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Observational Study of Ultomiris® Safety in Pregnancy

This study is looking at the safety of Ultomiris® (ravulizumab) for pregnant and breastfeeding individuals, and for their babies. Researchers want to understand how often pregnancy complications, maternal complications (health issues for the birthing parent), and fetal/infant outcomes (health of the baby) occur when Ultomiris® is used during pregnancy or breastfeeding. You might be able to join if you are a woman who has been exposed to Ultomiris® before or during pregnancy, or while breastfeeding. The study aims to enroll 75 participants. This is an observational study, meaning researchers will collect information without giving you any new treatments. The study status is currently unclear.

Study design
This is an observational study that plans to enroll 75 women. It will collect information about participants exposed to Ultomiris® during pregnancy and/or breastfeeding.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for pregnancy complications and maternal complications up to 4 weeks after delivery. Fetal/infant outcomes will be followed from in utero through 52 weeks of age.

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NCT06312644

Study of Ultomiris® (Ravulizumab) Safety in Pregnancy

Recruiting
Not specifiedAll AgesObservational
Alexion Pharmaceuticals, Inc.
~75 participants
Updated 2026-04-16 on ClinicalTrials.gov
What's tested:Ultomiris

At a glance

Recruiting sites
4 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pregnancy Complications
Measured over Up to 4 weeks post-delivery
+2 more outcomes measured

Conditions

Ultomiris-exposed Pregnant/ Postpartum
Pregnancy
Paroxysmal Nocturnal Hemoglobinuria (PNH)
Atypical Hemolytic Uremic Syndrome (aHUS)
Generalized Myasthenia Gravis (gMG)
Neuromyelitis Optica Spectrum Disorder (NMOSD)

Explore related trials

Atypical Hemolytic Uremic SyndromeMyasthenia Gravis, GeneralizedNeuromyelitis OpticaParoxysmal Nocturnal Hemoglobinuria

Where it's being run

7 sites across 7 states
Massachusetts1
Victoria1
France1
Norte-Westfalia1
Italy1
South Korea1
United Kingdom1

Study leadership

  • Sydney Williams · PRINCIPAL_INVESTIGATOR · North American Coordinating Center (NACC)

Who to contact

Alexion Pharmaceuticals, Inc. (Sponsor)
[email protected]
1-855-752-2356
Email the study team

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Eligibility criteria

Inclusion

Female participant must have a medically confirmed qualifying pregnancy (prospectively or retrospectively identified).
Participant informed consent (written or e-consent per local regulations or ethics committee requirements) must be obtained prior to the participant's enrollment. If the participant is a minor, consent must be obtained from the parent or legal guardian, with assent from the minor (as locally appropriate).
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 applicable to current local regulations.
Diagnosed with an indication for which Ultomiris is approved, based on HCP or medical records.
Exposed to Ultomiris at any point during the defined exposure window based on HCP or medical record documentation. (If exact exposure dates are unknown, the reporter must be able to specify or estimate trimester or timing of exposure \[prior to conception as LMP+14 days, or during breastfeeding\].)
Use of Ultomiris per local product information (i.e., United States Prescribing Information \[USPI\] or summary of product characteristics \[SmPC\])

Exclusion

Participants who are unable to provide consent or assent (as locally appropriate) (e.g., diagnosed with severe psychiatric conditions or severe intellectual disabilities) will be excluded from this study

What this trial measures

  • Pregnancy ComplicationsUp to 4 weeks post-delivery

    Pregnancy outcomes

  • Maternal ComplicationsUp to 4 weeks post-delivery

    Maternal Complications may include pre-eclampsia, eclampsia, deep-vein thrombosis (DVT), pregnancy-induced hypertension, gestational diabetes, preterm labor, placenta previa, and postpartum hemorrhage

  • Fetal/Infant OutcomesIn utero through 52 weeks of age after exposure to Ultomiris (in utero or via breastmilk)

    Fetal (in Utero)/infant (for Live Born Births) may include major congenital malformation (MCMs), full-term birth, preterm birth, low birth weight, size for gestational age, neonatal death, perinatal death, infant death, serious and severe infections of infants, infant hospitalization, growth delays, and abnormal postnatal growth and development