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

Last updated: July 16, 2025
Sponsor: Yipeng Liu
Overall Status: Active - Not Recruiting

Phase

N/A

Condition

Systemic Lupus Erythematosus

Lupus

Bone Diseases

Treatment

N/A

Clinical Study ID

NCT07069972
YXLL-KY-2025(106)
  • Ages 18-65
  • All Genders

Study Summary

The objective of this observational study is to compare the efficacy and safety of telitacicept versus belimumab in systemic lupus erythematosus (SLE) patients aged 18-65 years. The primary questions it aims to answer are:

  • In the overall SLE population: What are the SRI-4 response rates for both drugs?

  • In the lupus nephritis subgroup: What are the major renal response rates for both drugs?

Participants will autonomously select their treatment regimen (add-on telitacicept or belimumab) based on:

  • The patient's objective clinical condition at enrollment

  • Physician's assessment

  • Joint decision-making between physicians and patients/family members As an observational study, no active intervention will be implemented.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age range: 18 - 65 years old;

  • Meets the revised SLE classification criteria of the American College ofRheumatology in 1997 or the SLE diagnostic classification criteria issued byEULAR/ACR in 2019;

  • The SELENA-SLEDAI score is at least 8 points (clinical symptoms are no less than 6points, excluding positive anti-double-stranded DNA (anti-dsDNA) and lowcomplement);

  • Has not responded well to hormone and/or immunosuppressant treatment, is intolerantor has recurrence, and is willing to accept tixocortinib/belimumab as a therapeuticdrug.

Exclusion

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, lowgamma 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, orlactating women;

  • Participants who are simultaneously participating in other clinical studies;

  • Within 1 year before randomization, received B-cell targeted therapy (includingbelimumab);

  • During treatment, used traditional Chinese medicine with immunosuppressive effects (such as Tripterygium wilfordii, White Peony Root, etc.) in combination.

Study Design

Total Participants: 180
Study Start date:
August 01, 2025
Estimated Completion Date:
June 30, 2028

Connect with a study center

  • Qianfoshan Hospital

    Jinan, Shandong 250000
    China

    Site Not Available

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