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

April 8, 2024 updated by: RAPHAS

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
54

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Juyoung JIN, Sponser
  • Phone Number: +82-70-4483-9708
  • Email: jyjin@raphas.com

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Yonsei University Health System, Severance Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

19 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 1Arm A
As the maintenance UNIT, 200 PAU
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.
Placebo Comparator: 1Arm B
Placebo arm of 1Arm A.
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.
Experimental: 2Arm C
As the maintenance UNIT, 400 PAU
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.
Placebo Comparator: 2Arm D
Placebo arm of 2Arm C.
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.
Experimental: 3Arm E
As the maintenance UNIT, 800 PAU
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.
Placebo Comparator: 3Arm F
Placebo arm of 3Arm E.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Vital signs
Time Frame: 1 day before dosing, Post-study visit(within 15 days after clinical completion)
Blood pressure (mmHg), Heart rate (BPM), Body temperature(℃)
1 day before dosing, Post-study visit(within 15 days after clinical completion)
Health examination
Time Frame: 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
1 day before dosing, Post-study visit(within 15 days after clinical completion)
laboratory test
Time Frame: 1 day before dosing, Post-study visit(within 15 days after clinical completion)
Hematologic examination
1 day before dosing, Post-study visit(within 15 days after clinical completion)
laboratory test
Time Frame: 1 day before dosing, Post-study visit(within 15 days after clinical completion)
Blood coagulation test
1 day before dosing, Post-study visit(within 15 days after clinical completion)
laboratory test
Time Frame: 1 day before dosing, Post-study visit(within 15 days after clinical completion)
Blood chemistry test
1 day before dosing, Post-study visit(within 15 days after clinical completion)
Electrocardiography
Time Frame: 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.
1 day before dosing, Post-study visit(within 15 days after clinical completion)
Local Adverse Event
Time Frame: 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.
1 day before dosing, Post-study visit(within 15 days after clinical completion)
systemic adverse event
Time Frame: 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.
1 day before dosing, Post-study visit(within 15 days after clinical completion)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
RAPHAS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 20, 2022

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 21, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 15, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 16, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 31, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 1, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 10, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 8, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • RapMed 1506-11-A

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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