A Clinical Study of MIL62 in Systemic Lupus Erythematosus
- Registration Number
- NCT05796206
- Lead Sponsor
- Beijing Mabworks Biotech Co., Ltd.
- Brief Summary
This study will evaluate the efficacy, safety, pharmacokinetics(PK) 、pharmacodynamics(PD) and ADA of MIL62 compared with placebo in participants with systemic lupus erythematosus.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
Inclusion Criteria
- Age 18-80 ;
- Diagnosis of systemic lupus erythematosus according to European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) SLE classification criteria ;
- Positive antinuclear antibodies (ANA) ≥ 1:80 at screening or positive anti- dsDNA ;
- Low C3 and/or low C4 complement at screening ;
- High disease activity at screening ;
- On a stable SLE treatment regimen for at least 30 days prior to the first administration；
- Able and willing to provide written informed consent and to comply with the study protocol.
Exclusion Criteria
- Unsufficient organ function;
- Have received treatment with B cell targeted therapy within 9 months prior to the first administration;
- Subjects with CD4+ T lymphocyte count < 200 cells/μL;
- Receipt of any of the following prior to the first administration: Cyclophosphamide,Calcineurin inhibitor, blood transfusion ;
- Received TNF inhibitor, Beliumumab, and Tetasercept within 3 months prior to the first administration; Interleukin monoclonal antibody, JAK inhibitor, BTK inhibitor within 2 months prior to the first administration;
- Received live or attenuated vaccination within 28 days prior to the first administration;
- Participated in other clinical trials within 28 days prior to the first administration;
- Concomitant with other serious diseases；
- Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C;
- Subjects with known history of severe allergic reactions to humanized monoclonal antibodies，MIL62；
- Breastfeeding or pregnant women;
- Childbearing potential and unwillingness or impossibility to comply with a scientifically acceptable birth-control method;
- Other conditions unsuitable for participation in this study determined by the Investigator.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description MIL62(Part A and B) MIL62 - Placebo (Part A and B) placebo -
- Primary Outcome Measures
Name Time Method Part A and Part B:Percentage of participants achieving SRI-4 at Week 52 Week 52
- Secondary Outcome Measures
Name Time Method Part A and Part B:Proportion of participants achieving SRI-4 at Week 76 Week 76 Part A and Part B:Percent of patients achieving The British Isles Lupus Assessment Group (BILAG) Week 52 Part A and Part B:Proportion of participants achieving SRI-4 at Week 24. Week 24 Part A and Part B:Change From Baseline in EuroQol- 5 Dimension (EQ-5D) at Week 52 Baseline and Week 76 Part A and Part B:Change From Baseline in Serum Immunoglobulin Levels at Week 24 Baseline and Week 76 Change from baseline in the serum levels of IgG, IgA, IgM
Part A and Part B:Change From Baseline in biomarkers associated with disease anti-dsDNA ,complement component 3 (C3), and complement component 4 (C4) Baseline and Week 76 Part A and Part B:Percentage of Participants with Adverse Events From baseline to Week 76 Part A and Part B:Pharmacokinetic(PK) Parameters:Cmax up to Week76Day7 after enrollment Maximum concentration(Cmax) of the drug after administration
Part A and Part B:Pharmacokinetic(PK) Parameters: AUC up to Week76Day7 after enrollment The area under the curve (AUC) of serum concentration of the drug after the administration
Part A and Part B:Anti-Drug Antibodies (ADA) will be tested and percentage of ADA positive patients will be calculated to evaluate immunogenicity of MIL62 up to Week76Day7 after enrollment
Trial Locations
- Locations (1)
Peking University People's Hospital
🇨🇳Beijing, China