Phase 3 study of Efgartigimod IV in Adult Participants with AChR-Ab seronegative gMG

• Research type

  Research Study

• Full title

  A Randomized, Double-Blinded, Placebo-Controlled, Phase 3, Parallel-Group Design Study Evaluating the Efficacy and Safety of Efgartigimod IV in Adult Participants With Acetylcholine Receptor Binding Antibody Seronegative Generalized Myasthenia Gravis

• IRAS ID

  1010064

• Contact name

  Sabine Coppieters

• Contact email

  regulatory@argenx.com

• Sponsor organisation

  argenx BV

• Clinicaltrials.gov Identifier

  NCT06298552

• Research summary

  This is a phase 3 study in adult patients with Acetylcholine Receptor Binding Antibody Seronegative Generalized Myasthenia Gravis. The primary purpose of this study is to measure the efficacy and safety of efgartigimod intravenously (IV) compared to placebo in participants with Acetylcholine Receptor Binding Antibody (AChR-Ab) seronegative Generalized Myasthenia Gravis (gMG). Other objectives are to assess long-term efficacy, safety, and tolerability of efgartigimod. The study consists of a Part A where participants will be randomized to receive either efgartigimod IV or placebo and a Part B where participants completing part A will receive open-label efgartigimod IV. Participants will be in the study for up to (approximately) 2.5 years.

• REC name

  South Central - Hampshire A Research Ethics Committee

• REC reference

  24/SC/0320

• Date of REC Opinion

  5 Nov 2024

• REC opinion

  Further Information Favourable Opinion