nctId: NCT06375005 id: 2024-0381 briefTitle: Efficacy and Safety of Telitacicept in the Treatment of Systemic Sclerosis overallStatus: NOT_YET_RECRUITING date: 2024-06-01 date: 2025-08-01 date: 2026-12-31 date: 2024-04-19 date: 2024-04-19 name: Second Affiliated Hospital, School of Medicine, Zhejiang University class: OTHER briefSummary: This study is a prospective, open-label, randomized, controlled, multi-center clinical trial. The aim of this study is to investigate the efficacy and safety of Telitacicept in adults with early diffuse cutaneous systemic sclerosis (dcSSc), with Mycophenolate Mofetil (MMF) administered as a background treatment. conditions: Diffuse Cutaneous Systemic Sclerosis studyType: INTERVENTIONAL phases: PHASE2 allocation: RANDOMIZED interventionModel: PARALLEL primaryPurpose: TREATMENT masking: NONE count: 38 type: ESTIMATED name: Telitacicept name: Mycophenolate Mofetil measure: Change From Baseline in Modified Rodnan Skin Score (mRSS) at Week 48 measure: Percentage of Participants With Treatment-related Adverse Events (AEs) and Serious Adverse Events (SAEs) measure: Change From Baseline in Modified Rodnan Skin Score (mRSS) at Week 24 measure: Percentage of Participants Who Improved in Modified Rodnan Skin Score (mRSS) by ≥20%, ≥40%, ≥60% From Baseline to Week 24 and Week 48 measure: American College of Rheumatology Composite Response Index for Systemic Sclerosis (ACR-CRISS) and Revised ACR-CRISS at Week 24 and 48 measure: Change From Baseline in Forced Vital Capacity (FVC) Percent Predicted at Week 24 and Week 48 measure: Change From Baseline in Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) Percent Predicted (Corrected For Hemoglobin) at Week 24 and Week 48 measure: Change From Baseline in Patient's Global Assessment at Week 24 and Week 48 measure: Change From Baseline in Physician's Global Assessment at Week 24 and Week 48 measure: Change From Baseline in Short Form-36 (SF-36) Questionnaire at Week 24 and Week 48 measure: Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Week 24 and Week 48 measure: Change From Baseline in Physical Function Assessed by Scleroderma Health Assessment Questionnaire Disability Index (SHAQ-DI) at Week 24 and Week 48 measure: Change From Baseline in Tender Joint Counts at Week 24 and Week 48 measure: Change From Baseline in Swollen Joint Counts at Week 24 and Week 48 measure: Change From Baseline in Digital Ulcer Counts at Week 24 and Week 48 sex: ALL minimumAge: 18 Years maximumAge: 70 Years stdAges: ADULT stdAges: OLDER_ADULT facility: Affiliated Hospital of Yangzhou University city: Yangzhou state: Jiangsu zip: 225009 country: China lat: 32.39722 lon: 119.43583 facility: Huashan Hospital of Fudan University city: Shanghai state: Shanghai zip: 200433 country: China lat: 31.22222 lon: 121.45806 facility: Hangzhou First People's Hospital city: Hangzhou state: Zhejiang zip: 310006 country: China lat: 30.29365 lon: 120.16142 facility: Sir Run Run Shaw Hospital, Zhejiang University School Of Medicine city: Hangzhou state: Zhejiang zip: 310016 country: China lat: 30.29365 lon: 120.16142 facility: The Second Affiliated Hospital of Zhejiang University School of Medicine city: Hangzhou state: Zhejiang zip: 310016 country: China name: Jing Xue, PhD role: CONTACT phone: 86-13858121751 email: jingxue@zju.edu.cn lat: 30.29365 lon: 120.16142 facility: Changxing People's Hospital city: Huzhou state: Zhejiang zip: 313100 country: China lat: 30.8703 lon: 120.0933 facility: The First Hospital of Jiaxing city: Jiaxing state: Zhejiang zip: 314000 country: China lat: 30.7522 lon: 120.75 facility: Ningbo First Hospital city: Ningbo state: Zhejiang zip: 315000 country: China lat: 29.87819 lon: 121.54945 facility: The First Affiliated Hospital of Wenzhou Medical University city: Wenzhou state: Zhejiang zip: 325000 country: China lat: 27.99942 lon: 120.66682 hasResults: False