RecruitingPhase 3NCT07060885
A Research Study of House Dust Mite (HDM) SLIT-tablet for the Treatment of HDM Allergy in Chinese Participants Aged 12-65
A Randomised Double-blind Placebo-controlled Phase III Field Trial Evaluating the Efficacy and Safety of the House Dust Mite (HDM) SLIT-tablet in Chinese Participants Aged 12-65 Years With HDM Allergic Rhinitis/Rhinoconjunctivitis With or Without Asthma
Sponsor
ALK-Abelló A/S
Enrollment
300 participants
Start Date
Sep 1, 2025
Study Type
INTERVENTIONAL
Conditions
Summary
A research study of house dust mite (HDM) SLIT-tablet for the treatment of HDM allergy in Chinese participants aged 12-65.
Eligibility
Min Age: 12 YearsMax Age: 65 Years
Inclusion Criteria6
- 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 Criteria4
- 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
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)
Locations(30)
View Full Details on ClinicalTrials.gov
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NCT07060885
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