Study of the Clinical and Radiological Impact of Ravulizumab in People With Neuromyelitis Optica Spectrum Disorder

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT06398158
Status
Recruiting
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Conditions

  • Neuromyelitis Optica

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ravulizumab — DRUG
    All study participants will receive commercially covered ravulizumab consistent with the indication, dose and frequency contained within the approved label.

Study Details

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.

Key Dates

Start date
Jul 10, 2024
Status verified
Jul 2025
Primary completion
Dec 31, 2026
Completion
Jun 30, 2027

Study Design

Enrollment
35 participants (estimated)

Arms

  • Arm: NMOSD
    35 people with aquaporin-4 IgG antibody positive neuromyelitis optica spectrum disorder is planned with all individuals treated with commercially supplied ravulizumab at the recommendation of the healthcare provider, with use consistent with the approved indication and labeling. Approximately 50% of the cohort is anticipated to be Black/African American based on existing internal data.

Primary Outcome Measure

Number of participants with clinical relapses before and after treatment with ravulizumab [ Time Frame: 52 weeks - 78 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UT Southwestern Medical CenterDallasTexas75390
Diem Tran, PhD
[email protected]
214-645-9165
Darin T Okuda, MD
[email protected]
214-645-8800

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By research site
UT Southwestern Medical Center· Dallas, TX

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