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

April 23, 2026 updated by: InventisBio Co., Ltd

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Jiangxi
      • Linfen, Jiangxi, China
        • Recruiting
        • Linfen Central Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo Control Group
Drug: D-2570 Placebo
D-2570 Placebo
Experimental: Group A: D-2570 and placebo
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
Experimental: Group B: D-2570 and placebo
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
Experimental: Group C: D-2570
Drug: D-2570
Participants will be assigned to one of the following groups: Group A, Group B, Group C, or the placebo control group.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Proportion of subjects achieving the Systemic Lupus Erythematosus Responder Index-4 (SRI-4) at Week 32
Time Frame: Week 32
Week 32

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Proportion of subjects achieving SRI-4 at Weeks 4, 12, 24, and 48
Time Frame: Weeks 4, 12, 24, and 48
Weeks 4, 12, 24, and 48
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
Weeks 4, 12, 24, 32, and 48
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
Weeks 4, 12, 24, 32, and 48
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
Weeks 4, 12, 24, 32, and 48
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
Weeks 4, 12, 24, 32, and 48
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
Weeks 4, 12, 24, 32, and 48
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
Weeks 4, 12, 24, 32, and 48
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
Weeks 44-48
Incidence of adverse events rate based on NCI CTCAE V5.0
Time Frame: From enrollment to 52 weeks
From enrollment to 52 weeks
Changes from baseline of anti-double-stranded DNA (dsDNA) antibody
Time Frame: From enrollment to the end of treatment at 48 weeks
From enrollment to the end of treatment at 48 weeks
blood drug concentration of D-2570
Time Frame: From enrollment to the end of treatment at 48 weeks
From enrollment to the end of treatment at 48 weeks
Changes from baseline of complement (C3) levels
Time Frame: From enrollment to the end of treatment at 48 weeks
From enrollment to the end of treatment at 48 weeks
Changes from baseline of complement C4 levels
Time Frame: From enrollment to the end of treatment at 48 weeks
From enrollment to the end of treatment at 48 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
InventisBio Co., Ltd

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Xiaofeng, Zeng

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 12, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 31, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 16, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2025

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 30, 2025

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 24, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 23, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
December 1, 2025

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D2570-205

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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