A Research Study in Chinese People With Allergy to House Dust Mites, Using an Environmental Exposure Chamber

Phase 3TerminatedNCT04176185

ALK-Abelló A/S80 enrolled

Overview

This trial evaluates the efficacy and safety of HDM SLIT-tablet in treatment of HDM AR. The efficacy is evaluated using an environmental exposure chamber (EEC). Subjects will be randomised to receive treatment with HDM SLIT-tablet and placebo 1:1.

This trial is a 24 weeks, randomised, parallel-group, double-blind, placebo-controlled phase III trial. Approximately 202 subjects will be randomised (1:1) to receive treatment with HDM SLIT-tablet or placebo. The trial will be conducted in China, with subjects recruited and treated in China. Two EEC assessments (baseline and end of treatment) will take place at a validated EEC facility in Austria. The primary objective is to demonstrate the efficacy of the HDM SLIT-tablet (12 SQ-HDM) once daily compared to placebo in the treatment of HDM AR nasal symptom determined during the EEC session at week 24.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Allergic Rhinoconjunctivitis

Interventions

Sublingual allergy immunological tabletBIOLOGICAL

For daily administration (1 tablet per day)

PlaceboOTHER

For daily administration (1 tablet per day)

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion criteria * Male or female Chinese subjects aged ≥18 years * A clinical history of HDM AR/C with or without asthma * Positive SPT and IgE to Der p or Der f at screening * A TNSS of at least 6 of 12 within the first 2 hours of the screening EEC session prior to randomisation Exclusion criteria * Sensitised and regularly exposed perennial or seasonal allergens * Asthma requiring treatment with high-dose ICS * Reduced lung function * Has a nasal condition that could confound the efficacy or safety assessment * A relevant history of systemic allergic reaction

Locations (2)

Vienna Challenge Chamber

Vienna, Austria

Tongren Hospital

Beijing, China

Outcomes

Primary Outcomes

Total Nasal Symptom Score (TNSS)

Primary endpoint, average TNSS during the EEC session at week 24, defined as the average of all TNSS observed in the last 4 hours of the EEC session at week 24. Measured on a scale of 0 (no symptoms) to 12 (severe symptoms).

Time frame: Last 4 hours of the EEC session at week 24

Secondary Outcomes

Total Symptom Score (TSS)

Key secondary endpoint, average TSS during the EEC session at week 24, defined as the sum of the Total Ocular Symptom Score (TOSS) and TNSS observed in the last 4 hours of the EEC session at week 24. Measured on a scale of 0 (no symptoms) to 18 (severe symptoms).

Time frame: Last 4 hours of the EEC session at week 24

Data from ClinicalTrials.gov

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