Evaluating the effects of ravulizumab in patients with neuromyelitis optica spectrum disorder
Official title: Clinical and Radiological Outcomes in People With Aquaporin-4 IgG Positive Neuromyelitis Optica Spectrum Disorder Treated With Ravulizumab
Run by University of Texas Southwestern Medical Center · NCT06398158 · Data updated 2026-11-12
This study is testing if the medication ravulizumab can help people with neuromyelitis optica spectrum disorder feel better and improve their MRI results.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 35 (estimated) |
| Sponsor | University of Texas Southwestern Medical Center Academic / other |
| Drugs / interventions | ravulizumab, eculizumab |
| Locations | 1 site (Dallas, Texas) |
| Status | Recruiting |
| Started | July 10, 2024 |
| Main results expected | April 30, 2029 |
| Study ends | October 31, 2029 |
| Registry record updated | October 13, 2026 |
| Trial ID | NCT06398158 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults over 18 years old who are aquaporin-4 IgG positive and are being treated with ravulizumab.
✕Probably not a fit
Patients who are intolerant to MRI or have previously been treated with eculizumab without effective disease control may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to assess the clinical and radiological effects of ravulizumab in individuals diagnosed with aquaporin-4 IgG positive neuromyelitis optica spectrum disorder. Participants will be treated with ravulizumab as per FDA guidelines, and their clinical performance will be compared to their pre-treatment status. The study will also investigate conventional MRI outcomes and identify biomarkers related to disease activity. A total of 35 participants will be recruited from The University of Texas Southwestern Medical Center in Dallas, Texas.
Why it matters
Potential benefit: If successful, this study could enhance treatment strategies and improve outcomes for patients with neuromyelitis optica spectrum disorder.
How similar studies have gone: While this study focuses on a specific treatment and condition, similar studies have shown promise in evaluating the effects of monoclonal antibodies in neuromyelitis optica.
Who can join: the full rules
Show full inclusion / exclusion criteria
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
Where it's running
-
UT Southwestern Medical Center
Dallas, Texas, United States Recruiting
Study contacts
- Principal investigator: Darin T. Okuda, MD — University of Texas Southwestern Medical Center
- Study coordinator: Diem Tran, PhD
- Email: diemh.tran@utsouthwestern.edu
- Phone: 214-645-9165
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Ravulizumab for Generalized Myasthenia Gravis in Chinese Adults
This trial tests ravulizumab in Chinese adults with generalized myasthenia gravis to see if it helps symptoms while checking safety and how the drug behaves in the body.
-
Ravulizumab in Chinese adults with NMOSD
This study tests ravulizumab in Chinese adults with NMOSD who are AQP4 antibody positive to see if it helps reduce relapses and is safe.
-
Early ravulizumab for adults with myasthenic crisis in the ICU
This project will test whether giving ravulizumab early to adults with AChR-positive generalized myasthenia gravis who are in the ICU for a myasthenic crisis helps speed recovery.
-
Ravulizumab Outcomes in Polish Patients with aHUS
This observational study in Poland follows patients with atypical hemolytic uremic syndrome who are treated with ravulizumab to see how they do over time in real-world clinical care.
-
Ravulizumab for people with clinical aHUS
This study will test whether ravulizumab raises platelet counts in people diagnosed with clinical atypical hemolytic uremic syndrome (aHUS), including those with certain infections (excluding pneumococcal and STEC), pregnancy/postpartum, recent kidney transplant, malignant hypertension, or autoimmune conditions.
-
Oral steroid tapering for adults with generalized myasthenia gravis on ravulizumab.
This study will try a predefined prednisone taper to see if adults with generalized myasthenia gravis on ravulizumab can safely reduce their daily steroid dose.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.