At a glance
- What the study gets you
- Health checks and monitoring — no treatment given
- Type of study
- Observational (no treatment given)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Ultomiris (drug)
- How long the study runs
- Study runs about 115 months (dates as stated)
- About the drug or intervention
- Ultomiris — drug: Participants exposed to Ultomiris at any point during the 40 weeks prior to conception (LMP+14 days) or at any point during pregnancy or breastfeeding up to 52 weeks after birth.
- Patient visit burden
- Not specified by the sponsor
In plain English
This study looks at the safety of Ultomiris (ravulizumab) during pregnancy. It is for pregnant or postpartum women who were exposed to Ultomiris at some point around pregnancy or while breastfeeding. The study is run by Alexion Pharmaceuticals, Inc.
Who can take part
- You are female and have a medically confirmed pregnancy (found either before or after joining the study).
- You are willing and able to give informed consent (or assent if you are a minor, with consent from a parent or legal guardian where locally appropriate).
- You are willing to share your contact details.
- You are willing to allow your healthcare professionals to share your medical information and your baby's medical information with the study, where local rules allow.
- You have been diagnosed with a condition that Ultomiris is approved to treat, such as paroxysmal nocturnal haemoglobinuria (PNH), atypical haemolytic uraemic syndrome (aHUS), generalised myasthenia gravis (gMG), or neuromyelitis optica spectrum disorder (NMOSD).
- You were exposed to Ultomiris at any point during a defined window — before conception, during pregnancy, or while breastfeeding (exact dates not always needed; an estimate of timing is acceptable).
- Ultomiris was used according to local product information.
Who may not be able to
- You cannot provide consent or assent (for example, due to a severe psychiatric condition or severe intellectual disability).
What taking part involves
- • The study collects information about Ultomiris exposure during pregnancy, including timing before conception or while breastfeeding.
- • Not stated — ask the trial team about what else taking part involves.
Time commitment: Not stated — ask the trial team about study visits, how long the study lasts, and what taking part involves.
Plain-English summary (AI-generated) from registry data. Not eligibility advice — only the trial team can confirm whether you can take part. Use the eligibility checker to see how your health profile matches this trial.
- Type of study
- Observing health over time
- Ages
- Not specified
- Who
- Female
- Number of participants
- 75
- Started
- 2024-12-16
- Last checked
- 2026-04
Plain English Summary
What is this study?
- • Testing a new treatment for ultomiris-exposed pregnant/ postpartum
- • Clinical study - 75 participants
- • The primary objective of this study is to describe the frequency and characteristics of pregnancy outcomes and maternal complications among participants exposed to Ultomiris and to describe the frequency and characteristics of selected fetal/neonatal/infant outcomes in utero, at birth, and through 1 year of age after exposure in utero or via breastmilk
Who can take part?
- • Adults
- • Diagnosed with ultomiris-exposed pregnant/ postpartum
- • Female only
Where?
- • London - Research Site
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
The primary objective of this study is to describe the frequency and characteristics of pregnancy outcomes and maternal complications among participants exposed to Ultomiris and to describe the frequency and characteristics of selected fetal/neonatal/infant outcomes in utero, at birth, and through 1 year of age after exposure in utero or via breastmilk.
More detail
This observational study will collect prospective and retrospective data in participants exposed to Ultomiris during pregnancy and/or breastfeeding to assess risk of maternal complications, adverse effects on the developing fetus, and adverse effects on the infant.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: Not specified
- Who can join: Female only
Treatment history
Treatments you must have had:
- ✓ a medically confirmed qualifying pregnancy (prospectively or retrospectively identified)
What the study is looking for
- ✓Female participant must have a medically confirmed qualifying pregnancy (prospectively or retrospectively identified).
- ✓Willing to provide contact information for the participant.
- ✓Willing to authorize HCP(s) to release maternal and infant medical information to the study, upon request, if...
- ✓Diagnosed with an indication for which Ultomiris is approved, based on HCP or medical records.
- ✓Use of Ultomiris per local product information (i.e., United States Prescribing Information \[USPI\] or summary of...
See the full criteria
Where Is This Study? (1 UK site)
Research Site
London SE5 9NU, United Kingdom
How to Get in Touch
Alexion Pharmaceuticals, Inc. (Sponsor)
Sponsor contactCONTACT