Ignite Creation Date:
2025-12-25 @ 2:18 AM
Ignite Modification Date:
2026-02-22 @ 6:46 PM
Study NCT ID:
NCT05055934
Status:
COMPLETED
Last Update Posted:
2024-12-12
First Post:
2021-09-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of the Effectiveness and Safety of SHR-1314 for 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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 112}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-09', 'completionDateStruct': {'date': '2024-06-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-11', 'studyFirstSubmitDate': '2021-09-15', 'studyFirstSubmitQcDate': '2021-09-23', 'lastUpdatePostDateStruct': {'date': '2024-12-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of subjects achieving ACR 20 improvement at week 12', 'timeFrame': 'at week 12'}], 'secondaryOutcomes': [{'measure': 'The proportion of subjects who achieved ACR 50 improvement (week 12)', 'timeFrame': 'week 12'}, {'measure': 'The proportion of subjects who achieved ACR 70 improvement (week 12)', 'timeFrame': 'week 12'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Psoriatic Arthritis']}, 'descriptionModule': {'briefSummary': 'This study is a randomized, double-blind, multicenter, placebo-controlled Phase II clinical study, consisting of a 4-week screening period, a 12-week core treatment period, a 12-week maintenance treatment period, and an 8-week safety follow-up period. It is planned to include 111 adult subjects with psoriatic arthritis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. The subject voluntarily signs an informed consent form before any procedures related to the research start;\n2. Age ≥18 years old and ≤75 years old at the time of signing the informed consent form, regardless of gender;\n3. At the time of screening, it met the 2006 psoriatic arthritis classification standard (CASPAR);\n4. There is active PsA before randomization;\n5. Have active plaque psoriasis (at least one plaque skin lesion) at the time of screening, or have a history of plaque psoriasis;\n\nExclusion Criteria:\n\n1. Existence of any of the following medical history or comorbid diseases: drug-induced psoriasis; other active inflammatory diseases or autoimmune diseases; history of organ transplantation; history of lymphocytic proliferation; severe infections, etc.\n2. Have received psoriatic arthritis or psoriasis drugs, such as intra-articular injections, plant preparations, etc. within a certain period of time in the past.\n3. Those who are allergic to the drug ingredients or excipients in this study, or are allergic to other biological agents.\n4. A history of alcohol abuse or illegal drug abuse in pregnant or breastfeeding women, etc.'}, 'identificationModule': {'nctId': 'NCT05055934', 'briefTitle': 'Study of the Effectiveness and Safety of SHR-1314 for Psoriatic Arthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Suzhou Suncadia Biopharmaceuticals Co., Ltd.'}, 'officialTitle': 'A Multi-center, Randomized, Double-blind, Placebo-controlled Phase II Dose Exploratory Study to Evaluate the Effectiveness and Safety of SHR-1314 Injection in Adult Subjects With Active Psoriatic Arthritis', 'orgStudyIdInfo': {'id': 'SHR-1314-204'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SHR-1314 injection', 'interventionNames': ['Drug: SHR-1314 injection']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'interventionNames': ['Drug: placebo']}], 'interventions': [{'name': 'SHR-1314 injection', 'type': 'DRUG', 'description': 'SHR-1314 injection', 'armGroupLabels': ['SHR-1314 injection']}, {'name': 'placebo', 'type': 'DRUG', 'description': 'placebo', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200433', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'country': 'China', 'facility': 'Huashan Hospital of the Shanghai FuDan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Suzhou Suncadia Biopharmaceuticals Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}