Trial to Assess Safety and Efficacy of MOR202 in Anti-PLA2R + Membranous Nephropathy (aMN)

NCT04145440 | Completed Phase 1 Results FDA Drug

• 1 other identifier: MOR202C103
• Study Type: interventional
• Target: 31
• Locations: 9 countries
• Sites: 45

Brief Summary

This is an open-label, multicentre study to characterize the safety and efficacy of the human anti-CD38 antibody MOR202 in adult subjects with in Anti-PLA2R Antibody Positive Membranous Nephropathy (newly diagnosed/relapsed/refractory)

Conditions

Glomerulonephritis, Membranous; antiPLA2R Positive

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Adverse Events

  An adverse event (AE) was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

  Week 1 to Week 24

• Percentage of Participants With Adverse Events

  An AE was defined as any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. SAEs were defined as death, a life-threatening AE, inpatient hospitalization or prolongation of existing hospitalization, persistent or significant disability or incapacity, a congenital anomaly or birth defect, or an important medical event that jeopardized participant and required medical intervention to prevent 1 of the outcomes listed in this definition. A summary of other non-serious AEs and all serious AEs, regardless of causality is located in Reported AE section.

  Week 1 to Week 24

Secondary Outcomes (7)

• Best Immunological Response Rate (BIRR)

  Up to 52 weeks

• Number of Participants Tested Positive for Anti-felzartamab Antibodies

  Baseline; Up to 52 weeks

• Percentage of Participants Tested Positive for Anti-felzartamab Antibodies

  Baseline; Up to 52 weeks

• Antibody Titers of Participants Tested Positive for Anti-felzartamab Antibodies

  Baseline; Up to 52 weeks

• Felzartamab Serum Concentrations After Multiple Intravenous Administrations

  Pre Dose and Post Dose on Cycle 1 Day 1 (C1D1), C1D8, C1D15, C1D22, C2D1, C3D1, C4D1, C5D1, C6D1, End of Treatment (week 24), Follow-up visit (week 38), End of Study (up to 52 weeks)

Study Arms (2)

Cohort 1 (newly diagnosed or relapsed participants)

EXPERIMENTAL

Participants with newly diagnosed or relapsed membranous nephropathy received MOR202 as an intravenous infusion over 6 treatment cycles of 28-days each. Dosing occurred weekly in Cycle 1 and every 4 weeks in Cycles 2 to 6.

Drug: MOR202

Cohort 2 (refractory participants)

EXPERIMENTAL

Participants with membranous nephropathy refractory to immunosuppressive treatment received MOR202 as an intravenous infusion over 6 treatment cycles of 28-days each. Dosing occurred weekly in Cycle 1 and every 4 weeks in Cycles 2 to 6.

Drug: MOR202

Interventions

MOR202 DRUG

Patients received 9 doses of MOR202 as an intravenous infusion over 6 treatment cycles of 28-days each. Dosing occured weekly in Cycle 1 and every 4 weeks in Cycles 2 to 6.

Cohort 1 (newly diagnosed or relapsed participants); Cohort 2 (refractory participants)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 18 to \< 80 years (at date of signing informed consent form \[ICF\]).
• Urine protein to creatinine ratio (UPCR) of ≥ 3.000 g/g OR proteinuria ≥ 3.500 g/24 h from 24-h urine at screening
• Active anti-PLA2R antibody positive MN in need of immunosuppressive therapy (IST) according to investigator judgement and diagnosed on the basis of a biopsy, archival biopsy acquired within 5 years prior to screening is acceptable.
• Estimated glomerular filtration rate ≥ 50 ml/min/1.73m² or ≥ 30 and \<50 ml/min/1.73m², and interstitial fibrosis and tubular atrophy score of less than 25% on a renal biopsy obtained within the last 6 months prior to start of screening.
• Not in spontaneous remission despite proper treatment with ACEIs, ARBs (sufficient dose and treatment duration) as per clinical practice and scientific guidelines. If the subject is intolerant to an ACEI or ARB, the reason must be documented and approval obtained prior to enrolment.
• Systolic blood pressure BP ≤150 mmHg and diastolic BP ≤100 mmHg after 5 minutes of rest
• Vaccinated against Pneumococcus within the last 5 years prior to date of signing informed consent (subjects may be vaccinated during screening to meet this criterion; interval to first dose of MOR202 must be at least 14 days).
• Cohort 1 comprises newly diagnosed or relapsed subjects: Serum anti-PLA2R antibodies ≥50.0 RU/mL
• Cohort 2 comprises therapy refractory subjects: a Subject did not achieve immunological remission after prior IST(s) as documented by the investigator AND b Subject is without promising standard therapeutic options as documented by the investigator (i.e. investigator expects efficacy or safety issues with remaining IST options) AND c Serum anti-PLA2R antibodies ≥ 20.0 RU/mL measured at screening
• Note: France will only enroll patients in Cohort 2.

