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

Primary Purpose

Mite Allergy, Rhinitis, Allergic, House Dust Mite Rhinitis

Status

Recruiting

Phase

Phase 1

Locations

Korea, Republic of

Study Type

Interventional

Intervention

House Dust Mite Extract, Dermatophagoides Farinae

About this trial

This is an interventional treatment trial for Mite Allergy focused on measuring Microneedle, Micro Array Patch, House Dust Mite Rhinitis

Eligibility Criteria

19 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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.

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.

Sites / Locations

Yonsei University Health System, Severance HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

1Arm A

1Arm B

2Arm C

2Arm D

3Arm E

3Arm F

Arm Description

As the maintenance UNIT, 200 PAU

Placebo arm of 1Arm A.

As the maintenance UNIT, 400 PAU

Placebo arm of 2Arm C.

As the maintenance UNIT, 800 PAU

Placebo arm of 3Arm E.

Outcomes

Primary Outcome Measures

Vital signs

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

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

laboratory test

Hematologic examination

laboratory test

Blood coagulation test

laboratory test

Blood chemistry test

Electrocardiography

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

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.

systemic adverse event

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

Secondary Outcome Measures

Full Information

NCT ID

NCT05525650

First Posted

August 16, 2022

Last Updated

August 31, 2022

Sponsor

RAPHAS

1. Study Identification

Unique Protocol Identification Number

NCT05525650

Brief Title

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

Official Title

A Randomized, Double Blind, Placebo-controlled, Multiple-dose, Parallel Phase Ⅰ Study to Evaluate Safety and Compare the Immune Stimulating Efficacy of "DF19001" in Dermatophagoides Farinae Sensitized Allergic Rhinitis Volunteers

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Recruiting

Study Start Date

January 20, 2022 (Actual)

Primary Completion Date

December 21, 2024 (Anticipated)

Study Completion Date

June 15, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

RAPHAS

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Mite Allergy, Rhinitis, Allergic, House Dust Mite Rhinitis

Keywords

Microneedle, Micro Array Patch, House Dust Mite Rhinitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

54 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

1Arm A

Arm Type

Experimental

Arm Description

As the maintenance UNIT, 200 PAU

Arm Title

1Arm B

Arm Type

Placebo Comparator

Arm Description

Placebo arm of 1Arm A.

Arm Title

2Arm C

Arm Type

Experimental

Arm Description

As the maintenance UNIT, 400 PAU

Arm Title

2Arm D

Arm Type

Placebo Comparator

Arm Description

Placebo arm of 2Arm C.

Arm Title

3Arm E

Arm Type

Experimental

Arm Description

As the maintenance UNIT, 800 PAU

Arm Title

3Arm F

Arm Type

Placebo Comparator

Arm Description

Placebo arm of 3Arm E.

Intervention Type

Drug

Intervention Name(s)

House Dust Mite Extract, Dermatophagoides Farinae

Intervention Description

[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.

Primary Outcome Measure Information:

Title

Vital signs

Description

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

Time Frame