Systemic Lupus ErythematosusNCT07069972
A Prospective Comparative Study Involving Multiple Units to Evaluate the Efficacy and Safety of Telitacicept and Belimumab in the Treatment of Systemic Lupus Erythematosus.
An observational study of Systemic Lupus Erythematosus, run by Yipeng Liu at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 1 Feb 2026to 30 Sep 2029
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Qianfoshan Hospital
Jinan, Shandong, 250000
Yipeng Liu, 13064089262, 739058646@qq.com
About this study
Official title: Comparing Efficacy and Safety of Telitacicept and Belimumab in Systemic Lupus Erythematosus: A Prospective Multicenter Cohort Study.
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?
Read more
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
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of patients with a Systemic Lupus Erythematosus Response Index-4 (SRI-4) response(the overall SLE population)
- A reduction of ≥ 4 points in the SELENA-SLEDAI score from baseline;
- And no new BILAG A-level organ or ≤ 2 new BILAG B-level organs compared to baseline;
- And no worsening in the physician's global assessment (PGA) (an increase of < 0.30 points from baseline).
Measured: From baseline to the end of 2-year treatment period
The response rate for major kidney treatments(the lupus nephritis subgroup)
- 24-hour urine PCR ≤ 0.7 g/g (70 mg/mmol);
- eGFR decline does not exceed 20% of the baseline or is ≥ 60 ml/min/1.73 m2;
- No rescue treatment was adopted due to treatment failure.
Measured: From baseline to the end of 2-year treatment period
Secondary outcomes (4)
Complete renal response rate(the lupus nephritis subgroup)
- 24-hour urine PCR < 0.5 g/g (50 mg/mmol);
- Stable or improved renal function (not exceeding 10% - 15% of the baseline).
Measured: From baseline to the end of 2-year treatment period
Proportion of Participants with Stable SLEDAI and PGA Scores(the overall SLE population)
The percentage of study participants whose SLEDAI score decreased by at least 4 points and whose PGA did not worsen.
Measured: 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)
The ratio of study participants whose prednisone dose was reduced by ≥25% or ≤7.5 mg/day compared to the baseline at 44-48 weeks.
Measured: From baseline to the end of 2-year treatment period
The time of recurrence occurrence(the overall SLE population)
The time of the first recurrence or the first severe recurrence.
Measured: From baseline to the end of 2-year treatment period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2025
- Study start1 Feb 2026 (estimated)
- Primary completion30 Sep 2029 (estimated)
- Study completion30 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 180 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Yipeng Liu
- Sponsor type
- University, hospital or other
- Collaborators
- Renmin Hospital of Wuhan University, Affiliated Hospital of Shandong University of Traditional Chinese Medicine
- Responsible party
- Sponsor-investigator, Yipeng Liu, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07069972
- Sponsor's protocol ID
- YXLL-KY-2025(106)
- Status last verified
- Jun 2025
- First submitted
- 13 Jun 2025
- Last updated
- 2 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Efficacy and Safety of Telitacicept and Belimumab in Systemic Lupus Erythematosus: A Prospective Multicenter Cohort Study.
- ClinicalTrials.gov ID
- NCT07069972
- Acronym / sponsor ID
- YXLL-KY-2025(106)
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Systemic Lupus Erythematosus, Telitacicept, Belimumab, Efficacy and Safety
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Yipeng LiuUniversity, hospital or other
- Collaborators
- Renmin Hospital of Wuhan University, Affiliated Hospital of Shandong University of Traditional Chinese Medicine
- Study start
- 1 Feb 2026 (estimated)
- Primary completion
- 30 Sep 2029 (estimated)
- Study completion
- 30 Sep 2029 (estimated)
- First posted
- 17 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The percentage of patients with a Systemic Lupus Erythematosus Response Index-4 (SRI-4) response(the overall SLE population)
Time frame: From baseline to the end of 2-year treatment period
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).
The response rate for major kidney treatments(the lupus nephritis subgroup)
Time frame: From baseline to the end of 2-year treatment period
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.
4 secondary outcomes
Complete renal response rate(the lupus nephritis subgroup)
Time frame: From baseline to the end of 2-year treatment period
Proportion of Participants with Stable SLEDAI and PGA Scores(the overall SLE population)
Time frame: 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)
Time frame: From baseline to the end of 2-year treatment period
The time of recurrence occurrence(the overall SLE population)
Time frame: From baseline to the end of 2-year treatment period.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Systemic Lupus Erythematosus, run by Yipeng Liu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yipeng Liu (13064089262, 739058646@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The percentage of patients with a Systemic Lupus Erythematosus Response Index-4 (SRI-4) response(the overall SLE population) (time frame: From baseline to the end of 2-year treatment period). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.