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

March 7, 2023 updated by: Annexon, Inc.

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

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.

Study Overview

Status

Recruiting

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

216

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Dhaka, Bangladesh
        • Recruiting
        • National Institute of Neurosciences and Hospital (NINS)
        • Contact:
          • Zhahirul Islam, MD
      • Dhaka, Bangladesh
        • Recruiting
        • Dhaka Medical Center
        • Contact:
          • Zhahirul Islam, MD
      • Baguio, Philippines
        • Recruiting
        • Baguio General Hospital Medical Center
      • Batangas, Philippines
        • Recruiting
        • Batangas Medical Center
      • Batangas, Philippines
        • Recruiting
        • Mary Mediatrix Medical Center
      • Cebu City, Philippines
        • Recruiting
        • Perpetual Succour Hospital
      • Cotabato, Philippines
        • Recruiting
        • Cotabato Regional Medical Center
      • Davao, Philippines
        • Recruiting
        • Southern Philippines Medical Center
      • Manila, Philippines
        • Recruiting
        • Jose R. Reyes Memorial Medical Center
      • Manila, Philippines
        • Recruiting
        • West Visayas State University Medical Center
      • Zamboanga, Philippines
        • Recruiting
        • Zamboanga City Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: ANX005 Treatment Group - Dose 1
Participants will receive a single IV infusion of ANX005 (Dose 1) on Day 1.
Solution for intravenous infusion
Experimental: ANX005 Treatment Group - Dose 2
Participants will receive a single IV infusion of ANX005 (Dose 2) on Day 1.
Solution for intravenous infusion
Placebo Comparator: Placebo Group
Participants will receive a single IV infusion of placebo on Day 1.
Solution for intravenous infusion

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Study Director: Clinical Trials, Annexon, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 17, 2020

Primary Completion (Anticipated)

April 30, 2024

Study Completion (Anticipated)

April 30, 2024

Study Registration Dates

First Submitted

January 6, 2021

First Submitted That Met QC Criteria

January 7, 2021

First Posted (Actual)

January 8, 2021

Study Record Updates

Last Update Posted (Estimate)

March 9, 2023

Last Update Submitted That Met QC Criteria

March 7, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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