APG-2575: Take orally once daily (QD) for 12 weeks.
Placebo: Take orally once daily (QD) for 12 weeks.
Study summary
To evaluate the safety, tolerability, pharmacokinetics and pharmacokinetics of multi-dose APG-2575 in mild-to-moderate systemic lupus erythematosus (SLE).
Eligibility
Sex
FEMALE
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria:
* 1\. Diagnosis of systemic lupus erythematosus for at least 6 months.
* 2\. On stable treatment for systemic lupus erythematosus before first dose at least 28 days.
* 3\. SLEDIA-2000 score: 4-12
* 4.Other than systemic lupus erythematosus, subject should be in general good health.
Exclusion Criteria:
* 1\. Severe systemic lupus erythematosus.
* 2\. Significant autoimmune disease other than lupus.
* 3\. Significant, uncontrolled or unstable disease in any organ.
Primary outcome measure(s)
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0. — Up to 1 year According to CTCAE v5.0, the number and frequency of adverse events of test drug were assessed.
Trial sites (1)
Facility
City
Region
Status
Renji Hospital Shanghai Jiaotong University School of Medical
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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