A Study of APG-2575 in Patients With Mild-to-moderate Systemic Lupus Erythematosus.

• Status: Not yet recruiting
• Trial end date: 2026-12-01
• Target enrollment: 0
• Participant gender: Female

Summary

To evaluate the safety, tolerability, pharmacokinetics and pharmacokinetics of multi-dose APG-2575 in mild-to-moderate systemic lupus erythematosus (SLE).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ascentage Pharma Group Inc.
• Collaborator: Suzhou Yasheng Pharmaceutical Co., Ltd.

Criteria

Inclusion Criteria:

• 1. Diagnosis of systemic lupus erythematosus for at least 6 months.

• 2. On stable treatment for systemic lupus erythematosus for 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.