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.
1 other identifier
interventional
40
1 country
1
Brief Summary
To evaluate the safety, tolerability, pharmacokinetics and pharmacokinetics of multi-dose APG-2575 in mild-to-moderate systemic lupus erythematosus (SLE).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Aug 2024
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 3, 2023
CompletedFirst Posted
Study publicly available on registry
December 27, 2023
CompletedStudy Start
First participant enrolled
August 9, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
ExpectedDecember 16, 2025
December 1, 2025
1.6 years
December 3, 2023
December 14, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (4)
Peak Plasma Concentration (Cmax) 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.
At Day1 and Day 28 since the first dose of study drug.
Time to Peak (Tmax) 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.
Up to 1 year
Other Outcomes (2)
Change in the number and percentages of immune cells clusters.
Up to 1 year
Change in the number and percentages of cytokines.
Up to 1 year
Study Arms (2)
APG-2575
EXPERIMENTALDose escalation
Placebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- \. Diagnosis of systemic lupus erythematosus for at least 6 months.
- \. On stable treatment for systemic lupus erythematosus before first dose at least 28 days.
- \. SLEDIA-2000 score: 4-12
- Other than systemic lupus erythematosus, subject should be in general good health.
You may not qualify if:
- \. Severe systemic lupus erythematosus.
- \. Significant autoimmune disease other than lupus.
- \. Significant, uncontrolled or unstable disease in any organ.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Renji Hospital Shanghai Jiaotong University School of Medical
Shanghai, Shanghai Municipality, 200127, China
MeSH Terms
Interventions
Study Officials
- PRINCIPAL INVESTIGATOR
Sheng Chen, Ph.D
Renji Hospital Shanghai Jiaotong University School of Medical
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 3, 2023
First Posted
December 27, 2023
Study Start
August 9, 2024
Primary Completion
April 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
December 16, 2025
Record last verified: 2025-12