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NCT Number: NCT07311200

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

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.

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Key information

Conditions

Active Systemic Lupus Erythematosus

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 criteria

  • 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.

Treatment and study plan

D-2570

Drug

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

D-2570 Placebo

Drug

D-2570 Placebo

Primary outcomes

  1. Proportion of subjects achieving the Systemic Lupus Erythematosus Responder Index-4 (SRI-4) at Week 32

    Time frame: Week 32

Secondary outcomes

  1. Proportion of subjects achieving SRI-4 at Weeks 4, 12, 24, and 48

    Time frame: Weeks 4, 12, 24, and 48

  2. Proportion of subjects achieving Systemic Lupus Erythematosus Responder Index-6 (SRI-6) at Weeks 4, 12, 24, 32, and 48

    Time frame: Weeks 4, 12, 24, 32, and 48

  3. Improvement rate in the Systemic Lupus Erythematosus Disease Activity Index-2000 (SLEDAI-2K) score from baseline at Weeks 4, 12, 24, 32, and 48

    Time frame: Weeks 4, 12, 24, 32, and 48

  4. Proportion of subjects with a Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI) activity score improvement of ≥50% from baseline at Weeks 4, 12, 24, 32, and 48, among those with a baseline CLASI activity score of ≥10

    Time frame: Weeks 4, 12, 24, 32, and 48

  5. Proportion of subjects with ≥6 active (tender or swollen) joints at baseline who achieve a reduction of ≥50% in active (tender or swollen) joint count from baseline at Weeks 4, 12, 24, 32, and 48

    Time frame: Weeks 4, 12, 24, 32, and 48

  6. Proportion of subjects achieving the British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) at Weeks 4, 12, 24, 32, and 48

    Time frame: Weeks 4, 12, 24, 32, and 48

  7. Proportion of subjects achieving Lupus Low Disease Activity State (LLDAS) at Weeks 4, 12, 24, 32, and 48

    Time frame: Weeks 4, 12, 24, 32, and 48

  8. Proportion of subjects with a prednisone dose of ≤5.0 mg/day or a reduction of ≥25% from baseline dose during Weeks 44-48

    Time frame: Weeks 44-48

  9. Changes from baseline of anti-double-stranded DNA (dsDNA) antibody

    Time frame: From enrollment to the end of treatment at 48 weeks

  10. blood drug concentration of D-2570

    Time frame: From enrollment to the end of treatment at 48 weeks

  11. Incidence of adverse events rate based on NCI CTCAE V5.0

    Time frame: From enrollment to 52 weeks

  12. Changes from baseline of complement (C3) levels

    Time frame: From enrollment to the end of treatment at 48 weeks

  13. Changes from baseline of complement C4 levels

    Time frame: From enrollment to the end of treatment at 48 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Hang Ren, Master

CONTACT

[email protected]

86+15900699091

Sponsors and collaborators

Lead sponsor

InventisBio Co., Ltd

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Dec 30, 2025
Registry last updated
Apr 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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