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

Secondary

• Change from baseline to Month 6 in Quantitative Myasthenia Gravis (QMG) total score

  Time frame: Baseline to Month 6

• 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

  Time frame: Baseline to Month 6

• Proportion of participants with ≥ 3 points reduction from baseline to Month 6 of Myasthenia Gravis Activity of Daily Living (MG-ADL) scale total score without rescue medication and/or strongly confounding prohibited medication

  Time frame: Baseline to Month 6

• Proportion of participants achieving Minimal Symptom Expression (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

  Time frame: Month 6

• Change from baseline to Month 6 in Myasthenia Gravis Composite score (MGC) total score

  Time frame: Baseline to Month 6

• Change from baseline to Month 6 in revised Myasthenia Gravis Quality of Life Questionnaire (MG-QOL15r) survey score

  Time frame: Baseline to Month 6

• Incidence of adverse events

  Time frame: Baseline to Month 6

• Proportion of time during which participants showed a reduction of ≥ 2 points in MG-ADL total score, that was maintained up to Month 6

  Time frame: Baseline 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）

  Time frame: Baseline to week 4

• Change from baseline to Month 6 in EuroQol-5 Dimensions-5 Level (EQ-5D-5L)

  Time frame: Baseline to Month 6

• Proportion of participants achieving a reduction from baseline of ≥ 3 points in MGC total score at Month 6

  Time frame: Baseline to Month 6

• Change from baseline in MG-ADL total score

  Time frame: Baseline to Month 66

• Proportion of participants achieving a reduction from core part in oral corticosteroids (OCS) dose till the end of extension part

  Time frame: Baseline to month 66

• Incidence of adverse events

  Time frame: Month 7 to month 66