Status:
RECRUITING
A Study of APG-2575 in Patients With Mild-to-moderate Systemic Lupus Erythematosus.
Lead Sponsor:
Ascentage Pharma Group Inc.
Collaborating Sponsors:
Suzhou Yasheng Pharmaceutical Co., Ltd.
Conditions:
SLE
Eligibility:
FEMALE
18-65 years
Phase:
PHASE1
PHASE2
Brief Summary
To evaluate the safety, tolerability, pharmacokinetics and pharmacokinetics of multi-dose APG-2575 in mild-to-moderate systemic lupus erythematosus (SLE).
Detailed Description
This is a randomized, double-blind, placebo-controlled Phase I/II study. About 40 participants will be recruited to receive either APG-2575 or a placebo, with doses from 200mg up to 800mg.
Eligibility Criteria
Inclusion
- 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
- Other than systemic lupus erythematosus, subject should be in general good health.
Exclusion
- 1\. Severe systemic lupus erythematosus.
- 2\. Significant autoimmune disease other than lupus.
- 3\. Significant, uncontrolled or unstable disease in any organ.
Key Trial Info
Start Date :
August 9 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT06182969
Start Date
August 9 2024
End Date
December 1 2026
Last Update
December 16 2025
Active Locations (1)
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1
Renji Hospital Shanghai Jiaotong University School of Medical
Shanghai, Shanghai Municipality, China, 200127