Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-04-06 @ 9:29 PM
Study NCT ID:
NCT07355257
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-21
First Post:
2026-01-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
TELITACICEPT IN INFLAMMATORY MYOPATHIES(TELITACICEPT-IM)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009220', 'term': 'Myositis'}], 'ancestors': [{'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000722462', 'term': 'telitacicept'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Masking Description'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Model Description'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2027-03-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-19', 'studyFirstSubmitDate': '2026-01-19', 'studyFirstSubmitQcDate': '2026-01-19', 'lastUpdatePostDateStruct': {'date': '2026-01-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Physician's Global Assessment (PGA) Score", 'timeFrame': 'From enrollment to the end of treatment at 12 weeks'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Inflammatory Myopathy']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to evaluate the efficacy of Telitacicept in the treatment of inflammatory myopathy in patients with inflammatory diseases. The main question it aims to answer is: the safety and effectiveness of Telitacicept in treating inflammatory myopathy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥ 18 years and ≤ 70 years.\n* Patient has a confirmed diagnosis of inflammatory myopathy, meeting the 2017 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria for idiopathic inflammatory myopathies.\n* Inadequate response or intolerance to glucocorticoids and/or at least one immunosuppressant.\n* The patient or their legal guardian provides written informed consent.\n\nExclusion Criteria:\n\n* Female patients who are pregnant, breastfeeding, or planning a pregnancy during the trial period.\n* Patients with active infections, such as herpes zoster, HIV, active tuberculosis, active hepatitis, HBsAg-positive patients, or HCV antibody-positive patients.\n* Patients with positive test results indicating COVID-19 infection within 1 month prior to baseline.\n* Patients with a history of or currently diagnosed malignancy.\n* Patients with significant cardiovascular diseases (including severe arrhythmia), hepatic, renal, respiratory, endocrine, or hematological disorders, or any other medical condition that, in the investigator's judgment, would interfere with participation in the study or require hospitalization during the trial.\n* Patients who have received intravenous immunoglobulin (IVIG) or plasmapheresis within 1 month prior to baseline.\n* Patients who have received other targeted biologic therapies, such as rituximab, eculizumab, tocilizumab, etc., within 3 months prior to baseline.\n* Patients who have received any live vaccine within 3 months prior to baseline or plan to receive any vaccine during the study period.\n* Patients with a known allergy to human-derived biologics.\n* Patients currently participating in another clinical trial.\n* Patients deemed unsuitable for participation by the investigator for other reasons (e.g., severe psychiatric disorders)."}, 'identificationModule': {'nctId': 'NCT07355257', 'briefTitle': 'TELITACICEPT IN INFLAMMATORY MYOPATHIES(TELITACICEPT-IM)', 'organization': {'class': 'OTHER', 'fullName': 'Xinqiao Hospital of Chongqing'}, 'officialTitle': 'Safety and Efficacy of Telitacicept in Inflammatory Myopathies', 'orgStudyIdInfo': {'id': '2025-362'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: Treatment group', 'interventionNames': ['Drug: Telitacicept 240mg']}], 'interventions': [{'name': 'Telitacicept 240mg', 'type': 'DRUG', 'description': 'On the basis of the original foundational medication regimen, add Telitacicept 240mg administered via subcutaneous injection once a week for a total of 12 weeks.', 'armGroupLabels': ['Experimental: Treatment group']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Zhaoyou Meng', 'role': 'CONTACT', 'email': 'mengzhaoyou@tmmu.edu.cn', 'phone': '0086-023-68774449'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zhongming Qiu', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professer', 'investigatorFullName': 'Zhongming Qiu', 'investigatorAffiliation': 'Xinqiao Hospital of Chongqing'}}}}