Neuromyelitis Optica Spectrum DisorderNCT05909761
Observational Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® During Pregnancy
An observational study of Neuromyelitis Optica Spectrum Disorder and Pregnancy Related, run by Amgen at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 15 years and older, women only
- Conditions the study is for
- Neuromyelitis Optica Spectrum Disorder, Pregnancy Related
- What is being tested?
- UPLIZNA
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2026to 31 Oct 2032
- 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 15 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population will consist of participants who have been exposed to UPLIZNA during pregnancy and have signed an informed consent form (ICF).
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Colorado Denver
Aurora, Colorado, 80045
Amanda Piquet, MD, 303-724-4644, AMANDA.PIQUET@CUANSCHUTZ.EDU
Dr. Amanda Piquet, MD
About this study
Official title: An Observational Pregnancy Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® (Inebilizumab-cdon) During Pregnancy
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.
Read the detailed description
Acquired from Horizon in 2024.
- Being tested
- UPLIZNA
- Keywords
- Neuromyelitis Optica Spectrum Disorder, Pregnancy, UPLIZNA, inebilizumab, birth complications
- Medical subject headings
- Neuromyelitis Optica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UPLIZNADrug
Also called inebilizumab-cdon
Enrolled female participants with NMOSD who were exposed to UPLIZNA during pregnancy will be assessed. No study drug will be administered.
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of newborns with Major Congenital Malformations (MCMs)
Measured: Minimum of 10 years
Number of newborns with Preterm birth
Measured: Minimum of 10 years
Number of newborns with low birth weight
Measured: Minimum of 10 years
Number of stillbirths
Measured: Minimum of 10 years
Secondary outcomes (6)
Number of newborns with Minor Congenital Malformations
Measured: Minimum of 10 years
Number of infants with developmental milestone abnormalities
Measured: Minimum of 10 years
Number of infants with neurologic abnormalities
Measured: Minimum of 10 years
Number of infants with immune system development abnormalities
Measured: Minimum of 10 years
Number of Spontaneous Abortions
Measured: Minimum of 10 years
Number of Induced or Elective Abortions
Measured: Minimum of 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2023
- Study start15 Oct 2026 (estimated)
- Primary completion31 Oct 2032 (estimated)
- Study completion31 Oct 2032 (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 AmgenThe 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
- Other
- Time perspective
- Other
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05909761
- Sponsor's protocol ID
- VIB0551.P4.S4
- Other IDs
- EUPAS105613
- Status last verified
- Aug 2026
- First submitted
- 9 Jun 2023
- Last updated
- 31 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
- Expanded access
- Available