This clinical trial is focused on studying a condition called Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). CIDP is a neurological disorder that causes progressive weakness and impaired sensory function in the legs and arms. The study is testing a treatment called Batoclimab, which is a solution for injection. Batoclimab is also known by its code name IMVT-1401. The trial will compare the effects of Batoclimab to a placebo in adult participants who have active CIDP.
The purpose of the study is to evaluate how effective Batoclimab is in maintaining a clinical response in people with CIDP who are already receiving treatments like immune globulin or plasma exchange. Participants will be randomly assigned to receive either Batoclimab or a placebo. The study will be conducted over a period of time, and participants will receive regular injections. The trial aims to see if Batoclimab can help prevent relapses, which are periods when symptoms worsen.
Throughout the study, participants will be monitored to assess their response to the treatment. This will include checking for any changes in their condition and measuring their strength and ability to perform daily activities. The study will help determine if Batoclimab is a safe and effective treatment option for people with CIDP.
1joining the study
Upon joining the study, participation is confirmed for individuals aged 18 or older who have been diagnosed with chronic inflammatory demyelinating polyneuropathy (CIDP) or its variants.
Eligibility is based on specific clinical criteria and diagnostic tests that support the diagnosis of CIDP.
2treatment administration
Participants receive either the medication batoclimab or a placebo. The placebo is identical in appearance but contains no active substance.
The medication is administered as a subcutaneous injection, which means it is injected under the skin.
3monitoring and assessment
Throughout the study, participants are monitored to evaluate the effectiveness of the treatment in maintaining clinical response.
Assessments include measuring changes in the adjusted inflammatory neuropathy cause and treatment (Adj INCAT) score, grip strength, and other disability scales.
4evaluation of outcomes
The primary goal is to determine the proportion of participants who remain free from relapse at Week 36.
Secondary outcomes include the time to first relapse and changes in various clinical scores from the baseline to Week 36.
5completion of the study
The study is expected to conclude by January 31, 2027.
Participants’ health and response to the treatment are evaluated at the end of the study period.
Who Can Join the Study?
You must be 18 years or older at the time of the Screening Visit.
You should have been diagnosed with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), which is a condition affecting the nerves, or one of its variants like multifocal, focal, or motor CIDP.
For typical CIDP, you should have:
Muscle weakness that is getting worse or comes and goes, affecting both sides of the body, and involves both the upper and lower limbs.
Symptoms that have developed over at least 8 weeks.
Reduced or absent reflexes in all limbs.
For CIDP variants, you should have:
Multifocal CIDP: Sensory loss and muscle weakness in different areas, usually more in the upper limbs.
Focal CIDP: Sensory loss and muscle weakness in only one limb.
Motor CIDP: Only motor symptoms without sensory issues.
You need to have test results that support the diagnosis of CIDP, which may include:
Tests showing nerve issues that suggest demyelination, which means damage to the protective covering of nerves.
Improvement after treatment with immunoglobulin, plasma exchange, or corticosteroids.
Imaging tests like ultrasound or MRI showing nerve enlargement.
Spinal fluid tests showing high protein levels but normal white blood cell levels.
Nerve biopsy showing signs of CIDP like swelling or damage to the nerve covering.
For Cohort C, you must have a diagnosis of CIDP with strong evidence from nerve tests.
For Cohort D, you must meet the clinical criteria for typical CIDP or one of its variants.
There are additional criteria that are detailed in the study protocol.
Who Cannot Join the Study?
Patients who are not currently receiving treatments like immune globulin (IVIg or SCIg) or plasma exchange (PLEX) for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) cannot participate. Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) is a condition that affects the nerves, causing weakness and numbness.
Patients who are not able to maintain a clinical response, which means their condition is not stable or improving with current treatments, are excluded.
Patients who are not within the specified age range for the study cannot participate.
Patients who are part of a vulnerable population, meaning they might have additional health or social challenges, are excluded.
Batoclimab is a medication being studied for its potential to help people with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP). This condition affects the nerves and can cause weakness and numbness. The trial is looking at how well Batoclimab can maintain the clinical response in patients who are already receiving other treatments for CIDP.
Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) – This is a neurological disorder characterized by progressive weakness and impaired sensory function in the legs and arms. It is caused by damage to the myelin sheath, the protective covering of the nerves. The disease typically progresses slowly, with symptoms that may include tingling or numbness, muscle weakness, and loss of reflexes. Over time, these symptoms can lead to difficulties with walking and coordination. CIDP is considered a chronic condition, meaning it can persist for a long time and may require ongoing management. The progression of the disease can vary greatly among individuals, with some experiencing periods of improvement and others having a steady decline.
The website uses cookies to ensure the proper functioning of the site and to analyze internet traffic. Some cookies are essential for using the service and do not require consent. You can accept all cookies or use only the essential ones. Data is processed in accordance with our Privacy Policy. You have the right to withdraw your consent, access, rectify, delete, or limit the processing of your data at any time.