NCT05405361

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
51

participants targeted

Target at P25-P50 for phase_2

Timeline
42mo left

Started Jan 2023

Longer than P75 for phase_2

Geographic Reach
11 countries

27 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress49%
Jan 2023Sep 2029

First Submitted

Initial submission to the registry

May 17, 2022

Completed
20 days until next milestone

First Posted

Study publicly available on registry

June 6, 2022

Completed
8 months until next milestone

Study Start

First participant enrolled

January 18, 2023

Completed
6.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2029

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2029

Last Updated

March 11, 2026

Status Verified

March 1, 2026

Enrollment Period

6.7 years

First QC Date

May 17, 2022

Last Update Submit

March 9, 2026

Conditions

Multifocal Motor Neuropathy (MMN)

Outcome Measures

Primary Outcomes (1)

  • Safety outcomes based on adverse event (AE) monitoring.

    Until marketing authorization of ARGX-117, assessed up to 70 months or treatment discontinuation, whichever comes first

Secondary Outcomes (19)

  • Change from baseline in the mMRC-10 sum score

    Until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation, whichever comes first

  • Proportion of participants showing a deterioration of at least 2 points in mMRC-10 sum score

    Until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation, whichever comes first

  • Change from baseline in the mMRC-14 sum score

    Until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation, whichever comes first

  • Proportion of participants showing a deterioration of at least 2 points in the mMRC-14 sum score

    Until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation, whichever comes first

  • Change from baseline in the average score of the 2 most important muscle groups as assessed by the mMRC-14 sum score

    Until market authorization of ARGX-117, assessed up to 70 months or treatment discontinuation, whichever comes first

  • +14 more secondary outcomes

Study Arms (2)

ARGX-117

EXPERIMENTAL

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

Biological: ARGX-117

Placebo

EXPERIMENTAL

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

Biological: ARGX-117Other: Placebo

Interventions

ARGX-117BIOLOGICAL

Intravenous administration of ARGX-117

ARGX-117Placebo
PlaceboOTHER

Intravenous administration of placebo

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (27)

HonorHealth Neurology

Scottsdale, Arizona, 85251, United States

Location

NorthShore University HealthSystem

Glenview, Illinois, 60026, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55414, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

University of Pennsylvania - Perelman Center for Advanced Medicine

Philadelphia, Pennsylvania, 19104, United States

Location

Austin Neuromuscular Center

Austin, Texas, 78759, United States

Location

Medizinische Universitat Wien (Medical University of Vienna)

Vienna, 1090, Austria

Location

AZ Sint-Lucas

Ghent, 9000, Belgium

Location

University Health Network

Toronto, Canada

Location

CHU Bordeaux - Groupe Hospitalier Pellegrin

Bordeaux, 33076, France

Location

Hôpital Roger Salengro (CHU de Lille)

Lille, 59037, France

Location

CHU de Nice

Nice, 06001, France

Location

Hôpital de la Pitié Salpétrière

Paris, 75651, France

Location

Universitätsklinikum Essen

Essen, 45147, Germany

Location

Universitatsmedizin Gottingen (UMG) Georg-August-Universitaet

Göttingen, 37075, Germany

Location

IRCCS Ospedale San Raffaele S.r.l.

Milan, 20132, Italy

Location

Azienda Ospedaliero Universitaria Pisana

Pisa, 56126, Italy

Location

Azienda Ospedaliera Sant' Andrea

Rome, 00189, Italy

Location

IRCCS Humanitas Research Hospital

Rozzano, 20089, Italy

Location

Universitair Medisch Centrum Utrecht

Utrecht, 3584 CX, Netherlands

Location

Michalski i Partnerzy Lekarze Spolka Partnerska

Krakow, 31-426, Poland

Location

Warszawski Uniwersytet Medyczny

Warsaw, 02-097, Poland

Location

Hospital Universitario Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital de La Santa Creu i Sant Pau

Barcelona, 08041, Spain

Location

Hospital Universitari i Politecnic La Fe de Valencia

Valencia, 46026, Spain

Location

Queen Elizabeth University Hospital

Glasgow, G51 4TF, United Kingdom

Location

Oxford University Hospitals NHS Trust

Oxford, OX3 9DU, United Kingdom

Location

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Masking Details
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.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2022

First Posted

June 6, 2022

Study Start

January 18, 2023

Primary Completion (Estimated)

September 30, 2029

Study Completion (Estimated)

September 30, 2029

Last Updated

March 11, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

CA(1)IT(4)NL(1)FR(4)US(6)DE(2)AU(1)GB(2)PL(2)BE(1)ES(3)