Ignite Creation Date:
2025-12-24 @ 3:45 PM
Ignite Modification Date:
2026-02-26 @ 5:47 AM
Study NCT ID:
NCT04435392
Status:
COMPLETED
Last Update Posted:
2024-04-02
First Post:
2020-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Jaktinib Hydrochloride Cream For 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': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 107}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2022-09-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-31', 'studyFirstSubmitDate': '2020-06-15', 'studyFirstSubmitQcDate': '2020-06-16', 'lastUpdatePostDateStruct': {'date': '2024-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-09-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Proportion of Participants Achieving Physician's Global Assessment (PGA) Response of Clear or Almost Clear", 'timeFrame': '7 days after the last dose', 'description': 'A total PGA score of 0 or 1 or a decrease of ≥2 from baseline'}], 'secondaryOutcomes': [{'measure': 'Proportion of Participants With Response of Clear or Almost Clear From Baseline', 'timeFrame': 'Treatment at 8,16 weeks', 'description': 'PGA score of 0 or 1'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Atopic Dermatitis', 'Jaktinib'], 'conditions': ['Atopic Dermatitis']}, 'descriptionModule': {'briefSummary': 'This study includes a dose escalation part and a dose extension part.', 'detailedDescription': 'In the dose-increasing part, a multicenter, dose-increasing, randomized, double-blind, placebo-parallel control design was adopted. Subjects were enrolled into different dose groups in sequence according to the inclusion sequence, and each group was scheduled to give the drug for 8 weeks.Subjects in each group were observed for 4 weeks after administration. When the number of ≥2 grade drug-related adverse events (cases) was less than 50%, subjects in the next group could be enrolled.Otherwise, IDMC will decide whether to continue the next set of tests.Subjects in each group were randomly assigned to receive either Jaktinib cream (6 cases) or placebo (2 cases) in a ratio of 3 to 1.A total of 32 subjects are expected to be enrolled in 6 centers.\n\nThe dose expansion was a multicenter, randomized, double-blind, placebo-parallel control design in which subjects were randomly assigned to 3 groups (1 placebo group and 2 experimental drugs group).It is estimated that a total of 60 subjects will be enrolled in about 15 centers. This part is divided into two stages.Stage 2 test (9 \\~ 16 weeks) : Extension test.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* 18\\~ 65 years old (including boundary value), gender is not limited;\n* Have a clinical diagnosis of atopic dermatitis;\n* Have a PGA(Physician's Global Assessment) score of 2 (mild) or 3 (moderate) at baseline;\n* The total area of atopic dermatitis is about 10%\\~20% of the total area of the body surface at baseline.\n\nExclusion Criteria:\n\n* Evidence of certain skin conditions/infections at baseline;\n* Have certain laboratory abnormalities at baseline;\n* Females who are pregnant, breastfeeding, or are of childbearing potential not using highly effective contraception;\n* Other conditions that the investigators considered inappropriate to participate in the trial."}, 'identificationModule': {'nctId': 'NCT04435392', 'briefTitle': 'Jaktinib Hydrochloride Cream For Atopic Dermatitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Suzhou Zelgen Biopharmaceuticals Co.,Ltd'}, 'officialTitle': 'A Phase I/II Study Of The Efficacy,Safety and PharmacokineticsOf Jaktinib Hydrochloride Cream In Subjects With Mild To Moderate Atopic Dermatitis', 'orgStudyIdInfo': {'id': 'ZGJAKT002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1: Cohort 1, 0.5% Jaktinib Bid', 'description': 'Subjects were randomly assigned to receive either Jaktinib cream or a placebo in a ratio of 3 to 1.The Jaktinib hydrochloride 0.5% Cream will be applied topically twice daily.', 'interventionNames': ['Drug: Jaktinib Hydrochloride Cream', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1: Cohort 2,1.5% Jaktinib Bid', 'description': 'Subjects were randomly assigned to receive either Jaktinib cream or a placebo in a ratio of 3 to 1.The Jaktinib hydrochloride 1.5% Cream will be applied topically twice daily.', 'interventionNames': ['Drug: Jaktinib Hydrochloride Cream', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1: Cohort 3, 2.5% Jaktinib Qd', 'description': 'Subjects were randomly assigned to receive either Jaktinib cream or a placebo in a ratio of 3 to 1.The Jaktinib hydrochloride 2.5% Cream will be applied topically Once daily.', 'interventionNames': ['Drug: Jaktinib Hydrochloride Cream', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1: Cohort 4, 2.5% Jaktinib Bid', 'description': 'Subjects were randomly assigned to receive either Jaktinib cream or a placebo in a ratio of 3 to 1.The Jaktinib hydrochloride 2.5% Cream will be applied topically twice daily.', 'interventionNames': ['Drug: Jaktinib Hydrochloride Cream', 'Drug: Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Dose extension: Vehicle Control', 'description': 'the Vehicle Control cream will be applied topically twice daily', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Dose extension: low-dose group, X%', 'description': 'X% based on results of part 1. The Jaktinib Hydrochloride X% Cream will be applied topically twice daily', 'interventionNames': ['Drug: Jaktinib Hydrochloride Cream']}, {'type': 'EXPERIMENTAL', 'label': 'Dose extension: high-dose group, Y%', 'description': 'Y% based on results of part 1. The Jaktinib Hydrochloride Y% Cream will be applied topically twice daily', 'interventionNames': ['Drug: Jaktinib Hydrochloride Cream']}], 'interventions': [{'name': 'Jaktinib Hydrochloride Cream', 'type': 'DRUG', 'otherNames': ['Jaktinib'], 'description': 'Subjects in each group were scheduled to give the drug for 8 weeks.', 'armGroupLabels': ['Dose extension: high-dose group, Y%', 'Dose extension: low-dose group, X%', 'Part 1: Cohort 1, 0.5% Jaktinib Bid', 'Part 1: Cohort 2,1.5% Jaktinib Bid', 'Part 1: Cohort 3, 2.5% Jaktinib Qd', 'Part 1: Cohort 4, 2.5% Jaktinib Bid']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['Dose extension: Vehicle Control', 'Part 1: Cohort 1, 0.5% Jaktinib Bid', 'Part 1: Cohort 2,1.5% Jaktinib Bid', 'Part 1: Cohort 3, 2.5% Jaktinib Qd', 'Part 1: Cohort 4, 2.5% Jaktinib Bid']}]}, 'contactsLocationsModule': {'locations': [{'zip': '410008', 'city': 'Changsha', 'state': 'Hunan', 'country': 'China', 'facility': 'The Second Xiangya Hospital of Central South University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}], 'overallOfficials': [{'name': 'Qianjin Lu, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Central South University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Suzhou Zelgen Biopharmaceuticals Co.,Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}