D-2570 treatment for active systemic lupus erythematosus
Official 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
Run by InventisBio Co., Ltd · NCT07311200 · Data updated 2026-11-12
This trial will test whether daily D-2570 helps adults (18–70) with active systemic lupus erythematosus control their symptoms and disease activity better than a placebo over 48 weeks.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 120 (estimated) |
| Sponsor | InventisBio Co., Ltd Industry-sponsored |
| Locations | 1 site (Linfen, Jiangxi) |
| Status | Recruiting |
| Started | February 12, 2026 |
| Main results expected | August 31, 2028 |
| Study ends | December 31, 2028 |
| Registry record updated | April 24, 2026 |
| Trial ID | NCT07311200 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 to 70 with a confirmed SLE diagnosis for at least 24 weeks, a SLEDAI-2K score ≥8, and who are on stable lupus therapy are the intended participants.
✕Probably not a fit
Patients with recent or ongoing infections, significant uncontrolled organ disease, or those who do not meet the age or disease-activity criteria are unlikely to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized, double-blind, placebo-controlled Phase 2 trial assigns eligible adults with active SLE to one of three D-2570 dose groups or to placebo and follows them for 48 weeks of once-daily dosing. Participants must have had SLE for at least 24 weeks, a SLEDAI-2K score of ≥8, and be on stable background therapy before randomization. Investigators and participants remain blinded throughout treatment, with scheduled pharmacokinetic and pharmacodynamic blood sampling and routine safety assessments. After completing treatment subjects enter a safety follow-up period.
Why it matters
Potential benefit: If successful, D-2570 could lower lupus disease activity and symptoms and offer a new oral treatment option for adults with active SLE.
How similar studies have gone: While some approved therapies for SLE have shown benefit in randomized trials, D-2570 is a novel agent and has not yet been proven effective in SLE.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Linfen Central Hospital
Linfen, Jiangxi, China Recruiting
Study contacts
- Principal investigator: Xiaofeng — Zeng
- Study coordinator: Hang Ren, Master
- Email: hang.ren@inventisbio.com
- Phone: 86+15900699091
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.