An Open-Label Extension Study to Assess Long-term Safety and Tolerability of Batoclimab in Adult Participants with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
This research is an ongoing study checking the long-term safety of a new medicine called Batoclimab. It’s for adults who have a nerve condition called Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). CIDP can cause muscle weakness and numbness. In this study, doctors want to see if the medicine is safe to use over a longer period. They are mainly watching out for any side effects and how people feel while taking the treatment. They will also check if people need to stop the medicine because of side effects and will monitor changes in grip strength and a score used to measure CIDP symptoms, to understand how well the participants are doing while on Batoclimab.
At a glance
What is this study about?
This study is a long-term look at a new medicine called Batoclimab. It's designed for adults who have a condition called Chronic Inflammatory Demyelinating Polyneuropathy, often shortened to CIDP. CIDP is a condition where your body's immune system mistakenly attacks its own nerves, which can lead to muscle weakness, numbness, and other problems. Researchers want to make sure that Batoclimab is not only helpful but also safe to use for a longer time.
The main goal of this study is to keep a close eye on any side effects people might experience while taking Batoclimab. They're particularly interested in all types of side effects, serious ones, and any side effects that might lead someone to stop taking the medicine. Understanding these side effects is really important to know if a medicine is safe for widespread use.
Besides looking at safety, the study will also measure how people's symptoms change over time. They will use a specific scoring system for CIDP and also measure grip strength, which can be an indicator of nerve function. This helps doctors get a better idea of how people are managing their CIDP while on Batoclimab, even though the primary focus is on safety.
Key takeaways
- This study is testing the long-term safety of a new medicine, Batoclimab, for adults with CIDP.
- It's an 'open-label' study, meaning everyone knows you're getting Batoclimab.
- The main focus is on identifying any side effects and how well people tolerate the medicine.
- Researchers will also check changes in grip strength and CIDP symptoms over time.
- Participation involves regular clinic visits for health checks and assessments.
Who may be eligible?
To be considered for this study, you need to be an adult, aged 18 years or older. There is no upper age limit, meaning older adults are welcome to participate too.
This study is specifically for people who have been diagnosed with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP).
Both men and women can take part in this research. The study aims to include a diverse group of participants to get a broad understanding of how Batoclimab affects different people.
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?
- Have you been diagnosed with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)?
- Are you comfortable potentially taking a new medicine for an extended period?
- Are you able to attend regular clinic visits for health checks?
What does participation involve?
If you join this study, you will be taking a medicine called Batoclimab. The study is an 'open-label' one, which means both you and your study doctor will know you are receiving Batoclimab. The study is designed to assess the long-term effects of the medication, so you would likely be involved for an extended period, which could mean regular visits to the clinic. At these visits, you can expect health checks, blood tests, and assessments of your CIDP symptoms, like measurements of your grip strength and other physical tests. You may also be asked to report any side effects you experience. The exact number of visits and the total length of the study will be explained in detail by the study team.
Potential risks and benefits
Locations (10)
- —UnverifiedBelgium
- —UnverifiedDenmark
- —UnverifiedItaly
- —UnverifiedRomania
- —UnverifiedGermany
- —UnverifiedSlovakia
- —UnverifiedNorway
- —UnverifiedBulgaria
- —UnverifiedGreece
- —UnverifiedPoland
Common questions
What is CIDP?
CIDP stands for Chronic Inflammatory Demyelinating Polyneuropathy. It’s a rare condition where your body’s immune system attacks the protective covering of your nerves, leading to weakness and numbness.
What is Batoclimab?
Batoclimab is a new medicine being studied. This particular study is looking at its long-term safety for people with CIDP.
What does 'Open-Label' mean?
Open-label means that everyone involved in the study – you, your doctor, and the research team – will know that you are receiving the study medication, Batoclimab.
What kind of side effects are they looking for?
The study aims to record all side effects, including common ones, serious ones, and any that are severe enough to make someone stop taking the medicine.
Will this medicine cure my CIDP?
This study is primarily focused on understanding the long-term safety of Batoclimab. While it may help with symptoms, the main goal is to assess safety, not a cure.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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