Safety and Efficacy of Telitacicept in the Treatment of Systemic Lupus Erythematosus (SLE)

StatusUnknown
PhaseNot specified
Started

Record status This record was last updated November 19, 2024 (before its estimated December 1, 2024 completion). Its status may not reflect the trial's current state.

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Record History

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  1. Minor Changed Registry marked status Unknown (sponsor has not verified the record since Sep 2024); last known: Recruiting
  2. Notable Primary endpoints: 23 to 22
    • Primary completion date: Oct 1, 2024 to Dec 1, 2024
    • Study title shortened, about 1 word
    v3
  3. Minor Primary completion date: Jul 1, 2024 to Oct 1, 2024
    • Study completion date: Aug 31, 2024 to Dec 31, 2024
    • Collaborators revised (7)
    v2
  4. Minor Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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Systemic lupus erythematosus (SLE) is a highly specific autoimmune disease that involves multiple systems due to abnormal immune activation. It is a classical diffuse connective tissue disease with autoimmune inflammation as its prominent manifestation. B cells are the core of systemic lupus erythematosus (SLE) pathogenesis. B Lymphocyte Stimulator (BLyS, also called BAFF) and A Proliferation-Inducing Ligand (APRIL) are signals for B cell maturation. B Lymphocyte Stimulator (BLyS) participates in promoting the development and maturation of B cells, while A Proliferation-Inducing Ligand (APRIL) participates in promoting the activation of mature B cells and the secretion of antibodies by plasma cells. Telitacicept is composed of the extracellular specific soluble portion of Transmembrane Activator and Calcium-modulating Cyclophilin Ligand (CAML) Interactor (TACI) and the Fragment crystallizable (Fc) segment of human Immunoglobulin G1 (IgG1). It is the only globally approved dual-target biological agent for the treatment of systemic lupus erythematosus (SLE) , blocking B Lymphocyte Stimulator (BLyS) and A Proliferation-Inducing Ligand (APRIL), hindering the development and activation of B cells, and the production of antibodies, comprehensively inhibiting the maturation, proliferation, and differentiation of B cells at different stages. In this study, the investigators will explore the adherence and influencing factors of telitacicept in systemic lupus erythematosus (SLE) patients, its effectiveness, and safety, providing a stronger basis for clinical management of systemic lupus erythematosus (SLE) patients.
Trial Details
NCT Number NCT06458972
Lead Sponsor Tongji Hospital
Collaborators: Jingzhou Central Hospital, Wuhan Central Hospital, Xiangyang Central Hospital, Wuhan No.1 Hospital, China Three Gorges University, Yichang, China, Shanghai Zhongshan Hospital, The First People's Hospital of Jingzhou
Conditions
(from sponsor)
Systemic Lupus Erythematosus
Related terms Lupus Erythematosus, Systemic
Enrollment 139 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov