M281 for Autoimmune Hemolytic Anemia

(ENERGY Trial)

This trial tests a treatment called M281 (also known as Nipocalimab, a human monoclonal antibody) to evaluate its effectiveness and safety for people with warm autoimmune hemolytic anemia (wAIHA), a condition where the immune system attacks and destroys red blood cells. The trial includes different groups, with some participants receiving M281 every two or four weeks and others receiving a placebo (inactive treatment) for comparison. Eligible participants should have been diagnosed with wAIHA for at least three months and have received some form of treatment for it. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group of people, offering a chance to contribute to important advancements in wAIHA treatment.

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

Research has shown that M281, also known as nipocalimab, has undergone safety testing in several studies. One study with healthy volunteers found that a single dose was well-tolerated, with no serious side effects reported. This suggests potential safety for people, but further studies are necessary for confirmation.

M281 has also been studied for its ability to reduce harmful antibodies in the body. These antibodies can cause conditions like autoimmune hemolytic anemia, where the immune system attacks red blood cells.

Researchers are excited about M281 for autoimmune hemolytic anemia because it targets a part of the immune system in a novel way. Unlike the standard treatments like corticosteroids, which broadly suppress the immune system, M281 specifically binds to the neonatal Fc receptor (FcRn), which plays a role in prolonging the lifespan of antibodies. By interfering with this receptor, M281 reduces the levels of harmful antibodies that attack red blood cells, potentially offering more precise and effective treatment with fewer side effects. Additionally, this targeted approach could mean better management of symptoms and improved quality of life for patients.

Studies have shown that M281, also known as nipocalimab, may help treat warm autoimmune hemolytic anemia (wAIHA) by reducing harmful antibodies called IgG. These antibodies can mistakenly attack the body's own red blood cells, leading to anemia. Research indicates that M281 lowers these antibodies, improving symptoms and overall blood health. In earlier studies, patients taking M281 showed promising improvements in their condition. This trial will administer M281 in different dosing schedules, either every 2 weeks or every 4 weeks, to evaluate its effectiveness. M281 attaches to a specific part of the immune system, decreasing the levels of IgG antibodies, including those causing the disease. Overall, initial findings suggest that M281 could be an effective treatment option for people with wAIHA.²³⁴⁶⁷