Recruiting

Ravulizumab

Sponsor:

University of Texas Southwestern Medical Center

Code:

NCT06398158

Conditions

Neuromyelitis Optica

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ravulizumab

Study Details

Brief 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

Study ID

NCT06398158

Start date

Jul 10, 2024

Status verified date

Jul, 2025

Completion date

Jun 30, 2027

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

1. Signed informed consent available prior to conduct of any study associated activities
2. Men and women > 18 years of age
3. Aquaporin-4 IgG positive people with neuromyelitis optica spectrum disorder treated with commercially available ravulizumab in a manner consistent with the approved indication
4. Expanded Disability Status Scale score of <7.0

Exclusion Criteria:

1. Individuals who are intolerant to MRI
2. Individuals previously exposed to eculizumab with treatment discontinuation due to lack of effective disease control (i.e., clinical relapse or demonstration of MRI advancement after 12 weeks of sustained treatment exposure)
3. Unresolved meningococcal disease
4. History of an active infection
5. Existing participation in neuromyelitis optical spectrum disorder interventional clinical studies
6. Pregnant or lactating women

Study Design

Enrollment

35 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

Ravulizumab

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

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Diem Tran, PhD

214-645-9165diemh.tran@utsouthwestern.edu

Jose Santoyo

214-645-1878jose.santoyo@utsouthwestern.edu

Locations

UT Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

Diem Tran, PhD

214-645-9165diemh.tran@utsouthwestern.edu

Darin T Okuda, MD

214-645-8800darin.okuda@utsouthwestern.edu

More Information

Sponsor

University of Texas Southwestern Medical Center

Last update posted

Aug 5, 2025

Last verified

Jul, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Texas Southwestern Medical Center on 2025-08-05.