Systemic Lupus Erythematosus (SLE)Phase 4NCT06677801
Immune Cell Subsets in SLE Patients Treated with Telitacicept
A Phase 4 study testing Telitacicept 160mg in people with Systemic Lupus Erythematosus (SLE), run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial summary
This study is a single-center cohort study. Patients with SLE who met the inclusion criteria were treated with tetanercept 160 mg once a week for a total of 24 weeks, and the clinical and laboratory indicators were collected before treatment, at the 4th week, at the 12th week, and at the 24th week, and blood samples… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Systemic Lupus Erythematosus (SLE)
- What is being tested?
- Telitacicept 160mg
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 11 Oct 2024to 31 Oct 2027
- Phase
- Phase 4
- 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
Who may be able to join
- Patients with confirmed active SLE, who meet at least 4 of the 11 criteria for SLE revised by the United States College of Rheumatology in 1997 at the time of diagnosis;
- Age 18~65 years old, male or female, gender ratio is not limited;
- SLEDAI -2k score ≥ 8 points during the screening period;
- ANA positivity as defined by a clear reference range within half a year;
- Maintain a stable standard treatment regimen for at least 28 days prior to the date of the first dose of trial drug. Standard regimen refers to stable use of any of the following (alone or in combination): corticosteroids, antimalarials, nonsteroidal anti-inflammatory drugs (NSAIDs), other immunosuppressants or immunomodulators including azathioprine, mycophenolate (including mycophenolate mofetil, mycophenolate mofetil), cyclophosphamide, methotrexate, leflunomide, tacrolimus, and cyclosporine.
- Understand the purpose and trial steps of this trial, and voluntarily sign a written informed consent form.
Who cannot join
- Renal disease: severe lupus nephritis (defined as urine protein >6g/24 hours or serum creatinine >2.5mg/dL or 221μmol/L) within 8 weeks prior to randomization, or requiring active nephritis with protocol-prohibited medications, or requiring hemodialysis or receiving prednisone ≥100mg/d or equivalent corticosteroid therapy for ≥ 14 days;
- Neurological diseases: those with central nervous system diseases caused by SLE or non-SLE within 8 weeks prior to randomization, including but not limited to epilepsy, psychosis, organic encephalopathy syndrome, cerebrovascular accident, encephalitis, central nervous system vasculitis, etc.;
- Those with obvious abnormalities in laboratory examinations: a. ALT or AST≥2×ULN (upper limit of normal); b. Endogenous creatinine clearance < 30 mL/min; c. White blood cell count < 2.5×10 9/L; d. Hemoglobin <85g/L; Platelet count < 50×10 9/L;
- Current active hepatitis or previous severe liver lesions or medical history. Hepatitis B: excludes patients who are HBsAg positive. Patients who are HBsAg negative but HBcAb positive will need to be accounted for by HBV-DNA testing: if HBV-DNA is positive, the patient is excluded from participating in the study; If HBV-DNA is negative, the patient can participate in the study. Hepatitis C: excludes patients who are positive for hepatitis C antibodies;
- Immunodeficiency or active infection (such as herpes zoster, HIV virus infection, active tuberculosis, etc.) during the screening period;
- Patients with other connective tissue diseases, history of malignancy, or active/recurrent peptic ulcer;
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- Pregnant women, lactating women, and males or females with birth plans during the trial;
- Those who have received a live vaccine within 28 days prior to randomization;
- Participation in any clinical trial within 28 days prior to randomization or within 5 times the half-life of the investigational drug enrolled in the clinical trial (whichever is longer);
- Use of B-cell-targeted therapy agents such as rituximab, epacizumab or belimumab, etc., within 12 months prior to randomization;
- Use of tumor necrosis factor inhibitors, interleukin receptor blockers within 12 months prior to randomization;
- Those who have been treated with intravenous immunoglobulin (IVIG), prednisone ≥ 100mg/d, or equivalent corticosteroids for ≥ 14 days within 28 days prior to randomization, and those who have undergone plasmapheresis;
- Use of interleukin-2, thalidomide, tripterygium wilfordii and tripterygium wilfordii-containing traditional Chinese medicine preparations within 28 days prior to randomization;
- Allergic reactions: history of allergy to human-derived biological products;
- Mentally ill persons with depression or suicidal thoughts;
- Those who are considered inappropriate by the investigator to participate in this trial.
Trial locations and contacts
1 site in 1 country.
China1 site
the second affiliated hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310005
About this study
Official title: Changes of Immune Cell Subsets During the Treatment of Lupus with Telitacicept
This study is a single-center cohort study. Patients with SLE who met the inclusion criteria were treated with tetanercept 160 mg once a week for a total of 24 weeks, and the clinical and laboratory indicators were collected before treatment, at the 4th week, at the 12th week, and at the 24th week, and blood samples were collected for the detection of immune cell subsets.
