Status:
COMPLETED
Efficacy and Safety of ANX005 in Subjects With Guillain-Barré Syndrome
Lead Sponsor:
Annexon, Inc.
Conditions:
Guillain-Barre Syndrome
Eligibility:
All Genders
16+ years
Phase:
PHASE3
Brief 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...
Eligibility Criteria
Inclusion
- 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
- Clinically significant findings on the screening electrocardiogram (ECG), laboratory test results, or physical examination that are not specific to GBS that may interfere with the conduct of the study, the interpretation of the data, or increase the participant's risk.
- Body weight \<30 kilograms (kg) or \>150 kg at screening.
- Unresponsive (inexcitable) nerve conduction study results in all nerves tested during screening.
- Previous or intended 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.
- History of prior episode of GBS.
- GBS-related weakness that improved since symptom onset, including an improvement between screening and Day 1 (baseline).
Key Trial Info
Start Date :
December 17 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 20 2024
Estimated Enrollment :
242 Patients enrolled
Trial Details
Trial ID
NCT04701164
Start Date
December 17 2020
End Date
April 20 2024
Last Update
May 29 2025
Active Locations (11)
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1
Dhaka Medical Center
Dhaka, Bangladesh
2
National Institute of Neurosciences and Hospital (NINS)
Dhaka, Bangladesh
3
Baguio General Hospital Medical Center
Baguio City, Philippines
4
Batangas Medical Center
Batangas, Philippines