What this study is
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.
What's being tested
- UPLIZNA
Intervention · DRUG
Enrolled female participants with NMOSD who were exposed to UPLIZNA during pregnancy will be assessed. No study drug will be administered.
Study details
- Official title
- An Observational Pregnancy Safety Study in Women With Neuromyelitis Optica Spectrum Disorder (NMOSD) Exposed to UPLIZNA® (Inebilizumab-cdon) During Pregnancy
- Sponsor
- Amgen
- Conditions
- Neuromyelitis Optica Spectrum Disorder · Pregnancy Related
- Enrolling
- 60 people
- Starts
- 2027-01-15
- Est. completion
- 2032-10-31
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 15 Years and overSex FEMALEHealthy volunteers Not acceptedYou 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openUniversity of Colorado Denver
Aurora, Colorado, United States
- Amanda Piquet, MD · Contact303-724-4644AMANDA.PIQUET@CUANSCHUTZ.EDU
- Dr. Amanda Piquet, MD · Principal investigator
Recruiting
Study team
Sponsor
Amgen
Study ID VIB0551.P4.S4
Study director
MD
Amgen
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.