A Study of APG-2575 in Patients With Mild-to-moderate Systemic Lupus Erythematosus.
Recruiting · NCT06182969 · Interventional (participants receive a specific treatment) · Lead sponsor: Ascentage Pharma Group Inc.
View the official record on ClinicalTrials.gov →Interventions studied
APG-2575Placebo
What this trial is about
To evaluate the safety, tolerability, pharmacokinetics and pharmacokinetics of multi-dose APG-2575 in mild-to-moderate systemic lupus erythematosus (SLE).
Who can take part
Age range
18 Years to 65 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1, Phase 2
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
1 location listed.
- Renji Hospital Shanghai Jiaotong University School of Medical - Shanghai, Shanghai Municipality, China