Antiphospholipid Syndrome (APS)Phase 2NCT06747312
Effect of Belimumab on Antibody Titers in Primary APS Patients
A Phase 2 study testing Belimumab+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 Belimumab on the antiphospholipid antibody (aPL) as well as to observe related past and new clinical events in primary antiphospholipid syndrome patients. 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?
- Belimumab+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 Apr 2024to 31 May 2027
- Phase
- Phase 2
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old.
- Positive for high-titer antiphospholipid antibodies according to the criteria of the "EULAR Guidelines for the Treatment of Antiphospholipid Syndrome in Adults" published in 2019.
- Stable APS regimen according to EULAR recommendations for antiphospholipid syndrome.
- Female patients who are not pregnant, breastfeeding, of childbearing potential, or not using 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. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital
Shanghai, Shanghai Municipality, 200025
Chengde Yang, Dr, 0086-0021-64370045, yangchengde@sina.com
About this study
Official title: A Single Center, Randomized Controlled, Open Label Trial to Explore the Regulatory Effect of Belimumab on Antibody Titers in Primary Antiphospholipid Syndrome Patients Carrying Medium to High Titers of Antiphospholipid Antibodies
The purpose of this study is to evaluate the regulatory effect of Belimumab on the antiphospholipid antibody (aPL) as well as to observe related past and new clinical events in primary antiphospholipid syndrome patients.
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+Belimumab or SOC treatment. Belimumab is administered intravenously at a dose of 10mg/kg once a month for 18 months.
- Conditions
- Antiphospholipid Syndrome (APS)
- Being tested
- Belimumab+SOC, SOC
- Keywords
- Belimumab, Antiphospholipid Syndrome (APS), Antiphospholipid Antibodies
- Medical subject headings
- Antiphospholipid Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Belimumab+SOCDrug
10mg/kg once a month for 18 months
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+Belimumab arm | Experimental | Belimumab 10mg/kg once a month as an add-on treatment regimen. SOC treatment includes aspirin and/or vitamin K antagonists (VKA) and/or low molecular weight heparin. Receives: Drug: Belimumab+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 level of antiphospholipid antibody titers
Measured: 18 months
Secondary outcomes (2)
New thrombotic event
Any new thrombotic event during Belimumab treatment
Measured: 18 months
Effects of Belimumab on the genotype, phenotype, and functional heterogeneity of T and B cells
Application of single-cell RNA sequencing technology (scRNAseq)
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2024
- Study start1 Apr 2024
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2027 (estimated)
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 (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06747312
- Sponsor's protocol ID
- 2024136
- Status last verified
- Jul 2024
- First submitted
- 18 Dec 2024
- Last updated
- 24 Dec 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 24 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Randomized Controlled, Open Label Trial to Explore the Regulatory Effect of Belimumab on Antibody Titers in Primary Antiphospholipid Syndrome Patients Carrying Medium to High Titers of Antiphospholipid Antibodies
- ClinicalTrials.gov ID
- NCT06747312
- Acronym / sponsor ID
- 2024136
- Conditions
- Antiphospholipid Syndrome (APS)
- Keywords
- Belimumab, Antiphospholipid Syndrome (APS), Antiphospholipid Antibodies
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Apr 2024 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 24 Dec 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 Belimumab on the antiphospholipid antibody (aPL) as well as to observe related past and new clinical events in primary antiphospholipid syndrome patients.
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+Belimumab or SOC treatment. Belimumab is administered intravenously at a dose of 10mg/kg once a month for 18 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: SOC+Belimumab arm | Experimental | Drug: Belimumab+SOC, Drug: SOCBelimumab 10mg/kg once a month 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 (4 listed)
- Age ≥ 18 years old.
- Positive for high-titer antiphospholipid antibodies according to the criteria of the "EULAR Guidelines for the Treatment of Antiphospholipid Syndrome in Adults" published in 2019.
- Stable APS regimen according to EULAR recommendations for antiphospholipid syndrome.
- Female patients who are not pregnant, breastfeeding, of childbearing potential, or not using 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 |
|---|---|---|
| Belimumab+SOC10mg/kg once a month for 18 months | Drug | Experimental: SOC+Belimumab arm |
| SOCSOC treatment includes aspirin and/or vitamin K antagonists (VKA) and/or low molecular weight heparin. | Drug | Experimental: SOC arm, Experimental: SOC+Belimumab arm |
Primary outcome
The level of antiphospholipid antibody titers
Time frame: 18 months
2 secondary outcomes
New thrombotic event
Time frame: 18 months
Effects of Belimumab on the genotype, phenotype, and functional heterogeneity of T and B cells
Time frame: 18 months
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 24 Dec 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.
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 Belimumab+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 4 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: looking for participants now, as of the sponsor's last update on 24 Dec 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 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?
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 Hui Shi, Dr (008613585515854, sh12053@rjh.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The level of antiphospholipid antibody titers (time frame: 18 months). 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 24 Dec 2024; AzTrials last refreshed its copy on 26 Oct 2026.