NCT04733040已完成2 期
A Phase IIa, Open-Label, 2-Arm Multicenter Clinical Trial to Evaluate the Efficacy, Safety and PK/PD of the Human Anti-CD38 Antibody MOR202 in Anti-PLA2R Antibody Positive Membranous Nephropathy (NewPLACE)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 25
- 主要终点
- efficacy: percent change of anti-PLA2R antibody levels
研究概览
简要总结
This 2-arm, multi-center, open-label, parallel-group phase II trial will assess the efficacy, safety and pharmacokinetics/pharmacodynamics of the human antibody MOR202 in subjects with anti-PLA2R antibody-positive membranous nephropathy indicated for immunosuppressive therapy
详细描述
After treatment, subjects will enter a repeat treatment period (3 months) if necessary; and a final follow-up period of 15 to 18 months.
Study Sponsor, originally HI-Bio, Inc., is now HI-Bio, A Biogen Company.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects ≥ 18 to ≤ 80 years (at date of signing the informed consent form [ICF]).
- •Urine protein to creatinine ratio (UPCR) of ≥ 3.0 g/g or proteinuria ≥ 3.5 g/24 h
- •Estimated glomerular filtration rate (eGFR) ≥ 50 ml/min/1.73 m² (eGFR >30 and < 50 ml/min/1.73 m² can be included provided an interstitial fibrosis and tubular atrophy (IFTA) score of < 25% in a kidney biopsy)
- •Not in spontaneous remission despite proper treatment with angiotensin-converting enzyme inhibitors (ACEI), angiotensin receptor blockers (ARBs) (sufficient dose and treatment duration) as per clinical practice and scientific guidelines. If the subject is intolerant to ACEI and ARBs, the reason must be documented and approval for enrollment be obtained from the Medical Monitor.
- •Systolic blood pressure (BP) ≤150 mmHg and diastolic BP ≤100 mmHg after 5 minutes of rest.
- •Serum anti-PLA2R antibodies ≥ 50.0 RU/mL determined by Euroimmun ELISA.
- •Female subjects: A female is eligible to participate if she is not pregnant, not breastfeeding, and at least one of the following conditions applies:
- •Not a female of childbearing potential (FCBP)
- •A FCBP who agrees to follow the contraceptive guidance during the treatment period and for at least 3 months after the last dose of MOR202
排除标准
- •Hemoglobin < 80 g/L.
- •Thrombocytopenia: Platelets < 100.0 x 10^9/L.
- •Neutropenia: Neutrophils < 1.5 x 10^9/L.
- •Leukopenia: Leukocytes < 3.0 x 10^9/L.
- •Hypogammaglobulinemia: Serum immunoglobulins ≤ 4.0 g/L.
- •Subjects may receive supportive therapies to meet the above criteria
- •B-cells < 5 x 10^6/L
- •Diabetes mellitus type 2: Subjects with type 2 diabetes mellitus may only enter the clinical trial if a kidney biopsy performed within 6 months prior to screening shows MN without evidence of diabetic nephropathy and diabetes is controlled, as shown by:
- •Glycated hemoglobin (HbA1c) <8.0 % or 64 mmol/mol.
- •No diabetic retinopathy known.
- •No peripheral neuropathy known.
- •Total bilirubin, aspartate aminotransferase or alanine aminotransferase >1.5 x ULN, alkaline phosphatase >3.0 x ULN.
研究组 & 干预措施
MOR202 5 Doses
Experimental
5 doses administered on Day 1, 8, 15, 29, and 57
干预措施: MOR202 (Drug)
MOR202 2 Doses
Experimental
2 doses administered on Day 1 and 15
干预措施: MOR202 (Drug)
结局指标
主要结局
efficacy: percent change of anti-PLA2R antibody levels
时间窗: 3 months compared to baseline
efficacy of 2 different dosing regimens of MOR202 in subjects with anti-PLA2R antibody positive MN
次要结局
- efficacy: immunological complete response (ICR) rate(ICR rate at 3 months, 6 months, 12 months and 24 months)
- efficacy: overall proteinuria response (OPR) rate(OPR rate at 6 months, 12 months and 24 months.)
- safety: determined by the frequency, incidence and severity of TEAEs(through treatment completion, an average of 3 months per treatment period)
- PK profile(through study completion, an average of 1 year)
- immunogenicity(through study completion, an average of 1 year)
研究者
研究点 (25)
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