Registry of Patients With AQP4+ NMOSD Treated With Alexion C5 Inhibitor Therapies

June 17, 2026 updated by: Alexion Pharmaceuticals, Inc.

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)

Long-term, multicenter, multinational, observational, registry of patients with AQP4+ NMOSD that is designed to collect data on clinical outcomes and safety in patients prescribed Alexion C5 inhibitor therapies (C5IT). The registry will also collect data on patient reported outcomes (PROs), quality of life (QoL), and targeted AQP4+ NMOSD therapies used to provide evidence on the real-world impact of ALXN-C5IT on patients with AQP4+ NMOSD.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Detailed Description

At the time of enrollment in the Registry, participant records will be queried for retrospective information about the participant's medical history and AQP4+ NMOSD treatment history for the time period beginning 1 year prior to ALXN-C5IT initiation through Registry enrollment. The duration of data collection for the Registry will be approximately 5 years from the day the last participant is enrolled.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
122

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Recruiting
        • Clinical Trial Site
        • Contact:
          • Veronica Tkachuk
      • Buenos Aires, Argentina
        • Not yet recruiting
        • Clinical Trial Site
        • Contact:
          • Daniel Munoz, MD
  • Canada
    • British Columbia
      • Burnaby, British Columbia, Canada
        • Recruiting
        • Clinical Trial Site
        • Contact:
          • Galina Vorobeychik, MD
  • China
      • Beijing, China
        • Not yet recruiting
        • Clinical Trial Site
        • Contact:
          • Fudong Shi
      • Guangzhou, China
        • Not yet recruiting
        • Clinical Trial Site
        • Contact:
          • Wei Qiu
      • Henan, China
        • Not yet recruiting
        • Clinical Trial Site
        • Contact:
          • Yue Huang
      • Shanghai, China
        • Not yet recruiting
        • Clinical Trial Site
        • Contact:
          • Qian Cao
      • Sichuan, China
        • Not yet recruiting
        • Clinical Trial Site
        • Contact:
          • Hong Tan
      • Wuhan, China
        • Not yet recruiting
        • Clinical Trial Site
        • Contact:
          • Daishi Tian, MD
  • Germany
      • Dresden, Germany
        • Recruiting
        • Clinical Trial Site
        • Contact:
          • Tjalf Ziemssen
      • Essen, Germany
        • Recruiting
        • Clinical Trial Site
        • Contact:
          • Refik Pul
      • München, Germany
        • Not yet recruiting
        • Clinical Trial Site
        • Contact:
          • Achim Berthele
  • Italy
      • Naples, Italy
        • Recruiting
        • Clinical Trial Site
        • Contact:
          • Roberta Lanzillo
  • Japan
      • Fukuoka, Japan
        • Recruiting
        • Clinical Trial Site
        • Contact:
          • Katsuhisa Masaki
      • Kawasaki, Japan
        • Recruiting
        • Clinical Trial Site
        • Contact:
          • Kenzo Sakurai
      • Miyagi, Japan
        • Recruiting
        • Clinical Trial Site
        • Contact:
          • Ichiro Nakashima
      • Tokyo, Japan
        • Not yet recruiting
        • Clinical Trial Site
        • Contact:
          • Jin Nakahara
  • South Korea
      • Daejeon, South Korea
        • Recruiting
        • Clinical Trial Site
        • Contact:
          • Eun Hee Sohn
      • Gyeonggi-do, South Korea
        • Recruiting
        • Clinical Trial Site
        • Contact:
          • Ho Jin Kim
      • Seoul, South Korea
        • Recruiting
        • Clinical Trial Site
        • Contact:
          • Jun-Soon Kim
  • United States
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20010
        • Recruiting
        • Clinical Trial Site
        • Contact:
          • Benjamin Osborne
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Research Site
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Not yet recruiting
        • Clinical Trial Site
        • Contact:
          • Irena Dujmovic-Basuroski
    • Ohio
      • Columbus, Ohio, United States, 43215
        • Recruiting
        • Clinical Trial Site
        • Contact:
          • Jacqueline Nicholas
    • Texas
      • Plano, Texas, United States, 75024
        • Recruiting
        • Clinical Trial Site
        • Contact:
          • Annette Okai
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Recruiting
        • Clinical Trial Site
        • Contact:
          • Bhupendra Khatri

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants with a diagnosis of AQP4+ NMOSD who are being treated with ALXN-C5IT at the time of enrollment.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Annualized Relapse Rate (ARR)
Time Frame: Up to approximately 5 years
The ARR is defined as the total number of relapses divided by the total number of participant-years.
Up to approximately 5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Alexion Pharmaceuticals, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Pablo Lopez, Hospital Aleman

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 27, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 27, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 7, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 28, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • D9282C00003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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