NCT07311200

A Study of D-2570 in Patients With Active Systemic Lupus Erythematosus (SLE)

A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Study to Evaluate the Efficacy and Safety of D-2570 in Patients With Active Systemic Lupus Erythematosus

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: InventisBio Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

This study is a multicenter, randomized, double-blind, placebo-controlled Phase II clinical trial designed to evaluate the efficacy and safety of D-2570 in the treatment of active systemic lupus erythematosus.

Detailed description

Subjects who sign the informed consent form will enter the screening period, during which their eligibility will be assessed according to the inclusion and exclusion criteria. Eligible participants who meet the inclusion criteria and do not meet any exclusion criteria will be randomized. Participants will then be assigned to one of the following groups: Group A, Group B, Group C, or the placebo group. They will proceed to the treatment period, during which they will take the corresponding investigational product once daily for 48 consecutive weeks. After completing the treatment, subjects will undergo safety follow-up. Throughout the treatment period, both investigators and subjects will remain blinded. During the study, participants will be required to provide pharmacokinetic and pharmacodynamic blood samples at the time points specified in the trial protocol.

Conditions

• Active Systemic Lupus Erythematosus

Interventions

Type	Name	Description
DRUG	D-2570	Participants will be assigned to one of the following groups: Group A, Group B, Group C, or the placebo control group.
DRUG	D-2570 Placebo	D-2570 Placebo

Timeline

• Start date: 2026-01-15
• Primary completion: 2028-08-31
• Completion: 2028-12-31
• First posted: 2025-12-30
• Last updated: 2026-01-07