Study on Long-term Safety and Efficacy of Riliprubart for Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

3 1 1

What is this study about?

This clinical trial is focused on studying a condition called Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), which is a disease affecting the immune system. The study is evaluating a treatment known as riliprubart, also referred to by its code name SAR445088. Riliprubart is administered as a solution for injection using a pre-filled pen. The main goal of this study is to assess the long-term safety and tolerability of riliprubart in individuals with CIDP.

Participants in this study will receive riliprubart through subcutaneous injections, which means the medication is injected under the skin. The study will monitor participants over an extended period to observe any side effects or adverse events that may occur. Additionally, the study will track the percentage of participants who remain free from relapses and those who show improvement in their condition. Changes in disability scores, grip strength, and muscle strength will also be measured to evaluate the effectiveness of the treatment.

The study is designed to provide valuable information about the long-term use of riliprubart in managing CIDP. By participating in this study, researchers aim to gather data that could help improve treatment options for individuals living with this chronic condition. The study is expected to continue until 2029, allowing for comprehensive observation and analysis of the treatment’s impact over time.

1 joining the study

Upon joining the study, participants will be required to provide signed informed consent. This consent confirms understanding and agreement to comply with the study’s requirements and restrictions.

2 medication administration

Participants will receive the medication riliprubart through a subcutaneous injection. This means the medication is injected under the skin using a pre-filled pen designed for this purpose.

The frequency and dosage of the medication will be determined by the study protocol and communicated to participants by the study team.

3 monitoring and assessments

Throughout the study, participants will undergo regular monitoring to assess the safety and effectiveness of the medication. This includes checking for any adverse events or side effects, as well as conducting laboratory tests, electrocardiograms (ECGs), and measuring vital signs.

Participants will also be evaluated for improvements in their condition, such as changes in disability scores, grip strength, and muscle strength.

4 completion of the study

The study is expected to continue until July 31, 2029. Participants will be informed about the completion process and any follow-up requirements as the study progresses.

Who Can Join the Study?

  • Participants must have chronic inflammatory demyelinating polyneuropathy (CIDP) and be currently receiving the study medication called riliprubart.
  • Participants must have completed treatment in one of the following studies: Study PDY16744, Study EFC17236, or Study EFC18156. If participating in Part C of Study PDY16744, they must have completed the Part C End of Treatment visit.
  • All participants must agree to use birth control methods during and after the study as required. This applies to both men and women and should follow local rules about birth control for clinical study participants.
  • Participants must be able to give signed informed consent, which means they understand the study and agree to follow the study rules and restrictions.

Who Cannot Join the Study?

  • Participants with immune system diseases cannot join. This means if your body’s defense system, which fights off illnesses, is not working properly, you cannot participate.

Where you can join this trial?

Verified and Recommended Sites

Site Name City Country Status
Samodzielny Publiczny Szpital Kliniczny Nr 4 W Lublinie Lublin Poland

Verified Sites

Other Sites

Site Name City Country Status
Eszak-Budai Szent Janos Centrumkorhaz Budapest Hungary
Mnogoprofilna Bolnitsa Za Aktivno Lechenie Puls AD Blagoevgrad Bulgaria
Multiprofile Hospital For Active Treatment In Neurology And Psychiatry St. Naum EAD Sofia Bulgaria
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Ospedale San Raffaele S.r.l. Milan Italy
Fakultni Nemocnice Brno Brno Czechia
IRCCS Ospedale Policlinico San Martino Genoa Italy
Centre Hospitalier Universitaire De Montpellier Montpellier France
Rigshospitalet Copenhagen Denmark
A.O.U. Policlinico G. Martino Di Messina Messina Italy
Azienda Ospedaliero-Universitaria Sant Andre Rome Italy
Fondazione Istituto Neurologico Nazionale Casimiro Mondino Pavia Italy
Universitair Ziekenhuis Gent Gent Belgium
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
CCAB Centro Clinico Academico Braga Associacao Braga Portugal
Region Stockholm – SLSO Stockholm Sweden
ARNAS Civico Di Cristina Benfratelli Palermo Italy
General University Hospital Of Larissa Larissa Greece
University General Hospital Of Thessaloniki Ahepa Thessaloniki Greece
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Centrum Medyczne Medyk Sp. z o.o. Rzeszow Poland
Semmelweis University Budapest Hungary
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie Cracow Poland
Centre Hospitalier Universitaire De Nice Nice France
Region Midtjylland Aarhus Denmark
Vseobecna Fakultni Nemocnice V Praze Prague Czechia
Hopital Beaujon Clichy France
Multi-profile Hospital for Active Treatment Heart and Brain EAD Pleven Bulgaria
University Of Szeged Szeged Hungary
University Hospital Ostrava Ostrava Czechia
Azienda Ospedaliero Universitaria Pisana Pisa Italy
Hospital Pedro Hispano Matosinhos Portugal
Poje Tttfo Hvpanjye Ukstvlufofnt Sabadell Spain
Aokpbhndx Uba Amsterdam The Netherlands
Aexocdqwry Pwpragqe Hrbvsudx Dk Mktqojjcf Marseille France
Chdgzk Hhoawwjypm E Urlejmzrsybet Dd Cgouvxw Ewosvz Coimbra Portugal
Uiloeozxkintmmjaqmleg Mthmfopf Acq Munster Germany
Gjfxguseekazfxmcx Vhzdmqeni Peoi Aawjzc Ebjwxlfk Opveff Kjcsbb Gyor Hungary
Haautewj Dk Lv Sjcpz Cspi I Sizc Puh Barcelona Spain
Ekdrgor Uvuzhlgtvafc Mbfcrhe Cnskfub Rbtvkjqct (ehuuyep Moe Rotterdam The Netherlands
Hqqssbob Vzzk dmtwpuqg Barcelona Spain
Uqpxgqovjl Gaihbgd Hcyvbloh Aoybowf Athens Greece
Irhlijysxuhl Pmmcbqim Lvnbdxro Poluw dj hgwt nh mxvt Ketutq Rjzome Lublin Poland

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Not yet recruiting
01.04.2025
Bulgaria Bulgaria
Not yet recruiting
01.04.2025
Czechia Czechia
Recruiting
01.04.2025
Denmark Denmark
Recruiting
01.04.2025
France France
Recruiting
01.04.2025
Germany Germany
Recruiting
01.04.2025
Greece Greece
Not yet recruiting
01.04.2025
Hungary Hungary
Not yet recruiting
01.04.2025
Italy Italy
Recruiting
01.04.2025
Poland Poland
Recruiting
01.04.2025
Portugal Portugal
Recruiting
01.04.2025
Spain Spain
Recruiting
01.04.2025
Sweden Sweden
Recruiting
01.04.2025
The Netherlands The Netherlands
Recruiting
01.04.2025

Trial locations

Investigated drugs:

Riliprubart is a medication being studied for its effects on a condition called chronic inflammatory demyelinating polyneuropathy, or CIDP. CIDP is a disorder that affects the nerves, causing weakness and numbness. The purpose of this study is to see how safe and well-tolerated riliprubart is when used over a long period. Researchers want to understand if it can help manage the symptoms of CIDP and improve the quality of life for people with this condition. By participating in this study, patients will help determine if riliprubart can be a reliable treatment option for CIDP in the future.

Chronic Inflammatory Demyelinating Polyneuropathy – Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) is a neurological disorder characterized by progressive weakness and impaired sensory function in the legs and arms. It is caused by damage to the myelin sheath, the protective covering of the nerves, due to an abnormal immune response. The disease typically progresses slowly, with symptoms that may include tingling or numbness, muscle weakness, and loss of reflexes. Over time, individuals may experience difficulty with coordination and balance. The progression of CIDP can vary, with some experiencing periods of improvement and others having a steady decline in function. The condition is considered rare and can affect individuals differently, with varying degrees of severity.

Trial ID:
2024-517032-22-00
Protocol code:
LTS17261
NCT ID:
NCT06859099
Trial Phase:
Therapeutic confirmatory (Phase III)

Other Trials to Consider

  • A study to test if empasiprubart can improve function and is safe for adults with chronic inflammatory demyelinating polyneuropathy

    Recruiting

    3 1
    Investigated drugs:
    Austria Bulgaria Czechia Denmark Estonia Finland +9
  • A Study Comparing Empasiprubart Versus Intravenous Immunoglobulin in Adults With Chronic Inflammatory Demyelinating Polyneuropathy

    Recruiting

    3 1 1
    Austria Bulgaria Czechia Denmark Estonia France +13