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NCT06182969RecruitingPhase 1/2

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.

Source: ClinicalTrials.gov · Last updated 16 Dec 2025

Brief summary (registry, in English)

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

Status (registry)
Recruiting
Phase (registry)
Phase 1/2
Study type
Interventional
Enrollment
40 (estimated)
First submitted
3 Dec 2023
Start date
9 Aug 2024
Primary completion date
Apr 2026
Lead sponsor
Ascentage Pharma Group Inc.
Diseases
Lupus (SLE)
NCT number
NCT06182969

What you commit to

  • Study type: Interventional · Phase 1/2
  • Planned participants: 40
  • From 9 Aug 2024 to the primary completion date, Apr 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 2\. Significant autoimmune disease other than lupus.
  • 3\. Significant, uncontrolled or unstable disease in any organ.

Other

  • 1\. Severe systemic lupus erythematosus.

Who the study is looking for

  • 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.

Age in the registry: 18 years to 65 years · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Renji Hospital Shanghai Jiaotong University School of Medical
Coordinator of this site? Confirm its status
ShanghaiChinaRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.