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.

Status

Recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06182969

Enrollment

Registered

2023-12-27

Start date

2024-08-09

Completion date

2026-12-31

Last updated

2025-12-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

SLE

Keywords

SLE, APG-2575

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.

Interventions

DRUGAPG-2575

Take orally once daily (QD) for 12 weeks.

OTHERPlacebo

Take orally once daily (QD) for 12 weeks.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 65 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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.

Secondary

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

Other

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

Countries

China

Contacts

Primary ContactYifan Zhai

Yzhai@ascentage.com240-505-6608

Backup ContactXiaofeng Han

Xiaofeng.Han@ascentage.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026