An Efficacy and Safety Study of Ravulizumab in Adult Participants With NMOSD
NCT ID: NCT04201262
Last Updated: 2025-10-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
58 participants
INTERVENTIONAL
2019-12-09
2024-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Ravulizumab
During the Primary Treatment Period, all participants will receive open-label ravulizumab via intravenous (IV) infusion starting on Day 1. The end of the Primary Treatment Period will be triggered when the last enrolled participant completes between 26 and 50 weeks in the study (depending on the number of adjudicated On-Trial Relapse observed).
After completion of the Primary Treatment Period, all participants will have the opportunity to continue receiving ravulizumab in the Long-Term Extension Period of the study. For each participant, the Long-Term Extension Period continues for up to 3 years, or until ravulizumab is approved and/or available (in accordance with country-specific regulations), whichever occurs first.
Ravulizumab
Participants will receive a weight-based loading dose of ravulizumab via IV infusion on Day 1, followed by weight-based maintenance doses on Day 15, then once every 8 weeks until end of the Long-Term Extension Period.
Interventions
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Ravulizumab
Participants will receive a weight-based loading dose of ravulizumab via IV infusion on Day 1, followed by weight-based maintenance doses on Day 15, then once every 8 weeks until end of the Long-Term Extension Period.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. At least 1 attack or relapse in the last 12 months prior to the Screening Period.
3. Expanded Disability Status Scale score ≤7.
4. Participants who enter the study receiving supportive immunosuppressive therapy must be on a stable dosing regimen of adequate duration prior to Screening.
5. Body weight ≥40 kilograms.
6. Contraceptive use by men or women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
Exclusion Criteria
2. Human immunodeficiency virus (HIV) infection (evidenced by HIV-1 or HIV-2 antibody titer).
3. Previously or currently treated with a complement inhibitor.
4. Use of rituximab or mitoxantrone within 3 months prior to Screening.
5. Use of IV immunoglobulin within 3 weeks prior to Screening.
18 Years
100 Years
ALL
No
Sponsors
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Alexion Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
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Locations
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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
Napoli, , Italy
Research Site
Roma, , Italy
Research Site
Rome, , Italy
Research Site
Chiba, , Japan
Research Site
Fukuoka, , Japan
Research Site
Kawagoe-shi, , Japan
Research Site
Niigata, , Japan
Research Site
Sendai, , Japan
Research Site
Sendai, , Japan
Research Site
Katowice, , Poland
Research Site
Lódz, , Poland
Research Site
Goyang-si, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Barcelona, , Spain
Research Site
Madrid, , Spain
Research Site
Málaga, , Spain
Research Site
Oxford, , United Kingdom
Countries
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References
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Ortiz S, Pittock SJ, Berthele A, Levy M, Nakashima I, Oreja-Guevara C, Allen K, Mashhoon Y, Parks B, Kim HJ. Immediate and sustained terminal complement inhibition with ravulizumab in patients with anti-aquaporin-4 antibody-positive neuromyelitis optica spectrum disorder. Front Neurol. 2024 Jan 31;15:1332890. doi: 10.3389/fneur.2024.1332890. eCollection 2024.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Other Identifiers
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CHAMPION-NMO-307
Identifier Type: OTHER
Identifier Source: secondary_id
2019-003352-37
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
ALXN1210-NMO-307
Identifier Type: -
Identifier Source: org_study_id
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