Efficacy and Safety of Telitacicept in Early SLE

Sponsor
Peking Union Medical College Hospital
Study ID
NCT05899907
Phase
PHASE4
Status
Unknown

Conditions

  • Lupus Erythematosus, Systemic

Eligibility Criteria

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

Interventions

  • Telitacicept — DRUG
    160mg once a week for 48 weeks
  • Standard of Care — DRUG
    Steroid(≤1mg/kg/d) with or without proper immunosuppressants：CTX, MMF, AZA, CsA, FK 506, HCQ, MTX, LEF, SASP etc.

Study Details

The purpose of this study is to evaluate the safety and efficacy of Telitacicept in adult patients with early stage of SLE .

Key Dates

Start date
Sep 1, 2022
Status verified
Jun 2023
Primary completion
Mar 1, 2025
Completion
Sep 1, 2025

Study Design

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

Arms

  • Experimental: Treatment group
    Standard of care plus Telitacicept 160 mg sc per week; after week 12, the dose can be reduced to 80 mg per week due to safety considerations.
  • Other: Control group
    Standard of care

Primary Outcome Measure

Proportion of LLDAS in week 24 [ Time Frame: week 24 ]

Central Contacts

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