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

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

Recruiting
18-65 years
Female
Phase 1/2
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Overview

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

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

Inclusion Criteria:

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

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       2. On stable treatment for systemic lupus erythematosus before first dose at least
          28 days.

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3. SLEDIA-2000 score: 4-12

  • 4.Other than systemic lupus erythematosus, subject should be in general good health.

Exclusion Criteria:

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  1. Severe systemic lupus erythematosus.

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2. Significant autoimmune disease other than lupus.

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3. Significant, uncontrolled or unstable disease in any organ.

Study details
    SLE

NCT06182969

Ascentage Pharma Group Inc.

22 August 2025

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