D-2570: Participants will be assigned to one of the following groups: Group A, Group B, Group C, or the placebo control group.
D-2570 Placebo: D-2570 Placebo
Study 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.
Eligibility
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
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.
Primary outcome measure(s)
Proportion of subjects achieving the Systemic Lupus Erythematosus Responder Index-4 (SRI-4) at Week 32 — Week 32
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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