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

NCT05909761 | Recruiting FDA Drug

• 2 other identifiers: VIB0551.P4.S4EUPAS105613
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Neuromyelitis Optica Spectrum Disorder; Pregnancy Related

Keywords

Neuromyelitis Optica Spectrum Disorder; Pregnancy; UPLIZNA; inebilizumab; birth complications

Outcome Measures

Primary Outcomes (4)

• Number of newborns with Major Congenital Malformations (MCMs)

  Minimum of 10 years

• Number of newborns with Preterm birth

  Minimum of 10 years

• Number of newborns with low birth weight

  Minimum of 10 years

• Number of stillbirths

  Minimum of 10 years

Secondary Outcomes (6)

• Number of newborns with Minor Congenital Malformations

  Minimum of 10 years

• Number of infants with developmental milestone abnormalities

  Minimum of 10 years

• Number of infants with neurologic abnormalities

  Minimum of 10 years

• Number of infants with immune system development abnormalities

  Minimum of 10 years

• Number of Spontaneous Abortions

  Minimum of 10 years

Interventions

UPLIZNA DRUG

Enrolled female participants with NMOSD who were exposed to UPLIZNA during pregnancy will be assessed. No study drug will be administered.

Also known as: inebilizumab-cdon

Eligibility Criteria

• Age: 15 Years+
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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).

You may qualify if:

• 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

Sponsors & Collaborators

• Amgen: lead

Study Sites (1)

University of Colorado Denver

Aurora, Colorado, 80045, United States

RECRUITING

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Neuromyelitis Optica

Condition Hierarchy (Ancestors)

Myelitis, Transverse; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Optic Neuritis; Optic Nerve Diseases; Cranial Nerve Diseases; Demyelinating Diseases; Eye Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Central Study Contacts

Amgen Call Center

CONTACT

866-572-6436; medinfo@amgen.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Study Record Dates

• First Submitted: June 9, 2023
• First Posted: June 18, 2023
• Study Start: April 15, 2026
• Primary Completion (Estimated): October 31, 2032
• Study Completion (Estimated): October 31, 2032
• Last Updated: January 27, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

Locations

US (1)