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A Research Study of House Dust Mite (HDM) SLIT-tablet for the Treatment of HDM Allergy in Chinese Participants Aged 12-65

RECRUITINGPhase 3Sponsored by ALK-Abelló A/S
Actively Recruiting
PhasePhase 3
SponsorALK-Abelló A/S
Started2025-09-01
Est. completion2026-07
Eligibility
Age12 Years – 65 Years
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT07060885

Summary

A research study of house dust mite (HDM) SLIT-tablet for the treatment of HDM allergy in Chinese participants aged 12-65.

Eligibility

Age: 12 Years – 65 YearsHealthy volunteers accepted
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

Conditions3

Allergic RhinitisAllergic RhinoconjunctivitisAsthma

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