NCT06315530

Effect of Telitacicept on Antibody Titers in Primary APS Patients

A Single Center, Randomized Controlled, Open Label Trial Exploring the Regulatory Effect of Telitacicept on Antibody Titers in Primary Antiphospholipid Syndrome Patients Carrying High-risk Antiphospholipid Antibody Profiles

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• 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 Telitacicept on antibody titers in primary antiphospholipid syndrome patients carrying high-risk antiphospholipid antibody profiles.

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+Telitacicept or SOC treatment.Telitacicept is administered subcutaneously at a dose of 160mg once a week for 48 weeks.

Conditions

• Antiphospholipid Syndrome (APS)

Interventions

Type	Name	Description
DRUG	Telitacicept+SOC	160mg once a week for 48 weeks
DRUG	SOC	SOC treatment includes aspirin and/or vitamin K antagonists (VKA) and/or low molecular weight heparin.

Timeline

• Start date: 2023-12-01
• Primary completion: 2025-04-30
• Completion: 2026-01-06
• First posted: 2024-03-18
• Last updated: 2026-01-20

Locations

1 site across 1 country: China