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.
Subjects who sign the informed consent form will enter the screening period, during which their eligibility will be assessed according to the inclusion and exclusion criteria. Eligible participants who meet the inclusion criteria and do not meet any exclusion criteria will be randomized. Participants will then be assigned to one of the following groups: Group A, Group B, Group C, or the placebo group. They will proceed to the treatment period, during which they will take the corresponding investigational product once daily for 48 consecutive weeks. After completing the treatment, subjects will undergo safety follow-up. Throughout the treatment period, both investigators and subjects will remain blinded. During the study, participants will be required to provide pharmacokinetic and pharmacodynamic blood samples at the time points specified in the trial protocol.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
Participants will be assigned to one of the following groups: Group A, Group B, Group C, or the placebo control group.
D-2570 Placebo
Linfen Central Hospital
Linfen, Jiangxi, China
RECRUITINGProportion of subjects achieving the Systemic Lupus Erythematosus Responder Index-4 (SRI-4) at Week 32
Time frame: Week 32
Proportion of subjects achieving SRI-4 at Weeks 4, 12, 24, and 48
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Weeks 4, 12, 24, 32, and 48
Proportion of subjects achieving the British Isles Lupus Assessment Group-based Composite Lupus Assessment (BICLA) at Weeks 4, 12, 24, 32, and 48
Time frame: Weeks 4, 12, 24, 32, and 48
Proportion of subjects achieving Lupus Low Disease Activity State (LLDAS) at Weeks 4, 12, 24, 32, and 48
Time frame: Weeks 4, 12, 24, 32, and 48
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Proportion of subjects with a prednisone dose of ≤5.0 mg/day or a reduction of ≥25% from baseline dose during Weeks 44-48
Time frame: Weeks 44-48
Changes from baseline of anti-double-stranded DNA (dsDNA) antibody
Time frame: From enrollment to the end of treatment at 48 weeks
blood drug concentration of D-2570
Time frame: From enrollment to the end of treatment at 48 weeks
Incidence of adverse events rate based on NCI CTCAE V5.0
Time frame: From enrollment to 52 weeks
Changes from baseline of complement (C3) levels
Time frame: From enrollment to the end of treatment at 48 weeks
Changes from baseline of complement C4 levels
Time frame: From enrollment to the end of treatment at 48 weeks