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

• Status: Completed
• Trial end date: 2021-05-19
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Annexon, Inc.
• Collaborators: International Centre for Diarrhoeal Disease Research, Bangladesh; ResearchPoint Global
• Treatments: Antibodies; gamma-Globulins; Immunoglobulins; Immunoglobulins, Intravenous; Rho(D) Immune Globulin

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