Effect of Belimumab on Antibody Titers in Primary APS Patients

NCT ID: NCT06747312

Last Updated: 2024-12-24

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE2
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2027-05-31

Brief 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.

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)

Keywords

Belimumab; Antiphospholipid Syndrome (APS); Antiphospholipid Antibodies

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Experimental: SOC+Belimumab arm

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.

Group Type: EXPERIMENTAL

Belimumab+SOC

Intervention Type: DRUG

10mg/kg once a month for 18 months

SOC

Intervention Type: DRUG

SOC treatment includes aspirin and/or vitamin K antagonists (VKA) and/or low molecular weight heparin.

Experimental: SOC arm

SOC treatment includes aspirin and/or vitamin K antagonists (VKA) and/or low molecular weight heparin.

Group Type: ACTIVE_COMPARATOR

SOC

Intervention Type: DRUG

SOC treatment includes aspirin and/or vitamin K antagonists (VKA) and/or low molecular weight heparin.

Interventions

Belimumab+SOC

10mg/kg once a month for 18 months

Intervention Type: DRUG

SOC

SOC treatment includes aspirin and/or vitamin K antagonists (VKA) and/or low molecular weight heparin.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Ruijin Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Ruijin Hospital

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Hui Shi, Dr

Role: CONTACT

Phone: 008613585515854

Email: sh12053@rjh.com.cn

Facility Contacts

Chengde Yang, Dr

Role: primary

Other Identifiers

2024136

Identifier Type: -

Identifier Source: org_study_id