Mite AllergyPhase 1NCT05525650
Comparative Evaluation of Safety and Immune Activity of New Immunotherapeutic Agents for HDM Allergic Rhinitis Patients
A Phase 1 study testing House Dust Mite Extract, Dermatophagoides Farinae in people with Mite Allergy and Rhinitis, Allergic, run by RAPHAS at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 to 60 years
- Conditions the study is for
- Mite Allergy, Rhinitis, Allergic, House Dust Mite Rhinitis
- What is being tested?
- House Dust Mite Extract, Dermatophagoides Farinae
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteSouth Korea
- Study dates
- 20 Jan 2022to 15 Jun 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Yonsei University Health System, Severance Hospital
Seoul
About this study
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
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
- Being tested
- House Dust Mite Extract, Dermatophagoides Farinae
- Keywords
- Microneedle, Micro Array Patch, House Dust Mite Rhinitis
- Medical subject headings
- Rhinitis, Allergic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
House Dust Mite Extract, Dermatophagoides FarinaeDrug
[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.
| Study group | Role | What they receive |
|---|---|---|
| 1Arm A | Experimental | As the maintenance UNIT, 200 PAU Receives: Drug: House Dust Mite Extract, Dermatophagoides Farinae |
| 1Arm B | Placebo comparator | Placebo arm of 1Arm A. Receives: Drug: House Dust Mite Extract, Dermatophagoides Farinae |
| 2Arm C | Experimental | As the maintenance UNIT, 400 PAU Receives: Drug: House Dust Mite Extract, Dermatophagoides Farinae |
| 2Arm D | Placebo comparator | Placebo arm of 2Arm C. Receives: Drug: House Dust Mite Extract, Dermatophagoides Farinae |
| 3Arm E | Experimental | As the maintenance UNIT, 800 PAU Receives: Drug: House Dust Mite Extract, Dermatophagoides Farinae |
| 3Arm F | Placebo comparator | Placebo arm of 3Arm E. Receives: Drug: House Dust Mite Extract, Dermatophagoides Farinae |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vital signs
Blood pressure (mmHg), Heart rate (BPM), Body temperature(℃)
Measured: 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
Measured: 1 day before dosing, Post-study visit(within 15 days after clinical completion)
laboratory test
Hematologic examination
Measured: 1 day before dosing, Post-study visit(within 15 days after clinical completion)
laboratory test
Blood coagulation test
Measured: 1 day before dosing, Post-study visit(within 15 days after clinical completion)
laboratory test
Blood chemistry test
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 day before dosing, Post-study visit(within 15 days after clinical completion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2022
- Study start20 Jan 2022
- Primary completion21 Dec 2024 (estimated)
- Study completion15 Jun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mite AllergyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RAPHAS
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05525650
- Sponsor's protocol ID
- RapMed 1506-11-A
- Status last verified
- Apr 2024
- First submitted
- 16 Aug 2022
- Last updated
- 10 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05525650
- Acronym / sponsor ID
- RapMed 1506-11-A
- Conditions
- Mite Allergy, Rhinitis, Allergic, House Dust Mite Rhinitis
- Keywords
- Microneedle, Micro Array Patch, House Dust Mite Rhinitis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- RAPHASIndustry (pharma, biotech, devices)
- Study start
- 20 Jan 2022 (actual)
- Primary completion
- 21 Dec 2024 (estimated)
- Study completion
- 15 Jun 2025 (estimated)
- First posted
- 1 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| 1Arm A | Experimental | Drug: House Dust Mite Extract, Dermatophagoides FarinaeAs the maintenance UNIT, 200 PAU |
| 1Arm B | Placebo comparator | Drug: House Dust Mite Extract, Dermatophagoides FarinaePlacebo arm of 1Arm A. |
| 2Arm C | Experimental | Drug: House Dust Mite Extract, Dermatophagoides FarinaeAs the maintenance UNIT, 400 PAU |
| 2Arm D | Placebo comparator | Drug: House Dust Mite Extract, Dermatophagoides FarinaePlacebo arm of 2Arm C. |
| 3Arm E | Experimental | Drug: House Dust Mite Extract, Dermatophagoides FarinaeAs the maintenance UNIT, 800 PAU |
| 3Arm F | Placebo comparator | Drug: House Dust Mite Extract, Dermatophagoides FarinaePlacebo arm of 3Arm E. |
Who may qualify
- Ages
- 19 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | 1Arm A, 1Arm B, 2Arm C, 2Arm D, 3Arm E, 3Arm F |
Primary outcome
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(℃)
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
laboratory test
Time frame: 1 day before dosing, Post-study visit(within 15 days after clinical completion)
Hematologic examination
laboratory test
Time frame: 1 day before dosing, Post-study visit(within 15 days after clinical completion)
Blood coagulation test
laboratory test
Time frame: 1 day before dosing, Post-study visit(within 15 days after clinical completion)
Blood chemistry test
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.
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.
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing House Dust Mite Extract, Dermatophagoides Farinae in people with Mite Allergy and Rhinitis, Allergic, run by RAPHAS at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vital signs (time frame: 1 day before dosing, Post-study visit(within 15 days after clinical completion)). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2024.