Neuromyelitis Optica Spectrum DisorderNCT05966467
Registry of Patients With AQP4+ NMOSD Treated With Alexion C5 Inhibitor Therapies
An observational study of Neuromyelitis Optica Spectrum Disorder and NMOSD, run by Alexion Pharmaceuticals, Inc. at 33 sites in 8 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neuromyelitis Optica Spectrum Disorder, NMOSD, AQP4+ NMOSD
- How many people
- 200 participants
- Where
- 33 sitesin 8 countries
- Study dates
- 30 Aug 2023to 27 Sep 2029
- How long will I take part?
- 5 Years
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants with a diagnosis of AQP4+ NMOSD who are being treated with ALXN-C5IT at the time of enrollment.
Who may be able to join
- 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.
Who cannot join
- Participants currently enrolled in an interventional clinical study for the treatment of AQP4+ NMOSD in which the intervention is a drug.
Trial locations and contacts
33 sites in 8 countries. Contact the study team or a site near you to ask about taking part.
33 sites in 8 countries
South Korea8 sites, 8 recruiting
- Recruiting
Clinical Trial Site
Daejeon
Eun Hee Sohn
- Recruiting
Clinical Trial Site
Gyeonggi-do
Ho Jin Kim
- Recruiting
Clinical Trial Site
Seoul
Jeeyoung Oh
- Recruiting
Clinical Trial Site
Seoul
Young-Min Lim
- Recruiting
Clinical Trial Site
Seoul
Sung-Min Kim
- Recruiting
Clinical Trial Site
Seoul
Byoung Joon Kim
- Recruiting
Clinical Trial Site
Seoul
Woojun Kim
- Recruiting
Clinical Trial Site
Seoul
Jun-Soon Kim
United States6 sites, 6 recruiting
- Recruiting
Research Site
Boston, Massachusetts, 02114
- Not yet recruiting
Clinical Trial Site
Chapel Hill, North Carolina, 27599
Irena Dujmovic-Basuroski
- Recruiting
Clinical Trial Site
Columbus, Ohio, 43215
Jacqueline Nicholas
- Recruiting
Clinical Trial Site
Milwaukee, Wisconsin, 53215
Bhupendra Khatri
- Recruiting
Clinical Trial Site
Plano, Texas, 75024
Annette Okai
- Recruiting
Clinical Trial Site
Washington D.C., District of Columbia, 20010
Benjamin Osborne
China6 sites, 6 recruiting
- Not yet recruiting
Clinical Trial Site
Beijing
Fudong Shi
- Not yet recruiting
Clinical Trial Site
Guangzhou
Wei Qiu
- Not yet recruiting
Clinical Trial Site
Henan
Yue Huang
- Not yet recruiting
Clinical Trial Site
Shanghai
Qian Cao
- Not yet recruiting
Clinical Trial Site
Sichuan
Hong Tan
- Not yet recruiting
Clinical Trial Site
Wuhan
Daishi Tian, MD
Argentina4 sites, 4 recruiting
- Recruiting
Clinical Trial Site
Buenos Aires
Pablo Lopez
- Not yet recruiting
Clinical Trial Site
Buenos Aires
Daniel Munoz, MD
- Recruiting
Clinical Trial Site
Buenos Aires
Andres Villa, MD
- Recruiting
Clinical Trial Site
Buenos Aires
Veronica Tkachuk
Japan4 sites, 4 recruiting
- Recruiting
Clinical Trial Site
Fukuoka
Katsuhisa Masaki
- Recruiting
Clinical Trial Site
Kawasaki
Kenzo Sakurai
- Recruiting
Clinical Trial Site
Miyagi
Ichiro Nakashima
- Not yet recruiting
Clinical Trial Site
Tokyo
Jin Nakahara
Germany3 sites, 3 recruiting
- Recruiting
Clinical Trial Site
Dresden
Tjalf Ziemssen
- Recruiting
Clinical Trial Site
Essen
Refik Pul
- Not yet recruiting
Clinical Trial Site
München
Achim Berthele
Canada1 site, 1 recruiting
- Recruiting
Clinical Trial Site
Burnaby, British Columbia
Galina Vorobeychik, MD
About this study
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)
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.
Read the 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.
- Conditions
- Neuromyelitis Optica Spectrum Disorder, NMOSD, AQP4+ NMOSD
- Keywords
- Neuromyelitis Optica Spectrum Disorder, NMOSD, C5 Inhibitor Therapies, AQP4+ NMOSD, Patient Registry, Alexion C5IT, Soliris
- Medical subject headings
- Neuromyelitis Optica
What is being measured
The primary outcome is the main question the study is designed to answer.
Annualized Relapse Rate (ARR)
The ARR is defined as the total number of relapses divided by the total number of participant-years.
Measured: Up to approximately 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2023
- Study start30 Aug 2023
- Primary completion27 Sep 2029 (estimated)
- Study completion27 Sep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neuromyelitis Optica Spectrum DisorderStudies of the same condition, open and under way.
- More trials run by Alexion Pharmaceuticals, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Alexion Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pablo Lopez, Principal investigator, Hospital Aleman
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05966467
- Sponsor's protocol ID
- D9282C00003
- Status last verified
- Oct 2026
- First submitted
- 7 Jul 2023
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes