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

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.

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

Study Overview

• Status: Recruiting
• Conditions: SLE
• Intervention / Treatment: Drug: APG-2575; Other: Placebo

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Phase 2; Phase 1

Contacts and Locations

• Study Contact: Name: Yifan Zhai; Phone Number: 240-505-6608; Email: Yzhai@ascentage.com
• Study Contact Backup: Name: Xiaofeng Han; Email: Xiaofeng.Han@ascentage.com

Study Locations

• China
  • Shanghai Municipality
    • Shanghai, Shanghai Municipality, China, 200127
      • Recruiting
      • Renji Hospital Shanghai Jiaotong University School of Medical
      • Contact: Sheng Chen, Ph.D; Phone Number: 13917556052; Email: 13917556052@139.com
      • Principal Investigator: Sheng Chen, Ph.D.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Other: Placebo; Take orally once daily (QD) for 12 weeks.
Experimental: APG-2575; Dose escalation	Drug: APG-2575; Take orally once daily (QD) for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.	According to CTCAE v5.0, the number and frequency of adverse events of test drug were assessed.	Up to 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Peak Plasma Concentration (Cmax) of APG-2575 in SLE patients.	To evaluate the metabolic characteristics of APG-2575 in SLE patients	At Day1 and Day 28 since the first dose of study drug.
Area under the plasma concentration versus time curve (AUC) of APG-2575 in SLE patients.	To evaluate the metabolic characteristics of APG-2575 in SLE patients	At Day1 and Day 28 since the first dose of study drug.
Time to Peak (Tmax) of APG-2575 in SLE patients.	To evaluate the metabolic characteristics of APG-2575 in SLE patients	At Day1 and Day 28 since the first dose of study drug.
Assessment of SLE disease activity using SLEDAI（Systemic Lupus Erythematosus Disease Activity Index）-2000.	To evaluate the patients' efficacy.	Up to 1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in the number and percentages of immune cells clusters.	The changes of immune cell clusters from baseline.	Up to 1 year
Change in the number and percentages of cytokines.	The changes of cytokines from baseline.	Up to 1 year

Collaborators and Investigators

• Sponsor: Ascentage Pharma Group Inc.
• Collaborators: Suzhou Yasheng Pharmaceutical Co., Ltd.
• Investigators: Principal Investigator: Sheng Chen, Ph.D, Renji Hospital Shanghai Jiaotong University School of Medical

Study record dates

Study Major Dates

• Study Start (Actual): August 9, 2024
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: December 3, 2023
• First Submitted That Met QC Criteria: December 13, 2023
• First Posted (Actual): December 27, 2023

Study Record Updates

• Last Update Posted (Actual): December 16, 2025
• Last Update Submitted That Met QC Criteria: December 14, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: SLE; APG-2575
• Additional Relevant MeSH Terms: Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Lupus Erythematosus, Systemic; Lisaftoclax
• Other Study ID Numbers: APG2575SC101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No