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NCT Number: NCT04701164

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

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.

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Key information

Conditions

Guillain-Barre Syndrome Autoimmune Diseases Autoimmune Diseases of the Nervous System Chronic Disease Demyelinating Diseases Disease Attributes Immune System Diseases Nervous System Diseases Neuromuscular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Polyneuropathies Polyradiculoneuropathy Post-Infectious Disorders

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Dhaka Medical Center, Dhaka, Bangladesh

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

ANX005

Drug

Solution for intravenous infusion

Placebo

Drug

Solution for intravenous infusion

Primary outcomes

  1. GBS Disability Score (GBS-DS) at Week 8

    Time frame: Week 8

  2. Number of Participants with Adverse Events

    Time frame: Through Month 6

    Number participants recently diagnosed with GBS who experience adverse events.

Secondary outcomes

  1. Medical Research Council (MRC) Sum Score at Week 8

    Time frame: Week 8

  2. MRC Sum Score at Day 8

    Time frame: Day 8

  3. Duration (Days) of Ventilation Support Over 26 Weeks

    Time frame: 26 weeks

  4. GBS Disability Score (GBS-DS)

    Time frame: Week 26

  5. Number of Participants Requiring Intensive Care Unit Stay

    Time frame: 26 weeks

  6. Duration (Days) of Intensive Care Unit Stays

    Time frame: 26 weeks

  7. Patient Global Impression of Change Scores

    Time frame: Week 8 and Week 26

Sponsors and collaborators

Lead sponsor

Annexon, Inc.

Industry

Registry information

Official study title

A Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of ANX005 in Subjects With Guillain-Barré Syndrome

Important dates

Study start
2020
Primary completion
2024
Study completion
2024
First posted
Jan 8, 2021
Registry last updated
May 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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