Antiphospholipid Syndrome (APS)Phase 2NCT06315530
Effect of Telitacicept on Antibody Titers in Primary APS Patients
A Phase 2 study testing Telitacicept+SOC and SOC in people with Antiphospholipid Syndrome (APS), run by Ruijin Hospital at 1 site in China.
Trial summary
The purpose of this study is to evaluate the regulatory effect of Telitacicept on antibody titers in primary antiphospholipid syndrome patients carrying high-risk antiphospholipid antibody profiles. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Antiphospholipid Syndrome (APS)
- What is being tested?
- Telitacicept+SOC and SOC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- 1 Dec 2023to 6 Jan 2026
- Phase
- Phase 2
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥18 years;
- Diagnosis of primary APS, meet 2006 Sydney classification criteria or continuously positive for antiphospholipid antibodies within the first 12 months of inclusion (tested at least every 12 weeks), classified as high-risk antiphospholipid antibody spectrum based on the risk of antibody levels, in order to meet at least one of the following conditions: 1. Positive lupus anticoagulant (LAC) (tested according to ISTH guidelines); 2. Two or three types of aPL positivity (lupus anticoagulant, anticardiolipin antibody, and anti-β2 any two or all three types of glycoprotein I antibodies; 3. Or persistent high titer aPL;
- There are no other autoimmune diseases occurring simultaneously;
- According to EULAR recommendations for antiphospholipid syndrome, a stable APS treatment regimen should be adopted;
- Female patients who are not pregnant, breastfeeding, have no fertility potential, or have not undergone contraception.
Who cannot join
- Patients with a history of malignant tumor in the past 5 years, except for basal cell carcinoma or squamous cell carcinoma of skin or cervical carcinoma in situ treated locally, and there is no evidence of metastasis within 3 years;
- Patients with a history of primary immunodeficiency;
- Serious lack of IgG (IgG level \< 400 mg/dL);
- IgA deficiency (IgA level \< 10 mg/dL);
- Patients with a current history of infection;
- Patients with a current history of drug or alcohol abuse or dependence, or have a history of drug or alcohol abuse or dependence within 365 days before day 0;
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- HIV test is historically positive or HIV screening is positive;
- Hepatitis status;
- Patients with a history of allergic reaction caused by injection of contrast agent, human or mouse protein or monoclonal antibody;
- Patients with other abnormal laboratory values with clinical significance;
- If women with reproductive potential (WCBP) are included, please refer to the following special instructions;
- Patients with concurrent major medical or mental illnesss;
- Patients with diseases of liver, kidney, heart and other important organs,blood and Endocrine system;
- Patients who have been vaccinated with live vaccine in the last month;
- Patients who have participated in any clinical trial within 28 days before the initial screening and/or within 5 times of the half-life of the study compound (whichever is longer);
- Patients who use B-cell targeted therapy drugs within one year, such as rituximab or epratuzumab;
- Patients who use tumor necrosis factor inhibitor and interleukin receptor blocker within one year;
- Patients who use Intravenous gamma globulin (IVIG) and prednisone ≥100mg/d for more than 14 days within one year or plasma exchange;
- Patients with active infection (such as herpes zoster, HIV infection, active tuberculosis, etc.) during the screening period;
- Patients with depression or suicidal thoughts;
- Other conditions that the investigator considers would make the candidate unsuitable for the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single Center, Randomized Controlled, Open Label Trial Exploring the Regulatory Effect of Telitacicept on Antibody Titers in Primary Antiphospholipid Syndrome Patients Carrying High-risk Antiphospholipid Antibody Profiles
The purpose of this study is to evaluate the regulatory effect of Telitacicept on antibody titers in primary antiphospholipid syndrome patients carrying high-risk antiphospholipid antibody profiles.
Read the detailed description
This is a single center, randomized controlled trial in Ruijin Hospital. The enrolled patients will be randomized in a 1: 1 ratio to receive either SOC+Telitacicept or SOC treatment.Telitacicept is administered subcutaneously at a dose of 160mg once a week for 48 weeks.
