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

NCT ID: NCT05405361

Last Updated: 2025-05-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-18

Study Completion Date

2029-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Multifocal Motor Neuropathy (MMN)

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Caregivers Investigators
During the double-blinded rollover treatment period (DTP),the investigator, trial nurse/coordinator, participant, and the sponsor's designated contract research organization (CRO), and sponsor trial team (except the sponsor's clinical trial supplies team) are blinded to IMP. The interactive response technology (IRT) system is used for blinding.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

ARGX-117

Participants receiving ARGX-117 during the double-blinded treatment period (DTP) and the open-label treatment period (OLTP)

Group Type EXPERIMENTAL

ARGX-117

Intervention Type BIOLOGICAL

Intravenous administration of ARGX-117

Placebo

Participants receiving placebo during the double-blinded treatment period (DTP) and receiving ARGX-117 during the open-label treatment period (OLTP)

Group Type EXPERIMENTAL

ARGX-117

Intervention Type BIOLOGICAL

Intravenous administration of ARGX-117

Placebo

Intervention Type OTHER

Intravenous administration of placebo

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

ARGX-117

Intravenous administration of ARGX-117

Intervention Type BIOLOGICAL

Placebo

Intravenous administration of placebo

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Capable of providing signed informed consent and complying with protocol requirements. Participants must be able to read and write.
* Must have completed the double-blinded treatment period of the ARGX-117-2002 trial and considered to be eligible for treatment with ARGX-117.

Exclusion Criteria

* Clinically significant uncontrolled active or chronic bacterial, viral, or fungal infection.
* Clinical evidence of other significant serious diseases, have had a recent major surgery, or who have any other condition, in the opinion of the investigator, that could confound the results of the trial or put the participant at undue risk.
* Currently participating in another interventional clinical study.
* Pregnant or lactating or intend to become pregnant during the trial or within 15 months after last dose of the study drug.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

argenx

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

HonorHealth Neurology

Scottsdale, Arizona, United States

Site Status

NorthShore University HealthSystem

Glenview, Illinois, United States

Site Status

University of Minnesota

Minneapolis, Minnesota, United States

Site Status

The Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

University of Pennsylvania - Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, United States

Site Status

Austin Neuromuscular Center

Austin, Texas, United States

Site Status

Medizinische Universitat Wien (Medical University of Vienna)

Vienna, , Austria

Site Status

AZ Sint-Lucas

Ghent, , Belgium

Site Status

University Health Network

Toronto, , Canada

Site Status

CHU Bordeaux - Groupe Hospitalier Pellegrin

Bordeaux, , France

Site Status

Hôpital Roger Salengro (CHU de Lille)

Lille, , France

Site Status

CHU de Nice

Nice, , France

Site Status

Hôpital de la Pitié Salpétrière

Paris, , France

Site Status

Universitätsklinikum Essen

Essen, , Germany

Site Status

Universitatsmedizin Gottingen (UMG) Georg-August-Universitaet

Göttingen, , Germany

Site Status

IRCCS Ospedale San Raffaele S.r.l.

Milan, , Italy

Site Status

Azienda Ospedaliero Universitaria Pisana

Pisa, , Italy

Site Status

Azienda Ospedaliera Sant' Andrea

Rome, , Italy

Site Status

IRCCS Humanitas Research Hospital

Rozzano, , Italy

Site Status

Universitair Medisch Centrum Utrecht

Utrecht, , Netherlands

Site Status

Michalski i Partnerzy Lekarze Spolka Partnerska

Krakow, , Poland

Site Status

Warszawski Uniwersytet Medyczny

Warsaw, , Poland

Site Status

Hospital Universitario Vall d'Hebron

Barcelona, , Spain

Site Status

Hospital de La Santa Creu i Sant Pau

Barcelona, , Spain

Site Status

Hospital Universitari i Politecnic La Fe de Valencia

Valencia, , Spain

Site Status

Queen Elizabeth University Hospital

Glasgow, , United Kingdom

Site Status

Oxford University Hospitals NHS Trust

Oxford, , United Kingdom

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States Austria Belgium Canada France Germany Italy Netherlands Poland Spain United Kingdom

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2023-507052-69-00

Identifier Type: CTIS

Identifier Source: secondary_id

ARGX-117-2003

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.