NCT04733040

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

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2021

Typical duration for phase_2

Geographic Reach
7 countries

25 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 18, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

January 20, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 1, 2021

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 14, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 14, 2023

Completed
Last Updated

February 7, 2025

Status Verified

February 1, 2025

Enrollment Period

2.9 years

First QC Date

January 18, 2021

Last Update Submit

February 5, 2025

Conditions

GlomerulonephritisMembranous NephropathyantiPLA2R Positive

Outcome Measures

Primary Outcomes (1)

  • efficacy: percent change of anti-PLA2R antibody levels

    efficacy of 2 different dosing regimens of MOR202 in subjects with anti-PLA2R antibody positive MN

    3 months compared to baseline

Secondary Outcomes (5)

  • 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

Study Arms (2)

MOR202 5 Doses

EXPERIMENTAL

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

Drug: MOR202

MOR202 2 Doses

EXPERIMENTAL

2 doses administered on Day 1 and 15

Drug: MOR202

Interventions

MOR202DRUG

MOR202 will be administered as an intravenous infusion

Also known as: Felzartamab
MOR202 2 DosesMOR202 5 Doses

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (25)

Managadze National Center of Urology

Tbilisi, Georgia

Location

Tbilisi State Medical University and Ingorokva High Medical Technology University Clinic

Tbilisi, Georgia

Location

University Hospital Aachen

Aachen, Germany

Location

Charite

Berlin, Germany

Location

DaVita Clinical Research

Düsseldorf, Germany

Location

Uniklinikum

Essen, Germany

Location

Hospital of Johannes Gutenberg University

Mainz, Germany

Location

General Hospital of Athens

Athens, Greece

Location

General Hospital of Heraklion Venizeleio-Papaneio

Heraklion, Greece

Location

University General Hospital of Patras

Pátrai, Greece

Location

General Hospital of Thessaloniki

Thessaloniki, Greece

Location

Botkin Hospital Moscow

Moscow, Russia

Location

First Pavlov State Medical University of St. Petersburg

Saint Petersburg, Russia

Location

Hallym University Sacred Heart Hospital

Chuncheon, South Korea

Location

JeJu National University Hospital

Jeju City, South Korea

Location

Konkuk University Hospital

Seoul, South Korea

Location

Kyung Hee University Hospital at Gangdong

Seoul, South Korea

Location

Seoul National University Bundang Hospital

Seoul, South Korea

Location

Chang Gung Memorial Hospital

Kaohsiung City, Taiwan

Location

Shuang Ho Hospital

New Taipei City, Taiwan

Location

China Medical University Hospital

Taichung, Taiwan

Location

Taichung Veterans General Hospital

Taichung, Taiwan

Location

National Taiwan University Hospital

Taipei, Taiwan

Location

Kings College

London, United Kingdom

Location

Nottingham Renal and Transplant Unit

Nottingham, United Kingdom

Location

Related Publications (1)

  • 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.

    PMID: 40465397DERIVED

MeSH Terms

Conditions

GlomerulonephritisGlomerulonephritis, Membranous

Interventions

felzartamab

Condition Hierarchy (Ancestors)

NephritisKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Medical Director

    HI-Bio, A Biogen Company

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 18, 2021

First Posted

February 1, 2021

Study Start

January 20, 2021

Primary Completion

December 14, 2023

Study Completion

December 14, 2023

Last Updated

February 7, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will share

In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/

More information

Locations

TW(5)GE(2)GR(4)DE(5)RU(2)GB(2)KR(5)