Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity Study of Ravulizumab in Chinese Adults With Neuromyelitis Optica Spectrum Disorder (NMOSD)

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 group

Sponsors and collaborators