Telitacicept in Primary APS Patients

NCT05078710 | Terminated Phase 2

• 1 other identifier: PUMCH-ZS-3026
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Anti Phospholipid Syndrome

Keywords

anti phospholipid syndrome

Outcome Measures

Primary Outcomes (1)

• new thrombotic event

  any new thrombotic event during Telitacicept treatment

  24 weeks

Secondary Outcomes (6)

• improvement of thrombocytopenia during Telitacicept treatment

  24 weeks

• improvement of hemolytic anemia during Telitacicept treatment

  24 weeks

• improvement of aPL nephropathy during Telitacicept treatment

  24 weeks

• improvement of valve heart disease during Telitacicept treatment

  24 weeks

• improvement of neurological manifestations during Telitacicept treatment

  24 weeks

Study Arms (1)

Telitacicept arm

EXPERIMENTAL

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

Drug: Telitacicept

Interventions

Telitacicept DRUG

160mg once a week for 24 weeks

Also known as: traditional antithrombotic and immunosuppressive treatment

Telitacicept arm

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Beijing Municipality, 100730, China

Location

MeSH Terms

Conditions

Antiphospholipid Syndrome

Interventions

telitacicept

Condition Hierarchy (Ancestors)

Autoimmune Diseases; Immune System Diseases

Study Officials

• Jiuliang Zhao, M.D.

  Peking Union Medical College Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 24, 2021
• First Posted: October 14, 2021
• Study Start: July 1, 2021
• Primary Completion: July 1, 2022
• Study Completion: June 1, 2025
• Last Updated: June 8, 2025

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)