Recruiting

Alexion C5 Inhibitor

Sponsor:

Alexion Pharmaceuticals, Inc.

Code:

NCT05966467

Conditions

Neuromyelitis Optica Spectrum Disorder

NMOSD

AQP4+ NMOSD

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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.

Conditions

Neuromyelitis Optica Spectrum Disorder

NMOSD

AQP4+ NMOSD

Study ID

NCT05966467

Start date

Aug 30, 2023

Status verified date

Oct, 2026

Completion date

Sep 27, 2029

Anticipated

Primary completion date

Sep 27, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

200 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Annualized Relapse Rate (ARR) [ Time Frame: Up to approximately 5 years ]

Central Contacts and Locations

Central contacts

Alexion Pharmaceuticals, Inc. (Sponsor)

1-855-752-2356clinicaltrials@alexion.com

Locations

Clinical Trial Site

Recruiting

Washington D.C., District of Columbia, United States, 20010

Research Site

Recruiting

Boston, Massachusetts, United States, 02114

Clinical Trial Site

Recruiting

Columbus, Ohio, United States, 43215

Clinical Trial Site

Recruiting

Plano, Texas, United States, 75024

Clinical Trial Site

Recruiting

Milwaukee, Wisconsin, United States, 53215

Clinical Trial Site

Recruiting

Burnaby, British Columbia, Canada

More Information

Sponsor

Alexion Pharmaceuticals, Inc.

Last update posted

Oct 13, 2026

Last verified

Oct, 2026

Keywords

  • Neuromyelitis Optica Spectrum Disorder
  • NMOSD
  • C5 Inhibitor Therapies
  • AQP4+ NMOSD
  • Patient Registry
  • Alexion C5IT
  • Soliris

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by Alexion Pharmaceuticals, Inc. on 2026-10-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.