Ignite Creation Date:
2025-12-24 @ 5:07 PM
Ignite Modification Date:
2026-02-19 @ 7:01 AM
Study NCT ID:
NCT05525650
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-04-10
First Post:
2022-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Evaluation of Safety and Immune Activity of New Immunotherapeutic Agents for HDM Allergic Rhinitis Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065631', 'term': 'Rhinitis, Allergic'}], 'ancestors': [{'id': 'D012220', 'term': 'Rhinitis'}, {'id': 'D009668', 'term': 'Nose Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D010038', 'term': 'Otorhinolaryngologic Diseases'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D039741', 'term': 'Antigens, Dermatophagoides'}], 'ancestors': [{'id': 'D000941', 'term': 'Antigens'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 54}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2022-01-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-06-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-08', 'studyFirstSubmitDate': '2022-08-16', 'studyFirstSubmitQcDate': '2022-08-31', 'lastUpdatePostDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-21', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Vital signs', 'timeFrame': '1 day before dosing, Post-study visit(within 15 days after clinical completion)', 'description': 'Blood pressure (mmHg), Heart rate (BPM), Body temperature(℃)'}, {'measure': 'Health examination', 'timeFrame': '1 day before dosing, Post-study visit(within 15 days after clinical completion)', 'description': '\\- Physical examination of necessary body parts by interviewing and observing the height (cm), weight (kg), auscultation (lung, heart), and other clinical test subjects'}, {'measure': 'laboratory test', 'timeFrame': '1 day before dosing, Post-study visit(within 15 days after clinical completion)', 'description': 'Hematologic examination'}, {'measure': 'laboratory test', 'timeFrame': '1 day before dosing, Post-study visit(within 15 days after clinical completion)', 'description': 'Blood coagulation test'}, {'measure': 'laboratory test', 'timeFrame': '1 day before dosing, Post-study visit(within 15 days after clinical completion)', 'description': 'Blood chemistry test'}, {'measure': 'Electrocardiography', 'timeFrame': '1 day before dosing, Post-study visit(within 15 days after clinical completion)', 'description': 'Measure the 12 lead electrocardiogram. All electrocardiograms are measured after the subject rests for at least 3 minutes in a supine position.'}, {'measure': 'Local Adverse Event', 'timeFrame': '1 day before dosing, Post-study visit(within 15 days after clinical completion)', 'description': "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."}, {'measure': 'systemic adverse event', 'timeFrame': '1 day before dosing, Post-study visit(within 15 days after clinical completion)', 'description': 'Systemic adverse reaction evaluation was evaluated according to the WAO subcutaneous immunotherapy systemic reaction grading system.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Microneedle', 'Micro Array Patch', 'House Dust Mite Rhinitis'], 'conditions': ['Mite Allergy', 'Rhinitis, Allergic', 'House Dust Mite Rhinitis']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients aged 19 - 65years with allergic rhinitis caused by the house dust mite antigen.\n* ImmunoCAP® titer \\> 3.49 kUA/L for the house dust mite antigen.\n* Determined to be suitable for clinical trials as a result of laboratory tests.\n\nExclusion Criteria:\n\n* Patients with uncontrolled, severe, or moderate asthma according to the Global Initiative for Asthma (GINA) guidelines.\n* In case of lactation or pregnancy.\n* If an infectious disease that may affect this study is identified.\n* Patients with a history of rhinology surgery within 6 months prior to the first administration of the clinical investigational drug.\n* If the allergy skin prick test is negative for the house dust mite antigen.'}, 'identificationModule': {'nctId': 'NCT05525650', 'briefTitle': 'Comparative Evaluation of Safety and Immune Activity of New Immunotherapeutic Agents for HDM Allergic Rhinitis Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'RAPHAS'}, 'officialTitle': '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', 'orgStudyIdInfo': {'id': 'RapMed 1506-11-A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1Arm A', 'description': 'As the maintenance UNIT, 200 PAU', 'interventionNames': ['Drug: House Dust Mite Extract, Dermatophagoides Farinae']}, {'type': 'PLACEBO_COMPARATOR', 'label': '1Arm B', 'description': 'Placebo arm of 1Arm A.', 'interventionNames': ['Drug: House Dust Mite Extract, Dermatophagoides Farinae']}, {'type': 'EXPERIMENTAL', 'label': '2Arm C', 'description': 'As the maintenance UNIT, 400 PAU', 'interventionNames': ['Drug: House Dust Mite Extract, Dermatophagoides Farinae']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2Arm D', 'description': 'Placebo arm of 2Arm C.', 'interventionNames': ['Drug: House Dust Mite Extract, Dermatophagoides Farinae']}, {'type': 'EXPERIMENTAL', 'label': '3Arm E', 'description': 'As the maintenance UNIT, 800 PAU', 'interventionNames': ['Drug: House Dust Mite Extract, Dermatophagoides Farinae']}, {'type': 'PLACEBO_COMPARATOR', 'label': '3Arm F', 'description': 'Placebo arm of 3Arm E.', 'interventionNames': ['Drug: House Dust Mite Extract, Dermatophagoides Farinae']}], 'interventions': [{'name': 'House Dust Mite Extract, Dermatophagoides Farinae', 'type': 'DRUG', 'description': '\\[Group 1\\] Group A receives 100 PAU at week 1 and 200 PAU at week 2 as the induction phase.\n\n200 PAU is administered for 3 to 16 weeks as a maintenance phase.\n\nGroup B (placebo group) is the placebo arm of group A.\n\n\\[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.\n\nAs the maintenance phase, 400 PAU is administered for 5 to 16 weeks.\n\nGroup D (placebo) is the placebo group in Group C.\n\n\\[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.\n\nAs the maintenance phase, 800 PAU is administered from 7 to 16 weeks.\n\nGroup F (placebo) is the placebo arm of group E.', 'armGroupLabels': ['1Arm A', '1Arm B', '2Arm C', '2Arm D', '3Arm E', '3Arm F']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Seoul', 'country': 'South Korea', 'facility': 'Yonsei University Health System, Severance Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RAPHAS', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}