Allergic Rhinitis, Allergic Rhinoconjunctivitis
Conditions
Brief summary
A research study of house dust mite (HDM) SLIT-tablet for the treatment of HDM allergy in Chinese participants aged 12-65.
Detailed description
The trial aims to evaluate efficacy of the house dust mite (HDM) SLIT-tablet compared to placebo in Chinese participants aged 12-65 with HDM allergic rhinitis/rhinoconjunctivitis with or without asthma. Efficacy will be assessed based on the total combined rhinitis score during the last 4 weeks of treatment. The trial is a randomised, double-blind, parallel-group, placebo-controlled, multi-site, phase III trial conducted in China. The treatment period will be 24-28 weeks.
Interventions
BIOLOGICALHDM SLIT-tablet (12 SQ-HDM)
For daily administration (1 tablet per day) Other Names: Acarizax, Odactra
OTHERPlacebo
For daily administration (1 tablet per day)
Sponsors
ALK-Abelló A/S
Changchun GeneScience Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
12 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Male or female Chinese subjects aged 12-65 years * A clinical history of HDM AR/C (Allergic rhinitis/rhinoconjunctivitis) (with or without asthma) and with allergic rhinitis symptoms despite having received allergy pharmacotherapy during the previous year prior to screening * Have a certain level of AR (Allergic rhinitis) symptoms on at least 8 of the last 14 days of the baseline period * Use symptomatic medication for treatment of HDM allergic rhinitis during at least 8 of the last 14 days of the baseline period * Positive skin prick test (SPT) and IgE (Immunoglobulin E) to D. pteronyssinus or D. farinae at screening * Lung function ≥ 70% of predicted value
Exclusion criteria
* Sensitised and regularly exposed to perennial allergens * Any nasal or pharyngeal condition that could interfere with the safety or efficacy evaluation * Asthma requiring treatment with high dose of inhaled corticosteroid * A relevant history of systemic allergic reaction
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average daily total combined rhinitis score (TCRS) during the primary efficacy assessment period. | 4 weeks (primary efficacy assessment period), starting 24 weeks after initiation of IMP. | The average daily TCRS evaluates the treatment effect as the difference in daily rhinitis symptoms and medication score (on a scale from 0-24) between participants treated with 12 SQ-HDM and placebo. Higher scores indicate more severe symptoms and/or more use of rhinitis medication. The endpoint is calculated as the average score of all reported daily values during the 4-week primary efficacy assessment period. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Average daily values for rhinitis daily symptom score (DSS) during primary efficacy period. | 4 weeks (primary efficacy assessment period), starting 24 weeks after initiation of IMP. | The average rhinitis DSS evaluates the treatment effect as the difference in daily rhinitis symptoms score (on a scale from 0-12) between participants treated with 12 SQ-HDM and placebo. Higher scores indicate more severe symptoms. The endpoint is calculated as the average score of all reported daily values during the 4-week primary efficacy assessment period. |
| Average daily values for rhinitis daily medication score (DMS) during primary efficacy period. | 4 weeks (primary efficacy assessment period), starting 24 weeks after initiation of IMP. | Average rhinitis DMS evaluates the treatment effect as the difference in daily rhinitis medication use (on a scale of 0-12) between participants treated with 12 SQ-HDM and placebo. Higher scores indicate more medication use. The endpoint is calculated as the average score of all reported daily values during the 4-week primary efficacy assessment period. |
| Average daily total combined score (TCS) during primary efficacy period. | 4 weeks (primary efficacy assessment period), starting 24 weeks after initiation of IMP. | Average rhinoconjunctivitis TCS evaluates the treatment effect as the difference in daily rhinoconjunctivitis symptoms and medication use (on a scale of 0-38) between participants treated with 12 SQ-HDM and placebo. Higher scores indicate more severe symptoms and/or more medication use. The endpoint is calculated as the average score of all reported daily values during the 4-week primary efficacy assessment period. |
| Average rhinoconjunctivitis DSS during the primary efficacy assessment period | 4 weeks (primary efficacy assessment period), starting 24 weeks after initiation of IMP. | The average rhinoconjunctivitis DSS evaluates the treatment effect as the difference in daily rhinoconjunctivitis symptom score (on a scale of 0-18) between participants treated with 12 SQ-HDM and placebo. Higher scores indicate more severe symptoms. The endpoint is calculated as the average score of all reported daily values during the 4-week primary efficacy assessment period. |
| Average rhinoconjunctivitis DMS during the primary efficacy assessment period | 4 weeks (primary efficacy assessment period), starting 24 weeks after initiation of IMP. | The average rhinoconjunctivitis DMS evaluates the treatment effect as the difference in daily rhinoconjunctivitis medication use (on a scale of 0-20) between participants treated with 12 SQ-HDM and placebo. Higher scores indicate more medication use. The endpoint is calculated as the average score of all reported daily values during the 4-week primary efficacy assessment period. |
Countries
China
Outcome results
None listed