Clinical trial NCT05078710: Telitacicept in Primary APS Patients
Official title: A Pilot Study of Telitacicept Treatment in Primary APS Patients
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Anti Phospholipid Syndrome
Keywords: anti phospholipid syndrome
Lead sponsor: Peking Union Medical College Hospital
Sponsor class: OTHER
First posted: 2021-10-14
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: new thrombotic event
timeFrame: 24 weeks
Secondary outcomes:
measure: improvement of thrombocytopenia during Telitacicept treatment
timeFrame: 24 weeks
measure: improvement of hemolytic anemia during Telitacicept treatment
timeFrame: 24 weeks
measure: improvement of aPL nephropathy during Telitacicept treatment
timeFrame: 24 weeks
measure: improvement of valve heart disease during Telitacicept treatment
timeFrame: 24 weeks
measure: improvement of neurological manifestations during Telitacicept treatment
timeFrame: 24 weeks
measure: decrease of aPL titer during Telitacicept treatment
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Beijing
country: China
facility: Peking Union Medical College Hospital
state: Beijing
Study officials:
affiliation: Peking Union Medical College Hospital
name: Jiuliang Zhao, M.D.
role: PRINCIPAL_INVESTIGATOR
References: