An Open Label Clinical Study to Evaluate Tanruprubart (Also Commonly Known as ANX005) in Participants With Guillain-Barré Syndrome (FORWARD Study)

a study on Guillain-Barre Syndrome

Summary

Eligibility
for people ages 8-85 (full criteria)
Location
at Orange, California and other locations
Dates
study started
study ends around
Principal Investigator
by Bhavesh Trikamji

Description

Summary

The goal of this open label study is to measure pharmacokinetics, pharmacodynamics, early efficacy, and safety of tanruprubart in adult and pediatric participants, in the United States, Canada, and Europe.

Official Title

An Open-Label Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Efficacy, and Safety of a Single Dose of ANX005 in Participants With Guillain-Barré Syndrome

Keywords

Guillain-Barre Syndrome, GBS, ANX005, Tanruprubart, FORWARD study

Eligibility

You can join if…

Open to people ages 8-85

  • Diagnosis of GBS according to the National Institute of Neurological Disorders and Stroke Diagnostic Criteria for GBS.
  • Onset of GBS-related weakness ≤10 days before start of infusion on Day 1
  • GBS-disability score (DS) score of 3, 4, or 5 at screening and before start of infusion on Day 1.

You CAN'T join if...

  • Previous or planned treatment with either plasma exchange or IV immunoglobulin within 90 days of Day 1.
  • Diagnosis of any form of GBS that does not involve weakness of the extremities.

Other protocol-defined criteria may apply.

Locations

  • University of California Irvine accepting new patients
    Orange California 92868 United States
  • Children's Hospital of Orange County accepting new patients
    Orange California 92868 United States

Lead Scientist at UC Irvine

  • Bhavesh Trikamji
    Associate Clinical Professor, Neurology, School of Medicine. Authored (or co-authored) 31 research publications

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Annexon, Inc.
Links
Related Info
ID
NCT07020819
Phase
Phase 3 Guillain-Barre Syndrome Research Study
Study Type
Interventional
Participants
Expecting 30 study participants
Last Updated
Contact us about this trial