An Efficacy and Safety Study of Ravulizumab in Adult Participants With NMOSD

Arms (1)

1. type

   EXPERIMENTAL

   label

   Ravulizumab

   description

   During the Primary Treatment Period, all participants will receive open-label ravulizumab via intravenous (IV) infusion starting on Day 1. The end of the Primary Treatment Period will be triggered when the last enrolled participant completes between 26 and 50 weeks in the study (depending on the number of adjudicated On-Trial Relapse observed). After completion of the Primary Treatment Period, all participants will have the opportunity to continue receiving ravulizumab in the Long-Term Extension Period of the study. For each participant, the Long-Term Extension Period continues for up to 3 years, or until ravulizumab is approved and/or available (in accordance with country-specific regulations), whichever occurs first.

   interventionNames

   1. Biological: Ravulizumab

Primary outcomes (1)

1. measure

   Number of Participants With an Adjudicated On-trial Relapse in the Primary Treatment Period

   timeFrame

   Baseline up to 2.25 years (end of the Primary Treatment Period)

   description

   An On-trial Relapse was defined as a new onset of neurologic symptoms or worsening of existing neurologic symptoms with an objective change (clinical sign) on neurologic examination that persisted for more than 24 hours as confirmed by the treating physician. An adjudicated On-trial Relapse was defined by the protocol and positively adjudicated by the independent relapse adjudication committee.