ADVANCE SC+

• Research type

  Research Study

• Full title

  A Phase 3, Multicenter, Open-Label, Long-Term Trial to Evaluate the Safety and Efficacy of Efgartigimod (ARGX-113) PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia.

• IRAS ID

  1003696

• Contact name

  Wim Parys, MD

• Contact email

  regulatory@argenx.com

• Sponsor organisation

  argenx BV

• Eudract number

  2020-004033-20

• Clinicaltrials.gov Identifier

  NCT04812925

• Research summary

  This is an open-label, long-term extension of the ADVANCE SC study, to evaluate the safety and efficacy of Efgartigimod in adult participants with Primary Immune Thrombocytopenia (ITP). The study will be offered to participants who took part in the ADVANCE SC study, who completed the 24 week trial treatment period. All participants in this extension ADVANCE SC+ study will receive the study drug Efgartigimod PH20 subcutaneous.
  ITP is a disorder where the immune system attacks the body's platelets meaning the blood does not clot properly. The drug is a modified human antibody fragment designed to bind to a specific protein called FcRn. Antibodies are proteins that the body uses to fight and prevent infections. The drug is a compound that is similar to these proteins that are present in the human body by nature. Binding to FcRn reduces the body’s antibody levels and aims to reduce the levels of any antibodies against platelets in ITP. This study will also see how well the drug works, how the body processes the drug, what effect it has on the body and how the immune system reacts to the drug.
  The total trial duration per participant is up to 4 years + 8 weeks:
  • 52-week treatment period, extendable with three 52-week treatment periods
  • 8-week follow-up period

• REC name

  West of Scotland REC 1

• REC reference

  21/WS/0055

• Date of REC Opinion

  28 Jul 2021

• REC opinion

  Further Information Favourable Opinion