Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-130
SponsorAlexion Pharmaceuticals, Inc.
About this trial
The primary objective of this study is to confirm the efficacy, safety, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity of ravulizumab in the treatment of Chinese adults with anti-aquaporin-4 (AQP4) antibody (Ab) + neuromyelitis optica spectrum disorder (NMOSD).
Eligibility criteria
Qualifiers
Diagnosis: NMOSD per 2015 international consensus criteria, and anti AQP4 antibody positive at Screening.
Disease activity: ≥1 attack/relapse in the past 12 months.
Disability: EDSS ≤7.
Background therapy: If on IST and/or oral corticosteroids, participant should be on a stable maintenance regimen prior to Screening and plan to remain stable during the study unless relapse occurs. (Detailed agent specific duration/dose rules to be confirmed at screening.)
Disqualifiers
None
Trial design
Treatments tested in this trial
- Ravulizumab
Treatment groups
21 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov