A Study of Telitacicept in Lupus Nephritis

Sponsor
RemeGen Co., Ltd.
Study ID
NCT05680480
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Telitacicept 240 mg — BIOLOGICAL
    Participants will receive Telitacicept 240mg weekly in addition to SOC for 48 weeks.
  • Telitacicept 160 mg — BIOLOGICAL
    Participants will receive Telitacicept 160mg weekly in addition to SOC for 48 weeks.
  • Placebo — DRUG
    Participants will receive placebo weekly in addition to SOC for 48 weeks.

Study Details

The purpose of this study is to evaluate the safety and efficacy of Telitacicept in adult patients with active lupus nephritis.

Key Dates

Start date
Apr 17, 2023
Status verified
Sep 2024
Primary completion
Dec 31, 2025
Completion
Jan 31, 2026

Study Design

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

Arms

  • Experimental: Telitacicept 240 mg
    Telitacicept 240 mg given SC weekly plus standard therapy through week 48.
  • Experimental: Telitacicept 160 mg
    Telitacicept 160 mg given SC weekly plus standard therapy through week 48.
  • Placebo Comparator: Placebo
    Placebo given SC weekly plus standard therapy through week 48.

Primary Outcome Measure

Percentage of Participants with Complete Renal Response (CRR) [ Time Frame: Week 48 ]

Central Contacts

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