Telitacicept in Primary APS Patients

A Pilot Study of Telitacicept Treatment in Primary APS Patients

This is a single-arm pilot study in Peking Union Medical College Hospital. Telitacicept will be added on traditional antithrombotic and immunosuppressive treatment in primary antiphospholipid syndrome (APS) patients with three positive antiphospholipid antibodies (aPL) and at least one extra-criteria manifestations, including thrombocytopenia, autoimmune hemolytic anemia, aPL associated nephropathy, heart valvular disease, non-stroke neurological manifestations. This study aims to evaluate the efficacy of Telitacicept in preventing thrombosis and improving extra-criteria manifestations on high-risk APS patients.

Study Overview

• Status: Terminated
• Conditions: Anti Phospholipid Syndrome
• Intervention / Treatment: Drug: Telitacicept

Detailed Description

The study started on July 2021 and will last 1.5 years. Primary APS patients with three positive aPL and extra-criteria manifestations with be enrolled. This is a single-arm pilot study. Telitacicept 160mg once a week for 24 weeks will be added on traditional antithrombotic and immunosuppressive treatment. Patients will be followed on week 12 and week 24. The primary endpoint is new thrombotic event. The secondary endpoints are improvement of extra-criteria manifestations, and titer change of aPL.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Peking Union Medical College Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• meet 2006 Sapporo classification criteria of APS;
• diagnosis of primary APS, exclude other etiologies of thrombosis;
• with three aPL medium-to-high titer positivity, namely lupus anticoagulant, anti cardiolipin antibody, and anti-β2 glycoprotein antibody;
• with at least one extra-criteria manifestations of APS, including thrombocytopenia, hemolytic anemia, aPL nephropathy, valve heart disease and neurological manifestations.

Exclusion Criteria:

• overlap with other connective tissue diseases, such as systemic lupus erythematosus;
• during pregnancy;
• can not follow-up.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Telitacicept arm; Telitacicept 160mg once a week for 24 week as an add-on treatment regimen.	Drug: Telitacicept; 160mg once a week for 24 weeks; Other Names: traditional antithrombotic and immunosuppressive treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
new thrombotic event	any new thrombotic event during Telitacicept treatment	24 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
improvement of thrombocytopenia during Telitacicept treatment	elevated platelet counts	24 weeks
improvement of hemolytic anemia during Telitacicept treatment	elevated hemoglobin	24 weeks
improvement of aPL nephropathy during Telitacicept treatment	decrease of proteinuria or creatinine	24 weeks
improvement of valve heart disease during Telitacicept treatment	decrease of valve thickness or vegetation by echocardiogram	24 weeks
improvement of neurological manifestations during Telitacicept treatment	MRI improvement	24 weeks
decrease of aPL titer during Telitacicept treatment	titer change of lupus anticoagulant, anticardiolipin antibody and anti-β2 glycoprotein-I antibody	24 weeks

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Investigators: Principal Investigator: Jiuliang Zhao, M.D., Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2021
• Primary Completion (Actual): July 1, 2022
• Study Completion (Actual): June 1, 2025

Study Registration Dates

• First Submitted: September 24, 2021
• First Submitted That Met QC Criteria: October 12, 2021
• First Posted (Actual): October 14, 2021

Study Record Updates

• Last Update Posted (Actual): June 8, 2025
• Last Update Submitted That Met QC Criteria: June 4, 2025
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: anti phospholipid syndrome
• Additional Relevant MeSH Terms: Autoimmune Diseases; Immune System Diseases; Antiphospholipid Syndrome; Immunologic Factors; Physiological Effects of Drugs; Immunosuppressive Agents
• Other Study ID Numbers: PUMCH-ZS-3026

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No