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

ALK-Abelló

Status and phase: Enrolling; Phase 3

Conditions: Allergic Rhinitis; Allergic Rhinoconjunctivitis

Treatments: Biological: HDM SLIT-tablet (12 SQ-HDM); Other: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07060885

MT-21

2025-000321-14 (EudraCT Number)

Details and patient eligibility

About

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

Full 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 asthma. Efficacy will be assessed based on the total combined rhinitis score during the last 4 weeks of treatment.

The trial is a randomised, double-blind, parallel-group, placebo-controlled, multi-site, phase III trial conducted in China. The treatment period will be 24-28 weeks.

Enrollment: 300 estimated patients

Sex: All

Ages: 12 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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300 participants in 2 patient groups, including a placebo group

Active treatment

Experimental group

Description:

HDM SLIT-tablet plus symptom-relieving medication used to alleviate allergic rhinitis/rhinoconjunctivitis symptoms.

Treatment:

Biological: HDM SLIT-tablet (12 SQ-HDM)

Placebo

Placebo Comparator group

Description:

Placebo sublingual tablet plus symptom-relieving medication used to alleviate allergic rhinitis/rhinoconjunctivitis symptoms.

Treatment:

Other: Placebo