An Efficacy and Safety Study of Ravulizumab in Adult Participants With NMOSD
Study Identifier:
ALXN1210-NMO-307
ClinicalTrials.gov Identifier:
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Alexion Pharmaceuticals, Inc.
Study Contact Information:
N/A
Study Complete
Available Documents
Study Details
Medical Condition
- Neuromyelitis Optica
- Neuromyelitis Optica Spectrum Disorder
Study Drug
- Biological: Ravulizumab
Date
Dec 2019 - Mar 2022
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 100 Years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Sex
Female & Male
Age
18 - 100 Years
Study Details
Medical Condition
- Neuromyelitis Optica
- Neuromyelitis Optica Spectrum Disorder
Study Drug
- Biological: Ravulizumab
Date
Dec 2019 - Mar 2022
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 100 Years years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- 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.
Protocol Summary
The primary purpose of this study is to evaluate the efficacy and safety of ravulizumab for the treatment of adult participants with NMOSD.
Trial Locations
Location
Status
Location
Research Site
Aurora, Colorado, United States, 80045
Status
N/A
Location
Research Site
Fort Collins, Colorado, United States, 80528
Status
N/A
Location
Research Site
Washington D.C., District of Columbia, United States, 20007
Status
N/A
Location
Research Site
Miami, Florida, United States, 33136
Status
N/A
Location
Research Site
Boston, Massachusetts, United States, 02114
Status
N/A
Location
Research Site
Rochester, Minnesota, United States, 55905
Status
N/A
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