A Study Comparing Empasiprubart Versus Intravenous Immunoglobulin in Adults With Chronic Inflammatory Demyelinating Polyneuropathy

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What is this study about?

This study is looking at chronic inflammatory demyelinating polyneuropathy, which is a condition that affects the nerves outside the brain and spinal cord. In this condition, the protective covering of the nerves becomes damaged due to ongoing inflammation, leading to weakness, numbness, and difficulties with movement and daily activities. The study will compare two different treatments given through a vein. One treatment is empasiprubart, also called ARGX-117, which is a laboratory-made protein designed to block a specific part of the immune system that may contribute to nerve damage. The other treatment is human normal immunoglobulin given through a vein, which is a blood product containing antibodies that is already used to treat this condition. Some participants will receive placebo, which is an inactive substance that looks like the real treatment but contains no active medicine.

The purpose of this study is to show whether empasiprubart works better than human normal immunoglobulin in improving the ability to perform daily activities in adults with this nerve condition. During the study, participants will be randomly assigned to receive either empasiprubart or human normal immunoglobulin through a vein. The study uses a double-dummy design, which means that all participants will receive two infusions to ensure that neither the participants nor the doctors know which treatment is being given. The main assessment will happen at week 24, when doctors will measure changes in functional ability using a scoring system that evaluates arm and leg function.

Throughout the study, various measurements will be taken to assess how well participants can perform daily tasks, their muscle strength, their walking ability, and their overall quality of life. Grip strength will be measured regularly, and participants will complete questionnaires about their disability, fatigue, pain, and general health status. Blood samples will be taken to measure drug levels and to check for any immune responses to the treatment. Safety will be monitored by tracking any unwanted effects, changes in laboratory tests, heart rhythm recordings, and vital signs. The study will also look at how the treatments affect specific proteins in the blood that are involved in the immune response and nerve damage.

1 Treatment assignment

Upon joining the study, you will be randomly assigned to one of two treatment groups. This is done by chance, similar to flipping a coin.

One group will receive empasiprubart, which is the investigational medication being tested. The other group will receive intravenous immunoglobulin (also called IVIg), which is a standard treatment.

Neither you nor your doctor will know which treatment you are receiving during the study. This is called a double-blinded approach and helps ensure accurate results.

2 Medication administration

You will receive your assigned medication through an intravenous infusion, which means the medication will be delivered directly into your vein through a needle.

The infusions will be administered according to a schedule determined by the study protocol.

Each infusion session will take place at the study site, and the duration of each infusion will be explained to you by the study staff.

3 Regular assessments during treatment

Throughout the study, you will undergo regular assessments to measure how your condition is responding to treatment.

Your functional ability will be measured using the aINCAT score, which assesses your ability to perform daily activities involving your arms and legs.

Your overall disability will be evaluated using the I-RODS scale, which measures your ability to perform various tasks.

Your muscle strength will be tested using the MRC Sum Score, which examines the strength of different muscle groups.

Your grip strength will be measured in both hands, with particular focus on your dominant hand.

Your mobility will be assessed using the Timed Up and Go test, which measures how long it takes you to stand up, walk a short distance, turn around, walk back, and sit down.

You will be asked to complete questionnaires about your quality of life, fatigue, pain, and how your condition affects your daily activities and work.

4 Week 24 evaluation

At week 24, a comprehensive evaluation will be conducted to assess the effectiveness of your treatment.

The primary measure will be whether there is a decrease of at least 1 point in your aINCAT score compared to your baseline score at the start of the study.

Additional measurements will include changes in your disability scale scores, muscle strength, grip strength, and mobility compared to baseline.

5 Ongoing monitoring

Throughout the study, your safety will be continuously monitored.

Blood samples will be taken regularly to check for any changes in laboratory values and to measure medication levels in your blood.

The study team will monitor for the development of antibodies, which are proteins your immune system might produce in response to the study medication.

Your heart function will be monitored using electrocardiograms (ECGs), which record the electrical activity of your heart.

Your vital signs, such as blood pressure, heart rate, and temperature, will be measured regularly.

Any side effects or health changes you experience will be recorded and assessed by the study team.

