ANX005 and Intravenous Immunoglobulin (IVIg) in GBS subjects

• Research type

  Research Study

• Full title

  A Phase 1b Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ANX005 in Combination with Intravenous Immunoglobulin (IVIg) in Subjects with Guillain-Barré Syndrome

• IRAS ID

  270539

• Contact name

  Shree A.L. Martinez

• Contact email

  Smartinez@annexonbio.com

• Sponsor organisation

  Annexon Biosciences

• Eudract number

  2019-002863-92

• Duration of Study in the UK

  1 years, 5 months, 1 days

• Research summary

  This Phase 1b study will investigate the safety and tolerability between ANX005-GBS-03 and IVIg given to patients with Guillain-Barre syndrome. Patients will be required to receive ANX005-GBS-03 at the same time as IVIg, intravenously.
  The primary aim of the study is to evaluate the safety and tolerability of ANX005 when both drugs are administered in combination with one another.

  There will be 12 patients in the first group and approximately 12 patients in the second optional group. The study will be conducted in the following countries and is expected to have a duration of 180 days. There will be one site in the UK located in Glasgow, Scotland.

• REC name

  London - Central Research Ethics Committee

• REC reference

  19/LO/1391

• Date of REC Opinion

  14 Dec 2019

• REC opinion

  Further Information Favourable Opinion