NCT06182969

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
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Sponsor: Ascentage Pharma Group Inc. · Industry
• Sex: Female
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• SLE

Interventions

Type	Name	Description
DRUG	APG-2575	Take orally once daily (QD) for 12 weeks.
OTHER	Placebo	Take orally once daily (QD) for 12 weeks.

Timeline

• Start date: 2024-08-09
• Primary completion: 2026-04-01
• Completion: 2026-12-01
• First posted: 2023-12-27
• Last updated: 2025-12-16

Locations

1 site across 1 country: China