Telitacicept in Primary APS Patients

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Terminated; Phase 2

Conditions: Anti Phospholipid Syndrome

Treatments: Drug: Telitacicept

Study type: Interventional

Funder types: Other

Identifiers

NCT05078710

PUMCH-ZS-3026

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Telitacicept arm

Experimental group

Description:

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

Treatment:

Drug: Telitacicept