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

NCT07069972 | Not Yet Recruiting

• 1 other identifier: YXLL-KY-2025(106)
• Study Type: observational
• Target: 180
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Systemic Lupus Erythematosus

Keywords

Systemic Lupus Erythematosus; Telitacicept; Belimumab; Efficacy and Safety

Outcome Measures

Primary Outcomes (2)

• The percentage of patients with a Systemic Lupus Erythematosus Response Index-4 (SRI-4) response(the overall SLE population)

  1. A reduction of ≥ 4 points in the SELENA-SLEDAI score from baseline; 2. And no new BILAG A-level organ or ≤ 2 new BILAG B-level organs compared to baseline; 3. And no worsening in the physician's global assessment (PGA) (an increase of \< 0.30 points from baseline).

  From baseline to the end of 2-year treatment period

• The response rate for major kidney treatments(the lupus nephritis subgroup)

  1. 24-hour urine PCR ≤ 0.7 g/g (70 mg/mmol); 2. eGFR decline does not exceed 20% of the baseline or is ≥ 60 ml/min/1.73 m2; 3. No rescue treatment was adopted due to treatment failure.

  From baseline to the end of 2-year treatment period

Secondary Outcomes (4)

• Complete renal response rate(the lupus nephritis subgroup)

  From baseline to the end of 2-year treatment period

• Proportion of Participants with Stable SLEDAI and PGA Scores(the overall SLE population)

  From baseline to the end of 2-year treatment period

• The proportion of participants in the study who had their hormone dosage reduced(the overall SLE population)

  From baseline to the end of 2-year treatment period

• The time of recurrence occurrence(the overall SLE population)

  From baseline to the end of 2-year treatment period.

Study Arms (4)

The Telitacicept group（the overall SLE population）

The participants in this group were diagnosed with SLE and were selected to use Telitacicept as the treatment drug.This study is an observational study and no active intervention is carried out.

The Belimumab group（the overall SLE population）

The participants in this group were diagnosed with SLE and were selected to receive belimumab as the treatment drug.This study is an observational study and no active intervention is carried out.

The Telitacicept group（the lupus nephritis subgroup）

The participants in this group were diagnosed with LN and were selected to receive telitacicept as the treatment drug.This study is an observational study and no active intervention is carried out.

The Belimumab group（the lupus nephritis subgroup）

The participants in this group were diagnosed with LN and were selected to receive belimumab as the treatment drug.This study is an observational study and no active intervention is carried out.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who were diagnosed with systemic lupus erythematosus through clinical examination at the First Affiliated Hospital of Shandong First Medical University, the Affiliated Hospital of Shandong University of Traditional Chinese Medicine, and the People's Hospital of Wuhan University

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yipeng Liu: lead
• Renmin Hospital of Wuhan University: collaborator
• Affiliated Hospital of Shandong University of Traditional Chinese Medicine: collaborator

Study Sites (1)

Qianfoshan Hospital

Jinan, Shandong, 250000, China

Location

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

Yipeng Liu

CONTACT

13064089262; 739058646@qq.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: June 13, 2025
• First Posted: July 17, 2025
• Study Start: February 1, 2026
• Primary Completion (Estimated): September 30, 2029
• Study Completion (Estimated): September 30, 2029
• Last Updated: February 2, 2026

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)