Clinical trial Recruiting at 1 site Phase 2 Interventional Ages 18 to 70

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

PhasePhase 2
Study typeInterventional
Ages18 Years to 70 Years
SexAll
Enrollment120 (estimated)
SponsorInventisBio Co., Ltd
Industry-sponsored
Locations1 site (Linfen, Jiangxi)
StatusRecruiting
StartedFebruary 12, 2026
Main results expectedAugust 31, 2028
Study endsDecember 31, 2028
Registry record updatedApril 24, 2026
Trial IDNCT07311200 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

  • Linfen Central Hospital
    Linfen, Jiangxi, China
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.