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

NCT ID: NCT06182969

Last Updated: 2025-12-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-09

Study Completion Date

2026-12-31

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.

Conditions

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SLE

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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APG-2575

Dose escalation

Group Type EXPERIMENTAL

APG-2575

Intervention Type DRUG

Take orally once daily (QD) for 12 weeks.

Placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Take orally once daily (QD) for 12 weeks.

Interventions

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APG-2575

Take orally once daily (QD) for 12 weeks.

Intervention Type DRUG

Placebo

Take orally once daily (QD) for 12 weeks.

Intervention Type OTHER

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 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Suzhou Yasheng Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role collaborator

Ascentage Pharma Group Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sheng Chen, Ph.D

Role: PRINCIPAL_INVESTIGATOR

Renji Hospital Shanghai Jiaotong University School of Medical

Locations

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Renji Hospital Shanghai Jiaotong University School of Medical

Shanghai, Shanghai Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yifan Zhai

Role: CONTACT

240-505-6608

Xiaofeng Han

Role: CONTACT

Facility Contacts

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Sheng Chen, Ph.D

Role: primary

13917556052

Other Identifiers

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APG2575SC101

Identifier Type: -

Identifier Source: org_study_id