Ignite Creation Date:
2025-12-24 @ 12:01 PM
Ignite Modification Date:
2025-12-30 @ 4:40 PM
Study NCT ID:
NCT05051761
Status:
COMPLETED
Last Update Posted:
2025-03-14
First Post:
2021-09-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study to Evaluate the Safety and Efficacy of Jaktinib in Adults With Alopecia Areata
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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 425}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2023-12-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-13', 'studyFirstSubmitDate': '2021-09-11', 'studyFirstSubmitQcDate': '2021-09-20', 'lastUpdatePostDateStruct': {'date': '2025-03-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Achieving Severity of Alopecia Tool (SALT) ≤ 20 at Week 24', 'timeFrame': 'Week 24', 'description': 'SALT is a quantitative assessment of scalp hair loss with scores ranging in severity from 0 (no scalp hair loss) to a maximum of 100 (complete scalp hair loss).'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants Achieving 50% Improvement of SALT (SALT50)', 'timeFrame': 'Week 24', 'description': 'Percentage of participants achieving SALT50'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Alopecia Areata']}, 'descriptionModule': {'briefSummary': 'This is a multi-center Phase 3 study to evaluate the safety and effectiveness of an investigational study drug (called Jaktinib) in adults (≥18 years and \\<65 years) who have 50% or greater scalp hair loss. The study is placebo-controlled, meaning that some patients entering the study will not receive active study drug but will receive tablets with no active ingredients (a placebo). It is double-blinded, meaning that the Sponsor, the study doctors, the staff, and the patients will not know whether a patient is on active study drug (or the dose) or placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* participants voluntarily sign the informed consent form (ICF);\n* Age ≥ 18 years and \\<65 years, either male or female;\n* Clinical presentation compatible with alopecia areata with a current episode lasting not exceeding ≤8 years.\n* At least 50% scalp hair loss.\n* Willing to comply with the study visits and requirements of the study protocol.\n\nExclusion Criteria:\n\n* participants has taken a JAK inhibitor prior to randomization;\n* participants who are unsuitable to the trial, as identified by the investigator.'}, 'identificationModule': {'nctId': 'NCT05051761', 'acronym': 'AA', 'briefTitle': 'Study to Evaluate the Safety and Efficacy of Jaktinib in Adults With Alopecia Areata', 'organization': {'class': 'INDUSTRY', 'fullName': 'Suzhou Zelgen Biopharmaceuticals Co.,Ltd'}, 'officialTitle': 'A Multi-center, Randomized, Double-blind, Placebo-controlled Phase III Study to Evaluate the Efficacy and Safety of Jaktinib in Adult Patients With Severe Alopecia Areata', 'orgStudyIdInfo': {'id': 'ZGJAK018'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Jaktinib 50mg BID', 'description': 'Participants received Jaktinib 50mg tablets, orally, twice daily (BID) for up to 24 weeks.', 'interventionNames': ['Drug: Jaktinib']}, {'type': 'EXPERIMENTAL', 'label': 'Jaktinib 75mg BID', 'description': 'Participants received Jaktinib 75mg tablets, orally, twice daily (BID) for up to 24 weeks.', 'interventionNames': ['Drug: Jaktinib']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'description': 'Participants received Jaktinib matched placebo tablets, orally, twice daily (BID) for up to 24 weeks.', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'Jaktinib', 'type': 'DRUG', 'description': 'Administered orally.', 'armGroupLabels': ['Jaktinib 50mg BID', 'Jaktinib 75mg BID']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'Administered orally.', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100044', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': "Peking University People's Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '210042', 'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Hospital for Skin Diseases, Chinese Academy of medical Sciences', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'overallOfficials': [{'name': 'Jason Wu', 'role': 'STUDY_CHAIR', 'affiliation': 'Suzhou Zelgen Biopharmaceuticals Co.,Ltd'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Suzhou Zelgen Biopharmaceuticals Co.,Ltd', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}