NCT06747312

Effect of Belimumab on Antibody Titers in Primary APS Patients

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Ruijin Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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)

Interventions

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

Timeline

• Start date: 2024-04-01
• Primary completion: 2026-05-31
• Completion: 2027-05-31
• First posted: 2024-12-24
• Last updated: 2024-12-24

Locations

1 site across 1 country: China