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

Phase 3

Completed

• Conditions: Guillain-Barre Syndrome
• Interventions: Drug: ANX005; Drug: Placebo

• Registration Number: NCT04701164
• Lead Sponsor: Annexon, Inc.

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 of study participation is approximately 6 months.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-17
• Study First Submitted: 2021-01-06
• Study First Submitted QC: 2021-01-07
• Study First Posted: 2021-01-08
• Primary Completion: 2024-04-20
• Study Completion: 2024-04-20
• Status Verified: 2024-10
• Last Update Submitted: 2024-10-08
• Last Update Posted: 2024-10-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 242

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.

Read More

Exclusion Criteria

• 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).

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ANX005 Treatment Group - Dose 1	ANX005	Participants will receive a single IV infusion of ANX005 (Dose 1) on Day 1.
ANX005 Treatment Group - Dose 2	ANX005	Participants will receive a single IV infusion of ANX005 (Dose 2) on Day 1.
Placebo Group	Placebo	Participants will receive a single IV infusion of placebo on Day 1.

Primary Outcome Measures

Name	Time	Method
GBS Disability Score (GBS-DS) at Week 8	Week 8
Number of Participants with Adverse Events	Through Month 6	Number participants recently diagnosed with GBS who experience adverse events.

Secondary Outcome Measures

Name	Time	Method
Medical Research Council (MRC) Sum Score at Week 8	Week 8
MRC Sum Score at Day 8	Day 8
Duration (Days) of Ventilation Support Over 26 Weeks	26 weeks
GBS Disability Score (GBS-DS)	Week 26
Number of Participants Requiring Intensive Care Unit Stay	26 weeks
Duration (Days) of Intensive Care Unit Stays	26 weeks
Patient Global Impression of Change Scores	Week 8 and Week 26

Trial Locations

Locations (11)

Dhaka Medical Center; 🇧🇩 Dhaka, Bangladesh

National Institute of Neurosciences and Hospital (NINS); 🇧🇩 Dhaka, Bangladesh

Baguio General Hospital Medical Center; 🇵🇭 Baguio, Philippines

Batangas Medical Center; 🇵🇭 Batangas, Philippines

Mary Mediatrix Medical Center; 🇵🇭 Batangas, Philippines

Perpetual Succour Hospital; 🇵🇭 Cebu City, Philippines

Cotabato Regional Medical Center; 🇵🇭 Cotabato, Philippines

Southern Philippines Medical Center; 🇵🇭 Davao, Philippines

Jose R. Reyes Memorial Medical Center; 🇵🇭 Manila, Philippines

West Visayas State University Medical Center; 🇵🇭 Manila, Philippines

Zamboanga City Medical Center; 🇵🇭 Zamboanga, Philippines