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

NCT04733040 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2025-02-07

No results posted yet for this study

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

Conditions

Interventions

DRUG

MOR202

MOR202 will be administered as an intravenous infusion

Sponsors & Collaborators

  • HI-Bio, A Biogen Company

    lead INDUSTRY

Principal Investigators

  • Medical Director · HI-Bio, A Biogen Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-20
Primary Completion
2023-12-14
Completion
2023-12-14
FDA Drug
Yes

Countries

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

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04733040 on ClinicalTrials.gov