A research study of house dust mite (HDM) SLIT-tablet for the treatment of HDM allergy in Chinese participants aged 12-65.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
300
For daily administration (1 tablet per day) Other Names: Acarizax, Odactra
For daily administration (1 tablet per day)
Average daily total combined rhinitis score (TCRS) during the primary efficacy assessment period.
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.
Time frame: 4 weeks (primary efficacy assessment period), starting 24 weeks after initiation of IMP.
Average daily values for rhinitis daily symptom score (DSS) during primary efficacy period.
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.
Time frame: 4 weeks (primary efficacy assessment period), starting 24 weeks after initiation of IMP.
Average daily values for rhinitis daily medication score (DMS) during primary efficacy period.
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.
Time frame: 4 weeks (primary efficacy assessment period), starting 24 weeks after initiation of IMP.
Average daily total combined score (TCS) during primary efficacy period.
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.
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Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, China
RECRUITINGFujian Provincial Hospital
Fuzhou, Fujian, China
RECRUITINGThe first hospital affiliated Fujian medical University
Fuzhou, Fujian, China
RECRUITINGThe first affiliated hospital of guangzhou medical university-respiratory department
Guangzhou, Guangdong, China
RECRUITINGThe Third Affiliated Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China
RECRUITINGThe Third Affilliated Hospital of Southern Medical University
Guangzhou, Guangdong, China
RECRUITINGShenzhen Children's Hospital - Respiratory
Shenzhen, Guangdong, China
RECRUITINGHuazhong University of science and Technology Union Shenzhen Hospital(Nanshan Hospital) - Endocrinology
Shenzhen, Guangdong, China
RECRUITINGThe Fifth Affiliated Hospital of Sun Yat-Sen University - University Hospital
Zhuhai, Guangdong, China
RECRUITINGThe First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
RECRUITING...and 20 more locations
Time frame: 4 weeks (primary efficacy assessment period), starting 24 weeks after initiation of IMP.
Average rhinoconjunctivitis DSS during the primary efficacy assessment period
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.
Time frame: 4 weeks (primary efficacy assessment period), starting 24 weeks after initiation of IMP.
Average rhinoconjunctivitis DMS during the primary efficacy assessment period
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.
Time frame: 4 weeks (primary efficacy assessment period), starting 24 weeks after initiation of IMP.