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

SLE Clinical Trial

Official title:

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.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06182969
• Other study ID #: APG2575SC101
• Status: Not yet recruiting
• Phase: Phase 1/Phase 2
• Start date: December 2023
• Est. completion date: December 2026

Study information

• Verified date: December 2023
• Source: Ascentage Pharma Group Inc.
• Contact: Yifan Zhai
• Phone: 240-505-6608
• Email: Yzhai[@]ascentage.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 2026
• Est. primary completion date: April 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

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

• 2. On stable treatment for systemic lupus erythematosus for 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.

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• SLE

Intervention

Drug:
• APG-2575
Take orally once daily (QD) for 12 weeks.

Other:
• Placebo
Take orally once daily (QD) for 12 weeks.

Locations

Country	Name	City	State
China	Renji Hospital Shanghai Jiaotong University School of Medical	Shanghai	Shanghai

Sponsors (2)

Lead Sponsor	Collaborator
Ascentage Pharma Group Inc.	Suzhou Yasheng Pharmaceutical Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change in the number and percentages of immune cells clusters.	The changes of immune cell clusters from baseline.	Up to 1 year
Other	Change in the number and percentages of cytokines.	The changes of cytokines from baseline.	Up to 1 year
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	Assessment of SLE disease activity using SLEDAI(Systemic Lupus Erythematosus Disease Activity Index)-2000.	To evaluate the patients' efficacy.	Up to 1 year