Phase 3 Trial of Nipocalimab IV and SC for Adults With Generalized Myasthenia Gravis

What this Trial Is About

Researchers are evaluating nipocalimab, a drug given intravenously or subcutaneously, for adults with generalized myasthenia gravis gMG, a condition causing muscle weakness. This Phase 3 study aims to compare the effectiveness and safety of nipocalimab against a placebo and to understand how the drug works in the body when given by injection under the skin versus through a vein. The study includes a subcutaneous substudy to explore these differences in delivery methods. Participants receive nipocalimab intravenous infusions every two weeks for up to 24 weeks during a double-blind placebo-controlled phase. Those completing this phase can enter an open-label extension, choosing to continue receiving intravenous nipocalimab or switch to the subcutaneous form given weekly for eight weeks, with the option to continue longer in a long-term extension. Placebo is also given intravenously every two weeks in the control group during the double-blind phase. Throughout the study, participants undergo regular assessments including muscle function scores, quality of life evaluations, and blood tests measuring antibody levels and drug concentration. Researchers monitor safety by tracking adverse events and changes in clinical and laboratory parameters. The study measures changes in activities of daily living related to myasthenia gravis over time. Participation may last several years, as long-term monitoring continues after the initial treatment phases to evaluate ongoing effects and safety.

A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis