Batoclimab for CIDP
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a drug called batoclimab (an anti-FcRn monoclonal antibody) to determine its effectiveness for people with CIDP, a nerve condition that can cause muscle weakness and numbness. Researchers aim to assess whether batoclimab is safe and more effective than a placebo (a dummy treatment) for CIDP. Participants will be assigned to different groups based on their current CIDP treatment and symptoms, with some receiving batoclimab and others a placebo. This trial may suit adults who have had CIDP for at least 8 weeks and experience muscle weakness or numbness in their arms or legs. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group of people.
Will I have to stop taking my current medications?
The trial includes a 12-week washout period (time without taking certain medications), which suggests you may need to stop some current treatments. However, the protocol does not specify exactly which medications must be stopped, so it's best to discuss this with the trial team.
Is there any evidence suggesting that batoclimab is likely to be safe for humans?
Research has shown that batoclimab is generally well-tolerated in studies involving patients with various autoimmune disorders. For example, a study with patients who have myasthenia gravis (MG) found that batoclimab was safe and had positive effects. Although this study focused on a different condition, it provides some insight into the drug's safety, as both myasthenia gravis and CIDP are autoimmune diseases.
In these studies, some participants experienced mild to moderate side effects, with headaches and injection site reactions being the most common. Serious side effects were rare. The current trial is in phase 2, indicating that some safety information is available, but long-term safety is still under investigation. This phase aims to gather more detailed information on treatment tolerance.
Overall, while the safety data for batoclimab appears promising, it is still undergoing careful testing to ensure its safety for treating CIDP specifically.12345Why do researchers think this study treatment might be promising for CIDP?
Researchers are excited about Batoclimab for CIDP because it offers a novel approach by targeting the neonatal Fc receptor (FcRn), which plays a key role in regulating antibody levels. Unlike standard treatments for CIDP, such as corticosteroids, intravenous immunoglobulins (IVIG), or plasma exchange, Batoclimab specifically moderates the immune system's attack on nerves by reducing harmful antibodies. This targeted mechanism has the potential to provide more effective and sustained relief from symptoms, with fewer side effects. Additionally, Batoclimab is administered subcutaneously, which could offer a more convenient and less invasive alternative to the currently more cumbersome treatment options. This different mode of action and delivery method has the potential to significantly improve the quality of life for individuals suffering from CIDP.
What evidence suggests that batoclimab might be an effective treatment for CIDP?
Research has shown that batoclimab, a monoclonal antibody, may treat autoimmune diseases by blocking a specific part of the immune system. In studies on other autoimmune diseases, batoclimab has proven effective. For instance, in myasthenia gravis, a similar autoimmune disorder, patients experienced significant symptom improvement over 12 weeks. This trial will assess batoclimab's potential to manage symptoms of Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), with participants receiving different doses across various treatment arms. Although direct evidence for CIDP is still being gathered, these findings suggest promising potential benefits.12346
Are You a Good Fit for This Trial?
Adults over 18 with active Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP) who meet specific diagnostic criteria can join this trial. They should not have other types of polyneuropathies, IgM paraproteinemia, certain forms of CIDP like Distal or Sensory CIDP, poorly controlled diabetes, central demyelination signs, or be on high doses of corticosteroids.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Washout
Participants undergo a washout period to clear previous treatments
Randomized Treatment
Participants receive randomized treatment with batoclimab or placebo
Randomized Withdrawal
Participants undergo a withdrawal period to assess relapse rates
Long-term Extension (optional)
Participants may opt into continuation of treatment long-term
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Batoclimab
Batoclimab is already approved in European Union, United States for the following indications:
- Thyroid Eye Disease (TED)
- Thyroid Eye Disease (TED)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Immunovant Sciences GmbH
Lead Sponsor