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 Jan 2027to 31 Oct 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 Jan 2027 (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
- Oct 2026
- First submitted
- 9 Jun 2023
- Last updated
- 29 Oct 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
Study at a glance
From the registry record, last updated by the sponsor on 29 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Pregnancy Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® (Inebilizumab-cdon) During Pregnancy
- ClinicalTrials.gov ID
- NCT05909761
- Acronym / sponsor ID
- VIB0551.P4.S4
- Keywords
- Neuromyelitis Optica Spectrum Disorder, Pregnancy, UPLIZNA, inebilizumab, birth complications
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 15 Jan 2027 (estimated)
- Primary completion
- 31 Oct 2032 (estimated)
- Study completion
- 31 Oct 2032 (estimated)
- First posted
- 18 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Acquired from Horizon in 2024.
Study design
- Observational model
- Other
- Time perspective
- Other
Who may qualify
- Ages
- 15 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- 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).
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UPLIZNAAlso: inebilizumab-cdonEnrolled female participants with NMOSD who were exposed to UPLIZNA during pregnancy will be assessed. No study drug will be administered. | Drug | – |
Primary outcome
Number of newborns with Major Congenital Malformations (MCMs)
Time frame: Minimum of 10 years
Number of newborns with Preterm birth
Time frame: Minimum of 10 years
Number of newborns with low birth weight
Time frame: Minimum of 10 years
Number of stillbirths
Time frame: Minimum of 10 years
6 secondary outcomes
Number of newborns with Minor Congenital Malformations
Time frame: Minimum of 10 years
Number of infants with developmental milestone abnormalities
Time frame: Minimum of 10 years
Number of infants with neurologic abnormalities
Time frame: Minimum of 10 years
Number of infants with immune system development abnormalities
Time frame: Minimum of 10 years
Number of Spontaneous Abortions
Time frame: Minimum of 10 years
Number of Induced or Elective Abortions
Time frame: Minimum of 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Oct 2026.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
MD study director
Amgen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Neuromyelitis Optica Spectrum Disorder and Pregnancy Related, run by Amgen at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amgen Call Center (866-572-6436, medinfo@amgen.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of newborns with Major Congenital Malformations (MCMs) (time frame: Minimum of 10 years). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Oct 2026.