allergic conjunctivitis, China, Environmental exposure chamber
Brief summary
This trial evaluates the efficacy and safety of HDM SLIT-tablet in treatment of HDM AR. The efficacy is evaluated using an environmental exposure chamber (EEC). Subjects will be randomised to receive treatment with HDM SLIT-tablet and placebo 1:1.
Detailed description
This trial is a 24 weeks, randomised, parallel-group, double-blind, placebo-controlled phase III trial. Approximately 202 subjects will be randomised (1:1) to receive treatment with HDM SLIT-tablet or placebo. The trial will be conducted in China, with subjects recruited and treated in China. Two EEC assessments (baseline and end of treatment) will take place at a validated EEC facility in Austria. The primary objective is to demonstrate the efficacy of the HDM SLIT-tablet (12 SQ-HDM) once daily compared to placebo in the treatment of HDM AR nasal symptom determined during the EEC session at week 24.
Interventions
BIOLOGICALSublingual allergy immunological tablet
For daily administration (1 tablet per day)
OTHERPlacebo
For daily administration (1 tablet per day)
Sponsors
ALK-Abelló A/S
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
Randomised
Intervention model description
Parallel assignment
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female Chinese subjects aged ≥18 years * A clinical history of HDM AR/C with or without asthma * Positive SPT and IgE to Der p or Der f at screening * A TNSS of at least 6 of 12 within the first 2 hours of the screening EEC session prior to randomisation
Exclusion criteria
* Sensitised and regularly exposed perennial or seasonal allergens * Asthma requiring treatment with high-dose ICS * Reduced lung function * Has a nasal condition that could confound the efficacy or safety assessment * A relevant history of systemic allergic reaction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Nasal Symptom Score (TNSS) | Last 4 hours of the EEC session at week 24 | Primary endpoint, average TNSS during the EEC session at week 24, defined as the average of all TNSS observed in the last 4 hours of the EEC session at week 24. Measured on a scale of 0 (no symptoms) to 12 (severe symptoms). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total Symptom Score (TSS) | Last 4 hours of the EEC session at week 24 | Key secondary endpoint, average TSS during the EEC session at week 24, defined as the sum of the Total Ocular Symptom Score (TOSS) and TNSS observed in the last 4 hours of the EEC session at week 24. Measured on a scale of 0 (no symptoms) to 18 (severe symptoms). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Frequency of adverse events | 26 weeks | Number of Adverse events per treatment group |
| Assessment of lung function | 26 weeks | FEV1 |
| Total Ocular Symptom Score (TOSS) | Last 4 hours of the EEC session at week 24 | Average TOSS during the EEC session at week 24, defined as the average of all TOSS observed in the last 4 hours of the EEC session at week 24. Measured on a scale of 0 (no symptoms) to 6 (severe symptoms). |
| Immunology | Baseline to 24 weeks | Change from baseline in measurements of house-dust-mite-specific IgG & IgE antibodies |
Countries
Austria, China
Outcome results
None listed