A Study to Test the Effects and Safety of Riliprubart in People With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) for Which the Usual Treatments do Not Work
This research study is looking at a new treatment called riliprubart for a long-term nerve condition known as Chronic Inflammatory Demyelinating Polyneuropathy, or CIDP. CIDP causes nerve damage that can lead to weakness and numbness. The study is designed for adults with CIDP who haven't found enough relief from standard treatments like immunoglobulin therapy or steroids. Participants will either receive riliprubart or a placebo (a dummy medicine with no active ingredients). The main aim is to understand if riliprubart is effective in improving CIDP symptoms and if it's safe to use. We'll be comparing how people feel on riliprubart versus the placebo over a period of up to 111 weeks, including check-ups and follow-up after treatment.
At a glance
What is this study about?
This study is investigating a new medication called riliprubart for adults living with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). CIDP is a condition where your body's immune system mistakenly attacks the protective covering of your nerves, making it harder for messages to travel. This can lead to symptoms like muscle weakness, numbness, and tingling, which can affect your daily life.
The study focuses on people whose CIDP hasn't responded well to the usual treatments, such as intravenous immunoglobulin (IVIg) or steroids. For these individuals, finding an effective new treatment is very important. Researchers want to see if riliprubart can help improve their symptoms and quality of life.
Participants will be divided into groups, with some receiving riliprubart and others receiving a placebo, which looks like the study drug but contains no active medicine. This allows researchers to fairly compare the effects of riliprubart. The study will last for up to 111 weeks, including initial checks, the treatment period, and follow-up visits to monitor your health and any changes in your CIDP symptoms.
Key takeaways
- This study is for adults with CIDP whose usual treatments haven't helped enough.
- It tests a new medicine called riliprubart against a dummy medicine (placebo).
- The main goal is to see if riliprubart is safe and effective in improving CIDP symptoms.
- Your involvement could last up to 111 weeks, with regular check-ups.
- You have the right to withdraw from the study at any time.
Who may be eligible?
To join this study, you must be an adult with a confirmed diagnosis of CIDP or a similar condition like 'motor CIDP' or 'multifocal CIDP' (also known as Lewis-Sumner Syndrome). Crucially, your CIDP symptoms must not have significantly improved with standard treatments like immunoglobulin therapy or steroids in the past.
You'll need to show that your CIDP is currently causing you problems, and you'll have specific scores that show your condition is active. If you're on certain other medicines for your immune system, you'll need to have been taking them for at least six months. You might also be taking a low dose of steroids, but there are limits.
There are also some reasons why you might not be able to join. For example, if your nerve problems are caused by other conditions like Guillain-Barré syndrome, or if you are pregnant, breastfeeding, or planning to become pregnant. The research team will review your medical history carefully to make sure the study is a good fit for you.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you an adult aged 18 or over?
- Do you have a confirmed diagnosis of CIDP or a similar type, such as motor CIDP?
- Have your CIDP symptoms not improved enough with past treatments like immunoglobulin or steroids?
- Do you currently have active CIDP symptoms?
- Are you able to use contraception if sexually active, and not pregnant or breastfeeding?
What does participation involve?
If you decide to take part in this study, you would first go through a screening process to make sure you meet all the requirements. This involves various checks and tests. Once accepted, you would receive either the new medicine, riliprubart, or a placebo (a dummy treatment) over various treatment phases. You wouldn't know which one you are getting, and neither would your study doctor, to keep the results fair.
Throughout the study, you would come in for regular visits with the study team. They would monitor your health, perform examinations, and ask about your symptoms and any side effects you might be experiencing. These visits are important for tracking how you're responding to the treatment and ensuring your safety.
The total duration of your involvement could be up to 111 weeks, which includes all the initial checks, the period where you are receiving treatment, and follow-up visits after the treatment phase ends. The frequency of visits might change at different stages of the study. You will also need to have received certain vaccinations or start them before the study begins. If you are a woman of childbearing age or a man, you will need to follow specific contraception guidelines throughout your participation.
Potential risks and benefits
Locations (128)
- Alabama Neurology Associates- Site Number : 8400019Verified postcodeHomewood, United States· Recruiting
- USC Norris Comprehensive Cancer Center- Site Number : 8400002Verified postcodeLos Angeles, United States· Recruiting
- University of California Irvine - Manchester Pavilion- Site Number : 8400007Verified postcodeOrange, United States· Recruiting
- IMMUNOe International Research Centers - Centennial- Site Number : 8400049Verified postcodeCentennial, United States· Recruiting
- Yale University School of Medicine- Site Number : 8400018Verified postcodeNew Haven, United States· Recruiting
- Nova Clinical Research - Bradenton- Site Number : 8400044Verified postcodeBradenton, United States· Recruiting
- NorthShore University Health System - Glenbrook Hospital- Site Number : 8400024Verified postcodeGlenview, United States· Recruiting
- University of Kansas Medical Center- Site Number : 8400010Verified postcodeKansas City, United States· Recruiting
- NeuroMedical Clinic of Central Louisiana- Site Number : 8400031Verified postcodeAlexandria, United States· Recruiting
- Ochsner Medical Center - Jefferson Highway- Site Number : 8400030Verified postcodeNew Orleans, United States· Recruiting
- Johns Hopkins Hospital- Site Number : 8400015Verified postcodeBaltimore, United States· Recruiting
- Massachusetts General Hospital- Site Number : 8400009Verified postcodeBoston, United States· Recruiting
Common questions
What is CIDP?
CIDP is a long-term condition where your body's immune system attacks the nerves, causing weakness, numbness, and tingling, mostly in your arms and legs.
What is 'refractory' CIRP?
Refractory CIDP means that your condition has not improved enough, or has gotten worse, even after trying the usual treatments like immunoglobulin therapy or steroids.
What is a placebo?
A placebo is a dummy treatment that looks exactly like the study medicine but doesn't contain any active ingredients. It helps researchers compare the new medicine's effects accurately.
How long will the study last?
If you join, your involvement in the study could last for up to 111 weeks, which includes screening visits, treatment periods, and follow-up appointments.
Can I stop participating if I want to?
Yes, taking part is completely voluntary. You can choose to leave the study at any time, for any reason, and it won't affect your ongoing medical care.
How to find out more
Trial Transparency email recommended (Toll free for US & Canada)
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
Discussion
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