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

Rhinitis, Allergic Clinical Trial

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05525650
• Other study ID #: RapMed 1506-11-A
• Status: Enrolling by invitation
• Phase: Phase 1
• Start date: January 20, 2022
• Est. completion date: June 15, 2025

Study information

• Verified date: April 2024
• Source: RAPHAS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 54
• Est. completion date: June 15, 2025
• Est. primary completion date: December 21, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mite Allergy
• Rhinitis
• Rhinitis, Allergic

Intervention

Drug:
• House Dust Mite Extract, Dermatophagoides Farinae
[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.

Locations

Country	Name	City	State
Korea, Republic of	Yonsei University Health System, Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
RAPHAS

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vital signs	Blood pressure (mmHg), Heart rate (BPM), Body temperature(?)	1 day before dosing, Post-study visit(within 15 days after clinical completion)
Primary	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)
Primary	laboratory test	Hematologic examination	1 day before dosing, Post-study visit(within 15 days after clinical completion)
Primary	laboratory test	Blood coagulation test	1 day before dosing, Post-study visit(within 15 days after clinical completion)
Primary	laboratory test	Blood chemistry test	1 day before dosing, Post-study visit(within 15 days after clinical completion)
Primary	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)
Primary	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)
Primary	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)