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

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

Detailed Description
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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.

Official Title
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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.

Conditions
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SLE

Intervention / Treatment
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* Drug: APG-2575
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1. Diagnosis of systemic lupus erythematosus for at least 6 months. 2. On stable treatment for systemic lupus erythematosus for 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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: APG-2575<br>Dose escalation | Drug: APG-2575<br>* Take orally once daily (QD) for 12 weeks.<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* Take orally once daily (QD) for 12 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related adverse events as assessed by CTCAE v5.0. | According to CTCAE v5.0, the number and frequency of adverse events of test drug were assessed. | Up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Peak Plasma Concentration (Cmax) of APG-2575 in SLE patients. | To evaluate the metabolic characteristics of APG-2575 in SLE patients | 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. | To evaluate the metabolic characteristics of APG-2575 in SLE patients | At Day1 and Day 28 since the first dose of study drug. | 
| Time to Peak (Tmax) of APG-2575 in SLE patients. | To evaluate the metabolic characteristics of APG-2575 in SLE patients | 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. | To evaluate the patients' efficacy. | Up to 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SLE, APG-2575