A Study to Examine the Efficacy and Safety of Pozelimab and Cemdisiran Combination Therapy in Adult Patients With Symptomatic Generalized Myasthenia Gravis

Authors
Category Primary study
Registry of Trialsclinicaltrials.gov
Year 2021
The primary objective is: To evaluate the effect of pozelimab + cemdisiran on daily functioning that is impacted by signs and symptoms in patients with symptomatic generalized myasthenia gravis (gMG) The secondary objectives of the study are: * To evaluate the effect of pozelimab + cemdisiran (ie, combination) and cemdisiran monotherapy on: * Clinician-assessed signs of myasthenia gravis (MG) and muscle strength * Daily functioning that is impacted by signs and symptoms in patients with symptomatic gMG (cemdisiran monotherapy only). * Proportion of patients with improvements in daily function that is impacted by signs and symptoms of MG * Proportion of patients that have improvements in clinician-assessed signs of MG and muscle strength * Health related quality of life * Proportion of patients with minimal MG symptoms * Patient- and clinician-reported signs and symptoms of MG * To evaluate the safety and tolerability of pozelimab + cemdisiran and cemdisiran monotherapy * To assess the concentration of total pozelimab in serum * To assess the concentrations of cemdisiran and its metabolites in plasma * To assess the immunogenicity of pozelimab * To assess the concentration of total C5 in plasma * To assess the immunogenicity of cemdisiran * To study the effect of pozelimab + cemdisiran and cemdisiran monotherapy on complement activation
Epistemonikos ID: d1e9305285b22f768fb4f17974a7716c6ad66631
First added on: May 09, 2024