Exploring the Therapeutic Effect of Telitacicept on Lupus Erythematosus Complicated With Thrombocytopenia

Sponsor
Guanmin Gao
Study ID
NCT05929248
Phase
PHASE2
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • Telitacicept — DRUG
    160mg once a week for 48 weeks
  • conventional therapy — DRUG
    Steroid(≤1mg/kg/d) with or without proper immunosuppressants：CTX, MMF, AZA, CsA, FK 506, HCQ, MTX, LEF, SASP etc.
  • Placebo — DRUG
    Used once a week in combination with standard treatment

Study Details

The purpose of this study is to evaluate the efficacy of telitacicept in patients with systemic lupus erythematosus and refractory thrombocytopenia

Key Dates

Start date
Jul 1, 2023
Status verified
Jun 2023
Primary completion
Jun 30, 2024
Completion
Dec 30, 2024

Study Design

Enrollment
64 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment group
    conventional treatment plus Telitacicept 160 mg sc per week
  • Placebo Comparator: Control group
    Placebo plus conventional treatment

Primary Outcome Measure

The remission rate of SLE response index at month 12 of treatment [ Time Frame: months 12 ]

Central Contacts

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