Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity Study of Ravulizumab in … (NCT07557420) | Clinical Trial Compass
Not Yet RecruitingPhase 3
Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity Study of Ravulizumab in Chinese Adults With Neuromyelitis Optica Spectrum Disorder (NMOSD)
21 participantsStarted 2026-08-31
Plain-language 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).
Who can participate
Age range18 Years – 130 Years
SexALL
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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…