Registry of patients with AQP4+ NMOSD treated with C5 inhibitors
Official title: A Long-Term, Prospective, Observational, Registry of Patients With Anti-Aquaporin 4 Antibody-Positive (AQP4+) Neuromyelitis Optica Spectrum Disorder (NMOSD) Treated With Alexion Complement Component 5 (C5) Inhibitor Therapies (ALXN-C5IT)
Run by Alexion Pharmaceuticals, Inc. · NCT05966467 · Data updated 2026-11-12
This study is collecting information from people with AQP4+ NMOSD who are being treated with C5 inhibitors to see how well these treatments work and how they affect daily life over five years.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 200 (estimated) |
| Sponsor | Alexion Pharmaceuticals, Inc. Industry-sponsored |
| Drugs / interventions | eculizumab, ravulizumab |
| Locations | 33 sites (Washington D.C., District of Columbia and 32 other locations) |
| Status | Recruiting |
| Started | August 30, 2023 |
| Main results expected | September 27, 2029 |
| Study ends | September 27, 2029 |
| Registry record updated | October 13, 2026 |
| Trial ID | NCT05966467 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this registry are adults aged 18 and older with a confirmed diagnosis of AQP4+ NMOSD who are currently receiving treatment with Alexion's C5 inhibitors.
✕Probably not a fit
Patients currently enrolled in interventional clinical studies for AQP4+ NMOSD treatments that involve a drug will not benefit from this registry.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational registry collects long-term data on patients diagnosed with AQP4+ NMOSD who are being treated with Alexion's C5 inhibitor therapies. It aims to gather information on clinical outcomes, safety, and patient-reported outcomes over a period of approximately five years. Participants will provide retrospective medical histories and treatment details, allowing researchers to assess the real-world impact of these therapies on quality of life and disease management.
Why it matters
Potential benefit: If successful, this registry could provide valuable insights into the effectiveness and safety of C5 inhibitor therapies for patients with AQP4+ NMOSD.
How similar studies have gone: Other studies involving patient registries for chronic conditions have shown success in providing meaningful data, making this approach both relevant and potentially impactful.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Participant is ≥ 18 years of age at the time of enrollment in the Registry. * Participant must have a confirmed diagnosis of AQP4+ NMOSD. * At the time of enrollment in the Registry, participants must be receiving treatment with ALXN-C5IT for the purpose of chronic relapse prevention in a manner consistent with the local label. Specifically, they should have received at least 1 dose of eculizumab within 4 weeks prior to enrollment or at least 1 dose of ravulizumab within 12 weeks prior to enrollment. * Participants must have both the following historical data available to be enrolled in the Registry: ALXN-C5IT dosing information since initiation and number and types of relapses from 1 year prior to ALXN-C5IT initiation through Registry enrollment. Exclusion Criteria: * Participants currently enrolled in an interventional clinical study for the treatment of AQP4+ NMOSD in which the intervention is a drug.
Where it's running
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Washington D.C., District of Columbia, United States Recruiting -
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Boston, Massachusetts, United States Recruiting -
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Columbus, Ohio, United States Recruiting -
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Plano, Texas, United States Recruiting -
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Milwaukee, Wisconsin, United States Recruiting -
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Buenos Aires, Argentina Recruiting
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Burnaby, British Columbia, Canada Recruiting -
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Essen, Germany Recruiting -
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Fukuoka, Japan Recruiting -
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Kawasaki, Japan Recruiting -
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Miyagi, Japan Recruiting -
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Daejeon, South Korea Recruiting -
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Chapel Hill, North Carolina, United States Not yet recruiting -
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Buenos Aires, Argentina Not yet recruiting -
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Beijing, China Not yet recruiting -
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Guangzhou, China Not yet recruiting -
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Henan, China Not yet recruiting -
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Shanghai, China Not yet recruiting -
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Sichuan, China Not yet recruiting -
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Wuhan, China Not yet recruiting -
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München, Germany Not yet recruiting -
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Tokyo, Japan Not yet recruiting
Study contacts
- Principal investigator: Pablo Lopez — Hospital Aleman
- Study coordinator: Alexion Pharmaceuticals, Inc. (Sponsor)
- Email: clinicaltrials@alexion.com
- Phone: 1-855-752-2356
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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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.
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Evaluating satralizumab for children with neuromyelitis optica spectrum disorder
This study is testing a new treatment called satralizumab to see if it helps children aged 2 to 11 with neuromyelitis optica spectrum disorder feel better and stay safe.
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Transcranial alternating current stimulation for cognitive problems in inflammatory demyelinating CNS disorders
This trial will try transcranial alternating current stimulation to see if it improves thinking and memory in adults with multiple sclerosis and related inflammatory demyelinating central nervous system disorders.
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Rituximab vs multiple approved NMOSD therapies to prevent relapses
This study tests whether rituximab or one of four other approved medicines is better at preventing NMOSD relapses in adults who have AQP4-IgG.
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Pregnancy registry for women with chronic neurological conditions
This study is collecting information and samples from pregnant women with chronic neurological conditions to see how pregnancy affects their health and their baby's development.
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Targeted CAR-T therapy for autoimmune diseases
This study is testing a new CAR-T cell therapy to see if it can help people with autoimmune diseases like lupus, scleroderma, and multiple sclerosis feel better.
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.