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

Conditions: Allergic Rhinoconjunctivitis, Allergic Rhinitis

Sex: All

Ages: 12 Years – 65 Years

Healthy volunteers: No

Phase: PHASE3

Enrollment: 327

Sponsor: ALK-Abelló A/S

Location: Beijing Tongren Hospital, Capital Medical University Beijing Beijing Municipality

Summary

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

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

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07060885). StuddyBuddy aggregates publicly available trial information.