Efficacy and Safety Study of Nipocalimab for Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

To be considered for this study, you need to be an adult, 18 years or older, and have a confirmed diagnosis of CIDP that is either getting worse or coming back after treatment. Your CIDP diagnosis would need to be re-checked by an independent group of experts during the initial screening process. Your level of disability from CIDP will also be assessed, usually needing to be between a moderate to severe level, and this needs to be mainly due to leg weakness if your disability score is on the lower end.

You also need to be on specific types of CIDP treatment, or not on any at all. For example, you might be taking a certain dose of steroid tablets, or receiving treatments like intravenous immunoglobulin (IVIg) or subcutaneous immunoglobulin (SCIg), which you'd need to be willing to stop. If you're on a higher dose of steroid tablets, you'd need to be able to reduce it during the study start. People who haven't had treatment for CIDP before, or who stopped treatment at least three months ago, can also be considered. Importantly, your CIDP needs to be considered 'active', meaning it's currently causing problems.

There are also some reasons why you might not be able to join. These include having other serious or uncontrolled health conditions, such as severe liver disease, heart problems, or certain types of kidney, lung, digestive, or mental health issues. The study aims to make sure it's safe for everyone involved, so these checks are important.

If you decide to take part in this study, you'll go through several stages. First, there's a 'screening' period where doctors will confirm your CIDP diagnosis and check if you meet all the study requirements. This might involve physical exams, blood tests, and reviewing your medical history.

If you're eligible, you'll then enter 'Stage A'. During this stage, everyone will receive the new medicine, nipocalimab, as an infusion (given into a vein). Doctors will closely monitor your CIDP symptoms to see if they improve. This stage lasts for a set period, and you'll have regular visits to the clinic for assessments and to receive your medication.

If your CIDP symptoms get better on nipocalimab in Stage A, you might then move on to 'Stage B'. In this stage, you will either continue to receive nipocalimab or you will receive a placebo (dummy medicine). Neither you nor your study doctor will know which one you are getting. You'll continue to have regular clinic visits for infusions, physical examinations, and other tests to see how your CIDP is doing. The total duration of your participation in the study, including all visits and follow-ups, will be clearly explained to you by the study team.