drugset / Trial / NCT05405361

A Clinical Trial to Investigate the Long-term Safety and Tolerability, Efficacy, Pharmacodynamics, Pharmacokinetics, and Immunogenicity of ARGX-117 in Adults With Multifocal Motor Neuropathy

NCT05405361

Phase 2 Active not recruiting 51 enrolled argenx
RandomizedParallel-groupTriple-blindTreatment

Summary

This trial is an extension of the antecedent trial ARGX-117-2002. It is a multicenter trial that has been designed to evaluate the long-term safety and tolerability, efficacy, immunogenicity, Pharmacokinetics (PK), and Pharmacodynamics (PD) of ARGX-117 Intravenously (IV) in adults with Multifocal Motor Neuropathy (MMN). The trial will include a double-blinded rollover treatment period (DTP), an open-label treatment period (OTP), and a safety follow-up period.

Timeline

Start
2023-01-18
Primary completion
2029-09-30
Completion
2029-09-30

Drugs

EvaluationDrugModalityDoseRoute
Subject Empasiprubart Monoclonal antibody Intravenous