Evaluating APG-2575 for mild-to-moderate lupus
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.
This study is testing a new drug called APG-2575 to see if it is safe and effective for people with mild-to-moderate lupus.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | Female |
| Sponsor | Ascentage Pharma Group Inc. Industry-sponsored |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06182969 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are individuals diagnosed with systemic lupus erythematosus for at least six months and on stable treatment for the condition.
Not a fit: Patients with severe systemic lupus erythematosus or significant autoimmune diseases other than lupus may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with mild-to-moderate systemic lupus erythematosus.
How similar studies have performed: While this approach is being explored in this specific context, similar studies targeting systemic lupus erythematosus have shown promise, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Shanghai, Shanghai Municipality
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.