Systemic Lupus ErythematosusNCT07053137
A Comparative Study of the Efficacy and Safety of Telitacicept and Belimumab in the Treatment of Systemic Lupus Erythematosus Involving Multiple Units, Based on Previous Data.
An observational study of Systemic Lupus Erythematosus and Telitacicept, 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 tixocutibine and belizumab in the treatment of systemic lupus erythematosus in patients aged 18-65 years with systemic lupus erythematosus. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Systemic Lupus Erythematosus, Telitacicept, Belimumab
- How many people
- 180 participants
- Where
- 1 siteChina
- Study dates
- 30 Nov 2025to 31 Mar 2026
- 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: The inclusion period is from March 1, 2021 to March 1, 2024. Patients who visited the First Affiliated Hospital of Shandong University Medical University, the Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Wuhan University People's Hospital, and the Department of Nephrology of Capital Medical University Affiliated Beijing Friendship Hospital for clinical diagnosis of systemic lupus erythematosus were included.
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;
- SELENA-SLEDAI score of at least 8 points (clinical symptoms of no less than 6 points, excluding positive anti-double-stranded DNA (anti-dsDNA) and low complement);
- Patients who have been using tofacitinib or belimumab for at least 12 weeks.
Who cannot join
- Having active central nervous system diseases;
- eGFR < 30 mL/min/1.73m², or undergoing hemodialysis or kidney transplantation;
- Pregnant women, or women planning to get pregnant in the near future while taking the medication, or lactating women;
- Participants who are simultaneously participating in other clinical studies;
- Patients who have received treatment with tixagrel or belimumab for less than 12 weeks.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing Efficacy and Safety of Telitacicept and Belimumab in Systemic Lupus Erythematosus: A Retrospective Multicenter Cohort Study
The objective of this observational study is to compare the efficacy and safety of tixocutibine and belizumab in the treatment of systemic lupus erythematosus in patients aged 18-65 years with systemic lupus erythematosus. The main question it aims to answer is: In the overall population of systemic lupus erythematosus: What is the response rate (SRI-4) of the two drugs in treating systemic lupus erythematosus? Which drug has better efficacy and safety? This study is a retrospective study. The participants will not receive any treatment.
- 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 Belimumab group | The participants in the study had previously used belimumab as a therapeutic drug. | |
| The Telitacicept group | The participants in the study had previously used telitacicept as a therapeutic drug. |
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 SELENA-SLEDAI score decreased by ≥ 4 points compared to the baseline;
- And there were no new BILAG-assessed grade A organs or ≤ 2 new BILAG-assessed grade B organs compared to the baseline;
- And the overall physician assessment (PGA) did not deteriorate (an increase of < 0.30 points compared to the baseline).
Measured: From baseline to the end of 1-year treatment period
Secondary outcomes (3)
Proportion of Participants with Stable SLEDAI and PGA Scores
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 1-year treatment period
The proportion of participants in the study who had their hormone dosage reduced
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 1-year treatment period
The time of recurrence occurrence
The time of the first recurrence or the first severe recurrence.
Measured: From baseline to the end of 1-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 posted8 Jul 2025
- Study start30 Nov 2025
- Primary completion31 Mar 2026 (estimated)
- Study completion31 Mar 2026 (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
- Retrospective
- Enrolment
- 180 participants (estimated)
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, Beijing Friendship Hospital
- Responsible party
- Sponsor-investigator, Yipeng Liu, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07053137
- Sponsor's protocol ID
- YXLL-KY-2025(101)
- Status last verified
- Jul 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 Retrospective Multicenter Cohort Study
- ClinicalTrials.gov ID
- NCT07053137
- Acronym / sponsor ID
- YXLL-KY-2025(101)
- Study type
- Observational
- Recruitment status
- Active, not 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, Beijing Friendship Hospital
- Study start
- 30 Nov 2025 (actual)
- Primary completion
- 31 Mar 2026 (estimated)
- Study completion
- 31 Mar 2026 (estimated)
- First posted
- 8 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 tixocutibine and belizumab in the treatment of systemic lupus erythematosus in patients aged 18-65 years with systemic lupus erythematosus. The main question it aims to answer is: In the overall population of systemic lupus erythematosus: What is the response rate (SRI-4) of the two drugs in treating systemic lupus erythematosus? Which drug has better efficacy and safety? This study is a retrospective study. The participants will not receive any treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The Belimumab group | – | –The participants in the study had previously used belimumab as a therapeutic drug. |
| The Telitacicept group | – | –The participants in the study had previously used telitacicept as a therapeutic drug. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The inclusion period is from March 1, 2021 to March 1, 2024. Patients who visited the First Affiliated Hospital of Shandong University Medical University, the Affiliated Hospital of Shandong University of Traditional Chinese Medicine, Wuhan University People's Hospital, and the Department of Nephrology of Capital Medical University Affiliated Beijing Friendship Hospital for clinical diagnosis of systemic lupus erythematosus were included.
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;
- SELENA-SLEDAI score of at least 8 points (clinical symptoms of no less than 6 points, excluding positive anti-double-stranded DNA (anti-dsDNA) and low complement);
- Patients who have been using tofacitinib or belimumab for at least 12 weeks.
Key exclusion criteria (5 listed)
- Having active central nervous system diseases;
- eGFR < 30 mL/min/1.73m², or undergoing hemodialysis or kidney transplantation;
- Pregnant women, or women planning to get pregnant in the near future while taking the medication, or lactating women;
- Participants who are simultaneously participating in other clinical studies;
- Patients who have received treatment with tixagrel or belimumab for less than 12 weeks.
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
Time frame: From baseline to the end of 1-year treatment period
1. The SELENA-SLEDAI score decreased by ≥ 4 points compared to the baseline; 2. And there were no new BILAG-assessed grade A organs or ≤ 2 new BILAG-assessed grade B organs compared to the baseline; 3. And the overall physician assessment (PGA) did not deteriorate (an increase of < 0.30 points compared to the baseline).
3 secondary outcomes
Proportion of Participants with Stable SLEDAI and PGA Scores
Time frame: From baseline to the end of 1-year treatment period
The proportion of participants in the study who had their hormone dosage reduced
Time frame: From baseline to the end of 1-year treatment period
The time of recurrence occurrence
Time frame: From baseline to the end of 1-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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 and Telitacicept, 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 5 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: under way, not looking for participants, 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. 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 (time frame: From baseline to the end of 1-year treatment period). 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.