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

Systemic Lupus Erythematosus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06137053
• Other study ID #: ZGC2022-11-26
• Status: Recruiting
• Start date: November 1, 2022
• Est. completion date: December 31, 2025

Study information

• Verified date: November 2023
• Source: Qianfoshan Hospital
• Contact: Yanfeng Hou, Dr.
• Phone: 15168888165
• Email: yfhou1016[@]163.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus
• Therapy

Locations

Country	Name	City	State
China	Yanfeng Hou	Jinan	Shandong

Sponsors (1)

Lead Sponsor	Collaborator
Yanfeng Hou

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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