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

Launched by YANFENG HOU · Nov 13, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called Telitacicept to see how it affects certain immune cells in people with Systemic Lupus Erythematosus (SLE), a condition where the immune system attacks healthy tissues. Researchers want to understand how this treatment changes specific types of B cells, which are important for the immune response, and how it might influence substances in the body that help regulate inflammation. The trial is currently recruiting participants aged 18 to 70 who meet specific criteria, including a confirmed diagnosis of SLE and a certain level of disease activity.

To be eligible, participants must have been on stable lupus treatment for at least a month before starting Telitacicept and show signs of active disease. However, people with certain health issues, like active infections or severe liver disease, cannot participate. Those who join the trial can expect to undergo regular assessments to monitor their health and the effects of the treatment. It's important to know that this trial aims to provide insights into new therapies for SLE, which could lead to better management of the disease for many patients.

Gender

ALL

Eligibility criteria

• 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.