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HDM SLIT-tablet in Chinese Participants With HDM Allergic Rhinitis/Rhinoconjunctivitis
NCT07060885Phase 3
Key facts
- Status
- Completed
- Start
- Sep 2025
- Primary completion
- Aug 2026
- Countries
- 1
- Sponsor
- ALK-Abelló
- Modality
- Allergy Immunotherapy
- Conditions
- allergic rhinitis (AR)allergic rhinoconjunctivitis (ARC)
01
Overview
Phase 3, randomised, double-blind trial of house dust mite sublingual allergen extract in allergic rhinitis (AR) and allergic rhinoconjunctivitis (ARC) (2 arms), sponsored by ALK-Abelló. Primary endpoint: Total Combined Rhinitis Score. Started Sep 2025; status: completed.
02
Design
2 arms- Study design
- RandomizedDouble-blind
Active treatment
HDM SLIT-tablet (12 SQ-HDM) plus symptom-relieving medication.
Placebo
Placebo sublingual tablet plus symptom-relieving medication.
03
Who it enrols
Chinese patients aged 12-65 with a clinical history of HDM allergic rhinitis/rhinoconjunctivitis, positive SPT and IgE to HDM, and symptomatic despite pharmacotherapy.
04
Endpoints
Primary
Total Combined Rhinitis Score
Secondary
Daily Symptom Score
Daily Medication Score
Total Combined Score
Rhinoconjunctivitis Daily Symptom Score
Rhinoconjunctivitis Daily Medication Score
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