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Phase IB

A Clinical Study of ANX005 and IVIG in Subjects With Guillain Barré Syndrome (GBS)

  • Study HIC#:2000025922
  • Last Updated:07/12/2021

Brief Summary:

This study is a multi center, open-label, study of ANX005 in combination with IVIg in subjects diagnosed with GBS.

  • Age18 years and older
  • GenderBoth
  • Start Date10/16/2019
  • End Date09/30/2020

Trial Purpose and Description

To evaluate the pharmacokinetics and pharmacodynamics of ANX005 when administered in combination with IVIg in GBS subjects. 

To evaluate the clinical effectiveness of ANX005 when administered in
combination with IVIg.

Eligibility Criteria

Inclusion Criteria: 

  • Diagnosis of GBS according to the National Institute of Neurological Disorders and Stroke Diagnostic Criteria for Guillain Barré Syndrome 
  • Onset of GBS-related weakness ≤14 days prior to infusion 
  • GBS-DS score of 3, 4, or 5

Exclusion Criteria: 

  • Clinically significant findings that may interfere with the conduct of the study or the interpretation of the data 
  • Be at risk of suicide or self-harm 
  • Received previous treatment with plasma exchange for GBS 
  • Any diagnosis of a variant of GBS 
  • Have a history of anaphylaxis or severe systemic response to immunoglobulin 
  • Documented, clinically significant, pre-existing polyneuropathy from another cause 
  • Clinically significant intercurrent illness, medical condition, or medical history 
  • History of chronic use of steroid or immunosuppressant medication 
  • Active alcohol, drug, or substance abuse 
  • Females who are pregnant, breast feeding, or unable or unwilling to use highly effective methods of contraception throughout the study 


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