A Study of D-2570 in Patients With Active Systemic Lupus Erythematosus (SLE)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: D-2570, D-2570 Placebo.
- Who it may be relevant to
- Registry conditions: Active Systemic Lupus Erythematosus. Basic parameters: 18 years — 70 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Detailed description
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.
Interventions
- Drug D-2570
Participants will be assigned to one of the following groups: Group A, Group B, Group C, or the placebo control group. - Drug D-2570 Placebo
D-2570 Placebo
Primary outcome measures
- Proportion of subjects achieving the Systemic Lupus Erythematosus Responder Index-4 (SRI-4) at Week 32 [Time frame: Week 32]
Secondary outcome measures (12)
- 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]
- 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]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- Linfen Central Hospital — Linfen
Identifiers
NCT: NCT07311200 · D2570-205