Status:
RECRUITING
A Research Study of House Dust Mite (HDM) SLIT-tablet for the Treatment of HDM Allergy in Chinese Participants Aged 12-65
Lead Sponsor:
ALK-Abelló A/S
Conditions:
Allergic Rhinoconjunctivitis
Allergic Rhinitis
Eligibility:
All Genders
12-65 years
Phase:
PHASE3
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 asthm...
Eligibility Criteria
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
Key Trial Info
Start Date :
September 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT07060885
Start Date
September 1 2025
End Date
August 1 2026
Last Update
December 31 2025
Active Locations (30)
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1
Beijing Tongren Hospital, Capital Medical University
Beijing, Beijing Municipality, China, 100730
2
Fujian Provincial Hospital
Fuzhou, Fujian, China, 350001
3
The first hospital affiliated Fujian medical University
Fuzhou, Fujian, China, 350005
4
The first affiliated hospital of guangzhou medical university-respiratory department
Guangzhou, Guangdong, China, 510120