Ignite Creation Date:
2025-12-24 @ 5:17 PM
Ignite Modification Date:
2026-01-02 @ 1:57 AM
Study NCT ID:
NCT04957550
Status:
UNKNOWN
Last Update Posted:
2023-02-09
First Post:
2021-07-05
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
To Evaluate the Efficacy and Safety of SHR0302 Tablet in Subjects of Active Psoriatic Arthritis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015535', 'term': 'Arthritis, Psoriatic'}], 'ancestors': [{'id': 'D025242', 'term': 'Spondylarthropathies'}, {'id': 'D025241', 'term': 'Spondylarthritis'}, {'id': 'D013166', 'term': 'Spondylitis'}, {'id': 'D013122', 'term': 'Spinal Diseases'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D001168', 'term': 'Arthritis'}, {'id': 'D007592', 'term': 'Joint Diseases'}, {'id': 'D011565', 'term': 'Psoriasis'}, {'id': 'D017444', 'term': 'Skin Diseases, Papulosquamous'}, {'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', 'interventionModelDescription': 'SHR0302 tablets compared with placebo'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 444}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2021-08-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2024-11-13', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-02-07', 'studyFirstSubmitDate': '2021-07-05', 'studyFirstSubmitQcDate': '2021-07-05', 'lastUpdatePostDateStruct': {'date': '2023-02-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-13', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ACR20 response rate at week 24', 'timeFrame': 'Week 24', 'description': 'Percentage of Participants Meeting American College of Rheumatology Response Criteria Greater Than or Equal to (≥) 20% (ACR20) at week 24'}], 'secondaryOutcomes': [{'measure': 'ACR20 response rate at week 48', 'timeFrame': 'Week 48', 'description': 'Percentage of Participants Meeting American College of Rheumatology Response Criteria Greater Than or Equal to (≥) 20% (ACR20) at week 48'}, {'measure': 'ACR50/70 response rate at week 24 and week 48', 'timeFrame': 'Week 24 and week48', 'description': 'Percentage of Participants Meeting American College of Rheumatology Response Criteria Greater Than or Equal to (≥) 50%/70% (ACR50/70) at week 24 and week 48'}, {'measure': 'Change from baseline in DAS28-CRP week 24 and week 48', 'timeFrame': 'Week 24 and week 48', 'description': 'Change from baseline in the disease activity score-CRP(DAS 28-CRP) at week 24 and week 48'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Psoriatic Arthritis']}, 'descriptionModule': {'briefSummary': 'This study is a phase 3 study,to evaluate the efficacy and safety of different doses of JAK1 inhibitor SHR0302 in subjects with active psoriatic arthritis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Provide signed informed consent；\n2. Diagnosis of PsA fulfillment of the Classification Criteria for PsA (CASPAR) criteria with symptom onset at least 6 months prior to the Screening Visit；\n3. Active arthritis at screening/baseline as indicated by \\>/= 3 tender/painful and 3 swollen joints；\n4. Diagnosis of active plaque psoriasis or documented history of plaque psoriasis.\n\nExclusion Criteria:\n\n1. History of other autoimmune diseases; history of cancer or infection including tuberculosis and hepatitis; history of important cardiovascular events or thrombotic diseases；\n2. Non-plaque forms of psoriasis (with exception of nail psoriasis)；\n3. Previous treatment with cytotoxic drugs; JAK inhibitor or bDMARDs within 6 months of randomization.'}, 'identificationModule': {'nctId': 'NCT04957550', 'briefTitle': 'To Evaluate the Efficacy and Safety of SHR0302 Tablet in Subjects of Active Psoriatic Arthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Jiangsu HengRui Medicine Co., Ltd.'}, 'officialTitle': 'A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Clinical Study to Evaluate the Efficacy and Safety of SHR0302 in Active Psoriatic Arthritis Subjects', 'orgStudyIdInfo': {'id': 'SHR0302-303'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Treatment group A', 'description': 'SHR0302 tablets dose 1+ Placebo dose 2', 'interventionNames': ['Drug: SHR0302 tablets、Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Treatment group B', 'description': 'SHR0302 tablets dose 2+ Placebo dose 1', 'interventionNames': ['Drug: SHR0302 tablets、Placebo']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Treatment group C', 'description': 'Placebo dose1 + placebo dose 2', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'SHR0302 tablets、Placebo', 'type': 'DRUG', 'description': 'SHR0302 tablets dose 1 for 48 weeks', 'armGroupLabels': ['Treatment group A']}, {'name': 'SHR0302 tablets、Placebo', 'type': 'DRUG', 'description': 'SHR0302 tablets dose 2 for 48 weeks', 'armGroupLabels': ['Treatment group B']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'SHR0302 tablets blank preparation for 24 weeks then SHR0302 tablets dose 1/dose 2 for 24 weeks', 'armGroupLabels': ['Treatment group C']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200433', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Peking University Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jiangsu HengRui Medicine Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}