A Phase 3 Clinical Study of MIL62 in Systemic Lupus Erythematosus

Официальное название

A Phase 3 Clinical Study to Evaluate the Safety and Efficacy of Recombinant Humanized Monoclonal Antibody MIL62 Injection in the Treatment of Systemic Lupus Erythematosus.

Обзор

This study will evaluate the efficacy and safety of MIL62 compared with placebo in participants with systemic lupus erythematosus.

Вмешательства

• Препарат MIL62
  MIL62 will be administered by intravenous (IV) infusion at a dose of 1000 mg on Week (W) 1 Day (D) 1, W3D1, W25D1, W27D1.
• Препарат Placebo
  Placebo will be administered by intravenous (IV) infusion at a dose of 1000 mg on W1D1, W3D1, W25D1, W27D1.

Первичные конечные точки

• Percentage of participants achieving SRI-4 at Week 52 [Срок оценки: at Week 52]

Вторичные конечные точки (9)

• Proportion of participants achieving SRI-4 at Week 24 [Срок оценки: at Week 24]
• Changes in 24-hour urine protein in patients with baseline 24-hour urine protein elevation (24-hour urine protein ≥0.5g) at Week 24, 52 [Срок оценки: at Week 24,52]
• Percentage of participants who achieved or maintained a prednisone dose of ≤7.5 mg/day (or equivalent dose) during Weeks 40 to 52 [Срок оценки: from Week 40 to Week 52 after randomization]
• Change From Baseline in EuroQol 5-Dimensional Questionnaire at Week 24, 52 [Срок оценки: up to 52 weeks after randomization]
• Change From Baseline in Serum Immunoglobulin Levels at Week 24 Change from baseline in the serum levels of IgG, IgA, IgM [Срок оценки: up to 52 weeks after randomization]
• Change From Baseline in biomarkers associated with disease anti-dsDNA ,complement component 3 (C3), and complement component 4 (C4) [Срок оценки: up to 52 weeks after randomization]
• Percentage of Participants with Adverse Events [Срок оценки: up to 52 weeks after randomization]
• Pharmacodynamics(PD) characteristics: summarizing the changes in the absolute counts and percentages of peripheral blood CD19⁺ B cells [Срок оценки: up to 52 weeks after randomization]
• Anti-Drug Antibodies (ADA) will be tested and percentage of ADA positive patients will be calculated to evaluate immunogenicity of MIL62 [Срок оценки: up to 52 weeks after randomization]

Критерии участия

Критерии включения

• 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 ;
• High disease activity at screening ,SLEDAI-2000 score ≥8 (excluding alopecia score);
• On a stable dose of one or more standard treatments for SLE prior to the first administration；
• Able and willing to provide written informed consent and to comply with the study protocol.

Критерии исключения

• 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 8 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;
• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Peking University People's Hospital — Пекин

Идентификаторы

NCT: NCT07405970 · MIL62-CT309

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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