Ravulizumab for Neuromyelitis Optica Spectrum Disorders
What You Need to Know Before You Apply
What is the purpose of this trial?
The primary purpose of this study is to evaluate the efficacy and safety of ravulizumab for the treatment of adult participants with NMOSD.
Are You a Good Fit for This Trial?
Adults with NMOSD who weigh at least 40 kg, have had an attack in the past year, and are on stable immunosuppressive therapy can join. They must use contraception and have a disability score ≤7. People with HIV, recent rituximab or mitoxantrone treatment, IV immunoglobulin use within 3 weeks, or history of meningitis infection cannot participate.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Primary Treatment
Participants receive open-label ravulizumab via intravenous infusion
Long-Term Extension
Participants may continue receiving ravulizumab for up to 2 years or until it is approved/available
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Ravulizumab
Ravulizumab is already approved in United States, European Union for the following indications:
- Paroxysmal nocturnal hemoglobinuria (PNH)
- Atypical hemolytic uremic syndrome (aHUS)
- Paroxysmal nocturnal haemoglobinuria (PNH)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Alexion
Lead Sponsor
Marc Dunoyer
Alexion
Chief Executive Officer since 2021
PhD in Molecular Biology, University of Brussels
Christophe Hotermans
Alexion
Chief Medical Officer since 2021
MD, University of Leuven
Alexion Pharmaceuticals, Inc.
Lead Sponsor
Dr. Alberto R. Martinez
Alexion Pharmaceuticals, Inc.
Chief Medical Officer since 2010
MD from University of Sao Paulo
Marc Dunoyer
Alexion Pharmaceuticals, Inc.
Chief Executive Officer since 2021
PhD in Molecular Biology
Alexion Pharmaceuticals
Lead Sponsor
Marc Dunoyer
Alexion Pharmaceuticals
Chief Executive Officer since 2021
B.A. in Psychology from the University of New Hampshire
Christophe Hotermans
Alexion Pharmaceuticals
Chief Medical Officer since 2023
MD