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

NCT06546540 · Status: RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2024-08-09

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Telitacicept

160mg，once weekly

Sponsors & Collaborators

  • Peking University Third Hospital

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-06-08
Primary Completion
2025-12-10
Completion
2026-03-30

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06546540 on ClinicalTrials.gov