Actively Recruiting
Phase 2 Study of Telitacicept With Standard Therapy for Adults Aged 18 to 75 Treating Active Proliferative Lupus Nephritis with Weekly Subcutaneous Injections
Led by RemeGen Co., Ltd. · Updated on 2024-09-23
120
Participants Needed
45
Research Sites
4 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of Telitacicept in adults with active lupus nephritis, a kidney inflammation caused by lupus. This phase 2, multicenter, randomized, double-blind, placebo-controlled study compares Telitacicept to a placebo while all participants receive standard of care treatment. The research aims to understand how well Telitacicept works and how safe it is for patients with this condition. Participants will be randomly assigned to one of three groups Telitacicept 240 mg, Telitacicept 160 mg, or a placebo. Each group receives weekly subcutaneous injections along with standard therapy for 48 weeks. The study monitors participants throughout this period to observe treatment effects and safety. During the 48-week treatment, participants will undergo regular assessments including kidney function tests and monitoring for side effects. Researchers will measure the percentage of participants achieving complete renal response at week 48, along with partial response rates and any adverse events up to week 48. The study ensures careful follow-up to evaluate outcomes and participant safety over the full treatment duration.
CONDITIONS
Brief Title
A Study of Telitacicept in Lupus Nephritis
Research Team
B
Binghua Xiao
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