systemic lupus erythematosus
Conditions
Interventions
CM355 Treatment Group:CM355 Treatment Group
Sponsors
The Second Xiangya Hospital of CSU
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Research participants have the capacity to comprehend the nature of the study and voluntarily sign an informed consent form (ICF); 2.Age >= 18 to =8, and a score of >=6 on the SLEDAI-2K clinical symptoms, except when low complement levels and/or anti-ds-DNA antibody scores were present; 5.Definition of refractory SLE: Patients who have been treated with steroid + hydroxychloroquine + two or more kinds of immunosuppressants or steroid + hydroxychloroquine + one or more kinds of immunosuppressants + biological agents for more than 6 months in the past disease course, and still have persistent disease activity (SLEDAI-2K score >= 8 points) or >= 1 organ system in BILAG score is Class A and steroid cannot be maintained at low dose (for example: prednisone acetate dose >= 7. 5mg or equivalent potency glucocorticoid); 6.The treatment regimen for SLE was stable for more than 4 weeks before the first dose. Relevant drugs, maximum dose, required as follows: (1). Glucocorticoids: up to a maximum dose of 1 mg/kg/day (up to a maximum dose of 40 mg/day for prednisone and 32 mg/day for methylprednisolone). For subjects using alternate-day corticosteroids for SLE, the average daily dose of corticosteroids was calculated by averaging the 2-day dose; (2). Antimalarials: The maximum dose of hydroxychloroquine does not exceed 400 mg/day; (3). Immunosuppressants: including azathioprine (up to 200 mg/day), mycophenolate mofetil (up to 3000 mg/day), mycophenolate sodium (up to 2160 mg/day), methotrexate (up to 25 mg/week);
Exclusion criteria
Exclusion criteria: 1.Renal disease: Patients with severe lupus nephritis [defined as albumin 6g/24 hours or urine protein/creatinine ratio equivalent, or serum creatinine > 2.5 mg/dL or glomerular filtration rate (eGFR) = 100 mg/day or equivalent glucocorticoids for >= 14 days; 2.Patients with central nervous system diseases caused by SLE or not caused by SLE (including epilepsy, psychosis, organic brain syndrome, cerebrovascular accident, encephalitis, central nervous system vasculitis) within 8 weeks before the first dose; 3.Presence of the following laboratory abnormalities, including but not limited to: (1).Subjects with abnormal liver function: aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2.5 x upper limit of normal (ULN) or bilirubin > 1.5 x ULN, unless the patient has Gilbert's syndrome; (2).Subjects with abnormal hematology: WBC < 1.5 × 10^9/L, absolute neutrophil count < 1.0 × 10^2/L, absolute lymphocyte count (ALC) < 0.5 × 10^9/L, hemoglobin < 90 g/L, platelet count < 75 × 10^9/L; (3). Patients with absolute B cell count < 40 cells/µ L; 4.History of clinically significant diseases (such as circulatory system abnormalities, endocrine system abnormalities, nervous system disorders, hematological system disorders, immune system disorders, psychiatric disorders and unstable metabolic disorders, etc.) that, in the opinion of the investigator, may pose a risk to the safety of subjects during the study, or may affect the analysis and judgment of safety or effectiveness when the disease/condition is aggravated during the study, for example: (1) Cardiovascular diseases: acute myocardial infarction, or unstable angina pectoris, serious arrhythmia (multi-source and frequent ventricular premature beat, ventricular tachycardia, ventricular fibrillation, etc. within 6 months prior to screening; New York Heart Association (NYHA) class III-IV; (2) Subjects with known moderate or severe persistent asthma within 5 years prior to Screening, or subjects with current poorly controlled asthma. 5.Active hepatitis, or hepatitis B virus surface antigen (HBsAg) positive, or hepatitis B virus core antibody (HBcAb) + hepatitis B virus (HBV) deoxyribonucleic acid (DNA) positive, or hepatitis C virus (HCV) antibody + HCV-ribonucleic acid (HCV-RNA) positive at screening; 6.History or current diagnosis of active TB or untreated LTBI; 7.Patients who are infected with HIV or are HIV-positive at the screening stage; 8.Treponema pallidum antibody positive at screening; 9.Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, or antifungals within 4 weeks prior to screening or during the screening period (except for mild infections that have been cured as judged by the investigator, such as upper respiratory tract infection, viral gastroenteritis, etc.); 10.Known or suspected history of immunosuppression, including a history of invasive opportunistic infections (such as histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, and aspergillosis), even if the infection has resolved; Or unusually frequent, recurrent, or prolonged infections (as judged by
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of adverse events (AE); | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of TEAE and SAEs;SLE response index -4;SLICC/ACR damage index;PK;SELENA-SLEDAI score;Time to first seizure/first severe seizure;Immunogenicity: occurrence of antidrug antibodies;Changes from baseline values for serological markers (IgG, IgA, IgM, B cells, anti-dsDNA antibodies, complement levels C3 and C4);Number of subjects with a prednisone dosage of =7.5 mg/d or =25% reduction from baseline dosage at 24 weeks post-dose;(BILAG) - 2004 rating;Value of change from baseline in researcher global assessment (PGA) score;Number of subjects in BILAG's Comprehensive Lupus Assessment (BICLA);Pharmacokinetics; | — |
Countries
China
Contacts
Public ContactLong Hai
The Second Xiangya Hospital of CSU
Outcome results
None listed