6 Continued participation

The study will continue beyond week 24, with ongoing treatment and assessments.

You will continue to receive regular infusions and attend scheduled visits for evaluations.

Changes in your condition will be tracked over time to understand the long-term effects of the treatment.

7 Study completion

The study is expected to continue until May 2030.

Your individual participation duration will be explained to you by the study team.

Final assessments will be conducted at the end of your participation to evaluate your overall response to treatment and any long-term effects.

Who Can Join the Study?

  • You must meet the criteria for CIDP, which is a long-lasting condition where the body’s immune system attacks the protective covering of nerves, causing weakness and numbness
  • You must have either typical CIDP or one of these specific forms: motor CIDP (mainly affecting movement), multifocal CIDP (affecting multiple separate nerve areas, also called Lewis-Sumner syndrome), focal CIDP (affecting one specific area), or distal CIDP (affecting the parts of the body farthest from the center, like hands and feet)
  • You must have responded well to IVIg treatment in the past 5 years. IVIg is a medicine made from antibodies given through a vein to help your immune system work better
  • You must be currently receiving IVIg treatment as part of your regular maintenance therapy, with a minimum weekly dose of at least 0.125 grams per kilogram of your body weight
  • You must still have some disability and signs that the disease is still active despite current treatment
  • You can be male or female
  • You must be an adult to participate in this study

Who Cannot Join the Study?

  • The specific exclusion criteria (reasons why a patient cannot participate in this study) have not been provided in the available information
  • To find out if you can participate in this clinical trial, you will need to speak with the study team who can review the complete list of requirements
  • Generally, clinical trials have rules about who can join based on health conditions, medications being taken, and other medical factors

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Oslo Universitetssykehus HF Oslo Norway
Linden Sp. z o.o. sp.k. Cracow Poland
Medical University Of Vienna Vienna Austria
Centre Hospitalier Universitaire De Bordeaux Bordeaux France
Pomeranian Medical University Szczecin Poland
Oncopole Claudius Regaud Toulouse France
Galen Clinic Lublin Poland
IRCCS Humanitas Research Hospital Rozzano Italy
Policlinico “Tor Vergata”, Università degli Studi di Roma TOR VERGATA Rome Italy
Neurologia Slaska Centrum Medyczne Katowice Poland

