Study on the Effects and Safety of Riliprubart for Patients with Chronic Inflammatory Demyelinating Polyneuropathy Unresponsive to Usual Treatments

3 1

What is this study about?

This clinical trial is focused on studying a condition called Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). CIDP is a rare neurological disorder that causes progressive weakness and impaired sensory function in the legs and arms. The study is testing a new treatment called riliprubart, which is given as a solution for injection. The purpose of the study is to evaluate the effects and safety of riliprubart in people with CIDP for whom the usual treatments do not work.

Participants in the study will receive either riliprubart or a placebo, which is a substance with no active medication. The study will be conducted over a period of time, during which participants will receive regular injections and attend follow-up visits to monitor their health and the effects of the treatment. The study aims to assess how well riliprubart works in improving the symptoms of CIDP and its long-term effects on the condition.

Throughout the study, participants will be closely monitored for any changes in their condition and any side effects they may experience. The study will use various measures to evaluate the effectiveness of riliprubart, including changes in disability scores and grip strength. The goal is to determine if riliprubart can provide a meaningful improvement for people with CIDP who have not responded to other treatments.

1 initial assessment

Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying the diagnosis of chronic inflammatory demyelinating polyneuropathy (CIDP) and ensuring that previous treatments have been ineffective.

The assessment involves reviewing medical history, current medications, and conducting necessary tests to establish a baseline for the study.

2 treatment phase

Participants receive the study medication, riliprubart, or a placebo. The medication is administered through intravenous infusion or subcutaneous injection.

The dosage and frequency of administration are determined by the study protocol and are monitored closely by the study team.

3 monitoring and follow-up

Regular follow-up visits are scheduled to monitor the participant’s response to the treatment. This includes evaluating changes in symptoms and any side effects experienced.

Participants are assessed using various scales, such as the Inflammatory Neuropathy Cause and Treatment (INCAT) disability scale, to measure the effectiveness of the treatment.

4 long-term evaluation

The study aims to evaluate the long-term efficacy of riliprubart. Participants continue to be monitored for an extended period to assess the sustainability of the treatment effects.

This phase involves periodic assessments and may include additional tests to gather comprehensive data on the treatment’s impact over time.

5 completion of study

Upon completion of the study, participants undergo a final evaluation to document the overall outcomes and any lasting effects of the treatment.

Participants are provided with information regarding the study results and any further steps, if applicable.

Who Can Join the Study?

  • Participant must have CIDP (Chronic Inflammatory Demyelinating Polyneuropathy) or possible CIDP, based on specific guidelines.
  • All participants must agree to use contraception methods during and after the study as required.
  • Body weight must be between 35 kg (77 lbs) and 154 kg (340 lbs) at the start of the study.
  • Male participants must agree to not donate or preserve sperm and either remain abstinent or use a condom plus another effective contraceptive method during the study and for at least 55 weeks after the last dose of study medication.
  • Female participants must not be pregnant or breastfeeding and must agree to use a highly effective contraceptive method during the study and for at least 55 weeks after the last dose of study medication.
  • Participant must have either typical CIDP or specific variants like motor CIDP or multifocal CIDP, confirmed by a committee.
  • Participant must not respond well to either immunoglobulin therapy or corticosteroid therapy. This means they have not shown significant improvement after specific treatments.
  • Participant must have an INCAT score (a measure of disability) between 2 and 9, with a score of 2 coming only from leg disability.
  • Any allowed immunosuppressant drugs must have been taken for at least 6 months at a stable dose for at least 3 months before the study starts.
  • Participant may be taking low-dose oral corticosteroids, but only if the dose has been stable for at least 3 months before the study starts.
  • Participant must have active disease, shown by a CIDP disease activity score of 2 or more points at the start of the study.
  • Participant must have received vaccinations against certain bacterial infections within 5 years before the study or at least 14 days before the first dose of the study medication.

Who Cannot Join the Study?

  • Patients who have other serious health conditions that might interfere with the study.
  • Patients who are currently participating in another clinical trial.
  • Patients who have had a recent major surgery or are planning to have one during the study period.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a history of allergic reactions to the study medication or similar drugs.
  • Patients who are unable to follow the study procedures or attend the required visits.
  • Patients who have a history of substance abuse or alcohol dependency.
  • Patients who have certain mental health conditions that might affect their ability to participate.
  • Patients who are taking medications that might interfere with the study drug.
  • Patients who have an unstable medical condition that requires frequent changes in treatment.

