D-2570 treatment for active systemic lupus erythematosus
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 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 |
| Enrollment | 120 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | InventisBio Co., Ltd Industry-sponsored |
| Locations | 1 site (Linfen, Jiangxi) |
| Trial ID | NCT07311200 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Linfen, Jiangxi
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.