Ignite Creation Date:
2025-12-26 @ 12:19 PM
Ignite Modification Date:
2025-12-26 @ 12:19 PM
Study NCT ID:
NCT06058000
Status:
COMPLETED
Last Update Posted:
2025-03-12
First Post:
2023-09-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase 2 Study of QLM3003 Ointment in Participants With Mild or Moderate Atopic Dermatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}], 'ancestors': [{'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2024-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-11', 'studyFirstSubmitDate': '2023-09-21', 'studyFirstSubmitQcDate': '2023-09-21', 'lastUpdatePostDateStruct': {'date': '2025-03-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Achieving >=75% Improvement in Eczema Area and Severity Index Total Score (EASI-75) From Baseline at Weeks 8', 'timeFrame': 'Baseline, Weeks 8', 'description': "EASI evaluates severity of participant's AD (excluded scalp, palms, soles) based on severity of AD clinical signs and % of body surface area (BSA) affected. Severity of clinical signs of AD (erythema, induration/papulation, excoriation and lichenification) scored separately for each of 4 body regions(head and neck, upper limbs, trunk \\[including axillae and groin\\] and lower limbs \\[including buttocks\\]) on4-point scale: 0= absent; 1= mild; 2= moderate; 3= severe. EASI area score was based upon % BSA with AD in each 4 body region: 0 (0%), 1 (\\>0 to \\<10%), 2 (10 to \\<30%), 3 (30 to \\<50%), 4 (50 to \\<70%), 5 (70 to \\<90%) and 6 (90 to 100%). Total EASI score =0.1\\*Ah\\*(Eh+Ih+Exh+Lh) + 0.2\\*Au\\*(Eu+Iu+ExU+Lu) + 0.3\\*At\\*(Et+It+Ext+Lt) + 0.4\\*Al\\*(El+Il+Exl+Ll); A = EASI area score; E = erythema; I = induration/papulation; Ex = excoriation; L = lichenification; h = head and neck; u = upper limbs; t = trunk; l = lower limbs. Total EASI score ranged from 0.0 to 72.0, higher scores = greater severity of AD."}], 'secondaryOutcomes': [{'measure': "Percentage of Participants Achieving Investigator's Global Assessment (IGA) Score Clear (0) or Almost Clear (1) and a Reduction From Baseline of Greater Than or Equal to ( >=2) Points at Week 8", 'timeFrame': 'Baseline, Weeks 8', 'description': "IGA assesses severity of participant's AD on a 5 point scale. 0= clear, no inflammatory signs of AD; 1= almost clear, AD not fully cleared- light pink residual lesions (except post-inflammatory hyperpigmentation), just perceptible erythema, papulation/induration lichenification, excoriation, and no oozing/crusting; 2= mild AD with light red lesions, slight but definite erythema, papulation/induration, lichenification, excoriation and no oozing/crusting; 3= moderate AD with red lesions, moderate erythema, papulation/induration, lichenification, excoriation and slight oozing/crusting and 4= severe AD with deep dark red lesions, severe erythema, papulation/induration, lichenification, excoriation and moderate to severe oozing/crusting. Higher scores indicating more severity of AD. Assessment excluded soles, palms and scalp."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atopic Dermatitis']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess efficacy, safety, and pharmacokinetics (PK) of QLM3003 Ointment in participants with mild or moderate atopic dermatitis.', 'detailedDescription': 'This study is a Phase 2, randomized, double-blind,placebo controlled, parallel group study to assess efficacy, safety, and pharmacokinetics (PK) of QLM3003 Ointment in participants with mild or moderate atopic dermatitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* The subjects understand and comply with the study requirements, voluntarily participate in the study and sign the informed consent form.\n* Ages at ≥18 and ≤ 65 years.\n* The diagnosis of atopic dermatitis will be confirmed according to the criteria of Hanifin and Rajka at the Screening Visit and Have a clinical diagnosis of atopic dermatitis for at least 6 months.\n* Have an Investigator's Global Assessment (IGA) score of 2, or3 at screening and at baseline.\n* Have atopic dermatitis on the head (excluding hair-bearing scalp), neck, trunk, or limbs, covering at least 2% of total BSA and up to and including 20% of total BSA at Screening and at baseline.\n\nExclusion Criteria:\n\n* Subjects with other dermatologic disease besides AD whose presence or treatments could interfere the assessment of disease (eg, psoriasis).\n* In the opinion of the investigator, have any clinically significant laboratory abnormality that would affect the participant's participation in the study.\n* Use of topical treatments for AD within 2 weeks of baseline.\n* Vaccinated or exposed to a live or attenuated vaccine within the 12 weeks of baseline, or is expected to be vaccinated these vaccines during treatment.\n* A history of alcohol or substance abuse within 12 months prior to Screening that in the opinion of the investigator will preclude participation in the study."}, 'identificationModule': {'nctId': 'NCT06058000', 'briefTitle': 'A Phase 2 Study of QLM3003 Ointment in Participants With Mild or Moderate Atopic Dermatitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Qilu Pharmaceutical Co., Ltd.'}, 'officialTitle': 'A Phase 2, Randomized, Double-blind,Placebo Controlled, Parallel Group Study to Assess Efficacy, Safety, and Pharmacokinetics (PK) of QLM3003 Ointment in Participants With Mild or Moderate Atopic Dermatitis', 'orgStudyIdInfo': {'id': 'QLM3003-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'QLM3003 Low Dose', 'description': '2% cream applied once daily (QD)', 'interventionNames': ['Drug: 2% QLM3003']}, {'type': 'EXPERIMENTAL', 'label': 'QLM3003 Middle Dose', 'description': '1.5% cream applied twice daily (BID)', 'interventionNames': ['Drug: 1.5% QLM3003']}, {'type': 'EXPERIMENTAL', 'label': 'QLM3003 High Dose', 'description': '2% cream applied twice daily (BID)', 'interventionNames': ['Drug: 2% QLM3003']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Comparator: Vehicle', 'description': 'Vehicle cream applied twice daily (BID)', 'interventionNames': ['Drug: Vehicle (Placebo)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'High Placebo Comparator: Vehicle', 'description': 'Vehicle cream applied twice daily (BID)', 'interventionNames': ['Drug: Vehicle (Placebo)']}], 'interventions': [{'name': '1.5% QLM3003', 'type': 'DRUG', 'description': 'QLM3003 topical cream', 'armGroupLabels': ['QLM3003 Middle Dose']}, {'name': '2% QLM3003', 'type': 'DRUG', 'description': 'QLM3003 topical cream', 'armGroupLabels': ['QLM3003 High Dose', 'QLM3003 Low Dose']}, {'name': 'Vehicle (Placebo)', 'type': 'DRUG', 'description': 'Vehicle topical cream', 'armGroupLabels': ['High Placebo Comparator: Vehicle', 'Placebo Comparator: Vehicle']}]}, 'contactsLocationsModule': {'locations': [{'zip': '110001', 'city': 'Shenyang', 'state': 'Liaoning', 'country': 'China', 'facility': 'The First Hospital of China Medical University', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'zip': '276000', 'city': 'Jinan', 'state': 'Shandong', 'country': 'China', 'facility': 'Dermatology Hospital of Shandong First Medical University', 'geoPoint': {'lat': 36.66833, 'lon': 116.99722}}], 'overallOfficials': [{'name': 'Xinghua Gao, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'First Hospital of China Medical University'}, {'name': 'Furen zhang, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dermatology Hospital of Shandong First Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Qilu Pharmaceutical Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}