A Phase 2b, Multi-center, Randomized, Quadruple-blind, Placebo-controlled Study of Batoclimab Treatment in Adult Participants with Active Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
This clinical trial is looking at a new medicine called Batoclimab for adults who have Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). CIDP is a long-term condition that affects your nerves, often causing weakness and numbness. In this study, some people will receive Batoclimab, while others will receive a 'dummy' medicine (placebo) that looks the same but has no active ingredients. Researchers want to find out if Batoclimab can help prevent CIDP symptoms from coming back or getting worse over 36 weeks. The study is 'quadruple-blind,' meaning no one involved – patients, doctors, or staff – knows who is getting the real medicine. This helps make the study results fair and accurate. It's a key step in exploring new ways to manage CIDP.
At a glance
What is this study about?
This study is about a new medicine called Batoclimab, which researchers hope might help people living with Chronic Inflammatory Demyelinating Polyneuropathy, often shortened to CIDP. CIDP is a condition where your body's immune system mistakenly attacks its own nerves, leading to symptoms like muscle weakness, numbness, and tingling, which can get worse over time.
The main goal of this particular study is to see if Batoclimab can prevent CIDP symptoms from getting worse in adults. They'll be comparing it to a placebo, which looks exactly like the study medicine but doesn't contain any active drug. This comparison helps researchers understand if any improvements are truly due to Batoclimab or other factors. The study is designed so that neither the patient, the doctor, nor the research staff will know who is receiving which treatment, which helps ensure the results are unbiased.
Over 36 weeks, the research team will carefully monitor participants to see if their CIDP symptoms stay stable or relapse (get worse). They will use special scales and tests, like checking grip strength and overall nerve function, to measure any changes. The information gathered from this study is crucial for learning more about Batoclimab and whether it could become a helpful treatment option for people with CIDP in the future.
Key takeaways
- This study tests a new medicine, Batoclimab, for adults with CIDP.
- It aims to see if Batoclimab can stop CIDP symptoms from getting worse.
- The study compares Batoclimab to a dummy medicine (placebo).
- No one knows who gets which medicine ('quadruple-blind').
- It lasts 36 weeks with regular check-ups.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
To join this study, you must be an adult aged 18 years or older. There is no upper age limit for taking part.
The study is open to both men and women. The most important requirement is that you have a confirmed diagnosis of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) that is currently active, meaning you are experiencing symptoms.
There will be other detailed medical checks to make sure the study is a safe and suitable option for you. These will be discussed with you by the study team.
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 Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)?
- Are your CIDP symptoms currently active or causing problems?
- Are you able to attend regular clinic visits for 36 weeks?
What does participation involve?
If you decide to take part in this study, you will be assigned to either receive the study medicine, Batoclimab, or a placebo (a dummy medicine). You, your doctor, and the study team will not know which one you are receiving.
Throughout the study, you will have regular visits to the clinic over a period of 36 weeks. During these visits, the medical team will carry out various assessments. This includes checking your nerve function, muscle strength (like your grip), and how your symptoms are affecting your daily life. They will use specific questionnaires and tests to track any changes.
After the main treatment period, there will be a follow-up visit to monitor your health. The total duration of your involvement, including all visits and follow-ups, will be explained in detail by the study team. You will have multiple opportunities to ask questions before deciding to participate.
Potential risks and benefits
Locations (14)
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Common questions
What is CIDP?
CIDP, or Chronic Inflammatory Demyelinating Polyneuropathy, is a long-term condition where your body's immune system attacks your nerves, causing weakness, numbness, and tingling.
What is Batoclimab?
Batoclimab is the new medicine being tested in this study. Researchers want to see if it can help prevent CIDP symptoms from getting worse.
What does 'quadruple-blind' mean?
It means that no one involved in the study – not you, your doctor, or the study staff – knows whether you are receiving Batoclimab or the dummy medicine. This helps ensure fair results.
How long will I be in the study?
The main part of the study where your symptoms are regularly checked will last for 36 weeks, with follow-up visits after that.
Will I get the real medicine or a dummy one?
Participants are randomly assigned to receive either Batoclimab or a placebo (dummy medicine). You won't know which one you're getting, as it's a 'blinded' study.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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