Effect of Belimumab on Antibody Titers in Primary APS Patients

ConditionAntiphospholipid Syndrome (APS)

Trial statusRecruiting

Trial phasePhase 2

Trial typeInterventional

Biological sexAll

Age18+

SponsorRuijin Hospital

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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);

Trial design

Design model

Parallel

Treatments tested in this trial

Belimumab+SOC
Drug
10mg/kg once a month for 18 months
SOC
Drug
SOC treatment includes aspirin and/or vitamin K antagonists (VKA) and/or low molecular weight heparin.

Treatment groups

20 Participants

are divided into 2 treatment groups

Group A: Experimental: SOC+Belimumab armExperimental treatment 2 interventions

Group B: Experimental: SOC armActive comparator 1 intervention

Trial outcomes

Primary outcomes

The level of antiphospholipid antibody titers

Time frame

18 months

Secondary outcomes

New thrombotic event

Any new thrombotic event during Belimumab treatment

Time frame

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)

Time frame

18 months

Other outcomes

The incidence and severity of adverse events

Number and intensity of adverse events

Time frame

18 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Ruijin Hospital

Lead sponsor

Source ClinicalTrials.gov

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