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

NCT07311200 | Recruiting Phase 2 DMC

• 1 other identifier: D2570-205
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Active Systemic Lupus Erythematosus

Keywords

Active Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (1)

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

  Week 32

Secondary Outcomes (13)

• 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

Study Arms (4)

Group A: D-2570 and placebo

EXPERIMENTAL

Drug: D-2570; Drug: D-2570 Placebo

Group B: D-2570 and placebo

EXPERIMENTAL

Drug: D-2570; Drug: D-2570 Placebo

Group C: D-2570

EXPERIMENTAL

Drug: D-2570

Placebo Control Group

PLACEBO COMPARATOR

Drug: D-2570 Placebo

Interventions

D-2570 DRUG

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

Group A: D-2570 and placebo; Group B: D-2570 and placebo; Group C: D-2570

D-2570 Placebo DRUG

D-2570 Placebo

Group A: D-2570 and placebo; Group B: D-2570 and placebo; Placebo Control Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• InventisBio Co., Ltd: lead

Study Sites (1)

Linfen Central Hospital

Linfen, Jiangxi, China

RECRUITING

Study Officials

• Xiaofeng

  Zeng

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hang Ren, Master

CONTACT

86+15900699091; hang.ren@inventisbio.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 16, 2025
• First Posted: December 30, 2025
• Study Start: February 12, 2026
• Primary Completion (Estimated): August 31, 2028
• Study Completion (Estimated): December 31, 2028
• Last Updated: April 24, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)