Telitacicept Study in Chinese Subjects With Systemic Lupus Erythematosus

Sponsor
RemeGen Co., Ltd.
Study ID
NCT05247203
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Telitacicept — BIOLOGICAL
    subcutaneous injection
  • standard therapy — DRUG
    A standard regimen consists of the following medication(s) (alone or in combination)：corticosteroids, anti-malarials, non-steroidal anti-inflammatory drugs (NSAIDs), other immunosuppressive or immunomodulatory agents including azathioprine, mycophenolate mofetil, cyclophosphamide, methotrexate, leflunomide, tacrolimus, cyclosporine.

Study Details

This is a multi-center, open-label, phase I study.

Key Dates

Start date
May 11, 2022
Status verified
Dec 2023
Primary completion
Oct 25, 2023
Completion
Nov 13, 2023

Study Design

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

Arms

  • Experimental: Telitacicept Arm 1
    Telitacicept 80mg, once a week for 24 weeks plus standard therapy
  • Experimental: Telitacicept Arm 2
    Telitacicept 160mg, once a week for 24 weeks plus standard therapy
  • Experimental: Telitacicept Arm 3
    Telitacicept 160mg, once a week for 12 weeks followed by once every two weeks for another 12 weeks plus standard therapy
  • Experimental: Telitacicept Arm 4
    Telitacicept 240mg, once a week for 24 weeks plus standard therapy
  • Experimental: Telitacicept Arm 5
    Telitacicept 240mg, once every two weeks for 24 weeks plus standard therapy

Primary Outcome Measure

Peak plasma concentration (Cmax) of Telitacicept [ Time Frame: up to 42 days following the last dose of Telitacicept ]

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