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

StatusRecruiting
PhasePhase 3
Started
View on ClinicalTrials.gov ↗

Record History

  1. Notable Recruitment opened Trial sites expanded: 5 → 10 locations · Primary and study completion moved earlier from Oct 31, 2028 to Sep 19, 2028 · Enrollment target: 21 to 19 · 1 morev4 Show 4 more changesShow less
    • Trial sites expanded: 5 → 10 locations
    • Primary and study completion moved earlier from Oct 31, 2028 to Sep 19, 2028
    • Enrollment target: 21 to 19
    • Start date changed from estimate of Aug 31, 2026 to Jul 20, 2026
  2. Minor Enrollment increased: 19 → 21 participants Trial sites expanded: 1 → 5 locationsv3 Show 1 more changeShow less
    • Trial sites expanded: 1 → 5 locations
  3. Minor Enrollment target: 21 to 19 Study sites: 0 to 1v2 Show 1 more changeShow less
    • Study sites: 0 to 1
  4. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
727 trials monitored
See 61 trials at risk
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).
Trial Details
NCT Number NCT07557420
Lead Sponsor Alexion Pharmaceuticals, Inc.
Conditions NMOSD, Neuromyelitis Optica Spectrum Disorder
Enrollment 19 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov