EUCTR2019-000780-24-ES进行中（未招募）1 期
A Phase Ib/IIa, Open-Label, Multicenter Clinical Trial to Assess Safety and Efficacy of the Human Anti-CD38 Antibody MOR202 in anti-PLA2R antibody positive Membranous Nephropathy (aMN) - M-PLACE
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- MorphoSys AG
- 入组人数
- 31
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. =18 to =80 years (at date of signing ICF)
- •2. Urine protein to creatinine ratio (UPCR) of = 3.0 g/g (as measured from a 24 hour urine collection)
- •3. MN diagnosed on the basis of a biopsy, archival biopsy acquired within 5 years prior to screening is acceptable.
- •4. Estimated glomerular filtration rate (eGFR) =50 ml/min/1.73m² or >30 and <50 ml/min/1.73m², and IFTA (interstitial fibrosis and tub-ular atrophy) score of less than 25% on a renal biopsy obtained within the last 6 months prior to start of screening. If a subject falls into the latter range without availability of an adequate biopsy, a biopsy at screening should be performed for IFTA assessment.
- •5. The subject is on supportive treatment with an ACEI or an ARB for at least 4 weeks prior to screening. The ACEI or ARB treatment should have reached a stable dose according to best local practice.
- •6. Systolic BP = 150 mmHg and diastolic BP = 100 mmHg after a period of 5 minutes of rest as measured at screening
- •7. Subject vaccinated against Pneumococcus within the last 3 years prior to date of signing ICF (subjects may be vaccinated during screening to meet this criterion; interval to first dose of MOR202 must be at least 14 days (1)).
- •8. Cohort 1: Serum anti-PLA2R antibodies = 150.0 RU/mL as determined at screening by Euroimmun ELISA
- •9. Cohort 1: Serum anti-PLA2R antibodies before screening ris-ing or stable as judged by the investigator
- •10. Cohort 1, relapse subjects only: Must have had complete remission of proteinuria, or a combination of partial remission of proteinuria (demonstrating at least 50 % decrease) with a remission of serum anti-PLA2R anti-body titer to less than 20.0 RU/mL (Euroimmun ELISA) or negative Immunfluorescence Test (IFT). Remission must have lasted for at least 6 months according to clinical judgement.
- •11. Cohort 2: Failure of previous therapy, i.e. subject never achieved a reduction of serum anti-PLA2R antibody titers to below 20.0 RU/ml (Euroimmun ELISA) during or after completion of a recognized IST contain-ing CSA, tacrolimus, MMF, ACTH or alkylating agents (e.g. cy-clophosphamide), or RTX determined after at least 6 months after start of this IST.
- •12. Cohort 2: Subjects may have received a maximum of two prior treatment lines of immunosuppressive therapy (retreatment for re-lapse with the same regimen is considered a line of its own). A planned, fixed sequence of different therapeutic agents (e. g. STARMEN regimen) is considered as one regimen.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 20
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 10
排除标准
- •1. Hemoglobin < 90 g/L
- •2. Thrombocytopenia: Platelets < 100.0x10^9/L
- •3. Neutropenia: Neutrophils < 1.5x10^9/L
- •4. Leukopenia: Leukocytes < 3.0x10^9/L
- •5. Hypogammaglobulinemia: Serum immunoglobulins =5.0 g/L
- •6. Secondary cause of MN (e.g. SLE, medications, malignancies) as determined by the investigator
- •7. Concomitant renal disease other than MN (e.g., diabetic renal disease, lupus nephritis, IgA nephropathy)
研究者
相似试验
进行中（未招募）
1 期
Open Label Clinical Trial to assess Safety and Efficacy of MOR202 in Membranous NephropathyPrimary (anti-PLA2R antibody positive) Membranous NephropathyMedDRA version: 21.1Level: LLTClassification code 10027170Term: Membranous nephropathySystem Organ Class: 100000004857EUCTR2019-000780-24-PLMorphoSys AG30
进行中（未招募）
1 期
Open Label Clinical Trial to assess Safety and Efficacy of MOR202 in Membranous NephropathyPrimary (anti-PLA2R antibody positive) Membranous NephropathyMedDRA version: 21.1Level: LLTClassification code 10027170Term: Membranous nephropathySystem Organ Class: 100000004857EUCTR2019-000780-24-NLMorphoSys AG30
撤回
2 期
A Phase Ib/IIa, Open-Label, Multicenter Clinical Trial to Assess Safety and Efficacy of the Human Anti-CD38 Antibody MOR202 in Anti-PLA2R Anti-body Positive Membranous Nephropathy (aMN) - M-PLACENL-OMON49767MorphoSys AG2
进行中（未招募）
1 期
Open Label Clinical Trial to assess Safety and Efficacy of MOR202 in Membranous NephropathyPrimary (anti-PLA2R antibody positive) Membranous NephropathyMedDRA version: 21.1 Level: LLT Classification code 10027170 Term: Membranous nephropathy System Organ Class: 100000004857EUCTR2019-000780-24-FRMorphoSys AG30
进行中（未招募）
1 期
Open Label Clinical Trial to assess Safety and Efficacy of MOR202 in Membranous NephropathyEUCTR2019-000780-24-ITMorphoSys AG30