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Registry of patients with AQP4+ NMOSD treated with C5 inhibitors

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)

Observational Alexion Pharmaceuticals, Inc. · NCT05966467

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 typeObservational
Enrollment122 (estimated)
Ages18 Years and up
SexAll
SponsorAlexion Pharmaceuticals, Inc. Industry-sponsored
Drugs / interventionseculizumab, ravulizumab
Locations33 sites (Washington D.C., District of Columbia and 32 other locations)
Trial IDNCT05966467 on ClinicalTrials.gov

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.

Who should consider this trial

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.

Not a fit: Patients currently enrolled in interventional clinical studies for AQP4+ NMOSD treatments that involve a drug will not benefit from this registry.

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 performed: Other studies involving patient registries for chronic conditions have shown success in providing meaningful data, making this approach both relevant and potentially impactful.

Eligibility criteria

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 this trial is running

Washington D.C., District of Columbia and 32 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Neuromyelitis Optica Spectrum DisorderNMOSDAQP4+ NMOSDC5 Inhibitor TherapiesPatient RegistryAlexion C5ITSoliris
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.