LTS16637: CAD Extension

• Research type

  Research Study

• Full title

  An open label, long term, safety and tolerability study of patients with cold agglutinin disease previously treated with BIVV020.

• IRAS ID

  280182

• Contact name

  Nina Salinas

• Contact email

  Nina.Salinas@sanofi.com

• Sponsor organisation

  Bioverativ USA Inc.

• Eudract number

  2019-004423-21

• Duration of Study in the UK

  6 years, 0 months, 1 days

• Research summary

  Cold agglutinin disease is an autoimmune haemolytic anaemia caused by IgM-induced CP activation.
  BIVV020 is a humanized monoclonal antibody that binds to and selectively inhibits the activated form of human serine protease complement component 1, s subcomponent (C1s). BIVV020 is a second generation classical complement inhibitor.
  This study will provide clinical data on the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of BIVV020 in adults with CAD to facilitate the dose/dosing regimen selection for future clinical studies with BIVV020.

• REC name

  London - London Bridge Research Ethics Committee

• REC reference

  20/LO/1026

• Date of REC Opinion

  5 Oct 2020

• REC opinion

  Further Information Favourable Opinion