protocolSection identificationModule nctId: NCT06375005, orgStudyIdInfo id: 2024-0381, briefTitle: Efficacy and Safety of Telitacicept in the Treatment of Systemic Sclerosis, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06-01, primaryCompletionDateStruct date: 2025-08-01, completionDateStruct date: 2026-12-31, studyFirstPostDateStruct date: 2024-04-19, lastUpdatePostDateStruct date: 2024-04-19, sponsorCollaboratorsModule leadSponsor name: Second Affiliated Hospital, School of Medicine, Zhejiang University, class: OTHER, descriptionModule 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., conditionsModule conditions: Diffuse Cutaneous Systemic Sclerosis, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 38, type: ESTIMATED, armsInterventionsModule interventions name: Telitacicept, interventions name: Mycophenolate Mofetil, outcomesModule primaryOutcomes measure: Change From Baseline in Modified Rodnan Skin Score (mRSS) at Week 48, primaryOutcomes measure: Percentage of Participants With Treatment-related Adverse Events (AEs) and Serious Adverse Events (SAEs), secondaryOutcomes measure: Change From Baseline in Modified Rodnan Skin Score (mRSS) at Week 24, secondaryOutcomes measure: Percentage of Participants Who Improved in Modified Rodnan Skin Score (mRSS) by ≥20%, ≥40%, ≥60% From Baseline to Week 24 and Week 48, secondaryOutcomes measure: American College of Rheumatology Composite Response Index for Systemic Sclerosis (ACR-CRISS) and Revised ACR-CRISS at Week 24 and 48, secondaryOutcomes measure: Change From Baseline in Forced Vital Capacity (FVC) Percent Predicted at Week 24 and Week 48, secondaryOutcomes 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, secondaryOutcomes measure: Change From Baseline in Patient's Global Assessment at Week 24 and Week 48, secondaryOutcomes measure: Change From Baseline in Physician's Global Assessment at Week 24 and Week 48, secondaryOutcomes measure: Change From Baseline in Short Form-36 (SF-36) Questionnaire at Week 24 and Week 48, secondaryOutcomes measure: Change From Baseline in Health Assessment Questionnaire Disability Index (HAQ-DI) Score at Week 24 and Week 48, secondaryOutcomes measure: Change From Baseline in Physical Function Assessed by Scleroderma Health Assessment Questionnaire Disability Index (SHAQ-DI) at Week 24 and Week 48, secondaryOutcomes measure: Change From Baseline in Tender Joint Counts at Week 24 and Week 48, secondaryOutcomes measure: Change From Baseline in Swollen Joint Counts at Week 24 and Week 48, secondaryOutcomes measure: Change From Baseline in Digital Ulcer Counts at Week 24 and Week 48, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Affiliated Hospital of Yangzhou University, city: Yangzhou, state: Jiangsu, zip: 225009, country: China, geoPoint lat: 32.39722, lon: 119.43583, locations facility: Huashan Hospital of Fudan University, city: Shanghai, state: Shanghai, zip: 200433, country: China, geoPoint lat: 31.22222, lon: 121.45806, locations facility: Hangzhou First People's Hospital, city: Hangzhou, state: Zhejiang, zip: 310006, country: China, geoPoint lat: 30.29365, lon: 120.16142, locations facility: Sir Run Run Shaw Hospital, Zhejiang University School Of Medicine, city: Hangzhou, state: Zhejiang, zip: 310016, country: China, geoPoint lat: 30.29365, lon: 120.16142, locations facility: The Second Affiliated Hospital of Zhejiang University School of Medicine, city: Hangzhou, state: Zhejiang, zip: 310016, country: China, contacts name: Jing Xue, PhD, role: CONTACT, phone: 86-13858121751, email: jingxue@zju.edu.cn, geoPoint lat: 30.29365, lon: 120.16142, locations facility: Changxing People's Hospital, city: Huzhou, state: Zhejiang, zip: 313100, country: China, geoPoint lat: 30.8703, lon: 120.0933, locations facility: The First Hospital of Jiaxing, city: Jiaxing, state: Zhejiang, zip: 314000, country: China, geoPoint lat: 30.7522, lon: 120.75, locations facility: Ningbo First Hospital, city: Ningbo, state: Zhejiang, zip: 315000, country: China, geoPoint lat: 29.87819, lon: 121.54945, locations facility: The First Affiliated Hospital of Wenzhou Medical University, city: Wenzhou, state: Zhejiang, zip: 325000, country: China, geoPoint lat: 27.99942, lon: 120.66682, hasResults: False