Evaluating Telitacicept for treating Systemic Lupus Erythematosus in Chinese patients

Proteomics Combined With Metabolomics Studies on the Efficacy of Telitacicept in Chinese Patients of Systemic Lupus Erythematosus

This study is testing if a new treatment called Telitacicept can help Chinese patients with active Systemic Lupus Erythematosus who haven't found relief from other medications.

Quick facts

• Phase: PHASE4
• Study type: Interventional
• Enrollment: 30 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Central South University (other)
• Drugs / interventions: prednisone
• Locations: 1 site (Changsha, Hunan)
• Trial ID: NCT05666336 on ClinicalTrials.gov

What this trial studies

This study investigates the efficacy of Telitacicept, a biologic agent targeting B lymphocyte stimulator and APRIL, in patients with active Systemic Lupus Erythematosus (SLE) who have not responded to conventional treatments. The research aims to identify predictive biomarkers of efficacy using multi-omics approaches, including serum proteomics and metabolomics, to better understand the drug's mechanisms of action. By integrating various omics data, the study seeks to provide a comprehensive analysis of biological functions and regulatory mechanisms related to SLE treatment. The ultimate goal is to enhance precision medicine for SLE patients in China.

Who should consider this trial

Good fit: Ideal candidates include Chinese patients diagnosed with active SLE who have not responded to standard treatments and meet specific clinical criteria.

Not a fit: Patients with severe lupus nephritis or central nervous system involvement related to SLE may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more effective and personalized treatment options for patients with Systemic Lupus Erythematosus.

How similar studies have performed: Other studies have shown promise in using targeted biologic therapies for SLE, but the specific multi-omics approach in this study is relatively novel.

Eligibility criteria

Inclusion Criteria:

1. Patients with a clinical diagnosis of SLE according to American College of Rheumatology (ACR) classification criteria 1997 and clinically active disease.
2. Patients with good compliance, will sign the informed consent before the test.
3. Patients who have received conventional treatment for SLE, and the type and dose of treatment drugs have been stable for at least 30 days.
4. Patients who have a positive anti-nuclear antibody test result and SELENA-SLEDAI score ≥8 at screening. If there is a low complement and/or positive anti-dsDNA antibody, the SELENA-SLEDAI score can be defined as ≥ 6 points.

Exclusion Criteria:

1. Patients with severe lupus nephritis, defined as urinary protein \> 6g /24 hours or serum creatinine \> 221μmol/L within the last 2 months, or who require hemodialysis.
2. Patients with SLE-caused or non-SLE-caused central nervous system disease within the last 2 months.
3. Patients with severe condition in blood, important organs including heart, liver, gastrointestinal tract and endocrine system which are not related with SLE.
4. Patients who use prednisone ≥100mg/d over 14 days or receive plasma replacement and suffer from active infection within the last 1 month.
5. Patients who received any other targeted agents over the past 12 months.

Where this trial is running

Changsha, Hunan

• Department of Rheumatology and Immunology, Xiangya Second Hospital, Central South University — Changsha, Hunan, China (RECRUITING)

Study contacts

• Principal investigator: Fen Li, doctor — Central South University
• Study coordinator: Fen Li, doctor

Conditions: Systemic Lupus Erythematosus, Telitacicept, efficiency, omics