An Efficacy and Safety Study of Ravulizumab in Adult Participants With NMOSD

Completed · Phase 3 · Has a placebo group

Conditions studied: Neuromyelitis Optica, Neuromyelitis Optica Spectrum Disorder

In brief

The primary purpose of this study is to evaluate the efficacy and safety of ravulizumab for the treatment of adult participants with NMOSD.

Key facts

Study ID

NCT04201262

Run by

Alexion Pharmaceuticals, Inc.

People needed

58

Starts

2019-12-09

Expected to finish

2024-10-31

Last updated by the study team

2025-10-14

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Anti-aquaporin-4 antibody-positive and a diagnosis of NMOSD as defined by the 2015 international consensus diagnostic criteria.
• At least 1 attack or relapse in the last 12 months prior to the Screening Period.
• Expanded Disability Status Scale score ≤7.
• Participants who enter the study receiving supportive immunosuppressive therapy must be on a stable dosing regimen of adequate duration prior to Screening.
• Body weight ≥40 kilograms.
• Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.

You may not qualify if…

• History of Neisseria meningitidis infection.
• Human immunodeficiency virus (HIV) infection (evidenced by HIV-1 or HIV-2 antibody titer).
• Previously or currently treated with a complement inhibitor.
• Use of rituximab or mitoxantrone within 3 months prior to Screening.
• Use of IV immunoglobulin within 3 weeks prior to Screening.

Where it is running

• Research Site — Aurora, Colorado, United States
• Research Site — Fort Collins, Colorado, United States
• Research Site — Washington D.C., District of Columbia, United States
• Research Site — Miami, Florida, United States
• Research Site — Boston, Massachusetts, United States
• Research Site — Rochester, Minnesota, United States
• Research Site — Jackson, Mississippi, United States
• Research Site — St Louis, Missouri, United States
• Research Site — Cincinnati, Ohio, United States
• Research Site — Houston, Texas, United States
• Research Site — Camperdown, Australia
• Research Site — Fitzroy, Australia
• Research Site — Vienna, Austria
• Research Site — Burnaby, British Columbia, Canada
• Research Site — Aarhus, Denmark
• Research Site — Strasbourg, France
• Research Site — Berlin, Germany
• Research Site — Leipzig, Germany
• Research Site — München, Germany
• Research Site — Cefalù, Italy
• Research Site — Gallarate, Italy
• Research Site — Naples, Italy
• Research Site — Roma, Italy
• Research Site — Rome, Italy
• Research Site — Chiba, Japan

Full record on ClinicalTrials.gov

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