Comparative Evaluation of Safety and Immune Activity of New Immunotherapeutic Agents for HDM Allergic Rhinitis Patients

Phase 1

• Conditions: Rhinitis, Allergic; House Dust Mite Rhinitis; Mite Allergy
• Interventions: Drug: House Dust Mite Extract, Dermatophagoides Farinae

• Registration Number: NCT05525650
• Lead Sponsor: RAPHAS

Brief Summary

When administering clinical trial drugs to patients with house dust mite allergic rhinitis, safety/tolerance is comparatively evaluated as the primary outcome, and symptom improvement and immune activity of the disease are comparatively evaluated as secondary outcome.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-20
• Study First Submitted: 2022-08-16
• Study First Submitted QC: 2022-08-31
• Study First Posted: 2022-09-01
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-08
• Last Update Posted: 2024-04-10
• Primary Completion: 2024-12-21
• Study Completion: 2025-06-15

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• Patients aged 19 - 65years with allergic rhinitis caused by the house dust mite antigen.
• ImmunoCAP® titer > 3.49 kUA/L for the house dust mite antigen.
• Determined to be suitable for clinical trials as a result of laboratory tests.

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Exclusion Criteria

• Patients with uncontrolled, severe, or moderate asthma according to the Global Initiative for Asthma (GINA) guidelines.
• In case of lactation or pregnancy.
• If an infectious disease that may affect this study is identified.
• Patients with a history of rhinology surgery within 6 months prior to the first administration of the clinical investigational drug.
• If the allergy skin prick test is negative for the house dust mite antigen.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
2Arm C	House Dust Mite Extract, Dermatophagoides Farinae	As the maintenance UNIT, 400 PAU
1Arm A	House Dust Mite Extract, Dermatophagoides Farinae	As the maintenance UNIT, 200 PAU
1Arm B	House Dust Mite Extract, Dermatophagoides Farinae	Placebo arm of 1Arm A.
2Arm D	House Dust Mite Extract, Dermatophagoides Farinae	Placebo arm of 2Arm C.
3Arm E	House Dust Mite Extract, Dermatophagoides Farinae	As the maintenance UNIT, 800 PAU
3Arm F	House Dust Mite Extract, Dermatophagoides Farinae	Placebo arm of 3Arm E.

Primary Outcome Measures

Name	Time	Method
Vital signs	1 day before dosing, Post-study visit(within 15 days after clinical completion)	Blood pressure (mmHg), Heart rate (BPM), Body temperature(℃)
laboratory test	1 day before dosing, Post-study visit(within 15 days after clinical completion)	Blood chemistry test
Local Adverse Event	1 day before dosing, Post-study visit(within 15 days after clinical completion)	Local adverse events are removed from the subject 4 hours after attaching the clinical trial drug, and the attachment site is photographed and uploaded to the subject's diary (e-diary). The tester evaluates the presence of an adverse reaction through visual evaluation of the photo of the attachment site.
systemic adverse event	1 day before dosing, Post-study visit(within 15 days after clinical completion)	Systemic adverse reaction evaluation was evaluated according to the WAO subcutaneous immunotherapy systemic reaction grading system.
Health examination	1 day before dosing, Post-study visit(within 15 days after clinical completion)	- Physical examination of necessary body parts by interviewing and observing the height (cm), weight (kg), auscultation (lung, heart), and other clinical test subjects
Electrocardiography	1 day before dosing, Post-study visit(within 15 days after clinical completion)	Measure the 12 lead electrocardiogram. All electrocardiograms are measured after the subject rests for at least 3 minutes in a supine position.

Trial Locations

Locations (1)

Yonsei University Health System, Severance Hospital; 🇰🇷 Seoul, Korea, Republic of