Not recruitingRare disease

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

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What is this trial about?

A plain-language summary of the goals, design and what participants do

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.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 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.
Step 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.
Step 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.
Step 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.
Step 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 trial?

3 criteria

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 trial?

9 criteria

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.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Deutsches Zentrum Fuer Neurodegenerative Erkrankungen e.V.
Responsive
Bonn, Germany
Hospices Civils De Lyon
Responsive
Lyon, France
Katholisches Klinikum Bochum gGmbH
Responsive
Bochum, Germany

Trial locations

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Investigated drugs

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.

What is already known about the treatment

Nipocalimab – Nipocalimab is administered intravenously, meaning it is given directly into a vein. It is currently being studied in clinical trials for its effectiveness and safety in treating Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). This medication is designed to help delay the relapse of symptoms in patients who initially respond to it. Nipocalimab works by targeting and blocking certain proteins involved in the immune response, which can help reduce inflammation and nerve damage. It is classified as an immunomodulatory agent, which means it modifies the immune system's activity to achieve its therapeutic effects.

Investigated diseases

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.