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

NCT05922176 | Recruiting

• 1 other identifier: 4-2023-0353
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Analysis of transcriptomic profiles based on RNA

  Based on RNA extracted from skin samples, transcriptomic profiles are analyzed to identify related RNAs that show meaningful changes compared to normal people and immunotherapy using heatmap, and it is estimated that Th2 or Treg-related RNA profiles will be significantly different

  4-6 months after baseline

Secondary Outcomes (1)

• Differences in immunological efficacy by type of immunotherapy (subcutaneous, sublingual, percutaneous)

  4-6 months after baseline

Study Arms (2)

patient group of House dust mist allergic rhinitis

1. Adult male and female patients aged 19 to 60 with allergic rhinitis caused by the antigen of the American house dust mite (It is judged that the positive for the house dust mite is MAST ≥ Class 3 or ImmunoCAP® ≥3.5 kUA/L) 2. Moderate-severe persistent rhinitis when evaluated according to ARIA (Allergic rhinitis and its impact on asthma) 3. A person who has signed a written consent to participate in this clinical trial at his/her own discretion after fully explaining the purpose, contents, characteristics of the test drug, and expected adverse reactions prior to participation in the clinical trial

Other: Evaluation of clinical indicators, Sample collection before& after immunotherapy

control group

1. Adults 19 years of age or older who are judged to be free from skin diseases or allergic diseases through medical examination and visual observation by a specialist 2. A person who agrees to provide samples derived from the human body 3. A person who voluntarily agreed to this study and prepared a consent form after approval of the IRB

Other: Sample collection before& after immunotherapy

Interventions

Evaluation of clinical indicators, Sample collection before& after immunotherapy OTHER

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'

patient group of House dust mist allergic rhinitis

Sample collection before& after immunotherapy OTHER

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.)

control group

Eligibility Criteria

• Age: 19 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

1. Adult male and female patients aged 19 to 60 with allergic rhinitis caused by house dust mite antigen in the U.S. (If house dust mite is positive for MAST ≥ Class 3 or ImmunoCAP® ≥3.5 kUA/L) 2. Moderate-severe persistent rhinitis when evaluated according to ARIA (Allergic rhinitis and its impact on asthma)

You may qualify if:

• A. patient group of House dust mite
• Adult male and female patients aged 19 to 60 with allergic rhinitis caused by the antigen of the American house dust mite (It is judged that the positive for the house dust mite is MAST ≥ Class 3 or ImmunoCAP® ≥3.5 kUA/L)
• Moderate-severe persistent rhinitis when evaluated according to ARIA (Allergic rhinitis and its impact on asthma)
• A person who has signed a written consent to participate in this clinical trial at his/her own discretion after fully explaining the purpose, contents, characteristics of the test drug, and expected adverse reactions prior to participation in the clinical trial B. Control group (Normal person)
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• Adults 19 years of age or older who are judged to be free from skin diseases or allergic diseases through medical examination and visual observation by a specialist
• A person who agrees to provide samples derived from the human body
• A person who voluntarily agreed to this study and prepared a consent form after approval of the IRB

You may not qualify if:

• A. patient group of House dust mite
• Patients who are taking drugs that may affect efficacy evaluation (but can participate if there is no change in the drug taken during the study period)
• Within six months of participation in the study, other clinical trial drugs or biological equivalence test drugs, biological agents (e.g. Anti-IgE) were administered
• If there is a skin disease or tattoo in the area where the medication is applied
• Immunosuppressive therapy or systemic steroid therapy for acute and chronic inflammatory skin diseases
• A person in charge of testing or a person in charge of testing deemed inappropriate to participate in the test due to other reasons B. Control (Normal person)
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• Patients with allergic diseases such as atopic dermatitis or allergic asthma and rhinitis
• A person who voluntarily disagrees with this study after approval of the IRB and has not completed the consent form

Sponsors & Collaborators

• Yonsei University: lead
• Korea Health Industry Development Institute: collaborator

Study Sites (1)

Yonsei University Health System, Severance Hospital

Seoul, 03722, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum, skin tissue

MeSH Terms

Conditions

Rhinitis, Allergic

Condition Hierarchy (Ancestors)

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

Study Officials

• Kyung Hee Park

  Yonsei University Health System, Severance Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kyung Hee Park

CONTACT

+82-2-2228-1947; white182@yuhs.ac

Im Shin

CONTACT

+82-2-2228-5884; si1011@yuhs.ac

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: June 18, 2023
• First Posted: June 28, 2023
• Study Start: May 22, 2023
• Primary Completion: February 7, 2025
• Study Completion: March 31, 2026
• Last Updated: March 11, 2025

Record last verified: 2025-03

Locations

KR (1)