Study of Ultomiris® (Ravulizumab) Safety in Pregnancy

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.

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Key information

Conditions

Ultomiris-exposed Pregnant/ Postpartum Anemia Anemia, Hemolytic Atypical Hemolytic Uremic Syndrome Atypical Hemolytic Uremic Syndrome (aHUS) Autoimmune Diseases Autoimmune Diseases of the Nervous System Blood Platelet Disorders Bone Marrow Diseases Cranial Nerve Diseases Cytopenia Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Eye Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Generalized Myasthenia Gravis (gMG) Hematologic Diseases Hemic and Lymphatic Diseases Hemoglobinuria, Paroxysmal Hemolytic-Uremic Syndrome Immune System Diseases Kidney Diseases Male Urogenital Diseases Myasthenia Gravis Myelitis, Transverse Myelodysplastic Syndromes Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms Neurodegenerative Diseases Neuromuscular Diseases Neuromuscular Junction Diseases Neuromyelitis Optica Neuromyelitis Optica Spectrum Disorder (NMOSD) Optic Nerve Diseases Optic Neuritis Paraneoplastic Syndromes Paraneoplastic Syndromes, Nervous System Paroxysmal Nocturnal Hemoglobinuria (PNH) Pregnancy Thrombocytopenia Thrombotic Microangiopathies Uremia Urogenital Diseases Urologic Diseases

Sex eligibility

Female

Study type

Observational

Primary location

Research Site, Melbourne, Victoria, Australia

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

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 criteria

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

Treatment and study plan

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.

Other names: There is no interventional drug. Ultomiris treatment is an inclusion criterion.

Primary outcomes

Pregnancy Complications

Time frame: Up to 4 weeks post-delivery

Pregnancy outcomes
Maternal Complications

Time frame: Up 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 Outcomes

Time frame: In 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

Study contacts

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

Alexion Pharmaceuticals, Inc. (Sponsor)

CONTACT

[email protected]

1-855-752-2356

Sponsors and collaborators

Lead sponsor

Alexion Pharmaceuticals, Inc.

Industry

Registry information

Official study title

Observational Study of Ultomiris® (Ravulizumab) Safety in Pregnancy

Important dates

Study start: 2024
Primary completion: 2034
Study completion: 2034
First posted: Mar 15, 2024
Registry last updated: Apr 16, 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.

Published trials that share one or more normalized conditions with this study.

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