Evaluating APG-2575 for mild-to-moderate lupus

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to assess the safety, tolerability, and pharmacokinetics of APG-2575 in patients diagnosed with mild-to-moderate systemic lupus erythematosus (SLE). It is a randomized, double-blind, placebo-controlled study involving approximately 40 participants who will receive either the drug or a placebo in varying doses from 200mg to 800mg. The study will monitor participants over a defined period to gather data on the drug's effects and safety profile.

Why it matters

Who can join: the full rules

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.

Where it's running

• Renji Hospital Shanghai Jiaotong University School of Medical
  Shanghai, Shanghai Municipality, China Recruiting

Study contacts

• Principal investigator: Sheng Chen, Ph.D — Renji Hospital Shanghai Jiaotong University School of Medical
• Study coordinator: Yifan Zhai
• Email: Yzhai@ascentage.com
• Phone: 240-505-6608

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.