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

April 23, 2026 updated by: Alexion Pharmaceuticals, Inc.

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)

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).

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

21

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ravulizumab
Participants will receive a weight-based loading dose of ravulizumab on Day 1, followed by a weight-based maintenance treatment dose on Day 15 and every 8 weeks (q8w) thereafter for up to 50 weeks.
Drug: Ravulizumab
Participants will receive ravulizumab via intravenous (IV) infusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Adjudicated On-Trial Annualized Relapse Rate (ARR)
Time Frame: Baseline up to Week 50
Baseline up to Week 50

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexion Pharmaceuticals, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

August 31, 2026

Primary Completion (Estimated)

October 31, 2028

Study Completion (Estimated)

October 31, 2028

Study Registration Dates

First Submitted

April 23, 2026

First Submitted That Met QC Criteria

April 23, 2026

First Posted (Actual)

April 29, 2026

Study Record Updates

Last Update Posted (Actual)

April 29, 2026

Last Update Submitted That Met QC Criteria

April 23, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D9282C00006
  • ALXN1210-NMO-324 (Other Identifier: Alexion)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Alexion has a public commitment to allow requests for access to study data and will be supplying a protocol, CSR, and plain language summaries.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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