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

NCT05525650 | Enrolling By Invitation Phase 1

• 1 other identifier: RapMed 1506-11-A
• Study Type: interventional
• Target: 54
• Locations: 1 country
• Sites: 1

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.

Conditions

Mite Allergy; Rhinitis, Allergic; House Dust Mite Rhinitis

Keywords

Microneedle; Micro Array Patch; House Dust Mite Rhinitis

Outcome Measures

Primary Outcomes (8)

• Vital signs

  Blood pressure (mmHg), Heart rate (BPM), Body temperature(℃)

  1 day before dosing, Post-study visit(within 15 days after clinical completion)

• Health examination

  \- Physical examination of necessary body parts by interviewing and observing the height (cm), weight (kg), auscultation (lung, heart), and other clinical test subjects

  1 day before dosing, Post-study visit(within 15 days after clinical completion)

• laboratory test

  Hematologic examination

  1 day before dosing, Post-study visit(within 15 days after clinical completion)

• laboratory test

  Blood coagulation test

  1 day before dosing, Post-study visit(within 15 days after clinical completion)

• laboratory test

  Blood chemistry test

  1 day before dosing, Post-study visit(within 15 days after clinical completion)

• Electrocardiography

  Measure the 12 lead electrocardiogram. All electrocardiograms are measured after the subject rests for at least 3 minutes in a supine position.

  1 day before dosing, Post-study visit(within 15 days after clinical completion)

• Local Adverse Event

  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.

  1 day before dosing, Post-study visit(within 15 days after clinical completion)

• systemic adverse event

  Systemic adverse reaction evaluation was evaluated according to the WAO subcutaneous immunotherapy systemic reaction grading system.

  1 day before dosing, Post-study visit(within 15 days after clinical completion)

Study Arms (6)

1Arm A

EXPERIMENTAL

As the maintenance UNIT, 200 PAU

Drug: House Dust Mite Extract, Dermatophagoides Farinae

1Arm B

PLACEBO COMPARATOR

Placebo arm of 1Arm A.

Drug: House Dust Mite Extract, Dermatophagoides Farinae

2Arm C

EXPERIMENTAL

As the maintenance UNIT, 400 PAU

Drug: House Dust Mite Extract, Dermatophagoides Farinae

2Arm D

PLACEBO COMPARATOR

Placebo arm of 2Arm C.

Drug: House Dust Mite Extract, Dermatophagoides Farinae

3Arm E

EXPERIMENTAL

As the maintenance UNIT, 800 PAU

Drug: House Dust Mite Extract, Dermatophagoides Farinae

3Arm F

PLACEBO COMPARATOR

Placebo arm of 3Arm E.

Drug: House Dust Mite Extract, Dermatophagoides Farinae

Interventions

House Dust Mite Extract, Dermatophagoides Farinae DRUG

\[Group 1\] Group A receives 100 PAU at week 1 and 200 PAU at week 2 as the induction phase. 200 PAU is administered for 3 to 16 weeks as a maintenance phase. Group B (placebo group) is the placebo arm of group A. \[Group 2\] As the induction phase, group C received 100 PAU at week 1, 200 PAU at week 2, 300 PAU at week 3, and 400 PAU at week 4. As the maintenance phase, 400 PAU is administered for 5 to 16 weeks. Group D (placebo) is the placebo group in Group C. \[Group 3\] As the induction phase, group E received 100 PAU at week 1, 200 PAU at week 2, 300 PAU at week 3, 400 PAU at week 4, 600 PAU at week 5, and 800 PAU at week 6. As the maintenance phase, 800 PAU is administered from 7 to 16 weeks. Group F (placebo) is the placebo arm of group E.

1Arm A; 1Arm B; 2Arm C; 2Arm D; 3Arm E; 3Arm F

Eligibility Criteria

• Age: 19 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• RAPHAS: lead

Study Sites (1)

Yonsei University Health System, Severance Hospital

Seoul, South Korea

Location

MeSH Terms

Conditions

Rhinitis, Allergic

Interventions

Antigens, Dermatophagoides

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Antigens; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 16, 2022
• First Posted: September 1, 2022
• Study Start: January 20, 2022
• Primary Completion: December 21, 2024
• Study Completion: June 15, 2025
• Last Updated: April 10, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)