Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2026-01-01 @ 3:21 AM
Study NCT ID:
NCT06573593
Status:
RECRUITING
Last Update Posted:
2024-08-27
First Post:
2024-08-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety of JAK Inhibitors in Patients With AA: RWE Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000506', 'term': 'Alopecia Areata'}], 'ancestors': [{'id': 'D000505', 'term': 'Alopecia'}, {'id': 'D007039', 'term': 'Hypotrichosis'}, {'id': 'D006201', 'term': 'Hair Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C479163', 'term': 'tofacitinib'}, {'id': 'C000596027', 'term': 'baricitinib'}, {'id': 'C540383', 'term': 'ruxolitinib'}, {'id': 'C000613732', 'term': 'upadacitinib'}, {'id': 'C000634427', 'term': 'abrocitinib'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-07-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-25', 'studyFirstSubmitDate': '2024-08-25', 'studyFirstSubmitQcDate': '2024-08-25', 'lastUpdatePostDateStruct': {'date': '2024-08-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-08-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean SALT', 'timeFrame': 'at week 24', 'description': 'Reduction of Severity of Alopecia Tool (SALT) score compared with baseline'}, {'measure': 'SALT50', 'timeFrame': 'at week 24', 'description': 'Percentage of patient with more than 50% improvement in SALT score'}, {'measure': 'SALT75', 'timeFrame': 'at week 24', 'description': 'Percentage of patient with more than 70% improvement in SALT score'}], 'secondaryOutcomes': [{'measure': 'Mean SALT', 'timeFrame': 'at week 12, 36, 48, 56', 'description': 'Reduction of Severity of Alopecia Tool (SALT) score compared with baseline'}, {'measure': 'SALT50', 'timeFrame': 'at week 12, 36, 48, 56', 'description': 'Percentage of patient with more than 75% improvement in SALT score'}, {'measure': 'SALT75', 'timeFrame': 'at week 12, 36, 48, 56', 'description': 'Percentage of patient with more than 50% improvement in SALT score'}, {'measure': 'Safety profile', 'timeFrame': 'at week 4, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52, 56', 'description': 'Any adverse events including infection, hypohepatia, thrombus, gastrointestinal reaction and any other system events.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alopecia Areata', 'Janus Kinase Inhibitors']}, 'descriptionModule': {'briefSummary': 'The introduction of Janus Kinase inhibitors (JAKi) seems to revolutionize the field of alopecia areata (AA) therapeutics. However, the ideal JAKi is not yet settled and the real-world data are still missing. To provide evidence about effectiveness and safety of different JAKi including tofacitinib, baricitinib, ritlecitinib，abrocitinib, upadacitinib and ifidancitinib in real-world settings and describe baseline disease characteristics and patients profiles that are considered good candidates for JAKi in the daily practice. Furthermore, we intended to investigate the efficacy and safety of JAK Inhibitors in patients With AA, as well as to provide clinical evidence for the clinicians and patients when they formulate individualized treatment plans.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '2 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with alopecia areata treated with JAKi including tofacitinib, baricitinib, ritlecitinib，abrocitinib, upadacitinib and ifidancitinib for more than 3 months in Department of Dermatology, Second Affiliated Hospital, Zhejiang University School of Medicine', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with alopecia areata between 2 to 18 years old\n* Patients diagnosed with alopecia areata according to AA guideline\n* AA Patients treated with JAKi including tofacitinib, baricitinib, ritlecitinib，abrocitinib, upadacitinib and ifidancitinib for more than 3 months\n\nExclusion Criteria:\n\n* Patients had previously received hair implants\n* Other alopecia\n* Other diseases may induce alopecia including psoriasis, lichen planus, et al.\n* Unable to estimate SALT score at baseline or at follow-up\n* Patients are participating in other clinical trials'}, 'identificationModule': {'nctId': 'NCT06573593', 'briefTitle': 'Efficacy and Safety of JAK Inhibitors in Patients With AA: RWE Study', 'organization': {'class': 'OTHER', 'fullName': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}, 'officialTitle': 'Efficacy and Safety of JAK Inhibitors in Patients With Alopecia Areata: a Single-center, Real-world Study', 'orgStudyIdInfo': {'id': '20240699'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Tofacitinib treated group', 'description': 'In the real-world settings, patients with AA treated with tofacitinib.', 'interventionNames': ['Drug: Tofacitinib']}, {'label': 'Baritinib treated group', 'description': 'In the real-world settings, patients with AA treated with baritinib.', 'interventionNames': ['Drug: Baricitinib']}, {'label': 'Ruxolitinib treated group', 'description': 'In the real-world settings, patients with AA treated with ruxolitinib', 'interventionNames': ['Drug: Ruxolitinib']}, {'label': 'Upadacitinib treated group', 'description': 'In the real-world settings, patients with AA treated with upadacitinib.', 'interventionNames': ['Drug: Upadacitinib']}, {'label': 'Abrocitinib treated group', 'description': 'In the real-world settings, patients with AA treated with abhicitinib.', 'interventionNames': ['Drug: Abrocitinib']}, {'label': 'Ritlecitinib treated group', 'description': 'In the real-world settings, patients with AA treated with ritlecitinib.', 'interventionNames': ['Drug: Ritlecitinib']}], 'interventions': [{'name': 'Tofacitinib', 'type': 'DRUG', 'description': 'In the real-world settings, patients with AA treated with tofacitinib.', 'armGroupLabels': ['Tofacitinib treated group']}, {'name': 'Baricitinib', 'type': 'DRUG', 'description': 'In the real-world settings, patients with AA treated with Baricitinib.', 'armGroupLabels': ['Baritinib treated group']}, {'name': 'Ruxolitinib', 'type': 'DRUG', 'description': 'In the real-world settings, patients with AA treated with Ruxolitinib.', 'armGroupLabels': ['Ruxolitinib treated group']}, {'name': 'Upadacitinib', 'type': 'DRUG', 'description': 'In the real-world settings, patients with AA treated with Upadacitinib.', 'armGroupLabels': ['Upadacitinib treated group']}, {'name': 'Abrocitinib', 'type': 'DRUG', 'description': 'In the real-world settings, patients with AA treated with Abrocitinib.', 'armGroupLabels': ['Abrocitinib treated group']}, {'name': 'Ritlecitinib', 'type': 'DRUG', 'description': 'In the real-world settings, patients with AA treated with Ritlecitinib.', 'armGroupLabels': ['Ritlecitinib treated group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '310009', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Ru Dai, Ph.D', 'role': 'CONTACT', 'email': 'dairu@zju.edu.cn', 'phone': '86 15982215914'}], 'facility': 'Second Affiliated Hospital, School of Medicine, Zhejiang University, China', 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Ru Dai, MD', 'role': 'CONTACT', 'email': 'dairu@zju.edu.cn', 'phone': '15982215914'}, {'name': 'Wu', 'role': 'CONTACT', 'email': 'wuxianjie@zju.edu.cn'}], 'overallOfficials': [{'name': 'Xianjie Wu, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Second Affiliated Hospital, School of Medicine, Zhejiang University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Second Affiliated Hospital, School of Medicine, Zhejiang University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}