A randomized, double-blind, placebo-controlled phase III study to evaluate the efficacy, safety, and tolerability of remibrutinib in patients with generalized myasthenia gravis, followed by an open-label extension phase.

Generalized Myasthenia Gravis

Change from baseline to Month 6 in Myasthenia Gravis Activity of Daily Living (MG-ADL) total score

Change from baseline to Month 6 in Quantitative MG (QMG) total score, Proportion of participants with ≥ 5 points reduction from baseline to Month 6 of QMG total score without rescue medication and/or strongly confounding prohibited medication, Proportion of participants with ≥ 3 points reduction from baseline to Month 6 of MG-ADL total score without rescue medication and/or strongly confounding prohibited medication, Proportion of participants achieving MSE at Month 6, defined as MG-ADL score of 0 or 1 at Month 6 without rescue therapy and/or strongly confounding prohibited medication, Change from baseline to Month 6 in MGC total score, Change from baseline to Month 6 in revised MG Quality of Life Questionnaire (MG-QOL15r) survey score, Incidence of adverse events and changes in clinical laboratory values, vital signs, and electrocardiograms, Columbia Suicide Severity Rating, Proportion of time during which participants showed a reduction from baseline of ≥ 2 points in MG-ADL score that was maintained up to Month 6, Proportion of early MG-ADL responders during treatment (early responders with first MG-ADL improvement from baseline of ≥ 2 points occurring by week 4）, Change from baseline to Month 6 in EuroQol-5 Dimensions-5 Level (EQ-5D-5L), Proportion of participants achieving a reduction of ≥ 3 points from baseline to Month 6 in MGC total score.

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