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

NCT06137053 | Unknown

• 1 other identifier: ZGC2022-11-26
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Telitacicept; Systemic Lupus Erythematosus; Therapy

Outcome Measures

Primary Outcomes (4)

• 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

Study Arms (2)

Exposed group

Standard treatment for SLE + Telitacicept 160 mg qw

Control group

Standard treatment for SLE

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with systemic lupus erythematosus meeting inclusion criteria

You may qualify if:

• The diagnosis meets the 2019 EULAR/ACR classification criteria for SLE;
• Age 18-70 years old;
• 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);
• Lupus activity Index score (SELENA-SLEDAI) ≥ 8 at screening;
• Positive anti-nuclear antibody or anti-DSDNA antibody;
• Combined antiphospholipid syndrome should meet the diagnostic criteria: that is, meet one clinical criterion and one laboratory criterion.

You may not qualify if:

• Active infections (such as shingles, HIV infection, active tuberculosis, etc.) during the screening period;
• 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;
• Have active hepatitis or a history of severe liver disease;
• Patients with immune deficiency, uncontrolled severe infection, and active or recurrent digestive ulcer;
• Pregnant women, breastfeeding women and men or women who have planned to have a baby in the last 12 months;
• Allergic reaction: history of allergic reaction to human biological products;
• Those who received live vaccine within the last month;
• 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);
• B cell targeted therapy, such as rituximab or epazumab, within one year;
• Use tumor necrosis factor inhibitors and interleukin-receptor blockers within one year;
• Patients receiving intravenous gamma globulin (IVIG), prednisone ≥ 100 mg/d for more than 14 days within one month or undergoing plasmapheresis;
• Psychopaths with depression or suicidal thoughts.

Sponsors & Collaborators

• Yanfeng Hou: lead

Study Sites (1)

Yanfeng Hou

Jinan, Shandong, 250000, China

RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

Yanfeng Hou, Dr.

CONTACT

15168888165; yfhou1016@163.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: November 13, 2023
• First Posted: November 18, 2023
• Study Start: November 1, 2022
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: November 21, 2023

Record last verified: 2023-11

Locations

CN (1)