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

Phase 1

Recruiting

• Conditions: SLE
• Interventions: Drug: APG-2575; Other: Placebo

• Registration Number: NCT06182969
• Lead Sponsor: Ascentage Pharma Group Inc.

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.

Study Timeline

• Study First Submitted: 2023-12-03
• Study First Submitted QC: 2023-12-13
• Study First Posted: 2023-12-27
• Study Start: 2024-08-09
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-05
• Last Update Posted: 2024-12-10
• Primary Completion: 2026-04
• Study Completion: 2026-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
APG-2575	APG-2575	Dose escalation
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Assessment of SLE disease activity using SLEDAI（Systemic Lupus Erythematosus Disease Activity Index）-2000.	Up to 1 year	To evaluate the patients' efficacy.
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

Trial Locations

Locations (1)

Renji Hospital Shanghai Jiaotong University School of Medical; 🇨🇳 Shanghai, Shanghai, China