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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Mite Allergy, Rhinitis, Allergic, House Dust Mite Rhinitis

Intervention / Treatment
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* Drug: House Dust Mite Extract, Dermatophagoides Farinae


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1Arm A<br>As the maintenance UNIT, 200 PAU | Drug: House Dust Mite Extract, Dermatophagoides Farinae<br>* [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.<br>|
| Placebo Comparator: 1Arm B<br>Placebo arm of 1Arm A. | Drug: House Dust Mite Extract, Dermatophagoides Farinae<br>* [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.<br>|
| Experimental: 2Arm C<br>As the maintenance UNIT, 400 PAU | Drug: House Dust Mite Extract, Dermatophagoides Farinae<br>* [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.<br>|
| Placebo Comparator: 2Arm D<br>Placebo arm of 2Arm C. | Drug: House Dust Mite Extract, Dermatophagoides Farinae<br>* [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.<br>|
| Experimental: 3Arm E<br>As the maintenance UNIT, 800 PAU | Drug: House Dust Mite Extract, Dermatophagoides Farinae<br>* [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.<br>|
| Placebo Comparator: 3Arm F<br>Placebo arm of 3Arm E. | Drug: House Dust Mite Extract, Dermatophagoides Farinae<br>* [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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Microneedle, Micro Array Patch, House Dust Mite Rhinitis