Efficacy and Safety of Telitacicept for Prevention of Flares in SLE Patients

Sponsor
RenJi Hospital
Study ID
NCT06394063
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Telitacicept — BIOLOGICAL
    Telitacicept 160 mg SC every other week
  • Placebo — DRUG
    Placebo to Telitacicept

Study Details

This study is a randomized, double-blind, placebo-controlled single-center clinical trial. The aim of this study is to investigate the efficacy and safety of low-dose telitacicept for prevention of flares in SLE patients with low disease activity.

Key Dates

Start date
Jun 28, 2024
Status verified
Jul 2024
Primary completion
Jun 30, 2027
Completion
Jun 30, 2027

Study Design

Enrollment
176 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Telitacicept
    Telitacicept 160mg is administered subcutaneously every other week for 26 times on the background of standard therapy.
  • Placebo Comparator: Placebo
    Placebo is administered subcutaneously every other week for 26 times on the background of standard therapy.

Primary Outcome Measure

Percentage of patients with disease flares [ Time Frame: 52 weeks ]

Central Contacts

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