A Clinical Study of MIL62 in Systemic Lupus Erythematosus

Study Overview
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Brief Summary
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This study will evaluate the efficacy, safety, pharmacokinetics(PK) 、pharmacodynamics(PD) and ADA of MIL62 compared with placebo in participants with systemic lupus erythematosus.

Official Title
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A Phase Ⅱ/Ⅲ Clinical Study to Evaluate the Safety and Efficacy of Recombinant Humanized Monoclonal Antibody MIL62 Injection in the Treatment of Systemic Lupus Erythematosus.

Conditions
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Systemic Lupus Erythematosus

Intervention / Treatment
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* Drug: MIL62
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MIL62(Part A and B)<br> | Drug: MIL62<br>* An intravenous (IV) infusion of 1000 mg of MIL62 will be administered at W1D1、W3D1、W25D1、W27D1、W53D1、W55D1.<br>|
| Placebo Comparator: Placebo (Part A and B)<br> | Drug: placebo<br>* An intravenous (IV) infusion of placebo will be administered at W1D1、W3D1、W25D1、W27D1、W53D1、W55D1.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Part A and Part B:Percentage of participants achieving SRI-4 at Week 52 |  | Week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Change from baseline in the serum levels of IgG, IgA, IgM | Baseline and Week 76 | 
| 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 | The area under the curve (AUC) of serum concentration of the drug after the administration | up to Week76Day7 after enrollment | 
| Part A and Part B:Pharmacokinetic(PK) Parameters:Cmax | Maximum concentration(Cmax) of the drug after administration | up to Week76Day7 after enrollment | 
| 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 |