Actively Recruiting
Efficacy and Safety Study of Ravulizumab IV in Pediatric Participants With NMOSD
Led by Alexion Pharmaceuticals, Inc. · Updated on 2025-11-12
12
Participants Needed
21
Research Sites
353 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The primary purpose of this study is to evaluate the safety and efficacy of ravulizumab in pediatric participants with Neuromyelitis Optica Spectrum Disorder (NMOSD).
CONDITIONS
Official Title
Efficacy and Safety Study of Ravulizumab IV in Pediatric Participants With NMOSD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be anti-AQP4 antibody positive and diagnosed with NMOSD according to 2015 international criteria
- Complement inhibitor treatment-naFve participants must have had at least one attack or relapse in the last 12 months before screening
- Expanded Disability Status Scale (EDSS) score must be 7 or less
- Eculizumab-experienced participants must be clinically stable for 30 days, treated with eculizumab for at least 90 days before screening, and have no missed doses in the 2 months prior to Day 1
- Participants on supportive immunosuppressive therapies must be on a stable dosing regimen before and during screening
- All participants must be vaccinated against meningococcal infection
- Participants must have documented vaccination for Hib and Streptococcus pneumoniae at least 14 days before Day 1 according to guidelines
You will not qualify if you...
- Use of rituximab within 3 months before screening
- Current treatment with biologic medications other than eculizumab, or stopped such treatment without waiting 5 half-lives before screening
- Use of intravenous immunoglobulin (IVIg) or plasma exchange within 3 weeks before screening
- Participation in another investigational drug or device study within 5 half-lives of that product or within 30 days before first study drug dose
- Use of immunomodulatory therapies for multiple sclerosis within 3 months before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 21 locations
1
Research Site
Washington D.C., District of Columbia, United States, 20010
Actively Recruiting
2
Research Site
Miami, Florida, United States, 33136
Actively Recruiting
3
Research Site
Boston, Massachusetts, United States, 02114
Actively Recruiting
4
Research Site
St Louis, Missouri, United States, 63110
Withdrawn
5
Research Site
Durham, North Carolina, United States, 27705
Actively Recruiting
6
Research Site
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
7
Research Site
Edmonton, Alberta, Canada, T6G 1C9
Actively Recruiting
8
Research Site
Toronto, Ontario, Canada, M5G 1X8
Actively Recruiting
9
Research Site
Montreal, Quebec, Canada, H3T1C5
Actively Recruiting
10
Research Site
Le Kremlin-Bicêtre, France, 94270
Actively Recruiting
11
Research Site
Marseille, France, 13005
Actively Recruiting
12
Research Site
Montpellier, France, 34295
Actively Recruiting
13
Research Site
Bochum, Germany, 44791
Withdrawn
14
Research Site
Giessen, Germany, 35392
Withdrawn
15
Research Site
Catania, Italy, 95123
Withdrawn
16
Research Site
Chieti, Italy, 66013
Actively Recruiting
17
Research Site
Gallarate, Italy, 21013
Actively Recruiting
18
Research Site
Roma, Italy, 00165
Actively Recruiting
19
Research Site
Yokohama, Japan, 232-0024
Actively Recruiting
20
Research Site
Goyang-si, South Korea, 10408
Actively Recruiting
21
Research Site
Esplugues de Llobregat, Spain, 8950
Actively Recruiting
Research Team
A
Alexion Pharmaceuticals, Inc. (Sponsor)
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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