Efficacy and Safety of ANX005 in Subjects With Guillain-Barré Syndrome

• Status: Recruiting
• Trial end date: 2023-03-01
• Target enrollment: 0
• Participant gender: All

Summary

This study is intended to evaluate the efficacy and safety of ANX005 administered by intravenous (IV) infusion to participants recently diagnosed with Guillain-Barré Syndrome (GBS). The total duration of study participation is approximately 6 months.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Annexon, Inc.

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 ≤10 days prior to start of infusion.

• GBS-DS score of 3,4, or 5 at screening and at Day 1 prior to infusion.

Exclusion Criteria:

• Body weight >150 kg.

• Unresponsive nerve conduction study results in all nerves tested during screening.

• Previous or intended, future treatment with either plasma exchange or intravenous immunoglobulin for GBS.

• Diagnosis of a variant of GBS, including Miller Fisher syndrome, Bickerstaff's encephalitis, and overlap syndromes.

• Prior treatment with any monoclonal antibody.

• History of hypercoagulable diseases, hyper viscosity, thrombosis, or acute renal failure.

• Documented, clinically significant, pre-existing polyneuropathy from another cause.

• Females who are pregnant, breastfeeding, or unable or unwilling to use 2 methods of contraception throughout the study.