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NCT Number: NCT05909761

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

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Key information

Conditions

Neuromyelitis Optica Spectrum Disorder Autoimmune Diseases Autoimmune Diseases of the Nervous System Cranial Nerve Diseases Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Eye Diseases Immune System Diseases Myelitis, Transverse Nervous System Diseases Neuromyelitis Optica Optic Nerve Diseases Optic Neuritis Pregnancy Related

Age range

15 year and older

Sex eligibility

Female

Study type

Observational

Primary location

University of Colorado Denver

Aurora, Colorado, 80045, United States

Location status: Recruiting

Location contact

Amanda Piquet, MD

CONTACT

[email protected]

303-724-4319

Dr. Amanda Piquet, MD

PRINCIPAL_INVESTIGATOR

About this study

Acquired from Horizon in 2024.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Note: Other Protocol Defined Inclusion/Exclusion Criteria Apply

Treatment and study plan

UPLIZNA

Drug

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

Other names: inebilizumab-cdon

Primary outcomes

  1. Number of newborns with Major Congenital Malformations (MCMs)

    Time frame: Minimum of 10 years

  2. Number of newborns with Preterm birth

    Time frame: Minimum of 10 years

  3. Number of newborns with low birth weight

    Time frame: Minimum of 10 years

  4. Number of stillbirths

    Time frame: Minimum of 10 years

Secondary outcomes

  1. Number of newborns with Minor Congenital Malformations

    Time frame: Minimum of 10 years

  2. Number of infants with developmental milestone abnormalities

    Time frame: Minimum of 10 years

  3. Number of infants with neurologic abnormalities

    Time frame: Minimum of 10 years

  4. Number of infants with immune system development abnormalities

    Time frame: Minimum of 10 years

  5. Number of Spontaneous Abortions

    Time frame: Minimum of 10 years

  6. Number of Induced or Elective Abortions

    Time frame: Minimum of 10 years

Study contacts

Contact information is provided by the study sponsor or research team.

Amgen Call Center

CONTACT

[email protected]

866-572-6436

Sponsors and collaborators

Lead sponsor

Amgen

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2032
Study completion
2032
First posted
Jun 18, 2023
Registry last updated
Jan 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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