Clinical Trial

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

Study acronym: ARDA+
Active, Not Recruiting Phase 2
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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.
Protocol Amendment History 18 amendments
This ClinicalTrials.gov record has been amended 18 times since 2022-06-01; most recent amendment 2026-03-09.
Status change: Enrolling by Invitation → Active, Not Recruiting 2024-10-17
Status change: Recruiting → Enrolling by Invitation 2024-07-03
Status change: Not Yet Recruiting → Recruiting 2023-02-07
Trial Details
NCT Number NCT05405361
Lead Sponsor argenx
Conditions Multifocal Motor Neuropathy (MMN)
Enrollment 51 participants
Start Date 2023-01-18
Primary Completion 2029-09-30 (estimated)
Study Completion 2029-09-30 (estimated)
Updated on ClinicalTrials.gov 2026-03-11