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A Study of Telitacicept for the Treatment of Moderately to Severely Active Systemic Lupus Erythematosus (REMESLE-2)

Systemic Lupus Erythematosus Clinical Trial

Official title:
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Telitacicept Compared to Placebo in Patients With Moderately to Severely Active Systemic Lupus Erythematosus (REMESLE-2)

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of telitacicept in the treatment of moderately to severely active SLE.

Clinical Trial Description

Systemic Lupus Erythematosus (SLE) is a chronic autoimmune disease with heterogeneous manifestations and disease course. Despite advances in medical care, there are still significant unmet needs in SLE with diminished health-related quality of life (HRQoL), persistent disease activity, disease flares, intolerance to standard of care (SOC) therapies, and development of organ damage and co-morbidities. Telitacicept is a fully human TACI-Fc fusion protein that targets B lymphocyte stimulator (BLyS) and a proliferating-inducing ligand (APRIL). Blocking the interaction of BLyS and APRIL with their cell membrane receptors (TACI, B-cell maturation antigen (BCMA), and B-cell activating factor receptor (BAFF-R) would inhibit B cell proliferation and maturation, suppresses immune responses and may alleviate autoimmune symptoms. This is a multicenter, randomized, double-blind, placebo-controlled, phase 3 study to evaluate the efficacy and safety of telitacicept added to standard of care (SoC) therapy compared to placebo with SoC therapy in subjects with moderately to severely active SLE. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06456567
Study type Interventional
Source RemeGen Co., Ltd.
Contact RemeGen
Phone 800-910-6542
Email RC18_SLEstudy@remegenbio.com
Status Not yet recruiting
Phase Phase 3
Start date July 2024
Completion date April 2027
View Details
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