NCT04201262CompletedPhase 3
An Efficacy and Safety Study of Ravulizumab in Adult Participants With NMOSD
A Phase 3, External Placebo-Controlled, Open-Label, Multicenter Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Patients With Neuromyelitis Optica Spectrum Disorder (NMOSD)
Source: ClinicalTrials.gov · Last updated 14 Oct 2025
Brief summary (registry, in English)
The primary purpose of this study is to evaluate the efficacy and safety of ravulizumab for the treatment of adult participants with NMOSD.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 58 (actual)
- First submitted
- 11 Dec 2019
- Start date
- 9 Dec 2019
- Primary completion date
- 15 Mar 2022
- Lead sponsor
- Alexion Pharmaceuticals, Inc.
- Diseases
- Neuromyelitis optica (NMOSD)
- NCT number
- NCT04201262
- EudraCT number
- 2019-003352-37
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 58
- From 9 Dec 2019 to the primary completion date, 15 Mar 2022
- 37 sites in 13 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
Other illness
- History of Neisseria meningitidis infection.
- Human immunodeficiency virus (HIV) infection (evidenced by HIV-1 or HIV-2 antibody titer).
Who the study is looking for
- 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.
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (37)
Sites in registry order. Pick your city on the disease page to sort them by distance.
This page is information, not medical advice. Discuss any trial with your doctor.