A Clinical Study of MIL62 in Systemic Lupus Erythematosus
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2/Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: MIL62(Part A and B)
|
Drug: MIL62
An intravenous (IV) infusion of 1000 mg of MIL62 will be administered at W1D1、W3D1、W25D1、W27D1、W53D1、W55D1.
|
| Placebo Comparator: Placebo (Part A and B)
|
Drug: placebo
An intravenous (IV) infusion of placebo will be administered at W1D1、W3D1、W25D1、W27D1、W53D1、W55D1.
|
Outcome Measures
Primary Outcome Measures
- Part A and Part B:Percentage of participants achieving SRI-4 at Week 52 [Week 52]
Secondary Outcome Measures
- 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: 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:Pharmacokinetic(PK) Parameters:Cmax [up to Week76Day7 after enrollment]
Maximum concentration(Cmax) of the drug after 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]
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age 18-80 ;
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Diagnosis of systemic lupus erythematosus according to European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) SLE classification criteria ;
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Positive antinuclear antibodies (ANA) ≥ 1:80 at screening or positive anti- dsDNA ;
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Low C3 and/or low C4 complement at screening ;
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High disease activity at screening ;
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On a stable SLE treatment regimen for at least 30 days prior to the first administration；
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Able and willing to provide written informed consent and to comply with the study protocol.
Exclusion Criteria:
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Unsufficient organ function;
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Have received treatment with B cell targeted therapy within 9 months prior to the first administration;
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Subjects with CD4+ T lymphocyte count < 200 cells/μL;
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Receipt of any of the following prior to the first administration: Cyclophosphamide,Calcineurin inhibitor, blood transfusion ;
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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;
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Received live or attenuated vaccination within 28 days prior to the first administration;
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Participated in other clinical trials within 28 days prior to the first administration;
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Concomitant with other serious diseases；
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Infection with human immunodeficiency virus (HIV), hepatitis B or hepatitis C;
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Subjects with known history of severe allergic reactions to humanized monoclonal antibodies，MIL62；
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Breastfeeding or pregnant women;
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Childbearing potential and unwillingness or impossibility to comply with a scientifically acceptable birth-control method;
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Other conditions unsuitable for participation in this study determined by the Investigator.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Beijing Mabworks Biotech Co., Ltd.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MIL62-CT308