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

Ascentage Pharma Group

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: SLE

Treatments: Other: Placebo; Drug: APG-2575

Study type: Interventional

Funder types: Industry

Identifiers

NCT06182969

APG2575SC101

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 estimated patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 2 patient groups, including a placebo group

APG-2575

Experimental group

Description:

Dose escalation

Treatment:

Drug: APG-2575

Placebo

Placebo Comparator group

Treatment:

Other: Placebo