SLEPhase 1/2NCT06182969
A Study of APG-2575 in Patients With Mild-to-moderate Systemic Lupus Erythematosus.
A Phase 1/2 study testing APG-2575 in people with SLE, run by Ascentage Pharma Group Inc. at 1 site in China.
Trial summary
To evaluate the safety, tolerability, pharmacokinetics and pharmacokinetics of multi-dose APG-2575 in mild-to-moderate systemic lupus erythematosus (SLE). Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- SLE
- What is being tested?
- APG-2575
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 9 Aug 2024to Dec 2026
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 1. Severe systemic lupus erythematosus.
- 2. Significant autoimmune disease other than lupus.
- 3. Significant, uncontrolled or unstable disease in any organ.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Xiaofeng Han contact
China1 site, 1 recruiting
- Recruiting
Renji Hospital Shanghai Jiaotong University School of Medical
Shanghai, Shanghai Municipality, 200127
Sheng Chen, Ph.D, 13917556052, 13917556052@139.com
Sheng Chen, Ph.D.
About this study
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.
To evaluate the safety, tolerability, pharmacokinetics and pharmacokinetics of multi-dose APG-2575 in mild-to-moderate systemic lupus erythematosus (SLE).
Read the 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.
- Conditions
- SLE
- Being tested
- APG-2575, Placebo
- Keywords
- SLE, APG-2575
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
APG-2575Drug
Take orally once daily (QD) for 12 weeks.
PlaceboOther
Take orally once daily (QD) for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| APG-2575 | Experimental | Dose escalation Receives: Drug: APG-2575 |
| Placebo | Placebo comparator | Not described Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 1 year
Secondary outcomes (4)
Peak Plasma Concentration (Cmax) of APG-2575 in SLE patients.
To evaluate the metabolic characteristics of APG-2575 in SLE patients
Measured: 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
Measured: 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
Measured: 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.
Measured: Up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2023
- Study start9 Aug 2024
- Primary completionApr 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SLEStudies of the same condition, open and under way.
- More trials run by Ascentage Pharma Group Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ascentage Pharma Group Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Suzhou Yasheng Pharmaceutical Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Sheng Chen, Ph.D, Principal investigator, Renji Hospital Shanghai Jiaotong University School of Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06182969
- Sponsor's protocol ID
- APG2575SC101
- Status last verified
- Dec 2025
- First submitted
- 3 Dec 2023
- Last updated
- 16 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT06182969
- Acronym / sponsor ID
- APG2575SC101
- Conditions
- SLE
- Keywords
- SLE, APG-2575
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ascentage Pharma Group Inc.Industry (pharma, biotech, devices)
- Collaborators
- Suzhou Yasheng Pharmaceutical Co., Ltd.
- Study start
- 9 Aug 2024 (actual)
- Primary completion
- Apr 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 27 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| APG-2575 | Experimental | Drug: APG-2575Dose escalation |
| Placebo | Placebo comparator | Other: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 1. Severe systemic lupus erythematosus.
- 2. Significant autoimmune disease other than lupus.
- 3. Significant, uncontrolled or unstable disease in any organ.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| APG-2575Take orally once daily (QD) for 12 weeks. | Drug | APG-2575 |
| PlaceboTake orally once daily (QD) for 12 weeks. | Other | Placebo |
Primary outcome
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.
4 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.
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiaofeng Han contact
Sheng Chen, Ph.D principal investigator
Renji Hospital Shanghai Jiaotong University School of Medical
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing APG-2575 in people with SLE, run by Ascentage Pharma Group Inc. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yifan Zhai (240-505-6608, Yzhai@ascentage.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0. (time frame: Up to 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Dec 2025.