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

Recruiting now

Conditions studied: Neuromyelitis Optica Spectrum Disorder, NMOSD, AQP4+ NMOSD

In brief

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.

Key facts

Study ID

NCT05966467

Run by

Alexion Pharmaceuticals, Inc.

People needed

122

Starts

2024-02-01

Expected to finish

2029-09-27

Last updated by the study team

2026-06-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Participants currently enrolled in an interventional clinical study for the treatment of AQP4+ NMOSD in which the intervention is a drug.

Where it is running

• Clinical Trial Site — Washington D.C., District of Columbia, United States (enrolling)
• Research Site — Boston, Massachusetts, United States (enrolling)
• Clinical Trial Site — Kawasaki, Japan (enrolling)
• Clinical Trial Site — Miyagi, Japan (enrolling)
• Clinical Trial Site — Daejeon, South Korea (enrolling)
• Clinical Trial Site — Gyeonggi-do, South Korea (enrolling)
• Clinical Trial Site — Seoul, South Korea (enrolling)
• Clinical Trial Site — Seoul, South Korea (enrolling)
• Clinical Trial Site — Seoul, South Korea (enrolling)
• Clinical Trial Site — Seoul, South Korea (enrolling)
• Clinical Trial Site — Seoul, South Korea (enrolling)
• Clinical Trial Site — Seoul, South Korea (enrolling)
• Clinical Trial Site — Columbus, Ohio, United States (enrolling)
• Clinical Trial Site — Plano, Texas, United States (enrolling)
• Clinical Trial Site — Milwaukee, Wisconsin, United States (enrolling)
• Clinical Trial Site — Buenos Aires, Argentina (enrolling)
• Clinical Trial Site — Buenos Aires, Argentina (enrolling)
• Clinical Trial Site — Buenos Aires, Argentina (enrolling)
• Clinical Trial Site — Burnaby, British Columbia, Canada (enrolling)
• Clinical Trial Site — Dresden, Germany (enrolling)
• Clinical Trial Site — Essen, Germany (enrolling)
• Clinical Trial Site — Naples, Italy (enrolling)
• Clinical Trial Site — Fukuoka, Japan (enrolling)
• Clinical Trial Site — Chapel Hill, North Carolina, United States
• Clinical Trial Site — Guangzhou, China

Full record on ClinicalTrials.gov

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