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Trial to Assess Safety and Efficacy of MOR202 in Anti-PLA2R + Membranous Nephropathy (aMN) | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

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

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)

NCT04145440•HI-Bio, A Biogen Company

View on ClinicalTrials.gov

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)

Detailed Description

After treatment subjects will be observed for up to 1 year. Study Sponsor, originally HI-Bio, Inc., is now HI-Bio, A Biogen Company.

Eligibility

Age

18 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•\> 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.

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.
•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).

Locations (45)

North America Research Institute

Azusa, California, United States

UCSF Medical Center

San Francisco, California, United States

Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center

Torrance, California, United States

University of Miami Division of Nephrology & Hypertension

Miami, Florida, United States

GA Nephrology Associates

Lawrenceville, Georgia, United States

Northwest Louisiana Nephrology Research

Shreveport, Louisiana, United States

Kidney Care and Transplant Services of New England, PC

Springfield, Massachusetts, United States

Mayo Clinic

Rochester, Minnesota, United States

The Ohio State University Wexner Medical Center

Columbus, Ohio, United States

MedResearch, Inc

El Paso, Texas, United States

Key Dates

Start Date

October 15, 2019

Primary Completion Date

January 19, 2022

Completion Date

August 2, 2022

Last Updated

February 24, 2025

Enrollment

ACTUAL participants

Conditions

Glomerulonephritis, MembranousantiPLA2R Positive

Interventions

MOR202

DRUG

Mycophenolate Mofetil in Patients With Progressive Idiopathic Membranous Nephropathy

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Glomerulonephritis, Membranous

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UNKNOWNPHASE3

Rituximab Versus Steroids and Cyclophosphamide in the Treatment of Idiopathic Membranous Nephropathy

NCT03018535

Glomerulonephritis, Membranous

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 24, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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