RecruitingPhase 2NCT07311200

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


Sponsor

InventisBio Co., Ltd

Enrollment

120 participants

Start Date

Feb 12, 2026

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Inclusion Criteria5

  • The patient voluntarily participates in this study after full informed consent.
  • The age is 18 years ≤ age ≤ 70 years, regardless of gender.
  • Diagnosed with Systemic Lupus Erythematosus (SLE) at least ≥ 24 weeks prior to screening.
  • SLEDAI-2K total score ≥ 8.
  • On stable treatment for systemic lupus erythematosus at least 4 weeks prior to randomization, and should remain at a stable dose throughout the trial period.

Exclusion Criteria3

  • History of infection as defined in the protocol.
  • Any of the medical diseases or disorders listed in the protocol.
  • Significant, uncontrolled or unstable disease in any organ.

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Interventions

DRUGD-2570

Participants will be assigned to one of the following groups: Group A, Group B, Group C, or the placebo control group.

DRUGD-2570 Placebo

D-2570 Placebo


Locations(1)

Linfen Central Hospital

Linfen, Jiangxi, China

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NCT07311200