Study of Ultomiris® (Ravulizumab) Safety in Pregnancy

April 15, 2026 updated by: Alexion Pharmaceuticals, Inc.

Observational 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

75

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3050
        • Not yet recruiting
        • Research Site
        • Principal Investigator:
          • Dr. Jeff Szer
  • France
      • Paris, France, 75475
        • Recruiting
        • Research Site
        • Principal Investigator:
          • Dr Flore Sicre de Fontbrune
  • Germany
    • Norte-Westfalia
      • Essen, Norte-Westfalia, Germany, D-45147
        • Recruiting
        • Research Site
        • Principal Investigator:
          • Prof. Dr. Alexander Röth
  • Italy
      • Rome, Italy, 00168
        • Recruiting
        • Research Site
        • Principal Investigator:
          • Doctor Simona Sica
  • South Korea
      • Seoul, South Korea
        • Active, not recruiting
        • Research Site
  • United Kingdom
      • London, United Kingdom, SE5 9NU
        • Active, not recruiting
        • Research Site
  • United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants exposed to Ultomiris at any point up to 40 weeks prior to conception (Last Menstrual Period +14 days) through pregnancy and/or breastfeeding through the first 52 weeks of the infant's life.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
In utero through 52 weeks of age after exposure to Ultomiris (in utero or via breastmilk)
Pregnancy Complications
Time Frame: Up to 4 weeks post-delivery
Pregnancy outcomes
Up to 4 weeks post-delivery
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
Up to 4 weeks post-delivery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexion Pharmaceuticals, Inc.

Investigators

  • Principal Investigator: Sydney Williams, North American Coordinating Center (NACC)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 16, 2024

Primary Completion (Estimated)

July 11, 2034

Study Completion (Estimated)

July 11, 2034

Study Registration Dates

First Submitted

March 9, 2024

First Submitted That Met QC Criteria

March 9, 2024

First Posted (Actual)

March 15, 2024

Study Record Updates

Last Update Posted (Actual)

April 16, 2026

Last Update Submitted That Met QC Criteria

April 15, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D9289C00007

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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