NCT05306574

A Study of Telitacicept for the Treatment of Moderately to Severely Active Systemic Lupus Erythematosus (REMESLE-1)

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, 2-Stage Trial to Evaluate Efficacy and Safety of Telitacicept Compared to Placebo in Patients With Moderately to Severely Active Systemic Lupus Erythematosus (REMESLE-1)

• Status: Terminated
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 91 (actual)
• Sponsor: Vor Biopharma · Industry
• Sex: All
• Age: 12 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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 Phase 3 study is a 2-stage study to evaluate the efficacy and safety of telitacicept compared to placebo in patients with moderately to severely active SLE while receiving SoC treatment in a global patient population with active SLE disease. * Stage 1: a study to evaluate the efficacy, safety, pharmacokinetics (PK) and PD of two treatment arms of telitacicept compared to placebo in patients with moderately to severely active SLE while receiving SoC treatment. * Stage 2: a multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of telitacicept added to SoC compared to placebo with SoC therapy in patients with moderately to severely active SLE.

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
BIOLOGICAL	Telitacicept	Subcutaneous injection weekly for 52 weeks
BIOLOGICAL	Placebo	Subcutaneous injection weekly for 52 weeks

Timeline

• Start date: 2022-06-20
• Primary completion: 2025-01-06
• Completion: 2025-01-06
• First posted: 2022-04-01
• Last updated: 2026-01-09

Locations

78 sites across 15 countries: United States, Argentina, Australia, Bulgaria, Chile, Colombia, Germany, Guatemala, Hungary, Mauritius, Mexico, Philippines, Poland, Puerto Rico, Spain

Regulatory

• FDA-regulated drug study