Actively Recruiting
A Randomized, Double-blind, Placebo-controlled Phase I/II Study to Evaluate the Safety, Pharmacokinetics, and Pharmacodynamics of APG-2575 in Patients 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
On this page
Sponsors
A
Ascentage Pharma Group Inc.
Lead Sponsor
S
Suzhou Yasheng Pharmaceutical Co., Ltd.
Collaborating Sponsor
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 I/II 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.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of systemic lupus erythematosus for at least 6 months
- On stable treatment for systemic lupus erythematosus for at least 28 days before the first dose
- SLEDAI-2000 score between 4 and 12
- Generally in good health aside from systemic lupus erythematosus
You will not qualify if you...
- Severe systemic lupus erythematosus
- Significant autoimmune disease other than lupus
- Significant, uncontrolled, or unstable disease in any organ
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 12 weeks
Participants take APG-2575 or placebo orally once daily for 12 weeks.
Weekly visits for up to 12 weeks
Duration - Up to 1 year
Participants are monitored for safety and disease activity up to 1 year after treatment.
Periodic visits during follow-up
Trial Site Locations
Total: 1 location
1
Renji Hospital Shanghai Jiaotong University School of Medical
Shanghai, Shanghai Municipality, China, 200127
Actively Recruiting
Research Team
Y
Yifan Zhai
X
Xiaofeng Han
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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