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

NCT04176185 | Terminated Phase 3

• 1 other identifier: MT-16
• Study Type: interventional
• Target: 80
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Allergic Rhinoconjunctivitis

Keywords

House Dust Mite; Allergic rhinitis; Allergic conjunctivitis; China; Environmental exposure chamber

Outcome Measures

Primary Outcomes (1)

• 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).

  Last 4 hours of the EEC session at week 24

Secondary Outcomes (1)

• Total Symptom Score (TSS)

  Last 4 hours of the EEC session at week 24

Other Outcomes (4)

• Frequency of adverse events

  26 weeks

• Assessment of lung function

  26 weeks

• Total Ocular Symptom Score (TOSS)

  Last 4 hours of the EEC session at week 24

Study Arms (2)

Active

EXPERIMENTAL

HDM SLIT-tablet once daily for approximately 24 weeks

Biological: Sublingual allergy immunological tablet

Placebo

PLACEBO COMPARATOR

Placebo tablet once daily for approximately 24 weeks

Other: Placebo

Interventions

Sublingual allergy immunological tablet BIOLOGICAL

For daily administration (1 tablet per day)

Also known as: 12 SQ HDM SLIT-tablet, Acarizax

Active

Placebo OTHER

For daily administration (1 tablet per day)

Also known as: Placebo sublingual tablet

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ALK-Abelló A/S: lead

Study Sites (2)

Vienna Challenge Chamber

Vienna, 1150, Austria

Location

Tongren Hospital

Beijing, China

Location

MeSH Terms

Conditions

Rhinitis, Allergic; Conjunctivitis, Allergic

Condition Hierarchy (Ancestors)

Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Conjunctivitis; Conjunctival Diseases; Eye Diseases

Study Officials

• Luo Zhang, Prof.

  Beijing Tongren Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Randomised
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Parallel assignment

Study Record Dates

• First Submitted: October 25, 2019
• First Posted: November 25, 2019
• Study Start: November 4, 2019
• Primary Completion: December 17, 2019
• Study Completion: January 19, 2022
• Last Updated: June 30, 2022

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1); AU (1)