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

NCT06398158 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 35

Last updated 2025-08-05

No results posted yet for this study

Summary

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

  • Neuromyelitis Optica

Interventions

DRUG

Ravulizumab

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

Sponsors & Collaborators

  • Alexion Pharmaceuticals, Inc.

    collaborator INDUSTRY

  • University of Texas Southwestern Medical Center

    lead OTHER

Principal Investigators

  • Darin T. Okuda, MD · UT Southwestern Medical Center

  • Peter Sguigna, MD · UT Southwestern Medical Center

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-07-10
Primary Completion
2026-12-31
Completion
2027-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06398158 on ClinicalTrials.gov