Biomarker Screening for Immunotherapy Response Evaluation Using Microneedle Patch in Patients with Allergic Rhinitis

Summary

Allergic rhinitis is a disease in which the nasal mucous membrane overreacts to allergens, resulting in symptoms such as spasmodic and repetitive sneezing, rhinorrhea, and stuffy nose, and can be treated with immunotherapy for radical treatment. Immunotherapy treatments include subcutaneous injections, sublingual tablets, and sublingual fluids, and subcutaneous injections have the risk of anaphylaxis, the hassle of daily administration at home, and local allergic reactions. Transdermal absorption immunotherapy (DF19001) that can compensate for the shortcomings of these existing immunotherapy drugs is currently under clinical research in Korea (Severance Hospital IRB No. 4-2021-1345).

Immunotherapy requires periodic monitoring, such as analyzing immunological changes through sample collection and determining the dose and cycle of administration, because the treatment period is long and individual immune responses are different. Existing methods for confirming immune responses in samples used invasive skin biopsy and blood collection methods, but in-blood evaluation indicators have the disadvantage of being ineffective as initial efficacy evaluations or predictive evaluations before treatment. In addition, skin biopsy should be performed by a specialist, and there is a disadvantage that resistance occurs because the patient's pain is accompanied, and scars or bruises may remain. Therefore, since it is a biopsy through minimal invasion compared to a tissue biopsy, the investigators would like to use a method of collecting skin samples through a microstructure (micro needle patch), a method that has little pain and no scars. Through this study, RNA is obtained from patients with house dust mite allergic rhinitis through minimally invasive skin samples, and immunotherapy response evaluation biomarkers are screened according to immunotherapy implementation, and its use as an indicator of immunotherapy prognosis in allergic diseases.

Conditions

• Rhinitis, Allergic

Interventions

OTHER

Evaluation of clinical indicators, Sample collection before& after immunotherapy

A. Evaluation of clinical indicators before immunotherapy 1. Symptom Scale for Rhinitis: Total Nasal Symptom Score (TNSS), Rhnitis Quality of Life Questionnaire(RQLQ) 2. American house dust mite-specific immunogloblin G4 (sIgG4) 3. American house dust mite-specific immunogloblin E (sIgE) B. Sample collection before immunotherapy 1. Skin: Skin test using minimally invasive microstructure patch stripping method 2. Blood: Measurement of blood immunological indicators (Th2, Treg-related cytokine and blocking factor, etc.) C. Evaluation of clinical indicators 4 to 6 months after immunotherapy : Treatment is performed for about 4 months, and the progress of treatment is evaluated through the evaluation of the following clinical indicators. same as examination in 'A' D. Sample collection after 4 to 6 months of immunotherapy same as examination in 'B'

OTHER

Sample collection before& after immunotherapy

B. Sample collection before immunotherapy 1. Skin: Skin test using minimally invasive microstructure patch stripping method 2. Blood: Measurement of blood immunological indicators (Th2, Treg-related cytokine and blocking factor, etc.) D. Sample collection after 4 to 6 months of immunotherapy 1. Skin: Skin test using minimally invasive microstructure patch stripping method 2. Blood: Measurement of blood immunological indicators (Th2, Treg-related cytokine and blocking factor, etc.)

Sponsors & Collaborators

• Korea Health Industry Development Institute

  collaborator OTHER_GOV

• Yonsei University

  lead OTHER

Principal Investigators

• Kyung Hee Park · Yonsei University Health System, Severance Hospital

Eligibility

Min Age

19 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2023-05-22

Primary Completion

2025-02-07

Completion

2026-03-31

Countries

• South Korea

Study Locations