Effect of Telitacicept on Transitional Regulatory B Cells in Patients With Systemic Lupus Erythematosus

The effect of Telitacicept treatment on the changes of transitional regulatory B lymphocyte T1, T2B cell subsets and plasma blasts and the expression levels of cytokines IL-10, IL-35, April and BAFF in SLE.

Study Overview

• Status: Recruiting
• Conditions: Systemic Lupus Erythematosus; Therapy; Telitacicept

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Yanfeng Hou, Dr.; Phone Number: 15168888165; Email: yfhou1016@163.com

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China, 250000
      • Recruiting
      • Yanfeng Hou
      • Contact: Yanfeng Y Hou, Dr.; Phone Number: 15168888165; Email: yfhou1016@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patients with systemic lupus erythematosus meeting inclusion criteria

Description

Inclusion Criteria:

1. The diagnosis meets the 2019 EULAR/ACR classification criteria for SLE;
2. Age 18-70 years old;
3. To be on a stable SLE regimen, participants were required to receive standard treatment at least 1 month prior to treatment with a biologic (Telitacicept);
4. Lupus activity Index score (SELENA-SLEDAI) ≥ 8 at screening;
5. Positive anti-nuclear antibody or anti-DSDNA antibody;
6. Combined antiphospholipid syndrome should meet the diagnostic criteria: that is, meet one clinical criterion and one laboratory criterion.

Exclusion Criteria:

1. Active infections (such as shingles, HIV infection, active tuberculosis, etc.) during the screening period;
2. Central nervous system disease (including epilepsy, psychosis, organic encephalopathy syndrome, cerebrovascular accident, encephalitis, central nervous system vasculitis) caused by SLE or not caused by SLE in the last 2 months;
3. Have active hepatitis or a history of severe liver disease;
4. Patients with immune deficiency, uncontrolled severe infection, and active or recurrent digestive ulcer;
5. Pregnant women, breastfeeding women and men or women who have planned to have a baby in the last 12 months;
6. Allergic reaction: history of allergic reaction to human biological products;
7. Those who received live vaccine within the last month;
8. Participants who have participated in any clinical trial within 28 days prior to initial screening/or 5 times the half-life of the study compound (taking an older time);
9. B cell targeted therapy, such as rituximab or epazumab, within one year;
10. Use tumor necrosis factor inhibitors and interleukin-receptor blockers within one year;
11. Patients receiving intravenous gamma globulin (IVIG), prednisone ≥ 100 mg/d for more than 14 days within one month or undergoing plasmapheresis;
12. Psychopaths with depression or suicidal thoughts.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Exposed group; Standard treatment for SLE + Telitacicept 160 mg qw
Control group; Standard treatment for SLE

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of transitional regulatory B cells	"A subset of B cells, including T1 and T2 B cells, that secrete immunosuppressive factors and act as negative immune regulators.	prior treatment
Number of transitional regulatory B cells	"A subset of B cells, including T1 and T2 B cells, that secrete immunosuppressive factors and act as negative immune regulators.	After 12 weeks of treatment
Number of transitional regulatory B cells	"A subset of B cells, including T1 and T2 B cells, that secrete immunosuppressive factors and act as negative immune regulators.	After 24 weeks of treatment
Number of transitional regulatory B cells	"A subset of B cells, including T1 and T2 B cells, that secrete immunosuppressive factors and act as negative immune regulators.	After 36 weeks of treatment

Collaborators and Investigators

• Sponsor: Yanfeng Hou

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2022
• Primary Completion (Estimated): December 31, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: November 13, 2023
• First Submitted That Met QC Criteria: November 13, 2023
• First Posted (Actual): November 18, 2023

Study Record Updates

• Last Update Posted (Estimated): November 21, 2023
• Last Update Submitted That Met QC Criteria: November 19, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Connective Tissue Diseases; Lupus Erythematosus, Systemic
• Other Study ID Numbers: ZGC2022-11-26

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No