Open-Label Randomised Study of Nipocalimab or IVIG in Pregnancies At Risk of FNAIT

• Research type

  Research Study

• Full title

  Multicentre, Open-Label, Randomised Study of Nipocalimab or IVIG in Pregnancies At Risk of Fetal and Neonatal Alloimmune Thrombocytopaenia (FNAIT) - FREESIA-3

• IRAS ID

  1010250

• Contact name

  David Wright

• Contact email

  GCOUKSubmissions@its.jnj.com

• Sponsor organisation

  Janssen-Cilag International N.V.

• Eudract number

  2023-509434-19

• ISRCTN Number

  ISRCTN17841362

• Clinicaltrials.gov Identifier

  NCT06533098

• Research summary

  Fetal Neonatal Alloimmune Thrombocytopenia (or ‘FNAIT’) is a condition where a baby (in the womb or just after birth) has low platelets. This occurs because the mother’s immune system develops antibodies (proteins) that attack her baby’s platelets, and this may lead to bleeding in the baby. There is no approved treatment available for FNAIT. The purpose of this research study is to see if the study drug - called nipocalimab - can reduce the risk of FNAIT happening in pregnant women who had a previous pregnancy affected by FNAIT.
  Nipocalimab is ‘investigational’. This means that it has not been approved to treat FNAIT by any health authorities including the UK’s Medicine and Healthcare products Regulatory Agency (‘MHRA’). It is given as an intravenous infusion which means that it is given into a vein, usually in the arm.
  About 50 participants will take part in the study worldwide. Not everyone will receive nipocalimab. A small number of participants in the study will receive intravenous immunoglobulin (‘IVIG’) (also an intravenous infusion) with or without prednisone (a steroid given as a tablet). While not approved by health authorities for use in FNAIT, IVIG is considered standard of care treatment for FNAIT patients in many countries. The study comprises a screening period (up to 8 weeks long), treatment (weekly treatment with either nipocalimab or IVIG which will stop before the birth of a participant’s baby), follow-up of the mother (for 24 weeks from the birth of her baby) and follow-up of the baby once born until they are 2 years old. During study visits, participants will have various tests and assessments including blood tests, physical examinations and ultrasound scans of their unborn baby. Participants (and their babies once born) will be closely monitored throughout the study.

• REC name

  West of Scotland REC 1

• REC reference

  24/WS/0087

• Date of REC Opinion

  23 Aug 2024

• REC opinion

  Further Information Favourable Opinion