Ignite Creation Date:
2025-12-24 @ 6:36 PM
Ignite Modification Date:
2025-12-24 @ 6:36 PM
Study NCT ID:
NCT06640257
Status:
RECRUITING
Last Update Posted:
2024-11-12
First Post:
2024-10-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Study of the Efficacy and Safety of SHR-1314 for Adult 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'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2026-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-08', 'studyFirstSubmitDate': '2024-10-10', 'studyFirstSubmitQcDate': '2024-10-10', 'lastUpdatePostDateStruct': {'date': '2024-11-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-10-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of subjects achieving ACR 20 improvement at week 24', 'timeFrame': 'Week 24'}], 'secondaryOutcomes': [{'measure': 'The proportion of subjects who achieved ACR 50 improvement', 'timeFrame': 'Week 24'}, {'measure': 'The proportion of subjects who achieved ACR 70 improvement', 'timeFrame': 'Week 24'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Psoriatic Arthritis']}, 'descriptionModule': {'briefSummary': 'This study is a randomized, double-blind, multicenter, placebo-controlled Phase III clinical study, consisting of a 4-week screening period, a 24-week core treatment period, a 24-week maintenance treatment period, and an 8-week safety follow-up period. It is planned to include 150 adult subjects with psoriatic arthritis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], '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. At the time of screening, it met the 2006 psoriatic arthritis classification standard (CASPAR)；\n3. There is active PsA before randomization;\n4. Have active plaque psoriasis (at least one plaque skin lesion) at the time of screening, or have a history of plaque psoriasis;\n5. Participants who have previously been treated with csDMARDs and/or NSAIDs still have active psoriatic arthritis disease.\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': 'NCT06640257', 'briefTitle': 'A Study of the Efficacy and Safety of SHR-1314 for Adult Active Psoriatic Arthritis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Suzhou Suncadia Biopharmaceuticals Co., Ltd.'}, 'officialTitle': 'A Multicenter, Randomized, Double-blind, Placebo-controlled Phase III Trial Evaluating the Efficacy and Safety of SHR-1314 Injection in Adults With Active Psoriatic Arthritis', 'orgStudyIdInfo': {'id': 'SHR-1314-308'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SHR-1314 injection', 'interventionNames': ['Drug: SHR-1314 injection']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'placebo', 'interventionNames': ['Drug: SHR-1314 injection', 'Drug: Placebo']}], 'interventions': [{'name': 'SHR-1314 injection', 'type': 'DRUG', 'description': 'SHR-1314 injection', 'armGroupLabels': ['SHR-1314 injection', 'placebo']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo', 'armGroupLabels': ['placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '200433', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hejian Zou', 'role': 'CONTACT', 'email': 'hjzou@fudan.edu.cn'}, {'name': 'Weiguo Wan', 'role': 'CONTACT', 'email': 'Wgwan1969@sina.com'}, {'name': 'Hejian Zou', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Weiguo Wan', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Huashan Hospital of the Shanghai FuDan University', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Su Zhang, M.M', 'role': 'CONTACT', 'email': 'su.zhang.sz3@hengrui.com', 'phone': '0518-82342973'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Suzhou Suncadia Biopharmaceuticals Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}