NCT07069972Not yet recruiting
A Prospective Comparative Study Involving Multiple Units to Evaluate the Efficacy and Safety of Telitacicept and Belimumab in the Treatment of Systemic Lupus Erythematosus.
Comparing Efficacy and Safety of Telitacicept and Belimumab in Systemic Lupus Erythematosus: A Prospective Multicenter Cohort Study.
Source: ClinicalTrials.gov · Last updated 2 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 180 (estimated)
- First submitted
- 13 Jun 2025
- Start date
- 1 Feb 2026
- Primary completion date
- 30 Sept 2029
- Lead sponsor
- Yipeng Liu
- Diseases
- Lupus (SLE)
- NCT number
- NCT07069972
What you commit to
- Study type: Observational
- Planned participants: 180
- From 1 Feb 2026 to the primary completion date, 30 Sept 2029
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Within 1 year before randomization, received B-cell targeted therapy (including belimumab);
Other illness
- 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;
Lab values
- eGFR \< 30 mL/min/1.73m², or undergoing hemodialysis or kidney transplantation;
Other
- 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;
- During treatment, used traditional Chinese medicine with immunosuppressive effects (such as Tripterygium wilfordii, White Peony Root, etc.) in combination.
Who the study is looking for
- 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.
Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Qianfoshan Hospital Coordinator of this site? Confirm its status | Jinan | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.