Actively Recruiting
Phase IbIIa Study of GR1803 Injection for Adults with Systemic Lupus Erythematosus Evaluating Safety, Tolerability, and Effectiveness
Led by Genrix (Shanghai) Biopharmaceutical Co., Ltd. · Updated on 2026-03-10
44
Participants Needed
1
Research Sites
26 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and effectiveness of GR1803 injection in adults with systemic lupus erythematosus, an autoimmune disease. This clinical trial is a Phase IbIIa study focusing on patients with a confirmed diagnosis and a SLEDAI-2K score of 6 or higher. The study aims to better understand the treatments impact on this condition. Participants will receive GR1803 injection using a step-up dosing schedule with doses and frequency determined by the study protocol. There are four different dosing groups in this trial, all receiving the experimental medication. The study is non-randomized and unblinded, allowing participants and researchers to know the treatment details. During the 52-week study period, participants will be closely monitored for adverse events and treatment effects. Researchers will assess safety by tracking any side effects and evaluate efficacy by measuring disease activity over time. Participants will need to comply with the treatment and undergo regular assessments to support the studys goals.
CONDITIONS
Brief Title
A Study of GR1803 in Systemic Lupus Erythematosus
Research Team
N
Nian
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