Recruiting

Ultomiris

Sponsor:

Alexion Pharmaceuticals, Inc.

Code:

NCT06312644

Conditions

Ultomiris-exposed Pregnant/ Postpartum

Pregnancy

Paroxysmal Nocturnal Hemoglobinuria (PNH)

Atypical Hemolytic Uremic Syndrome (aHUS)

Generalized Myasthenia Gravis (gMG)

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Ultomiris

Study Details

Brief 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 exposure in utero or via breastmilk.

Conditions

Ultomiris-exposed Pregnant/ Postpartum

Pregnancy

Paroxysmal Nocturnal Hemoglobinuria (PNH)

Atypical Hemolytic Uremic Syndrome (aHUS)

Generalized Myasthenia Gravis (gMG)

Study ID

NCT06312644

Start date

Dec 16, 2024

Status verified date

Apr, 2026

Completion date

Jul 11, 2034

Anticipated

Primary completion date

Jul 11, 2034

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

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 Design

Enrollment

75 participants

Anticipated

Interventions and Outcome Measures

Interventions

Ultomiris

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.

Primary outcome measure

  • Pregnancy Complications [ Time Frame: Up to 4 weeks post-delivery ]
  • Maternal Complications [ Time Frame: Up to 4 weeks post-delivery ]
  • Fetal/Infant Outcomes [ Time Frame: In utero through 52 weeks of age after exposure to Ultomiris (in utero or via breastmilk) ]

Central Contacts and Locations

Central contacts

Alexion Pharmaceuticals, Inc. (Sponsor)

1-855-752-2356clinicaltrials@alexion.com

Locations

Research Site

Recruiting

Boston, Massachusetts, United States, 02210

Contacts

Sydney Willis

833-793-0563UltomirisPregnancyRegistry@iqvia.com

More Information

Sponsor

Alexion Pharmaceuticals, Inc.

Last update posted

Apr 16, 2026

Last verified

Apr, 2026

Keywords

  • Ultomiris
  • pregnancy
  • PNH
  • aHUS
  • gMG
  • NMOSD

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Alexion Pharmaceuticals, Inc. on 2026-04-16.