- Conditions
- Antiphospholipid Syndrome (APS)
- Being tested
- Telitacicept+SOC, SOC
- Keywords
- Telitacicept, Antiphospholipid Antibody Profiles
- Medical subject headings
- Antiphospholipid Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telitacicept+SOCDrug
160mg once a week for 48 weeks
SOCDrug
SOC treatment includes aspirin and/or vitamin K antagonists (VKA) and/or low molecular weight heparin.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: SOC+Telitacicept arm | Experimental | Telitacicept 160mg once a week for 48 week as an add-on treatment regimen. SOC treatment includes aspirin and/or vitamin K antagonists (VKA) and/or low molecular weight heparin. Receives: Drug: Telitacicept+SOC; Drug: SOC |
| Experimental: SOC arm | Active comparator | SOC treatment includes aspirin and/or vitamin K antagonists (VKA) and/or low molecular weight heparin. Receives: Drug: SOC |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of patients with decreased aPL titer at week 48 of treatment
Measured: week 48
Secondary outcomes (2)
new thrombotic event
any new thrombotic event during Telitacicept treatment
Measured: 48 weeks
Effects of Telitacicept on the genotype, phenotype, and functional heterogeneity of T and B cells
Application of single-cell RNA sequencing technology (scRNAseq)
Measured: baseline, week 12, 24, 36, 48
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2024
- Study start1 Dec 2023
- Primary completion30 Apr 2025
- Study completion6 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antiphospholipid Syndrome (APS)Studies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06315530
- Sponsor's protocol ID
- sh12053
- Status last verified
- Jan 2026
- First submitted
- 11 Mar 2024
- Last updated
- 20 Jan 2026
- 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 20 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Randomized Controlled, Open Label Trial Exploring the Regulatory Effect of Telitacicept on Antibody Titers in Primary Antiphospholipid Syndrome Patients Carrying High-risk Antiphospholipid Antibody Profiles
- ClinicalTrials.gov ID
- NCT06315530
- Acronym / sponsor ID
- sh12053
- Conditions
- Antiphospholipid Syndrome (APS)
- Keywords
- Telitacicept, Antiphospholipid Antibody Profiles
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 6 Jan 2026 (actual)
- First posted
- 18 Mar 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.
The purpose of this study is to evaluate the regulatory effect of Telitacicept on antibody titers in primary antiphospholipid syndrome patients carrying high-risk antiphospholipid antibody profiles.
Detailed description
This is a single center, randomized controlled trial in Ruijin Hospital. The enrolled patients will be randomized in a 1: 1 ratio to receive either SOC+Telitacicept or SOC treatment.Telitacicept is administered subcutaneously at a dose of 160mg once a week for 48 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: SOC+Telitacicept arm | Experimental | Drug: Telitacicept+SOC, Drug: SOCTelitacicept 160mg once a week for 48 week as an add-on treatment regimen. SOC treatment includes aspirin and/or vitamin K antagonists (VKA) and/or low molecular weight heparin. |
| Experimental: SOC arm | Active comparator | Drug: SOCSOC treatment includes aspirin and/or vitamin K antagonists (VKA) and/or low molecular weight heparin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age ≥18 years;
- Diagnosis of primary APS, meet 2006 Sydney classification criteria or continuously positive for antiphospholipid antibodies within the first 12 months of inclusion (tested at least every 12 weeks), classified as high-risk antiphospholipid antibody spectrum based on the risk of antibody levels, in order to meet at least one of the following conditions: 1. Positive lupus anticoagulant (LAC) (tested according to ISTH guidelines); 2. Two or three types of aPL positivity (lupus anticoagulant, anticardiolipin antibody, and anti-β2 any two or all three types of glycoprotein I antibodies; 3. Or persistent high titer aPL;
- There are no other autoimmune diseases occurring simultaneously;
- According to EULAR recommendations for antiphospholipid syndrome, a stable APS treatment regimen should be adopted;
- Female patients who are not pregnant, breastfeeding, have no fertility potential, or have not undergone contraception.
Key exclusion criteria (21 listed)
- Patients with a history of malignant tumor in the past 5 years, except for basal cell carcinoma or squamous cell carcinoma of skin or cervical carcinoma in situ treated locally, and there is no evidence of metastasis within 3 years;
- Patients with a history of primary immunodeficiency;
- Serious lack of IgG (IgG level \< 400 mg/dL);
- IgA deficiency (IgA level \< 10 mg/dL);
- Patients with a current history of infection;
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+SOC160mg once a week for 48 weeks | Drug | Experimental: SOC+Telitacicept arm |
| SOCSOC treatment includes aspirin and/or vitamin K antagonists (VKA) and/or low molecular weight heparin. | Drug | Experimental: SOC arm, Experimental: SOC+Telitacicept arm |
Primary outcome
The proportion of patients with decreased aPL titer at week 48 of treatment
Time frame: week 48
2 secondary outcomes
new thrombotic event
Time frame: 48 weeks
Effects of Telitacicept on the genotype, phenotype, and functional heterogeneity of T and B cells
Time frame: baseline, week 12, 24, 36, 48
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2026.
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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 2 study testing Telitacicept+SOC and SOC in people with Antiphospholipid Syndrome (APS), run by Ruijin Hospital 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 5 inclusion and 21 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: finished, as of the sponsor's last update on 20 Jan 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 proportion of patients with decreased aPL titer at week 48 of treatment (time frame: week 48). 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 20 Jan 2026.