Batoclimab for Chronic Inflammatory Demyelinating Polyradiculoneuropathy

This trial explores the long-term safety of batoclimab, a treatment for Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP), a condition affecting the nerves and causing weakness. Participants will receive a weekly injection of batoclimab for up to a year. The study is open to those who have already completed a related batoclimab study. Participants should not have any other major health issues that could interfere with the study. As a Phase 2 trial, the research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important findings.

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Research has shown that batoclimab has been tested for safety in treating other conditions. In one study with adults who have myasthenia gravis (MG), researchers compared batoclimab to a placebo to assess its safety. The study found that batoclimab was generally well-tolerated, with most participants not experiencing serious problems. Some side effects were reported, but they were mostly mild to moderate.

Unlike the standard treatments for Chronic Inflammatory Demyelinating Polyradiculoneuropathy (CIDP), which often include corticosteroids or immunoglobulin therapy, Batoclimab takes a different approach. It targets the neonatal Fc receptor (FcRn), which plays a key role in regulating the immune system and antibody levels. By interfering with this receptor, Batoclimab may reduce the harmful antibodies that attack the nervous system in CIDP. Researchers are excited about Batoclimab because this specific mechanism could offer a more targeted treatment, potentially leading to fewer side effects and improved efficacy compared to existing therapies.

Studies have shown that batoclimab effectively treats conditions similar to chronic inflammatory demyelinating polyneuropathy (CIDP). For instance, research on myasthenia gravis, a related autoimmune disorder, showed significant improvement in patient symptoms. This is encouraging for CIDP because both conditions involve the immune system attacking the body's nerves. Early findings suggest batoclimab can help reduce these attacks, potentially improving nerve function and relieving symptoms. Although more research is needed specifically for CIDP, these initial results offer hope for its effectiveness. Participants in this trial will receive batoclimab to further evaluate its potential benefits for CIDP.¹²³⁴⁵