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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-01-15

Study Completion Date

2032-10-31

Brief Summary

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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

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Acquired from Horizon in 2024.

Conditions

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Neuromyelitis Optica Spectrum Disorder Pregnancy Related

Keywords

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Neuromyelitis Optica Spectrum Disorder Pregnancy UPLIZNA inebilizumab birth complications

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Interventions

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UPLIZNA

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

Intervention Type DRUG

Other Intervention Names

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inebilizumab-cdon

Eligibility Criteria

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Inclusion Criteria

* 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

Minimum Eligible Age

15 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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MD

Role: STUDY_DIRECTOR

Amgen

Locations

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University of Colorado Denver

Aurora, Colorado, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Amgen Call Center

Role: CONTACT

Phone: 866-572-6436

Email: [email protected]

Facility Contacts

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Amanda Piquet, MD

Role: primary

Other Identifiers

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EUPAS105613

Identifier Type: OTHER

Identifier Source: secondary_id

VIB0551.P4.S4

Identifier Type: -

Identifier Source: org_study_id