- Conditions
- Systemic Lupus Erythematosus (SLE)
- Being tested
- Telitacicept 160mg
- 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.
Telitacicept 160mgBiological
Telitacicept 160mg weekly for 24 weeks, and peripheral subtypes of immune cells will be measured at week 0, 4, 12, and 24.
| Study group | Role | What they receive |
|---|---|---|
| Participant Group | Active comparator | SLE patients treated with Telitacicept Receives: Biological: Telitacicept 160mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes of immune cell subsets after treatment
Measured: 24 weeks
Secondary outcomes (1)
SLE responder index (SRI) -4
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2024
- Study start11 Oct 2024
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus Erythematosus (SLE)Studies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06677801
- Sponsor's protocol ID
- 2024-1010
- Status last verified
- Nov 2024
- First submitted
- 11 Oct 2024
- Last updated
- 7 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes of Immune Cell Subsets During the Treatment of Lupus with Telitacicept
- ClinicalTrials.gov ID
- NCT06677801
- Acronym / sponsor ID
- 2024-1010
- Conditions
- Systemic Lupus Erythematosus (SLE)
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- 11 Oct 2024 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 7 Nov 2024 (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.
This study is a single-center cohort study. Patients with SLE who met the inclusion criteria were treated with tetanercept 160 mg once a week for a total of 24 weeks, and the clinical and laboratory indicators were collected before treatment, at the 4th week, at the 12th week, and at the 24th week, and blood samples were collected for the detection of immune cell subsets.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participant Group | Active comparator | Biological: Telitacicept 160mgSLE patients treated with Telitacicept |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with confirmed active SLE, who meet at least 4 of the 11 criteria for SLE revised by the United States College of Rheumatology in 1997 at the time of diagnosis;
- Age 18~65 years old, male or female, gender ratio is not limited;
- SLEDAI -2k score ≥ 8 points during the screening period;
- ANA positivity as defined by a clear reference range within half a year;
- Maintain a stable standard treatment regimen for at least 28 days prior to the date of the first dose of trial drug. Standard regimen refers to stable use of any of the following (alone or in combination): corticosteroids, antimalarials, nonsteroidal anti-inflammatory drugs (NSAIDs), other immunosuppressants or immunomodulators including azathioprine, mycophenolate (including mycophenolate mofetil, mycophenolate mofetil), cyclophosphamide, methotrexate, leflunomide, tacrolimus, and cyclosporine.
Key exclusion criteria (16 listed)
- Renal disease: severe lupus nephritis (defined as urine protein >6g/24 hours or serum creatinine >2.5mg/dL or 221μmol/L) within 8 weeks prior to randomization, or requiring active nephritis with protocol-prohibited medications, or requiring hemodialysis or receiving prednisone ≥100mg/d or equivalent corticosteroid therapy for ≥ 14 days;
- Neurological diseases: those with central nervous system diseases caused by SLE or non-SLE within 8 weeks prior to randomization, including but not limited to epilepsy, psychosis, organic encephalopathy syndrome, cerebrovascular accident, encephalitis, central nervous system vasculitis, etc.;
- Those with obvious abnormalities in laboratory examinations: a. ALT or AST≥2×ULN (upper limit of normal); b. Endogenous creatinine clearance < 30 mL/min; c. White blood cell count < 2.5×10 9/L; d. Hemoglobin <85g/L; Platelet count < 50×10 9/L;
- Current active hepatitis or previous severe liver lesions or medical history. Hepatitis B: excludes patients who are HBsAg positive. Patients who are HBsAg negative but HBcAb positive will need to be accounted for by HBV-DNA testing: if HBV-DNA is positive, the patient is excluded from participating in the study; If HBV-DNA is negative, the patient can participate in the study. Hepatitis C: excludes patients who are positive for hepatitis C antibodies;
- Immunodeficiency or active infection (such as herpes zoster, HIV virus infection, active tuberculosis, etc.) during the screening period;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telitacicept 160mgTelitacicept 160mg weekly for 24 weeks, and peripheral subtypes of immune cells will be measured at week 0, 4, 12, and 24. | Biological | Participant Group |
Primary outcome
Changes of immune cell subsets after treatment
Time frame: 24 weeks
1 secondary outcome
SLE responder index (SRI) -4
Time frame: 24 weeks
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 7 Nov 2024.
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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?
A Phase 4 study testing Telitacicept 160mg in people with Systemic Lupus Erythematosus (SLE), run by Second Affiliated Hospital, Zhejiang University, School of Medicine 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 6 inclusion and 16 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 7 Nov 2024. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Changes of immune cell subsets after treatment (time frame: 24 weeks). 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 7 Nov 2024.