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
- Diseases
- Neuromyelitis optica (NMOSD)
- 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
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Colorado Denver Coordinator of this site? Confirm its status | Aurora | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.