Actively Recruiting
Study of the Clinical and Radiological Impact of Ravulizumab in People With Neuromyelitis Optica Spectrum Disorder
Led by University of Texas Southwestern Medical Center · Updated on 2025-08-05
35
Participants Needed
1
Research Sites
155 weeks
Total Duration
On this page
Sponsors
U
University of Texas Southwestern Medical Center
Lead Sponsor
A
Alexion Pharmaceuticals, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
This is an observational study to: * evaluate the on-treatment clinical performance of ravulizumab in relation to the pre-treatment time period (time period prior to exposure), * enhance knowledge regarding conventional MRI outcomes in people with NMOSD treated with ravulizumab, * identify factors suggestive of subclinical disease progression through conventional MRI sequences, * determine if treatment with ravulizumab, impacts longitudinal 3D conformational MRI measures at the dorsal medulla and other regions of the CNS, and * identify biomarkers (e.g., serum neurofilament light chain (sNfL), conventional and novel MRI markers, etc.) related to disease activity.
CONDITIONS
Official Title
Study of the Clinical and Radiological Impact of Ravulizumab in People With Neuromyelitis Optica Spectrum Disorder
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before any study activities
- Men and women over 18 years of age
- Aquaporin-4 IgG positive neuromyelitis optica spectrum disorder treated with commercially available ravulizumab as approved
- Expanded Disability Status Scale score less than 7.0
You will not qualify if you...
- Unable to tolerate MRI scans
- Previous eculizumab treatment stopped due to poor disease control after at least 12 weeks
- Unresolved meningococcal infection
- History of active infection
- Currently participating in other interventional NMOSD clinical studies
- Pregnant or lactating women
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
UT Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
Research Team
D
Diem Tran, PhD
CONTACT
J
Jose Santoyo
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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