You may not qualify if:

• 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.
• Secondary cause of MN (e.g. Systemic lupus erythematosus, medications, malignancies)
• Concomitant renal disease other than MN (e.g., diabetic renal disease, lupus nephritis, IgA nephropathy).

Sponsors & Collaborators

• HI-Bio, A Biogen Company: lead

Study Sites (45)

North America Research Institute

Azusa, California, 91702, United States

Location

UCSF Medical Center

San Francisco, California, 94143, United States

Location

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Torrance, California, 90502, United States

Location

University of Miami Division of Nephrology & Hypertension

Miami, Florida, 33136, United States

Location

GA Nephrology Associates

Lawrenceville, Georgia, 30046, United States

Location

Northwest Louisiana Nephrology Research

Shreveport, Louisiana, 71101, United States

Location

Kidney Care and Transplant Services of New England, PC

Springfield, Massachusetts, 01107, United States

Location

Mayo Clinic

Rochester, Minnesota, 55902, United States

Location

The Ohio State University Wexner Medical Center

Columbus, Ohio, 43210, United States

Location

MedResearch, Inc

El Paso, Texas, 79905, United States

Location

Texas Research Institute

Fort Worth, Texas, 76248, United States

Location

St. George Hospital

Sydney, New South Wales, 2217, Australia

Location

Royal Melbourne Hospital

Melbourne, Victoria, 3050, Australia

Location

Western Health

Melbourne, 3021, Australia

Location

O.L.V. Ziekenhuis

Aalst, 9300, Belgium

Location

C.H.U. Brugmann - Site Victor Horta

Brussels, 1020, Belgium

Location

Universitair Ziekenhuis Brussels

Brussels, 1090, Belgium

Location

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

UZ Leuven

Leuven, 3000, Belgium

Location

CHU de Liège

Liège, 4000, Belgium

Location

Groupe Hospitalier Pellegrin - Hôpital Pellegrin

Bordeaux, 33000, France

Location

CHU de Grenoble - Hôpital Albert Michallon

Grenoble, 38043, France

Location

Hopital Claude Huriez -CHU Lille

Lille, 59037, France

Location

Hopital Tenon Service de nephrologie

Paris, 75020, France

Location

CHU Saint Etienne - Hôpital Nord

Saint-Priest-en-Jarez, 42055, France

Location

Azienda Ospedaliera Universitaria Careggi

Florence, 50134, Italy

Location

Ospedale San Raffaele

Milan, 20132, Italy

Location

Ospedale Borgo Roma

Verona, 37124, Italy

Location

Radboud UMC Niimegen Nephrology

Nijmegen, 6525 GA, Netherlands

Location

SPZOZ Centralny Szpital Kliniczny UM w Lodzi

Lodz, 92213, Poland

Location

Centrum Zdrowia MDM

Warsaw, 00631, Poland

Location

Miedzyleski Szpital Specjalistyczny

Warsaw, 04749, Poland

Location

Chungnam National University Hospital

Daejeon, 35015, South Korea

Location

Hallym University Kangdong Sacred Heart Hospital

Seoul, 05355, South Korea

Location

Gangnam Severance Hospital

Seoul, 06273, South Korea

Location

The Catholic University of Korea

Seoul, 06591, South Korea

Location

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitari Vall d'Hebron

Barcelona, 8035, Spain

Location

Hospital Universitario Reina Sofia

Córdoba, 50134, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario Puerta de Hierro Majadahonda

Madrid, 28222, Spain

Location

Hospital Universitario Virgen del Rocio

Seville, 41013, Spain

Location

Hospital General Universitario de Valencia

Valencia, 46014, Spain

Location

Hospital Universitario Dr. Peset

Valencia, 46017, Spain

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: 40465397 DERIVED

MeSH Terms

Conditions

Glomerulonephritis, Membranous

Interventions

felzartamab

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: US Biogen Clinical Trial Center
• Organization: HI-Bio, A Biogen Company

clinicaltrials@biogen.com

866-633-4636

Study Officials

• Medical Director

  HI-Bio, A Biogen Company

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: The study is open label as all patients receive the same Investigational Medicinal Product (IMP) and same dose
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 2 cohorts by disease status (Cohort 1: Patients with newly diagnosed or relapsed membranous nephropathy; Cohort 2: Patients with membranous nephropathy refractory to immunosuppressive treatment)

Study Record Dates

• First Submitted: October 18, 2019
• First Posted: October 30, 2019
• Study Start: October 15, 2019
• Primary Completion: January 19, 2022
• Study Completion: August 2, 2022
• Last Updated: February 24, 2025
• Results First Posted: December 24, 2024

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share

Locations

PL (3); BE (6); FR (5); IT (3); NL (1); KR (5); AU (3); US (11); ES (8)