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Recruiting NCT06182969

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

Phase I / Phase II Interventional SLE

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: APG-2575, Placebo.
Who it may be relevant to
Registry conditions: SLE. Basic parameters: 18 years — 65 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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.

Overview

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

Detailed 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.

Interventions

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

Primary outcome measures

  • Number of participants with treatment-related adverse events as assessed by CTCAE v5.0. [Time frame: Up to 1 year]
Secondary outcome measures (4)
  • Peak Plasma Concentration (Cmax) of APG-2575 in SLE patients. [Time frame: At Day1 and Day 28 since the first dose of study drug.]
  • Area under the plasma concentration versus time curve (AUC) of APG-2575 in SLE patients. [Time frame: At Day1 and Day 28 since the first dose of study drug.]
  • Time to Peak (Tmax) of APG-2575 in SLE patients. [Time frame: At Day1 and Day 28 since the first dose of study drug.]
  • Assessment of SLE disease activity using SLEDAI（Systemic Lupus Erythematosus Disease Activity Index）-2000. [Time frame: Up to 1 year]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

China · 1 center
  • Renji Hospital Shanghai Jiaotong University School of Medical — Shanghai

Identifiers

NCT: NCT06182969 · APG2575SC101

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