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

A Phase 3b, Open-label, Single-arm, Multicenter Study to Evaluate the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of Ravulizumab in Chinese Adult Participants With Neuromyelitis Optica Spectrum Disorder (NMOSD)

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07557420
Enrollment
19
Registered
2026-04-29
Start date
2026-07-20
Completion date
2028-09-19
Last updated
2026-09-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Neuromyelitis Optica Spectrum Disorder, NMOSD

Keywords

Ravulizumab, NMOSD, Neuromyelitis optica spectrum disorder

Brief 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).

Interventions

DRUGRavulizumab

Participants will receive ravulizumab via intravenous (IV) infusion.

Sponsors

Alexion Pharmaceuticals, Inc.
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 130 Years
Healthy volunteers
No

Inclusion 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.

Design outcomes

Primary

MeasureTime frame
Adjudicated On-Trial Annualized Relapse Rate (ARR)Baseline up to Week 50

Secondary

MeasureTime frame
Number of Participants With Clinically Important Change From Baseline in Hauser Ambulation Index (HAI) ScoreBaseline up to Week 50
Number of Participants With Clinically Important Worsening From Baseline in Expanded Disability Status Scale (EDSS) ScoreBaseline up to Week 50
Change From Baseline in European Quality of Life Health 5-item Questionnaire (EQ-5D) Index ScoreBaseline, Week 50
Change From Baseline in EQ-5D Visual Analog Scale (VAS) ScoreBaseline, Week 50
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Treatment Emergent Serious Adverse Events (TESAEs) and Adverse Events of Special Interests (AESIs)Baseline up to Week 50
Serum Ravulizumab ConcentrationDay 1 to Day 351
Change From Baseline in Serum Free Complement Component 5 (C5) ConcentrationBaseline Up to Day 351
Number of Participants With Anti-Drug Antibodies (ADAs)Day 1 up to Day 351
Number of Participants With Neutralizing Antibodies (NAb)Day 1 up to Day 351

Countries

China

Contacts

CONTACTAlexion Pharmaceuticals, Inc. (Sponsor)
clinicaltrials@alexion.com1-855-752-2356

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 12, 2026