Not recruitingRare disease

Study on the Safety and Effects of NVG-2089 for Patients with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Verified siteInvestigationalNo placebo

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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 will evaluate a treatment known as NVG-2089, which is administered as a solution through an intravenous infusion. The purpose of the study is to assess the safety and tolerability of NVG-2089 in individuals diagnosed with CIDP.

Participants in the study will receive NVG-2089 over a period of time, and researchers will monitor them to observe any side effects or improvements in their condition. The study will involve regular check-ups and assessments to ensure the well-being of the participants and to gather data on how the treatment affects their symptoms. The study aims to provide valuable information on the potential benefits and risks of using NVG-2089 for treating CIDP.

Throughout the study, participants will be closely observed for any changes in their health, including any adverse reactions to the treatment. The study will also track improvements in symptoms such as muscle strength and overall physical ability. This research is important for understanding how NVG-2089 can be used to help people with CIDP and to determine its effectiveness and safety as a treatment option.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial visit
Upon joining the study, you will attend an initial visit. During this visit, a healthcare professional will review your medical history and conduct a physical examination. This is to ensure you meet the study requirements.
A blood sample will be taken to confirm a negative pregnancy test if applicable. This is necessary for female participants of childbearing potential.
Step 2
Treatment phase
You will receive the study medication, NVG-2089, which is administered as a solution through an intravenous infusion. This means the medication is given directly into your vein.
The frequency and dosage of the medication will be determined by the study protocol and your healthcare provider. The treatment phase will last for a specified period, during which you will receive regular infusions.
Step 3
Regular monitoring
Throughout the study, you will have regular visits to monitor your health and the effects of the medication. These visits will include physical examinations, blood tests, and other assessments as needed.
You will be asked about any side effects or changes in your condition. This information is important to evaluate the safety and effectiveness of the treatment.
Step 4
Follow-up visits
After completing the treatment phase, you will have follow-up visits. These visits are to check your health status and gather additional information about the long-term effects of the medication.
The follow-up period is an essential part of the study to ensure your well-being and to collect comprehensive data on the treatment's impact.

Who can join the trial?

10 criteria

Participants must be at least 18 years old.
Participants must have been diagnosed with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) or possible CIDP according to specific criteria.
Participants must have a specific score on a test called INCAT, which measures disability. This score must be at least 2 for those who have not been treated before, and between 2 and 7 for those who have been treated before. The score of 2 should come from leg disability.
For those who have been treated before, there must be evidence of either worsening symptoms when treatment was stopped or reduced, or improvement in symptoms with standard treatment. This should be documented in medical records.
Participants who have not been treated before should not have used certain treatments like IVIg, SCIg, corticosteroids, or experimental therapies for CIDP.
Participants who have been treated before should be on a stable dose of IVIg or SCIg without worsening of the disease for 8 weeks before the study. They must be willing to stop these treatments before starting the study drug.
Female participants who can have children must have a negative pregnancy test before starting the study and on the first day of the study.
Female participants who are sexually active with a male partner must use two forms of birth control, including a barrier method, starting 28 days before the study and continuing for 90 days after the last dose of the study drug. They should not donate eggs during this time. Exceptions are made for those who are surgically sterile or post-menopausal.
Male participants with female partners who can have children must agree to use highly effective barrier contraception during the study and for 90 days after the last dose of the study drug.
Participants must be able to provide informed consent, or have a legally authorized representative who can do so on their behalf.

Who cannot join the trial?

5 criteria

Patients who do not have Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) cannot participate. CIDP is a condition that affects the nerves, causing weakness and numbness.
Patients who are not within the specified age range for the study cannot participate. The study is open to certain age groups only.
Patients who are not part of the specified clinical trial groups cannot participate. The study is designed for specific groups of people.
Patients who are not male or female cannot participate. The study includes both male and female participants.
Patients who are not considered part of a vulnerable population cannot participate. Vulnerable populations may include groups like children, pregnant women, or the elderly.

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Verified sites

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

Assistance Publique Hopitaux De Marseille
Verified
Marseille, France
Azienda Ospedaliero-Universitaria Sant Andre
Responsive
Rome, Italy
Neurologia Slaska Centrum Medyczne
Responsive
Katowice, Poland

Trial locations

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Investigated drugs

NVG-2089 is a medication being tested in this clinical trial for people with a condition called Chronic Inflammatory Demyelinating Polyneuropathy, or CIDP. This condition affects the nerves and can cause weakness and numbness. The medication is given through an intravenous infusion, which means it is delivered directly into the bloodstream through a vein. The main goal of using NVG-2089 in this study is to see if it is safe and well-tolerated by the participants, as well as to check if it helps improve their symptoms related to CIDP.

NVG-2089

What is already known about the treatment

NVG-2089 – NVG-2089 is administered through an intravenous method, meaning it is given directly into the bloodstream via a vein. This medication is currently being studied in clinical trials to assess its safety and effectiveness for treating Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), a condition that affects the nerves. The main goal of the trial is to determine how well patients tolerate the medication and to observe any potential benefits. NVG-2089 works at the molecular level by targeting specific pathways involved in the inflammation and damage of nerve fibers, aiming to reduce symptoms and improve nerve function. It is classified under pharmacological agents that modulate immune responses, helping to manage chronic inflammatory conditions.

Investigated diseases

Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) – 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. The disease progresses slowly, often over several months, and can lead to significant disability. Symptoms may include tingling or numbness, muscle weakness, loss of deep tendon reflexes, and fatigue. The progression of CIDP can vary, with some individuals experiencing periods of improvement and others having a steady decline in function. The exact cause of CIDP is unknown, but it is believed to involve an autoimmune response.