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Recruiting NCT07557420

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

Conditions: NMOSD, Neuromyelitis Optica Spectrum Disorder

Sex: All
Ages: 18 Years – 130 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 19
Sponsor: Alexion Pharmaceuticals, Inc.

Location: Research Site Beijing

Summary

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

Key Inclusion (essential) * 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.) * Body weight: ≥40 kg. * Vaccinated against meningococcal infections from serogroups A, C, W, Y (and B where available) within the 3 years prior to study intervention administration on Day 1. Key Exclusion (essential) * Pregnancy/lactation: Pregnant, breastfeeding, or intending to conceive during the study. * Infection risk: History of meningococcal disease or unresolved meningococcal disease, active systemic infection within 14 days, or fever ≥38°C within 7 days before Day 1. * Hypersensitivity: To murine proteins or ravulizumab excipients. * Serious comorbidities: Any condition that in the Investigator's judgment adds risk or interferes with participation/assessment. * Viral infections: Known HIV, active HBV, or active HCV. * Prior/concomitant immunomodulatory treatments: * B cell-depleting therapy (e.g., rituximab, inebilizumab) within 3 months before Screening. * Mitoxantrone or satralizumab within 3 months before Screening. * IVIg within 3 weeks before Screening. * Any prior or current complement inhibitor. Note: Other protocol-defined criteria may apply and should be verified during full eligibility review.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT07557420). StuddyBuddy aggregates publicly available trial information.