Alexion Pregnancy Registry

• Research type

  Research Study

• Full title

  Observational study of Ultomiris® (ravulizumab) safety in pregnancy

• IRAS ID

  343684

• Contact name

  Shreyans Gandhi

• Contact email

  shreyans.gandhi@nhs.net

• Sponsor organisation

  Alexion Pharmaceutical

• Clinicaltrials.gov Identifier

  NCT06312644, https://clinicaltrials.gov/

• Duration of Study in the UK

  5 years, 11 months, 9 days

• Research summary

  This is a multi-centre, observational, non-interventional pregnancy study. Retrospective and/or prospective data will be collected directly from pregnant/ postpartum participants treated with Ultomiris and/or their and their infant’s healthcare providers (HCPs). This observational study is voluntary, and eligible pregnant participants exposed to Ultomiris at any point during the 40 weeks prior to conception or at any point during pregnancy or breastfeeding up to 52 weeks after birth may enrol.

  The maximum duration of participation is approximately 21 months (9 months of pregnancy and 12 months of infant follow-up), and the maximum duration of the study will be 10 years, starting from the date of the final protocol submission to the Food and Drug Administration
  This study will be conducted initially in the US and Europe, with other countries to be added based on feasibility product launch and use. One coordinating centre (CC) per country will be responsible for obtaining informed consent and all participant/ HCP interactions with accompanying data collection throughout the study.

  HCPs who prescribe Ultomiris, obstetricians, and investigators, including investigators involved in Alexion-sponsored registries, will be informed of the study and asked to refer any pregnant or breastfeeding patient who has been exposed to Ultomiris in the protocol-defined exposure window to the appropriate study CC. HCPs and patients will be advised that the study is observational, and participation is voluntary. Patients exposed to Ultomiris while pregnant and/or breastfeeding may be made aware of this study from other registries, observational studies, and/or other post marketing studies.

  The end of the study will be the completion of any follow-up monitoring and data collection as described in the protocol, in all participants from all the countries.
  

• REC name

  London - Surrey Research Ethics Committee

• REC reference

  25/PR/0301

• Date of REC Opinion

  24 Mar 2025

• REC opinion

  Favourable Opinion