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

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: Recruiting
• Conditions: Active Systemic Lupus Erythematosus
• Intervention / Treatment: Drug: D-2570; Drug: D-2570 Placebo

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: Interventional
• Enrollment (Estimated): 120
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Hang Ren, Master; Phone Number: 86+15900699091; Email: hang.ren@inventisbio.com

Study Locations

• China
  • Jiangxi
    • Linfen, Jiangxi, China
      • Recruiting
      • Linfen Central Hospital
      • Contact: Shuhua Qiang; Phone Number: +86 18636785653; Email: qsh18636785653@126.com

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Time Frame
Proportion of subjects achieving the Systemic Lupus Erythematosus Responder Index-4 (SRI-4) at Week 32	Week 32

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of subjects achieving SRI-4 at 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	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	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	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	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	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	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	Weeks 44-48
Incidence of adverse events rate based on NCI CTCAE V5.0	From enrollment to 52 weeks
Changes from baseline of anti-double-stranded DNA (dsDNA) antibody	From enrollment to the end of treatment at 48 weeks
blood drug concentration of D-2570	From enrollment to the end of treatment at 48 weeks
Changes from baseline of complement (C3) levels	From enrollment to the end of treatment at 48 weeks
Changes from baseline of complement C4 levels	From enrollment to the end of treatment at 48 weeks

Collaborators and Investigators

• Sponsor: InventisBio Co., Ltd
• Investigators: Principal Investigator: Xiaofeng, Zeng

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2026
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: December 16, 2025
• First Submitted That Met QC Criteria: December 16, 2025
• First Posted (Actual): December 30, 2025

Study Record Updates

• Last Update Posted (Actual): April 24, 2026
• Last Update Submitted That Met QC Criteria: April 23, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Active Systemic Lupus Erythematosus
• Other Study ID 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