OCTAGON:A Phase 4, Single Arm Study to Investigate Oral Corticosteroid Tapering in Adult Patients with Generalized Myasthenia Gravis Treated with Ravulizumab

Generalized Myasthenia Gravis

Proportion of adult participants with gMG who either: • Discontinue OCS (0 mg/day), or • Reduce their daily OCS dosage ≤ 5 mg/day, if the reason for no further OCS reduction is suspected adrenal insufficiency and maintain this status for ≥ 4 weeks without clinical deterioration of gMG

Proportion of adult participants with gMG who discontinue OCS (0 mg/day), sustained ≥ 4 weeks without clinical deterioration of gMG, Percentage change from daily OCS dose (mg/day) at baseline to the daily OCS dose (mg/day) at 4 weeks after OCS tapering is complete, Change from Baseline to 4 weeks after OCS tapering is complete in the MG-QoL-15r among adult participants with gMG • Change from Baseline to 4 weeks after OCS tapering is complete in MG-ADL total score among adult participants with gMG, Summary of GTI-MD including Cumulative Worsening Score and Aggregate Improvement Score at 4 weeks after OCS tapering is complete as assessed by BMI, glucose intolerance, blood pressure, and low-density lipoprotein collected at Baseline and at 4 weeks after OCS tapering is complete among adult participants with gMG, Proportion of adult participants with gMG with MG clinical deterioration events (including crises, exacerbations, MG-related hospitalization) at any time over the follow-up period • Proportion of adult participants with gMG with suspected adrenal insufficiency, based on symptoms as assessed at any time during the follow-up period, Proportion of adult participants with gMG with adrenal insufficiency confirmed by morning cortisol • Incidence of adverse events and serious adverse events among adult participants with gMG after initiation of reduction in OCS dose • Change from Baseline to 4 weeks after OCS tapering completion in laboratory parameters including HbA1c and LDL-C in adult participants with gMG, Summary of the Social Impact and Sleep questionnaire at 4 weeks after OCS tapering is complete among adult participants with gMG.

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