NCT07557420 Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity Study of Ravulizumab in Chinese Adults With Neuromyelitis Optica Spectrum Disorder (NMOSD)
| NCT ID | NCT07557420 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Alexion Pharmaceuticals, Inc. |
| Condition | NMOSD |
| Study Type | INTERVENTIONAL |
| Enrollment | 19 participants |
| Start Date | 2026-07-20 |
| Primary Completion | 2028-09-19 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 19 participants in total. It began in 2026-07-20 with a primary completion date of 2028-09-19.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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).
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07557420 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 130 Years, studying NMOSD. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07557420 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 19 participants.
Is NCT07557420 currently recruiting?
Yes, NCT07557420 is actively recruiting participants. Contact the research team at clinicaltrials@alexion.com for enrollment information.
Where is the NCT07557420 trial being conducted?
This trial is being conducted at Beijing, China, Beijing, China, Chengdu, China, Dongguan, China and 6 additional locations.
Who is sponsoring the NCT07557420 clinical trial?
NCT07557420 is sponsored by Alexion Pharmaceuticals, Inc.. The trial plans to enroll 19 participants.