Study on the Effectiveness and Safety of Nipocalimab for Adults with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

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What is this study about?

This clinical trial is focused on studying a condition called Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). CIDP is a neurological disorder that causes progressive weakness and impaired sensory function in the legs and arms. The study is testing a treatment called nipocalimab, which is given as a solution for infusion. The purpose of the study is to evaluate how effective and safe nipocalimab is in delaying the return of symptoms in adults with CIDP who initially respond to the treatment.

Participants in the study will receive either nipocalimab or a placebo, which is a substance with no active medication. The study is designed to be double-blind, meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo. This helps ensure that the results are not biased. The study will take place over several stages, and participants will be monitored for any changes in their condition, as well as any side effects they may experience.

The trial will involve regular assessments to track the progression of CIDP symptoms and the overall health of the participants. These assessments will include checking muscle strength, grip strength, and other physical abilities. The study aims to provide valuable information on whether nipocalimab can be a beneficial treatment option for people living with CIDP.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria, including age and diagnosis of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).

The diagnosis is verified by an independent committee during the screening period.

2 stage A: initial treatment

Participants receive nipocalimab, a solution for infusion, to assess initial response.

The goal is to evaluate the effectiveness of nipocalimab in delaying relapse.

3 stage B: withdrawal phase

Participants who respond to nipocalimab in Stage A enter a randomized, double-blind, placebo-controlled phase.

The objective is to compare the efficacy of nipocalimab against a placebo in preventing relapse.

4 monitoring and assessments

Throughout the trial, various assessments are conducted, including changes in disability scores, muscle strength, and grip strength.

Regular monitoring of vital signs, ECG, and laboratory values is performed to ensure safety.

5 end of trial

The trial is estimated to conclude by July 31, 2030.

Final assessments are conducted to evaluate the long-term efficacy and safety of nipocalimab.

Who Can Join the Study?

  • Must be an adult, 18 years or older.
  • Must have a diagnosis of CIDP (Chronic Inflammatory Demyelinating Polyneuropathy), which is a condition affecting the nerves, according to specific medical guidelines. This diagnosis will be confirmed by a special committee during the screening process.
  • Must have an INCAT disability score between 2 and 9. This score measures the level of disability, and a score of 2 must be due to leg disability.

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 infection or illness that could affect the study results.
  • Patients who are pregnant or breastfeeding.
  • Patients who have a history of allergic reactions to similar medications.
  • Patients who are unable to follow the study procedures or attend scheduled visits.
  • Patients who have a history of substance abuse that could interfere with the study.
  • Patients who have received certain treatments recently that might affect the study.
  • Patients who have a condition called Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) but do not respond to the study medication in the initial stage.

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 Policlinico G. Rodolico-San Marco Di Catania Catania Italy
Centre Hospitalier Universitaire De Nimes Nimes France
Fondazione Istituto Neurologico Nazionale Casimiro Mondino Pavia Italy
Katholisches Klinikum Bochum gGmbH Bochum Germany
CCAB Centro Clinico Academico Braga Associacao Braga Portugal
Hospital Universitario Basurto Bilbao Spain
Clinical Research Center Sp. z o.o. Medic-R sp.k. Poznan Poland
Martha-Maria Krankenhaus Halle-Doelau gGmbH Halle (Saale) Germany
Deutsches Zentrum Fuer Neurodegenerative Erkrankungen e.V. Bonn Germany
Fondation A De Rothschild Paris France
University General Hospital Of Thessaloniki Ahepa Thessaloniki Greece
General Hospital Of Thessaloniki Papageorgiou Thessaloniki Greece
Azienda Ospedaliero-Universitaria San Luigi Gonzaga Orbassano Italy
Fakultni Nemocnice Hradec Kralove Novy Hradec Kralove Czechia
IRCCS Ospedale Policlinico San Martino Genoa Italy
Hospices Civils De Lyon Lyon France
Centre Hospitalier Universitaire De Nice Nice France
Hopital Beaujon Clichy France
Fondazione I.R.C.C.S. Istituto Neurologico Besta Milan Italy
Universitaetsklinikum Leipzig AöR Leipzig Germany
University General Hospital Attikon General Hospital Of West Attica H Agia Varvara Chaidari Greece
Azienda Ospedaliero Universitaria Pisana Pisa Italy
Clinirem Sp. z o.o. Lublin Poland
Cntr Dx Crnz Itej Sdpojr Milan Italy
Mnefysggpesa Vijatzbnydyyxahyyv Sqb Jyoguudfodttbteaze Paopcwi Goqu Potsdam Germany
Azzhjoftug Prcaeask Hvomxlsa Db Mirtzaqbg Marseille France
Hsvqefwz Uurcannkdgagw Dotxumrw Donostia / San Sebastian Spain
Jaspzqhnme Ktpvhpcovlb Bxyxnw Skxnldwt Dkf Brpouidpgbotd Rygfnn Berlin Germany
Hdidkmcc Vkpg dmhqpxnr Barcelona Spain
Hrsmkxxt Ubbpmxxsmeybzc Sqeovikttn &crycbs Hnqkkas dk Hxgyqovtgyh STRASBOURG, Alsace France

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

Trial status

Country Status Recruitment Start
Czechia Czechia
Recruiting
02.01.2023
France France
Recruiting
02.01.2023
Germany Germany
Recruiting
02.01.2023
Greece Greece
Recruiting
02.01.2023
Italy Italy
Recruiting
02.01.2023
Poland Poland
Recruiting
02.01.2023
Portugal Portugal
Recruiting
02.01.2023
Spain Spain
Recruiting
02.01.2023

Trial locations

Nipocalimab is a medication being studied for its ability to help people with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). This condition affects the nerves and can cause weakness and numbness. The trial is testing if nipocalimab can delay the return of symptoms in patients who initially respond well to the treatment.

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. The disease progresses slowly, often over several months, and can lead to significant disability if untreated. Symptoms may include tingling or numbness, muscle weakness, loss of deep tendon reflexes, and fatigue. The condition can vary greatly in severity and may have periods of improvement and worsening. It is considered a rare disease and can affect individuals differently, with some experiencing a relapsing-remitting course.

Trial ID:
2023-508425-28-00
Protocol code:
80202135CDP3001
Trial Phase:
Therapeutic exploratory (Phase II)

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