Systemic Lupus Erythematosus
Conditions
Brief summary
This study was designed to investigate the safety and efficacy of CM355 in patients with refractory SLE.
Detailed description
This study is designed to investigate the safety and efficacy of CM355 in patients with moderately to severely active SLE who are refractory to treatment, and to analyze its pharmacokinetic profile , pharmacodynamic effects, and immunogenicity.
Interventions
BIOLOGICALCM355
CM355 injection
Sponsors
Second Xiangya Hospital of Central South University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
Healthy volunteers
No
Inclusion criteria
* Ability to understand the nature of the study and voluntarily sign the informed consent form (ICF); * Age ≥ 18 to ≤ 65 years old, male or female; * At screening, patients must meet the 2019 European League Against Rheumatism (EULAR)/ American college of Rheumatology (ACR)classification criteria for systemic lupus erythematosus (SLE) as assessed by a qualified doctor, and have a disease course of ≥ 12 months； * systemic lupus erythematosus disease activity index2000 (SLEDAI-2K)≥8 points at screening. If there is a low complement and/or anti-ds-DNA antibody score, the SLEDAI-2K) clinical symptoms (excluding low complement and/or anti-ds-DNA antibody) score ≥ 6 points or ≥ 1 organ system in BILAG score should be Class A at screening； * Definition of refractory SLE; * The treatment regimen for SLE was stable for more than 4 weeks before the first dose.
Exclusion criteria
* Renal disease: patients with severe lupus nephritis; * Patients with central nervous system diseases; * Patients who have received monoclonal antibodies targeting Cluster of Differentiation 19(CD19) or Cluster of Differentiation 20(CD20) or other B-cell depleting agents within 6months prior to the first dose ; * Any other condition assessed by investigator as unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| adverse events (AE) | Throughout the study，an average of about 1 year | Incidence and severity of adverse events (AE) |
Countries
China
Contacts
Primary ContactQianjin Lu
Outcome results
None listed