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
Azienda Ospedaliero-Universitaria Sant Andre Rome Italy
Fondazione Istituto Neurologico Nazionale Casimiro Mondino Pavia Italy
Hospital Universitario Puerta De Hierro De Majadahonda Majadahonda Spain
Katholisches Klinikum Bochum gGmbH Bochum Germany
Hospital Universitario Basurto Bilbao Spain
Region Stockholm – SLSO Stockholm Sweden
ARNAS Civico Di Cristina Benfratelli Palermo Italy
Zentrum fuer klinische Forschung Dr. I. Schoell GmbH Bad Homburg Germany
General University Hospital Of Larissa Larissa Greece
Mnogoprofilna Bolnitsa Za Aktivno Lechenie Puls AD Blagoevgrad Bulgaria
Multiprofile Hospital For Active Treatment In Neurology And Psychiatry St. Naum EAD Sofia Bulgaria
University General Hospital Of Thessaloniki Ahepa Thessaloniki Greece
Universitaetsklinikum Tuebingen AöR Tuebingen Germany
Ospedale San Raffaele S.r.l. Milan Italy
Fakultni Nemocnice Brno Brno Czechia
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
Centre Hospitalier Universitaire De Montpellier Montpellier France
Universidade De Santiago De Compostela Santiago De Compostela Spain
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W Krakowie Cracow Poland
Justus-Liebig-Universitaet Giessen Giessen Germany
Rigshospitalet Copenhagen Denmark
Centrum Medyczne Medyk Sp. z o.o. Rzeszow Poland
A.O.U. Policlinico G. Martino Di Messina Messina Italy
Hopital Beaujon Clichy France
Unidade Local De Saude De Matosinhos E.P.E. Senhora Da Hora Portugal
Multi-profile Hospital for Active Treatment Heart and Brain EAD Pleven Bulgaria
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara Chaidari Greece
Azienda Ospedaliero Universitaria Pisana Pisa Italy
Neurologie Berlin, Clinical Practice and Study Center Berlin Germany
Indywidualna Praktyka Lekarska Prof. Dr hab Konrad Rejdak Lublin Poland
Azienda Ospedaliero-Universitaria San Luigi Gonzaga Orbassano Italy
Uyhqqilimyjvsudsnpams Esdid Ank Essen Germany
Scfqvhjuvaq Pfljjeidf Sqybyff Kzhnozbai Na 1 Ijlamshgsgxyscjewy Slbdeje Sijvcteud Utrpygtbzqor Mbiikxjihs W Kjzncemrsm Zabrze Poland
Pank Tmyll Hpdkkyan Urwjszvmeruv Sabadell Spain
Arqwjurkw Ujo Amsterdam The Netherlands
Alxaxtjryj Prepscbm Hzqfjrmn Df Mkjnbhoac Marseille France
Ekubypq Upfhvtdyscre Mckggjv Chfuwhu Rfxgxmnyr (xkgypbs Mho Rotterdam The Netherlands
Apbifq Uclkridgee Hbjttgub Aarhus Denmark
Hebqpzya Dm Ls Sgilo Cudq I Socj Pgg Barcelona Spain
Hzjwkfwk Vzec dqruuadg Barcelona Spain
Cxtybw Heldeksfwt E Uwcqrtensvlpl Dh Crbbgyl Evphqm Coimbra Portugal
Axqvcfw Ojmcuehkoke Ugntglujbvhic Oyzidldw Rkkygwu Foggia Italy

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

Trial status

Country Status Recruitment Start
Belgium Belgium
Not recruiting
25.05.2024
Bulgaria Bulgaria
Not recruiting
25.05.2024
Czechia Czechia
Not recruiting
25.05.2024
Denmark Denmark
Not recruiting
25.05.2024
France France
Not recruiting
25.05.2024
Germany Germany
Not recruiting
25.05.2024
Greece Greece
Not recruiting
25.05.2024
Italy Italy
Not recruiting
25.05.2024
Poland Poland
Not recruiting
25.05.2024
Portugal Portugal
Not recruiting
25.05.2024
Spain Spain
Not recruiting
25.05.2024
Sweden Sweden
Not recruiting
25.05.2024
The Netherlands The Netherlands
Not recruiting
25.05.2024

Trial locations

Investigated drugs:

Riliprubart is a medication being studied for its effectiveness in treating refractory chronic inflammatory demyelinating polyneuropathy, a condition that affects the nerves and can cause weakness and numbness. The trial aims to assess how well riliprubart works in improving the symptoms of this condition, using a specific scale to measure changes in disability. The study also looks at the long-term benefits of using riliprubart for this condition.

Chronic Inflammatory Demyelinating Polyneuropathy – This 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 inflammation. The disease typically progresses slowly, with symptoms that may fluctuate over time, including numbness, tingling, and muscle weakness. As the condition advances, individuals may experience difficulty with coordination and balance. The progression can vary greatly among individuals, with some experiencing periods of improvement and others having a steady decline. It is considered a rare disease and can significantly impact daily activities and quality of life.

Trial ID:
2023-506503-26-00
Protocol code:
EFC17236
NCT ID:
NCT06290128
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