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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Page 1 of 8 (30 locations)

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