Clinical trial NCT05666336: Multi-omics Studies on the Efficacy of Telitacicept in Chinese SLE Patients
Official title: Proteomics Combined With Metabolomics Studies on the Efficacy of Telitacicept in Chinese Patients of Systemic Lupus Erythematosus
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Systemic Lupus Erythematosus
Keywords: Systemic Lupus Erythematosus
Telitacicept
efficiency
omics
Lead sponsor: Central South University
Sponsor class: OTHER
First posted: 2022-12-27
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Systemic lupus erythematosus (SLE) is a systemic autoimmune disease with abnormal activation of B lymphocytes, which may result in many adverse consequences and even death if not treated actively. Telitacicept, approved conditionally in China in March 2021, is a biologic agent targeting B lymphocyte stimulator (BLyS）and a proliferating inducing ligand (APRIL) dually for patients with active SLE patients who have not responded to conventional treatment. The investigators hope to screen predictive biomarkers of efficacy and explore the mechanism of difference in efficacy of Telitacicept with Chinese characteristics by omics.

Detailed description: Systemic lupus erythematosus (SLE) is a systemic autoimmune disease with abnormal activation of B lymphocytes, which may result in many adverse consequences and even death if not treated actively. Due to the poor therapeutic efficacy and prominent adverse reactions after long-term use of glucocorticoid combined immunosuppressants, the development of targeted drug use for SLE has become a hot area of research for several years. Telitacicept, approved conditionally in China in March 2021, is a biologic agent targeting B lymphocyte stimulator (BLyS）and a proliferating inducing ligand (APRIL) dually for patients with active SLE patients who have not responded to conventional treatment. As another important part of targeted drug use, the research on biomarkers predictive of drug response is also in full swing in the treatment of SLE. The omics technology has unique advantages in screening biomarkers and exploring the mechanism of drug action. The integrated analysis of multi omics can mutually verify and supplement the screening results of a single omics, so as to more systematically and comprehensively analyze the biological molecular functions and regulatory mechanisms. Therefore, this topic selects serum proteomics combined with metabolomics to screen biomarkers for the prediction of the efficacy of Telitacicept, and to explore the mechanism of the difference in the efficacy of Telitacicept, with a view to providing meaningful reference for the exploration of SLE precise treatment.

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.

Primary outcomes:
measure: SLE Responder Index (SRI) 4 response rate
timeFrame: week 24
Secondary outcomes:
measure: The changes of glucocorticoids dose
timeFrame: week 24
measure: The variation of serum markers
timeFrame: week 24
measure: Proteomics
timeFrame: week 24
measure: Metabonomics
timeFrame: week 24
Other outcomes:
Locations:
city: Changsha
country: China
facility: Department of Rheumatology and Immunology, Xiangya Second Hospital, Central South University
state: Hunan
Study officials:
affiliation: Central South University
name: Fen Li, doctor
role: PRINCIPAL_INVESTIGATOR
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