Other Sites

Site Name City Country Status
Diagnostics And Consultation Center Convex Ltd. Sofia Bulgaria
Azienda Ospedaliero-Universitaria Sant Andre Rome Italy
Centro Ricerche Cliniche Di Verona S.r.l. Verona Italy
Fondazione Istituto Neurologico Nazionale Casimiro Mondino Pavia Italy
Universitaetsklinikum Schleswig-Holstein AöR Kiel Germany
Hospital General Universitario Gregorio Maranon Madrid Spain
UNIVERZITETNI KLINICNI CENTER MARIBOR Maribor Slovenia
Univerzitna Nemocnica Martin Martin Slovakia
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego Warsaw Poland
Clinical Research Center Sp. z o.o. Medic-R sp.k. Poznan Poland
Clinexpert Kft. Budapest Hungary
Diagnostic-consultative center “Aleksandrovska” EOOD Sofia Bulgaria
Universitair Medisch Centrum Utrecht Utrecht The Netherlands
Azienda Unita Sanitaria Locale Di Bologna Bologna Italy
Charite Universitaetsmedizin Berlin KöR Berlin Germany
Tartu University Hospital Tartu Estonia
Fakultni Nemocnice Brno Brno Czechia
Semmelweis University Budapest Hungary
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie Cracow Poland
Kepler Universitaetsklinikum GmbH Linz Austria
Medical Center – University Of Freiburg Freiburg Im Breisgau Germany
Centre Hospitalier Universitaire De Nice Nice France
University General Hospital Of Alexandroupoli Alexandroupoli Greece
University Medical Center Ljubljana Ljubljana Slovenia
Neurocentrum Bydgoszcz Sp. z o.o. Bydgoszcz Poland
Rigshospitalet Copenhagen Denmark
Centro Hospitalar Universitario De Santo Antonio E.P.E. Porto Portugal
Centrum Medyczne Medyk Sp. z o.o. Rzeszow Poland
Hopital Beaujon Clichy France
Queen Silvia Childrens Hospital – Sahlgrenska University Hospital – Vaestra Goetalandsregionen Gothenburg Sweden
Multi-profile Hospital for Active Treatment Heart and Brain EAD Pleven Bulgaria
Emergency Institute For Cardiovascular Diseases And Transplant Targu Mures Romania
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Clinic4U OÜ Tallin Estonia
Bicetre Hospital Le Kremlin-Bicetre France
Galen Clinic Warsaw Poland
Byrxdsxc Ctiajx Stamhz Constanta Romania
Ilfujpniea Nixoenzc Dg Nnudpmdryf Se Bboi Nyhhticphyhsmj Bwprhvsvz Bucharest Romania
Mrgurxczb Ibqqzvgrmz Cqsfqeev Svqxhnnz Sep z onzv Warsaw Poland
Amsrtfskv Url Amsterdam The Netherlands
Axplljquuf Pbuhqvmi Htzbgdan Du Mydhwhqmg Marseille France
Hujlqmng Db Lf Setjq Clun I Srdt Psp Barcelona Spain
Urhhettbmd Dkyym Sdsnh Do Rxvk Lx Sylezzps Rome Italy
Huzfikdm Vsus dvjxkoyw Barcelona Spain
Uxudrgniok Gpsflxs Hhhbrnht Awjncdn Athens Greece
Hcvypmwf Uudxunbijkhwiy Sryjwmwyfn &arjrfh Hngaijk dz Hifsnamwbdv 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
Recruiting
04.12.2025
Bulgaria Bulgaria
Not recruiting
04.12.2025
Czechia Czechia
Recruiting
04.12.2025
Denmark Denmark
Recruiting
04.12.2025
Estonia Estonia
Recruiting
04.12.2025
France France
Recruiting
04.12.2025
Germany Germany
Recruiting
04.12.2025
Greece Greece
Recruiting
04.12.2025
Hungary Hungary
Recruiting
04.12.2025
Italy Italy
Recruiting
04.12.2025
Norway Norway
Recruiting
04.12.2025
Poland Poland
Recruiting
04.12.2025
Portugal Portugal
Recruiting
04.12.2025
Romania Romania
Recruiting
04.12.2025
Slovakia Slovakia
Recruiting
04.12.2025
Slovenia Slovenia
Recruiting
04.12.2025
Spain Spain
Recruiting
04.12.2025
Sweden Sweden
Recruiting
04.12.2025
The Netherlands The Netherlands
Recruiting
04.12.2025

Trial locations

Empasiprubart is an investigational medication given through an intravenous infusion, which means it is delivered directly into a vein. This medication is being studied as a potential treatment for chronic inflammatory demyelinating polyneuropathy, a condition that affects the nerves and can cause weakness and numbness. The purpose of testing this medication in the trial is to see if it can help improve a person’s ability to perform daily activities and functions.

Intravenous Immunoglobulin (also known as IVIg) is a medication made from antibodies collected from healthy blood donors. It is given through an intravenous infusion directly into a vein. This medication is already used to treat various conditions where the immune system is not working properly or is attacking the body’s own tissues. In this trial, it is being used as a comparison treatment to see how well the investigational medication works against a treatment that is already known to help people with chronic inflammatory demyelinating polyneuropathy.

Chronic Inflammatory Demyelinating Polyneuropathy – Chronic inflammatory demyelinating polyneuropathy is a neurological disorder that affects the peripheral nerves throughout the body. The condition occurs when the immune system mistakenly attacks the protective covering of nerves called myelin, leading to nerve damage. This damage causes progressive weakness and reduced sensation in the arms and legs. Patients typically experience difficulty with movement, coordination, and performing daily activities due to muscle weakness. The disease develops slowly over time, usually lasting more than eight weeks, which distinguishes it from similar acute conditions. Symptoms may include numbness, tingling, fatigue, and problems with balance and walking.

Trial ID:
2024-520097-36-00
Protocol code:
ARGX-117-2401
NCT ID:
NCT06920004
Trial Phase:
Therapeutic confirmatory (Phase III)

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