Clinical Trials List
2020-11-30 - 2022-03-28
Phase II
Recruiting5
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)
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Trial Applicant
GEORGE CLINICAL ASIA PACIFIC LIMITED
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Sponsor
MorphoSys AG
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
- Mei-Yi Wu 無
- Li-Yee Hong 無
- Yu-Wei Chen 無
- Chia-Te Liao 無
- Cai-Mei Zheng 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- Wen-Chin Lee 無
- 黃惠勇 無
- Chien-Hsing Wu 無
- 郭韋宏 無
- 邱鼎育 無
- 鄭本忠 無
- 李岳庭 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 王怡寬 無
- Chiu-Ching Huang 無
- 陳怡儒 無
- 郭慧亮 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- CHENG-HSU CHEN 無
- 蔡尚峰 無
- 吳軍毅 無
- 徐佳鈿 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Co-Principal Investigator
- 陳怡婷 無
- 黃道民 無
- VIN-CENT Wu 無
- - - 無
- 林維洲 無
- Yung-Ming Chen 無
- CHUN-FU LAI 無
- SHUEI-LIONG LIN 無
- 楊紹佑 無
The Actual Total Number of Participants Enrolled
0 Recruiting
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Dosage
Endpoints
efficacy of 2 different dosing regimens of MOR202 in subjects with anti-PLA2R antibody positive MN
Inclution Criteria
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
Exclusion Criteria
Hemoglobin < 80 g/L.
Thrombocytopenia: Platelets < 100.0 x 109/L.
Neutropenia: Neutrophils < 1.5 x 109/L.
Leukopenia: Leukocytes < 3.0 x 109/L.
Hypogammaglobulinemia: Serum immunoglobulins ≤ 4.0 g/L.
Subjects may receive supportive therapies to meet the above criteria
B-cells < 5 x 106/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 (HbAlc) <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.
The Estimated Number of Participants
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Taiwan
10 participants
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Global
22 participants
