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

NCT ID: NCT04701164

Last Updated: 2025-05-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 242 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-12-17
• Study Completion Date: 2024-04-20

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.

Conditions

Guillain-Barre Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

ANX005 Treatment Group - Dose 1

Participants will receive a single IV infusion of ANX005 (Dose 1) on Day 1.

Group Type: EXPERIMENTAL

ANX005

Intervention Type: DRUG

Solution for intravenous infusion

ANX005 Treatment Group - Dose 2

Participants will receive a single IV infusion of ANX005 (Dose 2) on Day 1.

Group Type: EXPERIMENTAL

ANX005

Intervention Type: DRUG

Solution for intravenous infusion

Placebo Group

Participants will receive a single IV infusion of placebo on Day 1.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Solution for intravenous infusion

Interventions

ANX005

Solution for intravenous infusion

Intervention Type: DRUG

Placebo

Solution for intravenous infusion

Intervention Type: DRUG

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 ≤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

• 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).

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Annexon, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Annexon, Inc.

Locations

Dhaka Medical Center

Dhaka, , Bangladesh

National Institute of Neurosciences and Hospital (NINS)

Dhaka, , Bangladesh

Baguio General Hospital Medical Center

Baguio City, , Philippines

Batangas Medical Center

Batangas, , Philippines

Mary Mediatrix Medical Center

Batangas, , Philippines

Perpetual Succour Hospital

Cebu City, , Philippines

Cotabato Regional Medical Center

Cotabato City, , Philippines

Southern Philippines Medical Center

Davao City, , Philippines

Jose R. Reyes Memorial Medical Center

Manila, , Philippines

West Visayas State University Medical Center

Manila, , Philippines

Zamboanga City Medical Center

Zamboanga City, , Philippines

Countries

Bangladesh; Philippines

Other Identifiers

ANX005-GBS-02

Identifier Type: -

Identifier Source: org_study_id