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Study of Ultomiris® (Ravulizumab) Safety in Pregnancy

NCT06312644 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 75

Last updated 2026-04-16

No results posted yet for this study

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)
  • Neuromyelitis Optica Spectrum Disorder (NMOSD)

Interventions

DRUG

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.

Sponsors & Collaborators

  • Alexion Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Sydney Williams · North American Coordinating Center (NACC)

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-12-16
Primary Completion
2034-07-11
Completion
2034-07-11
FDA Drug
Yes

Countries

  • United States
  • Australia
  • France
  • Germany
  • Italy
  • South Korea
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06312644 on ClinicalTrials.gov