NCT05306574

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

Terminated Phase 3 Last updated 9 January 2026

What this trial tests

Phase 3 trial testing Telitacicept in Systemic Lupus Erythematosus in 91 participants. Terminated before completion.

Timeline

20 June 2022

Primary endpoint
6 January 2025

6 January 2025

Quick facts

Lead sponsor	Vor Biopharma
Phase	Phase 3
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	quadruple
Primary purpose	treatment
Enrollment	91
Start date	20 June 2022
Primary completion	6 January 2025
Estimated completion	6 January 2025
Sites	78 locations across Colombia, Mauritius, Chile, Germany, Hungary, Mexico, Philippines, Poland

Drugs / interventions tested

• Telitacicept — full drug profile →
• Placebo

Conditions studied

• Systemic Lupus Erythematosus — all drugs for Systemic Lupus Erythematosus →

Sponsor

Vor Biopharma — full company profile →

Who can join

Adults 12 to 70, any sex, with Systemic Lupus Erythematosus. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Systemic lupus erythematosus: pathogenesis and targeted therapy.
   Su X, Yu H, Lei Q, Chen X, et al · · 2024 · cited 33× · PMID 39472388 · DOI 10.1186/s43556-024-00217-8
2. Targeting TNF/TNFR superfamilies in immune-mediated inflammatory diseases.
   Veerasubramanian PK, Wynn TA, Quan J, Karlsson FJ. · · 2024 · cited 26× · PMID 39297883 · DOI 10.1084/jem.20240806
3. Immune cell aberrations in Systemic Lupus Erythematosus: navigating the targeted therapies toward precision management.
   Wu Y, Zhang W, Liao Y, Sun T, et al · · 2025 · cited 11× · PMID 40524185 · DOI 10.1186/s11658-025-00749-z
4. Targeted Therapy for SLE-What Works, What Doesn't, What's Next.
   Venturelli V, Isenberg DA. · · 2023 · cited 8× · PMID 37176637 · DOI 10.3390/jcm12093198
5. Immunotherapeutic approaches for systemic lupus erythematosus: early overview and future potential.
   Huang H. · · 2023 · cited 6× · PMID 38282801 · DOI 10.1515/mr-2023-0032
6. The role of B cell-activating factor system in autoimmune diseases: mechanisms, disease implications, and therapeutic advances.
   Li L, Shen S, Shao S, Dang E, et al · · 2025 · cited 4× · PMID 40547016 · DOI 10.3389/fimmu.2025.1538555
7. Targeting rheumatoid arthritis: a molecular perspective on biologic therapies and clinical progress.
   Jain A, Bishnoi M, Prajapati SK, Acharya S, et al · · 2025 · cited 3× · PMID 40707975 · DOI 10.1186/s13036-025-00534-8
8. Juvenile-onset Systemic Lupus Erythematosus: Recent Advances in Pathogenesis and Treatment.
   Natoli V, Charras A, Smith EM, Hedrich CM. · · 2025 · cited 1× · PMID 41410901 · DOI 10.1007/s11926-025-01207-7