Who may be eligible for the Study of Ultomiris® (Ravulizumab) Safety in Pregnancy trial?

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

ClinicalTrials.gov record NCT06312644

Study of Ultomiris® (Ravulizumab) Safety in Pregnancy

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Aug 22, 2026

Observational Study of Ultomiris® (Ravulizumab) Safety in Pregnancy

About this page. This page shows the study's official ClinicalTrials.gov record ↗, with added help to make it easier to understand. We explain medical terms, highlight key details in plain language, and suggest questions you may want to ask the study team.

The record is periodically copied from ClinicalTrials.gov and may lag behind changes. AI summaries are checked by software, not a clinician.Read moreShow less

The official record is written by the study sponsor and published on ClinicalTrials.gov. It may not always reflect the latest changes. Before making any decisions, please confirm important information with the study team and your own healthcare team.

Where you see "AI summary", AI was used to create a plain-language explanation and software checked it against the source. It has not been reviewed by a clinician, so it may contain mistakes or leave out important details.

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.

Study typeObservationalA study in which researchers do not assign participants to a treatment or other intervention. They observe or measure what happens, which may include study visits, tests, questionnaires or a review of medical records.

SexFemale

LocationAustralia, France, Germany, Italy, South Korea, United Kingdom, United States

AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This observational study collects retrospective and prospective medical data from people exposed to Ultomiris during pregnancy and/or breastfeeding. It describes pregnancy outcomes and maternal complications, and selected fetal, neonatal and infant outcomes through the first year of life. Data collection is planned around a roughly 21-month time frame.

What it is studying. The study aims to describe how often and what kinds of pregnancy outcomes and maternal complications occur after Ultomiris exposure, and to describe selected fetal, neonatal and infant outcomes in utero, at birth, and through 1 year of age after in utero exposure or exposure via breastmilk.

What the researchers hope to learn. To describe the frequency and characteristics of pregnancy outcomes and maternal complications among people exposed to Ultomiris, and to describe selected fetal, neonatal and infant outcomes up to 52 weeks of age after in utero or breastmilk exposure.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

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.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug: Ultomiris

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

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

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

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.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This observational study collects medical information about the mother and infant from medical records and may use both past (retrospective) and ongoing (prospective) data. Participants give informed consent, provide contact details, and may be asked to authorize their health-care providers to release relevant maternal and infant medical records. The study records pregnancy outcomes (through about 4 weeks after delivery) and follows infants up to 52 weeks of age after in utero or breastmilk exposure. The registry does not list study-specific invasive procedures; it focuses on collecting and following medical record information and outcomes.

How the study is structured. An observational study that collects both retrospective and prospective medical information. Participants are not given any study-assigned treatment; the study records real-world pregnancy and infant outcomes after exposure to Ultomiris. The planned data-collection period is about 21 months, with infant outcomes followed through 52 weeks of age where applicable.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

This is an observational study, so the study itself gives no treatment. What would taking part involve for me, and would it change my usual care?
The listed sites are in Australia, France, Germany, Italy, South Korea, United Kingdom, United States. Is any of them reachable for me, and does the study help with travel?
Which of the eligibility criteria would need to be checked with tests before I could join?

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This trial is also listed on this site under paroxysmal nocturnal hemoglobinuria.

Clinical trials13 trials listed for atypical hemolytic uremic syndromeEvery trial the registry lists for atypical hemolytic uremic syndrome, with recruitment status, phase and sites, updated from ClinicalTrials.gov.See all trials →Research updatesWhat changed in atypical hemolytic uremic syndrome researchLatest monthly update: September 2026. Includes: Ravulizumab and labs. New research summarized each month in plain language, with links to every source paper.Read the latest update →

Important dates

Study start: Dec 16, 2024
Primary completion: Jul 11, 2034 (estimated)
Study completion: Jul 11, 2034 (estimated)
Target enrollment: 75 participants (estimated)
Last updated on registry: Apr 16, 2026
Data verified: Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor: Alexion Pharmaceuticals, Inc.

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Alexion Pharmaceuticals, Inc. (Sponsor) 📞 1-855-752-2356 ✉ clinicaltrials@alexion.com

Participating sites (7)

Filter by country:

Research SiteRecruiting
Boston, Massachusetts, 02210 · United States
- Sydney Willis · 833-793-0563 · UltomirisPregnancyRegistry@iqvia.com
Research SiteNot Yet Recruiting
Melbourne, Victoria, 3050 · Australia
- Dr. Jeff Szer
Research SiteRecruiting
Paris, 75475 · France
- Dr Flore Sicre de Fontbrune
Research SiteRecruiting
Essen, Norte-Westfalia, D-45147 · Germany
- Prof. Dr. Alexander Röth
Research SiteRecruiting
Rome, 00168 · Italy
- Doctor Simona Sica
Research SiteActive Not Recruiting
Seoul · South Korea
Research SiteActive Not Recruiting
London, SE5 9NU · United Kingdom

Terms used on this page · explanations by MedicalUpdates.ai

primary objective: The main result the study is designed to measure and report on. Other results, called secondary outcomes, are also collected.
informed consent: The process of explaining a study, including its risks and what participation involves, so that a person can decide freely whether to take part. Consent is usually documented in writing, and a participant can choose to leave the study later.
enrollment: The number of participants a study plans to include, or has included. 'Estimated' means the planned number; 'actual' means the number who joined.
legal guardian: A person who is legally allowed to make decisions, including consent to research, on behalf of someone who cannot consent for themselves.
assent: A child's or dependent adult's agreement to take part, given alongside the formal consent of a parent or legal representative.
Inclusion Criteria: The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria: The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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