The Safety and Efficacy of Telitacicept in the Treatment of Systemic Sclerosis

Sponsor
Peking University Third Hospital
Study ID
NCT06546540
Phase
PHASE4
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

Study Details

Systemic sclerosis (SSc) is a chronic, multisystem autoimmune disease characterized by potentially widespread and progressive skin fibrosis and vascular abnormalities, and may involve the musculoskeletal, gastrointestinal, pulmonary, cardiac, renal, neuromuscular, and urogenital systems. At present, there is no clear and effective drug treatment for the progression of scleroderma skin lesions, and there is a lack of authoritative treatment recommendations. In recent years, research on the treatment of B cells in SSc suggests that targeted B cell therapy has certain safety and effectiveness for SSc patients. Telitacicept is a fully human fusion protein that is a fusion of TACI protein and IgG1 protein. Telitacicept can inhibit the further development and maturation of immature B cells by blocking BLyS. At the same time, Telitacicept can also inhibit the differentiation of mature B cells into plasma cells by blocking APRIL, and affect the secretion of abnormal self reactive plasma cell autoantibodies, better controlling disease activity. The effectiveness and safety of SSc treatment require further research. This study is an evaluator blind, parallel controlled clinical trial that included 20 SSc patients who still had skin progression despite conventional treatment. The patients were divided into two groups, one group included patients who did not improve with conventional treatment for skin lesions, and the other group included patients who received traditional conventional treatment. The main outcome of the study was to evaluate the efficacy and safety of Telitacicept in the treatment of progressive skin lesions in SSc, and the secondary outcome was to evaluate the impact of Telitacicept on lung function, gastrointestinal symptoms, pulmonary arterial hypertension, disease activity, and quality of life in SSc.

Key Dates

Start date
Jun 8, 2024
Status verified
Aug 2024
Primary completion
Dec 10, 2025
Completion
Mar 30, 2026

Study Design

Enrollment
20 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Telitacicept
  • No Intervention: Conventional

Primary Outcome Measure

Changes of mRSS in patients after 52 weeks of treatment [ Time Frame: base line and week 52 ]

Central Contacts

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