Efficacy, Safety and PK/PD of MOR202 in Anti-PLA2R+ Membranous Nephropathy (aMN) (NewPLACE)

NCT ID: NCT04733040

Last Updated: 2025-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-01-20
• Study Completion Date: 2023-12-14

Brief Summary

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

Detailed Description

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.

Conditions

Glomerulonephritis; Membranous Nephropathy; antiPLA2R Positive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

MOR202 5 Doses

5 doses administered on Day 1, 8, 15, 29, and 57

Group Type: EXPERIMENTAL

MOR202

Intervention Type: DRUG

MOR202 will be administered as an intravenous infusion

MOR202 2 Doses

2 doses administered on Day 1 and 15

Group Type: EXPERIMENTAL

MOR202

Intervention Type: DRUG

MOR202 will be administered as an intravenous infusion

Interventions

MOR202

MOR202 will be administered as an intravenous infusion

Intervention Type: DRUG

Other Intervention Names

Felzartamab

Eligibility Criteria

Inclusion 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:

1. Not a female of childbearing potential (FCBP)

2. 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 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:

1. Glycated hemoglobin (HbA1c) <8.0 % or 64 mmol/mol.

2. No diabetic retinopathy known.

3. No peripheral neuropathy known.

• Total bilirubin, aspartate aminotransferase or alanine aminotransferase >1.5 x ULN, alkaline phosphatase >3.0 x ULN.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

HI-Bio, A Biogen Company

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Medical Director

Role: STUDY_DIRECTOR

HI-Bio, A Biogen Company

Locations

Managadze National Center of Urology

Tbilisi, , Georgia

Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic

Tbilisi, , Georgia

University Hospital Aachen

Aachen, , Germany

Charite

Berlin, , Germany

DaVita Clinical Research

Düsseldorf, , Germany

Uniklinikum

Essen, , Germany

Hospital of Johannes Gutenberg University

Mainz, , Germany

General Hospital of Athens

Athens, , Greece

General Hospital of Heraklion Venizeleio-Papaneio

Heraklion, , Greece

University General Hospital of Patras

Pátrai, , Greece

General Hospital of Thessaloniki

Thessaloniki, , Greece

Botkin Hospital Moscow

Moscow, , Russia

First Pavlov State Medical University of St. Petersburg

Saint Petersburg, , Russia

Hallym University Sacred Heart Hospital

Chuncheon, , South Korea

JeJu National University Hospital

Jeju City, , South Korea

Konkuk University Hospital

Seoul, , South Korea

Kyung Hee University Hospital at Gangdong

Seoul, , South Korea

Seoul National University Bundang Hospital

Seoul, , South Korea

Chang Gung Memorial Hospital

Kaohsiung City, , Taiwan

Shuang Ho Hospital

New Taipei City, , Taiwan

China Medical University Hospital

Taichung, , Taiwan

Taichung Veterans General Hospital

Taichung, , Taiwan

National Taiwan University Hospital

Taipei, , Taiwan

Kings College

London, , United Kingdom

Nottingham Renal and Transplant Unit

Nottingham, , United Kingdom

Countries

Georgia; Germany; Greece; Russia; South Korea; Taiwan; United Kingdom

References

Ahmad SB, Jefferson JA. Targeting B Cells and Plasma Cells in Glomerular Disease. J Am Soc Nephrol. 2025 Jun 4;36(9):1844-1857. doi: 10.1681/ASN.0000000772.

Reference Type: DERIVED

PMID: 40465397 (View on PubMed)

Other Identifiers

MOR202C205

Identifier Type: -

Identifier Source: org_study_id