Evaluating Belimumab's effect on antibody levels in patients with Antiphospholipid Syndrome

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

This study is testing if adding Belimumab to standard treatment can lower antibody levels in people with Antiphospholipid Syndrome.

Quick facts

• Phase: PHASE2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Ruijin Hospital (other)
• Drugs / interventions: rituximab, epratuzumab, prednisone, Belimumab
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT06747312 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the impact of Belimumab on antiphospholipid antibody levels in patients diagnosed with primary Antiphospholipid Syndrome (APS). It is a single-center, randomized controlled trial conducted at Ruijin Hospital, where participants will be assigned to receive either standard of care plus Belimumab or standard of care alone. Belimumab will be administered intravenously at a dosage of 10mg/kg once a month for a duration of 18 months, allowing researchers to monitor both antibody titers and related clinical events throughout the study period.

Who should consider this trial

Good fit: Ideal candidates for this study are adults aged 18 and older who have high-titer antiphospholipid antibodies and are on a stable APS treatment regimen.

Not a fit: Patients with a history of certain malignancies, primary immunodeficiencies, or significant immunoglobulin deficiencies may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved management of Antiphospholipid Syndrome by effectively reducing antibody levels and associated clinical events.

How similar studies have performed: While there have been studies on Belimumab for other conditions, this specific application in primary APS is novel and has not been extensively tested.

Eligibility criteria

Inclusion 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.

Exclusion Criteria:

* 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;
* 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.

Where this trial is running

Shanghai, Shanghai Municipality

• Ruijin Hospital — Shanghai, Shanghai Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Hui Shi, Dr

Conditions: Antiphospholipid Syndrome, Belimumab, Antiphospholipid Antibodies