Actively Recruiting
Study of APG-2575 Safety and Effects in Women Aged 18 to 65 With Mild to Moderate Systemic Lupus Erythematosus
Led by Ascentage Pharma Group Inc. · Updated on 2025-12-16
40
Participants Needed
1
Research Sites
34 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the safety, tolerability, and how the body processes multiple doses of APG-2575 in adults with mild-to-moderate systemic lupus erythematosus SLE. This randomized, double-blind, placebo-controlled Phase III study aims to better understand the effects of APG-2575 on this condition. Participants will receive either the study drug APG-2575 or a placebo, taken orally once daily for 12 weeks. The doses will range from 200mg up to 800mg, with a dose escalation design. About 40 participants will be enrolled and randomly assigned to one of the two groups. During the study, participants will be monitored for treatment-related side effects and how the drug behaves in their bodies through blood tests taken at the start and after 28 days of treatment. Disease activity will be assessed using the SLE Disease Activity Index over the course of up to one year. Safety and health will be closely followed throughout the study period.
CONDITIONS
Brief Title
A Study of APG-2575 in Patients With Mild-to-moderate Systemic Lupus Erythematosus.
Research Team
Y
Yifan Zhai
X
Xiaofeng Han
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