Ultomiris-exposed Pregnant/ PostpartumNCT06312644
Study of Ultomiris® (Ravulizumab) Safety in Pregnancy
An observational study of Ultomiris-exposed Pregnant/ Postpartum and Pregnancy, run by Alexion Pharmaceuticals, Inc. at 7 sites in 7 countries.
Trial summary
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… Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Ultomiris-exposed Pregnant/ Postpartum, Pregnancy, Paroxysmal Nocturnal Hemoglobinuria (PNH)
- What is being tested?
- Ultomiris
- How many people
- 75 participants
- Where
- 7 sitesin 7 countries
- Study dates
- 16 Dec 2024to 11 Jul 2034
- How long will I take part?
- 21 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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])
Who cannot join
- 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
Trial locations and contacts
7 sites in 7 countries. Contact the study team or a site near you to ask about taking part.
7 sites in 7 countries
United States1 site, 1 recruiting
- Recruiting
Research Site
Boston, Massachusetts, 02210
Sydney Willis, 833-793-0563, UltomirisPregnancyRegistry@iqvia.com
Australia1 site, 1 recruiting
- Not yet recruiting
Research Site
Melbourne, Victoria, 3050
Dr. Jeff Szer
France1 site, 1 recruiting
- Recruiting
Research Site
Paris, 75475
Dr Flore Sicre de Fontbrune
Germany1 site, 1 recruiting
- Recruiting
Research Site
Essen, Norte-Westfalia, D-45147
Prof. Dr. Alexander Röth
United Kingdom1 site
- Active, not recruiting
Research Site
London, SE5 9NU
About this study
Official title: 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.
Read the 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.
- Conditions
- Ultomiris-exposed Pregnant/ Postpartum, Pregnancy, Paroxysmal Nocturnal Hemoglobinuria (PNH), Atypical Hemolytic Uremic Syndrome (aHUS), Generalized Myasthenia Gravis (gMG), Neuromyelitis Optica Spectrum Disorder (NMOSD)
- Being tested
- Ultomiris
- Keywords
- Ultomiris, pregnancy, PNH, aHUS, gMG, NMOSD
- Medical subject headings
- Hemoglobinuria, Paroxysmal, Atypical Hemolytic Uremic Syndrome, Myasthenia Gravis, Neuromyelitis Optica
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltomirisDrug
Also called There is no interventional drug. Ultomiris treatment is an inclusion criterion.
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Pregnancy Complications
Pregnancy outcomes
Measured: Up to 4 weeks post-delivery
Maternal Complications
Maternal Complications may include pre-eclampsia, eclampsia, deep-vein thrombosis (DVT), pregnancy-induced hypertension, gestational diabetes, preterm labor, placenta previa, and postpartum hemorrhage
Measured: Up to 4 weeks post-delivery
Fetal/Infant Outcomes
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
Measured: In utero through 52 weeks of age after exposure to Ultomiris (in utero or via breastmilk)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start16 Dec 2024
- Primary completion11 Jul 2034 (estimated)
- Study completion11 Jul 2034 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Ultomiris-exposed Pregnant/ PostpartumStudies of the same condition, open and under way.
- More trials run by Alexion Pharmaceuticals, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 75 participants (estimated)
- Target duration
- 21 Months
Sponsor and investigators
- Lead sponsor
- Alexion Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sydney Williams, Principal investigator, North American Coordinating Center (NACC)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06312644
- Sponsor's protocol ID
- D9289C00007
- Status last verified
- Apr 2026
- First submitted
- 9 Mar 2024
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Carrillo Infante C, Mujeebuddin A, Koneru M, Williams C. Safety of Ravulizumab Use in Pregnancy: Insights from a Global Pharmacovigilance Analysis. Adv Ther. 2026 Oct 9. doi: 10.1007/s12325-026-03816-9. Online ahead of print.
PubMed 42853533
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Ultomiris® (Ravulizumab) Safety in Pregnancy
- ClinicalTrials.gov ID
- NCT06312644
- Acronym / sponsor ID
- D9289C00007
- Conditions
- Ultomiris-exposed Pregnant/ Postpartum, Pregnancy, Paroxysmal Nocturnal Hemoglobinuria (PNH), Atypical Hemolytic Uremic Syndrome (aHUS), Generalized Myasthenia Gravis (gMG), Neuromyelitis Optica Spectrum Disorder (NMOSD)
- Keywords
- Ultomiris, pregnancy, PNH, aHUS, gMG, NMOSD
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Alexion Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Dec 2024 (actual)
- Primary completion
- 11 Jul 2034 (estimated)
- Study completion
- 11 Jul 2034 (estimated)
- First posted
- 15 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 21 Months
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltomirisAlso: There is no interventional drug. Ultomiris treatment is an inclusion criterion.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. | Drug | – |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Derived from this study: PubMed 42853533Carrillo Infante C, Mujeebuddin A, Koneru M, Williams C. Safety of Ravulizumab Use in Pregnancy: Insights from a Global Pharmacovigilance Analysis. Adv Ther. 2026 Oct 9. doi: 10.1007/s12325-026-03816-9. Online ahead of print.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sydney Williams principal investigator
North American Coordinating Center (NACC)
7 sites in 7 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ultomiris-exposed Pregnant/ Postpartum and Pregnancy, run by Alexion Pharmaceuticals, Inc. at 7 sites in 7 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Australia, France, Germany, Italy and 2 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alexion Pharmaceuticals, Inc. (Sponsor) (1-855-752-2356, clinicaltrials@alexion.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pregnancy Complications (time frame: Up to 4 weeks post-delivery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06312644, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.