A Prospective Comparative Study Involving Multiple Units to Evaluate the Efficacy and Safety of Telitacicept and Belimumab in the Treatment of Systemic Lupus Erythematosus.

Launched by YIPENG LIU · Jul 16, 2025

Keywords

ClinConnect Summary

This clinical trial is studying two medicines, telitacicept and belimumab, to see how well and how safely they work for people with systemic lupus erythematosus (SLE), a disease where the immune system attacks the body. The study wants to compare how many patients respond positively to each treatment overall, and also look specifically at people with lupus that affects the kidneys (called lupus nephritis) to see how well their kidneys improve with each drug. Patients and their doctors will decide together which medicine to take, and the study will observe the results without changing the treatment plan.

To take part, patients need to be between 18 and 65 years old and have a confirmed diagnosis of lupus with active symptoms. They should have tried other treatments like hormones or immunosuppressants but not had good results or experienced side effects. People with severe kidney problems, infections like HIV or hepatitis, pregnant or breastfeeding women, or those taking certain other medicines won’t be eligible. Participants can expect their health to be monitored as they follow their chosen treatment, helping researchers learn more about which medicine might work better for lupus patients in real-life settings.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Age range: 18 - 65 years old;
• • Meets the revised SLE classification criteria of the American College of Rheumatology in 1997 or the SLE diagnostic classification criteria issued by EULAR/ACR in 2019;
• • The SELENA-SLEDAI score is at least 8 points (clinical symptoms are no less than 6 points, excluding positive anti-double-stranded DNA (anti-dsDNA) and low complement);
• • Has not responded well to hormone and/or immunosuppressant treatment, is intolerant or has recurrence, and is willing to accept tixocortinib/belimumab as a therapeutic drug.
• Exclusion Criteria:
• • Any of the following conditions exists: active central nervous system disease, severe active lupus nephritis, HIV infection, hepatitis B or C virus infection, low gamma globulinemia, liver dysfunction;
• • eGFR \< 30 mL/min/1.73m², or undergoing hemodialysis or kidney transplantation;
• • Pregnant women, or women who are about to become pregnant in the near future, or lactating women;
• • Participants who are simultaneously participating in other clinical studies;
• • Within 1 year before randomization, received B-cell targeted therapy (including belimumab);
• • During treatment, used traditional Chinese medicine with immunosuppressive effects (such as Tripterygium wilfordii, White Peony Root, etc.) in combination.