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Recruiting Phase 1, Phase 2 NCT06182969

NCT06182969 A Study of APG-2575 in Patients With Mild-to-moderate Systemic Lupus Erythematosus.

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Clinical Trial Summary
NCT ID NCT06182969
Status Recruiting
Phase Phase 1, Phase 2
Sponsor Ascentage Pharma Group Inc.
Condition SLE
Study Type INTERVENTIONAL
Enrollment 40 participants
Start Date 2024-08-09
Primary Completion 2026-04

Eligibility & Interventions

Sex Female only
Min Age 18 Years
Max Age 65 Years
Study Type INTERVENTIONAL
Interventions
APG-2575Placebo

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.

This trial targets 40 participants in total. It began in 2024-08-09 with a primary completion date of 2026-04.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

Brief Summary

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

Eligibility Criteria

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.

Contact & Investigator

Central Contact

Yifan Zhai

✉ Yzhai@ascentage.com

📞 240-505-6608

Principal Investigator

Sheng Chen, Ph.D

PRINCIPAL INVESTIGATOR

Renji Hospital Shanghai Jiaotong University School of Medical

Frequently Asked Questions

Who can join the NCT06182969 clinical trial?

This trial is open to female participants only, aged 18 Years or older, up to 65 Years, studying SLE. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

What phase is the NCT06182969 trial and what does that mean for participants?

Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.

Is NCT06182969 currently recruiting?

Yes, NCT06182969 is actively recruiting participants. Contact the research team at Yzhai@ascentage.com for enrollment information.

Where is the NCT06182969 trial being conducted?

This trial is being conducted at Shanghai, China.

Who is sponsoring the NCT06182969 clinical trial?

NCT06182969 is sponsored by Ascentage Pharma Group Inc.. The principal investigator is Sheng Chen, Ph.D at Renji Hospital Shanghai Jiaotong University School of Medical. The trial plans to enroll 40 participants.

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ClinicalMetric — Independent clinical trial intelligence platform. Not affiliated with NIH, ClinicalTrials.gov, the U.S. FDA, or any pharmaceutical company, hospital, or clinical research organization. Trial data is sourced from ClinicalTrials.gov for informational purposes only and does not constitute medical advice. Do not make any treatment, enrollment, or health decisions based solely on information found here — always consult a qualified healthcare professional. Full Disclaimer  ·  Last Reviewed: July 2026  ·  Data Methodology