A Phase 2, multicenter, open-label, non-randomized, proof-of-concept study evaluating the efficacy, safety, and tolerability of SAR445088 in adults with chronic inflammatory demyelinating polyneuropathy (CIDP)
This research study is looking at a new drug called riliprubart (also known as SAR445088) for adults living with Chronic Inflammatory Demyelinating Polyradiculoneuropathy, or CIDP. CIDP is a condition where your body's immune system mistakenly attacks your nerves, which can cause muscle weakness, numbness, and tingling. This study is in an early stage (Phase 2), meaning researchers are still checking if the drug works and is safe. They want to find out if riliprubart can help control CIDP symptoms, stop them from returning after current treatments are stopped, or help those who haven't improved with existing therapies. The study will also carefully watch for any side effects.
At a glance
What is this study about?
This study is designed to learn more about a new medication called riliprubart (also known as SAR445088) for adults with a condition called Chronic Inflammatory Demyelinating Polyradiculoneuropathy, or CIDP. CIDP is a long-term health problem where your body's defence system, called the immune system, starts attacking the protective covering around your nerves. This can lead to various symptoms like weakness in your arms and legs, numbness, or tingling sensations. Current treatments often involve dampening the immune system, but not everyone responds well, and some people may have their symptoms return.
The main goal of this study is to see if riliprubart is effective and safe for people with CIDP. Researchers are particularly interested in whether it can prevent symptoms from coming back in people who are currently stable on their usual CIDP treatment but then stop it. They also want to see if it can help people whose CIDP hasn't improved with their standard treatments, or those who haven't tried any treatments yet. By carefully observing participants, the study aims to understand how well the drug works and if there are any side effects.
This is a 'Phase 2' study, which means it's an important step in developing new medicines. It's not yet known if riliprubart will become a widely available treatment. The information gathered from this study will help decide if it's promising enough to be tested in larger studies in the future. The researchers will be looking closely at how participants respond to the drug and monitoring their health throughout the study.
Key takeaways
- This study is testing a new drug for adults with CIDP.
- It aims to see if the drug is safe and helps improve symptoms or stop them coming back.
- The study includes people with different experiences of CIDP treatment.
- Participants will receive the new drug and have regular health checks.
- It's a Phase 2 study, meaning the drug is still in early development.
Who may be eligible?
To be part of this study, you must be an adult, aged 18 years or older, with a confirmed diagnosis of Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP).
The study is looking for different groups of people with CIDP. This includes those who are currently being treated for their CIDP and are stable, as well as people whose CIDP hasn't responded well to their usual treatments. They are also looking for individuals who haven't received any CIDP treatment before.
There will be specific health checks and tests to make sure that taking part in the study is right and safe for you. The study team will explain all the requirements in detail.
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 18 years old or older?
- Do you have a diagnosis of CIDP?
- Are you currently on CIDP treatment and stable?
- Has your CIDP not responded well to past treatments?
- Have you never received treatment for your CIDP before?
What does participation involve?
If you decide to take part in this study, you will be given the new medication, riliprubart, under close medical supervision. The study has different parts, depending on whether you are currently on CIDP treatment, haven't responded to treatment, or haven't had treatment before. For some participants, this might involve gradually stopping your current CIDP medication while starting the new one.
You will need to attend regular visits to the clinic. These visits will include various assessments, such as physical examinations, blood tests, and possibly nerve tests, to monitor your health, how your CIDP symptoms are changing, and how the new medication is affecting you. The researchers will also be checking for any side effects and looking at how your body reacts to the drug.
The total duration of your involvement in the study will vary, as some parts involve a treatment period and others include an extension period to see the longer-term effects. The study team will provide a detailed schedule of visits and what to expect at each stage, ensuring you know the overall commitment before you start.
Potential risks and benefits
Locations (6)
- —UnverifiedPoland
- —UnverifiedGermany
- —UnverifiedFrance
- —UnverifiedSpain
- —UnverifiedItaly
- —UnverifiedNetherlands
Common questions
What is CIDP?
CIDP (Chronic Inflammatory Demyelinating Polyradiculoneuropathy) is a condition where your immune system attacks the protective covering of your nerves, leading to weakness, numbness, and tingling.
What is riliprubart?
Riliprubart (also called SAR445088) is the new medication being tested in this study to see if it can help people with CIDP.
What does 'Phase 2' mean for a study?
Phase 2 means it's an early stage of testing where researchers are checking if the new drug works, what dose is best, and if it's safe, but it's not yet approved for general use.
Will I have to stop my current CIDP treatment?
For some parts of the study, you might gradually stop your current CIDP treatment and start the new medication, but this will be carefully managed by the study doctors.
How long will I be in the study?
The length of time you'll be involved varies depending on which part of the study you join, but the study team will give you a clear schedule.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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