Positive Phase III top-line results for rozanolixizumab in gMG

10 December 2021

Belgium’s largest drugmaker UCB (Euronext Brussels: UCB) has announced positive top-line results from the Phase III MycarinG (MG0003) trial study investigating the efficacy and safety of rozanolixizumab, a subcutaneously infused monoclonal antibody targeting the neonatal Fc receptor (FcRn), versus placebo in patients with generalized myasthenia gravis (gMG).

The trial met its primary endpoint, demonstrating a statistically-significant and clinically-meaningful change from baseline in the Myasthenia Gravis-Activities of Daily Living Profile (MG-ADL), an eight-item patient-reported scale developed to assess MG symptoms and their effects on daily activities, total score at Day 43.
All secondary endpoints were also met with statistical significance. Secondary endpoints include response rates, changes in the Myasthenia Gravis composite (MGC) score, the Quantitative MG (QMG) score, patient-reported outcomes and adverse events (AEs).

Overall rozanolixizumab was well tolerated, and no new safety signals were identified. The final Phase III data and additional details will be presented at a forthcoming medical meeting in 2022.

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