TelitaciceptNCT06137053
Effect of Telitacicept on Transitional Regulatory B Cells in Patients With Systemic Lupus Erythematosus
An observational study of Telitacicept and Systemic Lupus Erythematosus, run by Yanfeng Hou at 1 site in China.
Trial summary
The effect of Telitacicept treatment on the changes of transitional regulatory B lymphocyte T1, T2B cell subsets and plasma blasts and the expression levels of cytokines IL-10, IL-35, April and BAFF in SLE. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Telitacicept, Systemic Lupus Erythematosus, Therapy
- How many people
- 50 participants
- Where
- 1 siteChina
- Study dates
- 1 Nov 2022to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- Adult, Older adult
Study population: Patients with systemic lupus erythematosus meeting inclusion criteria
Who may be able to join
- The diagnosis meets the 2019 EULAR/ACR classification criteria for SLE;
- Age 18-70 years old;
- To be on a stable SLE regimen, participants were required to receive standard treatment at least 1 month prior to treatment with a biologic (Telitacicept);
- Lupus activity Index score (SELENA-SLEDAI) ≥ 8 at screening;
- Positive anti-nuclear antibody or anti-DSDNA antibody;
- Combined antiphospholipid syndrome should meet the diagnostic criteria: that is, meet one clinical criterion and one laboratory criterion.
Who cannot join
- Active infections (such as shingles, HIV infection, active tuberculosis, etc.) during the screening period;
- Central nervous system disease (including epilepsy, psychosis, organic encephalopathy syndrome, cerebrovascular accident, encephalitis, central nervous system vasculitis) caused by SLE or not caused by SLE in the last 2 months;
- Have active hepatitis or a history of severe liver disease;
- Patients with immune deficiency, uncontrolled severe infection, and active or recurrent digestive ulcer;
- Pregnant women, breastfeeding women and men or women who have planned to have a baby in the last 12 months;
- Allergic reaction: history of allergic reaction to human biological products;
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- Those who received live vaccine within the last month;
- Participants who have participated in any clinical trial within 28 days prior to initial screening/or 5 times the half-life of the study compound (taking an older time);
- B cell targeted therapy, such as rituximab or epazumab, within one year;
- Use tumor necrosis factor inhibitors and interleukin-receptor blockers within one year;
- Patients receiving intravenous gamma globulin (IVIG), prednisone ≥ 100 mg/d for more than 14 days within one month or undergoing plasmapheresis;
- Psychopaths with depression or suicidal thoughts.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Yanfeng Hou
Jinan, Shandong, 250000
Yanfeng Y Hou, Dr., 15168888165, yfhou1016@163.com
About this study
The effect of Telitacicept treatment on the changes of transitional regulatory B lymphocyte T1, T2B cell subsets and plasma blasts and the expression levels of cytokines IL-10, IL-35, April and BAFF in SLE.
- Conditions
- Telitacicept, Systemic Lupus Erythematosus, Therapy
- 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 |
|---|---|---|
| Exposed group | Standard treatment for SLE + Telitacicept 160 mg qw | |
| Control group | Standard treatment for SLE |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of transitional regulatory B cells
"A subset of B cells, including T1 and T2 B cells, that secrete immunosuppressive factors and act as negative immune regulators.
Measured: prior treatment
Number of transitional regulatory B cells
"A subset of B cells, including T1 and T2 B cells, that secrete immunosuppressive factors and act as negative immune regulators.
Measured: After 12 weeks of treatment
Number of transitional regulatory B cells
"A subset of B cells, including T1 and T2 B cells, that secrete immunosuppressive factors and act as negative immune regulators.
Measured: After 24 weeks of treatment
Number of transitional regulatory B cells
"A subset of B cells, including T1 and T2 B cells, that secrete immunosuppressive factors and act as negative immune regulators.
Measured: After 36 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2023
- Study start1 Nov 2022
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for TelitaciceptStudies 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
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Yanfeng Hou
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yanfeng Hou, Qianfoshan Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06137053
- Sponsor's protocol ID
- ZGC2022-11-26
- Status last verified
- Nov 2023
- First submitted
- 13 Nov 2023
- Last updated
- 21 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Telitacicept on Transitional Regulatory B Cells in Patients With Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT06137053
- Acronym / sponsor ID
- ZGC2022-11-26
- Conditions
- Telitacicept, Systemic Lupus Erythematosus, Therapy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Yanfeng HouUniversity, hospital or other
- Study start
- 1 Nov 2022 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 18 Nov 2023 (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 effect of Telitacicept treatment on the changes of transitional regulatory B lymphocyte T1, T2B cell subsets and plasma blasts and the expression levels of cytokines IL-10, IL-35, April and BAFF in SLE.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exposed group | – | –Standard treatment for SLE + Telitacicept 160 mg qw |
| Control group | – | –Standard treatment for SLE |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients with systemic lupus erythematosus meeting inclusion criteria
Key inclusion criteria (6 listed)
- The diagnosis meets the 2019 EULAR/ACR classification criteria for SLE;
- Age 18-70 years old;
- To be on a stable SLE regimen, participants were required to receive standard treatment at least 1 month prior to treatment with a biologic (Telitacicept);
- Lupus activity Index score (SELENA-SLEDAI) ≥ 8 at screening;
- Positive anti-nuclear antibody or anti-DSDNA antibody;
Key exclusion criteria (12 listed)
- Active infections (such as shingles, HIV infection, active tuberculosis, etc.) during the screening period;
- Central nervous system disease (including epilepsy, psychosis, organic encephalopathy syndrome, cerebrovascular accident, encephalitis, central nervous system vasculitis) caused by SLE or not caused by SLE in the last 2 months;
- Have active hepatitis or a history of severe liver disease;
- Patients with immune deficiency, uncontrolled severe infection, and active or recurrent digestive ulcer;
- Pregnant women, breastfeeding women and men or women who have planned to have a baby in the last 12 months;
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
Number of transitional regulatory B cells
Time frame: prior treatment
"A subset of B cells, including T1 and T2 B cells, that secrete immunosuppressive factors and act as negative immune regulators.
Number of transitional regulatory B cells
Time frame: After 12 weeks of treatment
"A subset of B cells, including T1 and T2 B cells, that secrete immunosuppressive factors and act as negative immune regulators.
Number of transitional regulatory B cells
Time frame: After 24 weeks of treatment
"A subset of B cells, including T1 and T2 B cells, that secrete immunosuppressive factors and act as negative immune regulators.
Number of transitional regulatory B cells
Time frame: After 36 weeks of treatment
"A subset of B cells, including T1 and T2 B cells, that secrete immunosuppressive factors and act as negative immune regulators.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2023.
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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.
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 Telitacicept and Systemic Lupus Erythematosus, run by Yanfeng Hou 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 12 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: status not confirmed, as of the sponsor's last update on 21 Nov 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yanfeng Hou, Dr. (15168888165, yfhou1016@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of transitional regulatory B cells (time frame: prior treatment). The study lists 4 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 21 Nov 2023.