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NCT05909761Recruiting

Observational Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® During Pregnancy

An Observational Pregnancy Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® (Inebilizumab-cdon) During Pregnancy

Source: ClinicalTrials.gov · Last updated 29 Oct 2026

Brief summary (registry, in English)

This is an observational study to monitor female participants exposed to UPLIZNA during pregnancy. This study requires voluntary reporting of pregnancies in female participants with NMOSD exposed to UPLIZNA during pregnancy or within 6 months preceding conception. Pregnancy-related data, potential confounding factors and information related to pregnancy outcome will be collected. The schedule of office visits and all treatment regimens will be determined by the treating healthcare provider. Duration of the study is 10 years, at minimum.

Status (registry)
Recruiting
Study type
Observational
Enrollment
60 (estimated)
First submitted
9 Jun 2023
Start date
15 Jan 2027
Primary completion date
31 Oct 2032
Lead sponsor
Amgen
NCT number
NCT05909761

What you commit to

  • Study type: Observational
  • Planned participants: 60
  • From 15 Jan 2027 to the primary completion date, 31 Oct 2032
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Who the study is looking for

  • Provide informed consent
  • Are a female of reproductive potential with a confirmed or suspected diagnosis of NMOSD
  • Have been exposed to UPLIZNA during pregnancy as defined by receipt of any dose during pregnancy or within 6 months preceding conception
    • Note: Other Protocol Defined Inclusion/Exclusion Criteria Apply

Age in the registry: 15 years to - · Sex: Female · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
University of Colorado Denver
Coordinator of this site? Confirm its status
AuroraUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.