Study comparing empasiprubart versus intravenous immunoglobulin for treating adults with multifocal motor neuropathy

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What is this study about?

This study focuses on adults with Multifocal Motor Neuropathy, a rare neurological condition that affects motor nerves and causes progressive muscle weakness. The research compares two treatments: a new medication called empasiprubart and standard therapy with intravenous immunoglobulin (a treatment made from donated blood plasma that contains antibodies). The study will also use placebo solutions for comparison purposes.

The main purpose of this research is to determine if empasiprubart is effective at improving muscle strength compared to intravenous immunoglobulin in people with Multifocal Motor Neuropathy. Both medications will be given through intravenous infusion, which means they are administered directly into a vein.

The study is divided into two parts. During the treatment period, participants will receive either empasiprubart or intravenous immunoglobulin along with their matching placebos. Throughout the study, doctors will measure changes in muscle strength and other aspects of the condition. The research team will also monitor the safety of the treatments and collect information about how well participants feel and function in their daily activities.

1 Initial phase preparation

Before starting treatment, you will receive vaccinations against bacterial infections (N. meningitidis and S. pneumoniae) if you haven’t had them in the past 5 years

The vaccination must be completed at least 14 days before starting the study medication

2 Treatment period – Part A

The study will compare two treatments: empasiprubart and intravenous immunoglobulin (IVIg)

You will receive treatment through intravenous infusion (medication given directly into a vein)

The treatment period lasts 24 weeks

Your muscle strength will be measured regularly, with special attention to hand strength

Various assessments will be performed, including tests of hand function and daily activities

Blood samples will be taken to monitor medication levels and immune system response

3 Monitoring and assessments

Regular checks of vital signs and heart activity (ECG)

Laboratory tests to monitor your health status

Assessment of fatigue levels and quality of life

Evaluation of hand function using specific tests

Regular monitoring of any side effects or reactions to the treatment

4 Extended observation – Part B

Continued monitoring of muscle strength and hand function

Ongoing assessment of daily activities and quality of life

Regular blood tests to check medication levels

Continued monitoring of side effects and safety

Who Can Join the Study?

  • Must be at least 18 years old and able to legally consent to participate in clinical studies
  • Must have a confirmed diagnosis of Multifocal Motor Neuropathy (MMN), either definite or probable, according to established medical guidelines
  • Must have shown positive response to IVIg treatment (intravenous immunoglobulin – a treatment given through a vein) within the past 5 years
  • Must currently be receiving IVIg treatment every 2, 3, 4, or 5 weeks, with a dose between 0.4 to 2.0 grams per kilogram of body weight per treatment cycle
  • Must be on a stable IVIg treatment plan for at least 8 weeks before screening (or 10 weeks for those receiving treatment every 5 weeks), with no major changes in frequency or dose
  • Must receive a minimum weekly IVIg dose of at least 0.125 grams per kilogram of body weight
  • Must either have received vaccines against certain bacteria (N. meningitidis and S. pneumoniae) within the past 5 years, or be willing to get vaccinated at least 14 days before starting the study medication

Who Cannot Join the Study?

  • History of severe allergic reactions to immunoglobulin treatments (antibody-based medications given through IV)
  • Presence of other neurological conditions that could affect muscle strength assessment
  • Active infections or severe illnesses that could interfere with study participation
  • Previous treatment with experimental medications within 3 months before the study
  • Pregnancy or breastfeeding
  • Significant kidney or liver disease
  • History of blood clotting disorders
  • Uncontrolled high blood pressure
  • Recent surgery within the past 3 months
  • Current participation in other clinical trials
  • Known immunodeficiency conditions (weakened immune system)
  • History of cancer within the past 5 years
  • Severe mental health conditions that could affect ability to follow study procedures
  • Alcohol or drug abuse within the past year
  • Unable to provide informed consent

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Other Sites

Site Name City Country Status
Pauls Stradins Clinical University Hospital Riga Latvia
Azienda Ospedaliero-Universitaria Sant Andre Rome Italy
Centre Hospitalier Regional De La Citadelle Liege Belgium
Klinikum Wels-Grieskirchen GmbH Wels Austria
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone Palermo Italy
University Hospital Bratislava Bratislava Slovakia
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos Kaunas Lithuania
Univerzitna Nemocnica Martin Martin Slovakia
Hospital Universitario Basurto Bilbao Spain
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego Warsaw Poland
Hospital Quironsalud Malaga Malaga Spain
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
University General Hospital Of Thessaloniki Ahepa Thessaloniki Greece
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Ospedale San Raffaele S.r.l. Milan Italy
Azienda Ospedaliero-Universitaria San Luigi Gonzaga Orbassano Italy
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
Azienda Unita Sanitaria Locale Di Bologna Bologna Italy
Fakultni Nemocnice Brno Brno Czechia
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
IRCCS Ospedale Policlinico San Martino Genoa Italy
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie Cracow Poland
Justus-Liebig-Universitaet Giessen Giessen Germany
Centre Hospitalier Universitaire De Nice Nice France
Region Midtjylland Aarhus Denmark
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
University Medical Center Ljubljana Ljubljana Slovenia
Rigshospitalet Copenhagen Denmark
Centro Hospitalar Universitario De Santo Antonio E.P.E. Porto Portugal
A.O.U. Policlinico G. Martino Di Messina Messina Italy
Centre Hospitalier Lyon Sud Pierre Benite France
Hopital Beaujon Clichy France
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen Gothenburg Sweden
Clinic4U OÜ Tallin Estonia
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara Chaidari Greece
Bicetre Hospital Le Kremlin-Bicetre France
EMC Instytut Medyczny S.A. Poznan Poland
Clinirem Sp. z o.o. Lublin Poland
Ckvornncy Uykibbxncdddem Shoofbxin Woluwe-Saint-Lambert Belgium
Unthhhznvmtgdoalcmfkj Ezmwp Apf Essen Germany
Mvekvvkqwwff Vyiidbzosuukjuvzqv Ssc Jxvuupuaflvkhghmrm Pkzfkqn Gaef Potsdam Germany
Cqsotf Cbfqrlx Ndsn Milan Italy
Mzuyaresu Ifguwjrvcc Czomsktd Sowitiaq Sdk z omzy Warsaw Poland
Ctpfhq Hwajcjdjlvv Em Uyxjxvpasldmo Dn Lucjzcf Limoges France
Amcxagnfl Uwr Amsterdam The Netherlands
Ahhjjxohon Pmhifegt Hhqcqvim Dp Mlasbxveu Marseille France
Uqrcsrihgshxhsjiujllh Mydrrfcp Aqw Munster Germany
Hdqcyxnm Uwhapgdqpyfgz Dtbseryp Donostia / San Sebastian Spain
Usayibswebuilnjoenqsv Wccavquei Azq Wuerzburg Germany
Hgwigfkl Dy Lp Syzvr Cozc I Sqie Pxe Barcelona Spain
Uqsgylrzsq Os Avshhoe Edegem Belgium
Hwwtuhma Uxanzcygioihf Hwmvifpd Thzcg y Psuclu Imzfgdfc Clyrue dbifkarfwtssthhrt (yitk Badalona Spain
Hthjibjf Vqji dlkebapm Barcelona Spain
Hfopafsa Uyqiqmfwltkiit Seciyapnnf &funxho Hehlihq dc Hqmrgcruqob STRASBOURG, Alsace France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Austria Austria
Not recruiting
31.07.2025
Belgium Belgium
Not recruiting
31.07.2025
Czechia Czechia
Not recruiting
31.07.2025
Denmark Denmark
Not recruiting
31.07.2025
Estonia Estonia
Not recruiting
31.07.2025
France France
Not recruiting
31.07.2025
Germany Germany
Not recruiting
31.07.2025
Greece Greece
Not recruiting
31.07.2025
Italy Italy
Not recruiting
31.07.2025
Latvia Latvia
Not recruiting
31.07.2025
Lithuania Lithuania
Not recruiting
31.07.2025
Norway Norway
Not recruiting
31.07.2025
Poland Poland
Not recruiting
31.07.2025
Portugal Portugal
Not recruiting
31.07.2025
Slovakia Slovakia
Not recruiting
31.07.2025
Slovenia Slovenia
Not recruiting
31.07.2025
Spain Spain
Not recruiting
31.07.2025
Sweden Sweden
Not recruiting
31.07.2025
The Netherlands The Netherlands
Not recruiting
31.07.2025

Trial locations

Empasiprubart is an investigational medication being studied for treating multifocal motor neuropathy, a rare neurological condition that affects muscle strength. This medication is being developed as a potential alternative to current treatments.

Intravenous Immunoglobulin (IVIg) is a treatment made from donated blood plasma that contains healthy antibodies. It is given through a vein and is currently used as a standard treatment for multifocal motor neuropathy. IVIg helps reduce inflammation and supports the immune system to improve muscle strength in patients with this condition.

Multifocal Motor Neuropathy – A rare neurological disorder that affects multiple motor nerves in the body. The condition causes progressive muscle weakness, primarily affecting the arms and hands, though it can also impact the legs. The weakness typically begins on one side of the body and gradually spreads to affect multiple areas. The disease specifically targets motor nerves while leaving sensory nerves intact, which distinguishes it from other neurological conditions. Muscle weakness is often accompanied by muscle cramping and uncontrolled twitching.

Trial ID:
2024-516473-72-00
Protocol code:
ARGX-117-2302
NCT ID:
NCT06742190
Trial Phase:
Therapeutic confirmatory (Phase III)

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