NCT06375005 Efficacy and Safety of Telitacicept in the Treatment of Systemic Sclerosis
| NCT ID | NCT06375005 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University |
| Condition | Diffuse Cutaneous Systemic Sclerosis |
| Study Type | INTERVENTIONAL |
| Enrollment | 38 participants |
| Start Date | 2025-01-06 |
| Primary Completion | 2027-01-06 |
Trial Parameters
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Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Men or women aged 18-70 years old. * Systemic sclerosis, as defined by ACR/EULAR (American College of Rheumatology/European League Against Rheumatism) 2013 criteria. * dcSSc (diffuse cutaneous systemic sclerosis) according to the LeRoy criteria. * Disease duration of ≤ 18 months (defined as time from the first non-Raynaud's phenomenon manifestation). * ≥ 10 mRSS units at the screening visit. * Negative serum pregnancy test in a woman of childbearing potential at the screening visit. * Ability to render informed consent in accordance with institutional guidelines. Exclusion Criteria: * Limited scleroderma. * Disease duration of greater than 3 years. * Rheumatic autoimmune disease other than SSc. * Systemic sclerosis-like illness associated with environmental agents such as vinyl chloride, or bleomycin. * Any prior history of renal crisis. * Intermediate- or high-risk pulmonary arterial hypertension. * Pulmonary disease with FVC \< 50% of predicted or DLCO (hemoglob