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New treatment option for Antiphospholipid Syndrome (APS)
Official title Effect of Belimumab on Antibody Titers in Primary APS Patients
ClinicalTrials.gov ID: NCT06747312
What this study is testing
What is Belimumab+SOC?
Belimumab+SOC is an investigational medicine, given as a monthly infusion into a vein, being studied as a potential treatment for antiphospholipid syndrome (aps).
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- Age ≥ 18 years old.
- Positive for high-titer antiphospholipid antibodies according to the criteria of the "EULAR Guidelines for the Treatment of Antiphospholipid Syndrome...
- Stable APS regimen according to EULAR recommendations for antiphospholipid syndrome.
- Female patients who are not pregnant, breastfeeding, of childbearing potential, or not using contraception.
You likely can't join if
- 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...
- 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...
See the full eligibility criteria
- 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.
- 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...
- 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;
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, Shanghai Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, Shanghai Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.