A Phase 3 interventional study of Sublingual allergy immunological tablet and Placebo in Allergic Rhinoconjunctivitis, sponsored by ALK-Abelló A/S. Terminated at 2 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-30.
Sponsored by ALK-Abelló A/S · Phase 3, Interventional, and Treatment
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.
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.
361 studies on the registry are indexed under Conjunctivitis; 17 are open to participants now.
This study's enrollment of 80 is below the median of 100 across 299 interventional studies indexed under Conjunctivitis.
Browse Conjunctivitis studies →ALK-Abelló A/S is the lead sponsor of 66 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria
HDM SLIT-tablet once daily for approximately 24 weeks
Biological: Sublingual allergy immunological tablet
Placebo tablet once daily for approximately 24 weeks
Other: Placebo
For daily administration (1 tablet per day)
Also known as: 12 SQ HDM SLIT-tablet, Acarizax
For daily administration (1 tablet per day)
Also known as: Placebo sublingual tablet
Total Nasal Symptom Score (TNSS)
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).
Time frame: Last 4 hours of the EEC session at week 24
Total Symptom Score (TSS)
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).
Time frame: Last 4 hours of the EEC session at week 24
Frequency of adverse events
Number of Adverse events per treatment group
Time frame: 26 weeks
Assessment of lung function
FEV1
Time frame: 26 weeks
Total Ocular Symptom Score (TOSS)
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).
Time frame: Last 4 hours of the EEC session at week 24
Immunology
Change from baseline in measurements of house-dust-mite-specific IgG \& IgE antibodies
Time frame: Baseline to 24 weeks
Plan to share: No
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This study is terminated, as verified in Feb 2021. You cannot join it, but the record below documents what was studied.
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ALK-Abelló A/S