Effect of Telitacicept on Antibody Titers in Primary APS Patients

Sponsor
Ruijin Hospital
Study ID
NCT06315530
Phase
PHASE2
Status
Completed

Conditions

  • Antiphospholipid Syndrome (APS)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Telitacicept+SOC — DRUG
    160mg once a week for 48 weeks
  • SOC — DRUG
    SOC treatment includes aspirin and/or vitamin K antagonists (VKA) and/or low molecular weight heparin.

Study Details

The purpose of this study is to evaluate the regulatory effect of Telitacicept on antibody titers in primary antiphospholipid syndrome patients carrying high-risk antiphospholipid antibody profiles.

Key Dates

Start date
Dec 1, 2023
Status verified
Jan 2026
Primary completion
Apr 30, 2025
Completion
Jan 6, 2026

Study Design

Enrollment
20 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Experimental: SOC+Telitacicept arm
    Telitacicept 160mg once a week for 48 week as an add-on treatment regimen. SOC treatment includes aspirin and/or vitamin K antagonists (VKA) and/or low molecular weight heparin.
  • Active Comparator: Experimental: SOC arm
    SOC treatment includes aspirin and/or vitamin K antagonists (VKA) and/or low molecular weight heparin.

Primary Outcome Measure

The proportion of patients with decreased aPL titer at week 48 of treatment [ Time Frame: week 48 ]

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