Telitacicept in Primary APS Patients

Phase 2

• Conditions: Anti Phospholipid Syndrome
• Interventions: Drug: Telitacicept

• Registration Number: NCT05078710
• Lead Sponsor: Peking Union Medical College Hospital

Brief Summary

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.

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 Timeline

• Status Verified: 2021-07
• Study Start: 2021-07-01
• Study First Submitted: 2021-09-24
• Study First Submitted QC: 2021-10-12
• Last Update Submitted: 2021-10-12
• Study First Posted: 2021-10-14
• Last Update Posted: 2021-10-14
• Primary Completion: 2022-07-01
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Telitacicept arm	Telitacicept	Telitacicept 160mg once a week for 24 week as an add-on treatment regimen.

Primary Outcome Measures

Name	Time	Method
new thrombotic event	24 weeks	any new thrombotic event during Telitacicept treatment

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Peking Union Medical College Hospital; 🇨🇳 Beijing, Beijing, China