NCT05796206
Active, not recruiting
Phase 2
A Phase 2 Clinical Study to Evaluate the Safety and Efficacy of Recombinant Humanized Monoclonal Antibody MIL62 Injection in the Treatment of Systemic Lupus Erythematosus.
Beijing Mabworks Biotech Co., Ltd.1 site in 1 country120 target enrollmentMay 26, 2023
Overview
- Phase
- Phase 2
- Intervention
- MIL62
- Conditions
- Systemic Lupus Erythematosus
- Sponsor
- Beijing Mabworks Biotech Co., Ltd.
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Part A and Part B:Percentage of participants achieving SRI-4 at Week 12
- Status
- Active, not recruiting
- Last Updated
- 4 months ago
Overview
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.
Investigators
Eligibility Criteria
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;
- •Received rituximab or any B-cell depleting drug within 9 months prior to the first dose;
- •Subjects with CD4+ T lymphocyte count \< 200 cells/μL;
- •Received cyclophosphamide within 8 weeks prior to the first dose; received calcineurin inhibitors (cyclosporine, tacrolimus, etc., except for topical use) or plasma exchange therapy within 4 weeks prior to the first dose;
- •Received a B-cell stimulating factor inhibitor such as Belimumab, and Telitacicept within 12 weeks prior to the first administration; TNF inhibitor, interleukin monoclonal antibody, JAK inhibitor, BTK inhibitor, TYK2 inhibitor, or thalidomide within 4 weeks 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;
- •Positive for hepatitis B surface antigen (HBsAg) and/or hepatitis B core antibody (HBcAb) with HBV DNA titer above the normal range; positive for hepatitis C virus (HCV) antibody; positive for human immunodeficiency virus (HIV);
- •Subjects with known history of severe allergic reactions to humanized monoclonal antibodies MIL62 ;
Arms & Interventions
MIL62(Part A and B)
Intervention: MIL62
Placebo (Part A and B)
Intervention: placebo
Outcomes
Primary Outcomes
Part A and Part B:Percentage of participants achieving SRI-4 at Week 12
Time Frame: at Week 12
Secondary Outcomes
- Part A: Pharmacokinetic(PK) Parameters:Cmax(up to 76 weeks after randomization)
- Part A and Part B:Percentage of participants who achieved or maintained a prednisone dose of ≤7.5 mg/day (or equivalent dose) during Weeks 40 to 52(from Week 40 to Week 52 after randomization)
- Part A and Part B:Change From Baseline in EuroQol- 5 Dimension (EQ-5D) at Week 24, 52, 76(up to 76 weeks after randomization)
- Part A and Part B:Proportion of participants achieving SRI-4 at Week 52(at Week 52)
- Part A and Part B:Proportion of participants achieving SRI-4 at Week 24(at Week 24)
- Part A and Part B:Proportion of participants achieving SRI-4 at Week76(at Week 76)
- Part A and Part B:Change From Baseline in 24-hour urine protein in participants with elevated baseline urine protein (24-hour urine protein ≥ 0.5g) at Week 24,52,76(up to 76 weeks after randomization)
- 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(up to 76 weeks after randomization)
- Part A and Part B:Percentage of Participants with Adverse Events(up to 76 weeks after randomization)
- Part A: Pharmacokinetic(PK) Parameters: AUC(up to 76 weeks after randomization)
- Part A and Part B:Change From Baseline in biomarkers associated with disease anti-dsDNA ,complement component 3 (C3), and complement component 4 (C4)(up to 76 weeks after randomization)
- Part Aand 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 76 weeks after randomization)
- Part A and Part B: Pharmacodynamics(PD) characteristics：summarizing the changes in the absolute counts and percentages of peripheral blood CD19⁺ B cells, CD3⁺CD4⁺ T cells, CD3⁺CD8⁺ T cells, NK cells, CD19⁺CD27⁺ B cells, and CD19⁺CD27- naïve B cells(up to 76 weeks after randomization)
Study Sites (1)
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