Renji Hospital Shanghai Jiaotong University School of Medical
Shanghai, Shanghai Municipality, 200127, China
Location status: Recruiting
Recruiting
NCT Number: NCT06182969
A Study of APG-2575 in Patients With Mild-to-moderate Systemic Lupus Erythematosus.
To evaluate the safety, tolerability, pharmacokinetics and pharmacokinetics of multi-dose APG-2575 in mild-to-moderate systemic lupus erythematosus (SLE).
Recruiting
Interested in participating?
Request InfoKey information
Conditions
Age range
18 year–65 year
Sex eligibility
Female
Study type
Interventional
Phase
Phase 1 / Phase 2
Primary location
About this study
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.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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.
Treatment and study plan
APG-2575
DrugTake orally once daily (QD) for 12 weeks.
Placebo
OtherTake orally once daily (QD) for 12 weeks.
Primary outcomes
-
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.
Time frame: Up to 1 year
According to CTCAE v5.0, the number and frequency of adverse events of test drug were assessed.
Secondary outcomes
-
Peak Plasma Concentration (Cmax) of APG-2575 in SLE patients.
Time frame: At Day1 and Day 28 since the first dose of study drug.
To evaluate the metabolic characteristics of APG-2575 in SLE patients
-
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.
To evaluate the metabolic characteristics of APG-2575 in SLE patients
-
Time to Peak (Tmax) of APG-2575 in SLE patients.
Time frame: At Day1 and Day 28 since the first dose of study drug.
To evaluate the metabolic characteristics of APG-2575 in SLE patients
-
Assessment of SLE disease activity using SLEDAI（Systemic Lupus Erythematosus Disease Activity Index）-2000.
Time frame: Up to 1 year
To evaluate the patients' efficacy.
Other outcomes
-
Change in the number and percentages of immune cells clusters.
Time frame: Up to 1 year
The changes of immune cell clusters from baseline.
-
Change in the number and percentages of cytokines.
Time frame: Up to 1 year
The changes of cytokines from baseline.
Study contacts
Contact information is provided by the study sponsor or research team.
Sponsors and collaborators
Lead sponsor
Ascentage Pharma Group Inc.
Industry
Collaborators
- Suzhou Yasheng Pharmaceutical Co., Ltd.
Registry information
Official study 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.
Important dates
- Study start
- 2024
- Primary completion
- 2026
- Study completion
- 2026
- First posted
- Dec 27, 2023
- Registry last updated
- Dec 16, 2025
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Related clinical trials
Published trials that share one or more normalized conditions with this study.
Recruiting
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study With an Open-Label Extension Evaluating the Efficacy and Safety of VENT-03 in Adult Participants With Active Cutaneous Lupus Erythematosus With or Without Systemic Lupus Erythematosus
NCT07260877
Autoimmune Diseases, CLE
Beverly Hills, California, United States
View Trial Details
Recruiting
CD19-Directed Chimeric Antigen Receptor Autologous T Cells (CART19) for Lupus
NCT06839976
Autoimmune Diseases, CAR T Cell
Philadelphia, Pennsylvania, United States
View Trial Details
Recruiting
A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Systemic Lupus Erythematosus
NCT06613360
Autoimmune Diseases, Connective Tissue Diseases
Avondale, Arizona, United States
View Trial Details
Recruiting
Clinical Study on Targeted CD19/BCMA CAR-T Therapy for Autoimmune Diseases
NCT06775912
ANCA Associated Vasculitis (AAV), Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis
Lianyungang, Jiangus, China
View Trial Details