A Phase 1 interventional study of House Dust Mite Extract, Dermatophagoides Farinae in Mite Allergy, Rhinitis, Allergic and House Dust Mite Rhinitis, sponsored by RAPHAS. Enrolling by invitation at 1 site in Korea, Republic of. Open to participants aged 19 Years to 60 Years. Per ClinicalTrials.gov, last updated 2024-04-10.
Sponsored by RAPHAS · Phase 1, Interventional, and Treatment
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.
717 studies on the registry are indexed under Rhinitis, Allergic; 94 are open to participants now.
This study's planned enrollment of 54 is below the median of 68 across 552 interventional studies indexed under Rhinitis, Allergic.
Browse Rhinitis, Allergic studies →This is the only study on the registry with RAPHAS as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
As the maintenance UNIT, 200 PAU
Drug: House Dust Mite Extract, Dermatophagoides Farinae
Placebo arm of 1Arm A.
Drug: House Dust Mite Extract, Dermatophagoides Farinae
As the maintenance UNIT, 400 PAU
Drug: House Dust Mite Extract, Dermatophagoides Farinae
Placebo arm of 2Arm C.
Drug: House Dust Mite Extract, Dermatophagoides Farinae
As the maintenance UNIT, 800 PAU
Drug: House Dust Mite Extract, Dermatophagoides Farinae
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.
Vital signs
Blood pressure (mmHg), Heart rate (BPM), Body temperature(℃)
Time frame: 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
Time frame: 1 day before dosing, Post-study visit(within 15 days after clinical completion)
laboratory test
Hematologic examination
Time frame: 1 day before dosing, Post-study visit(within 15 days after clinical completion)
laboratory test
Blood coagulation test
Time frame: 1 day before dosing, Post-study visit(within 15 days after clinical completion)
laboratory test
Blood chemistry test
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 1 day before dosing, Post-study visit(within 15 days after clinical completion)
Plan to share: No
No publications or documents are linked to this record.
Started Jan 2022 (actual). Primary completion is estimated for Dec 2024, 35 months after the start.
Of 25 phase 1 interventional studies under Rhinitis, Allergic, half reached primary completion within 5 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 16. This study's planned 35 months is above that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
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Studies of the drug tested here: Dermatophagoides farinae