MINT Trial Design: Steroid Taper, Patient Selection, and the 52-Week Framework

The evaluation of novel biologic therapies in generalized myasthenia gravis requires trial designs that reflect both disease heterogeneity and real-world treatment practices. As newer agents are introduced, understanding how studies incorporate background immunosuppression, disease severity, and clinically meaningful endpoints is essential for interpreting results and applying them in practice.

At the 2026 AAN Annual Meeting in Chicago, Richard Nowak, MD, MS, associate professor of neurology at Yale School of Medicine, spoke with NeurologyLive® about the phase 3 MINT trial evaluating inebilizumab in patients with generalized myasthenia gravis. The study design incorporated patients with active disease across both AChR- and MuSK-positive populations, while also integrating real-world elements such as concomitant immunosuppressive therapy and a protocol-defined steroid taper. Nowak emphasized how these design features help contextualize both early and longer-term findings.

In this episode, Nowak walks through the structure of the MINT trial, including eligibility criteria, randomization, and dosing, while highlighting the importance of the forced prednisone taper and the rationale behind the 52-week randomized control period, particularly in assessing durability of response in AChR-positive patients.