Moderate to severe active systemic lupus erythematosus
Conditions
Interventions
2mg group:oral
3mg group:oral
0mg group:oral
Sponsors
Peking Union Hospital, Chinese Academy of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Subjects must have been diagnosed with systemic lupus erythematosus at least 12 weeks prior to screening and must be assessed to meet 2019 EULAR/ACR SLE classification criteria during screening; 2. the subject must meet one of the following at screening: a. ANA titer =1:80;b. anti-dsDNA antibody positive; c. Anti-Smith antibody positive. 3. At least one of the following SLE background standard therapies (including no more than one immunosuppressant) was required for 12 weeks prior to randomization, and the dose must remain stable at least 30 days until randomization and throughout study participation.
Exclusion criteria
Exclusion criteria: 1. Active lupus nephritis (defined as urinary protein >1g/24 h or urinary total protein/creatinine ratio (UPCR) >1 mg/mg (113 mg/mmol) within 8 weeks prior to screening or at randomization). 2. Active lupus of the central nervous system (CNS) (including epilepsy, psychosis, organic encephalopathy syndrome, cerebrovascular accident, encephalitis, or CNS vasculitis) within 60 days prior to randomization. 3. Myocardial infarction, unstable angina pectoris, stroke, transient ischemic attack, decompensated heart failure requiring hospitalization, grade III/IV heart failure, or untreated severe sleep apnea occurred =6 months before screening. 4. Previous or current atrioventricular block of degree ? or ?, sick sinus syndrome, symptomatic bradycardia, atrial flutter or atrial fibrillation, ventricular arrhythmia or syncope associated with heart disease, or other arrhythmia deemed clinically significant and requiring intervention or treatment. 5. A history of severe respiratory disease or pulmonary fibrosis was found based on the medical history, lung function and chest CT examination conducted during screening or within 3 months prior to screening;Or abnormal pulmonary function of medical significance: 1 second forced expiratory volume (FEV1) or forced vital capacity (FVC) 8%, or diabetic subjects with organ involvement (e.g. retinopathy or kidney disease).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Peripheral blood lymphocyte count; | — |
Secondary
| Measure | Time frame |
|---|---|
| mSLEDAI-2K scores;SLE SRI-4;physician's global assessment PGA; | — |
Countries
China
Contacts
Public ContactXiaofeng Zeng
Peking Union Hospital
Outcome results
None listed