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 12-85 (full criteria)
Location
at UC Irvine
Dates
study started
study ends around

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 Tanruprubart (Also Commonly Known as ANX005) in Participants With Guillain-Barré Syndrome (GBS) (FORWARD Study)

Keywords

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

Eligibility

You can join if…

Open to people ages 12-85

  • 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 intended treatment with either plasma exchange or IV immunoglobulin for GBS.
  • Diagnosis of a variant of GBS, including Miller Fisher syndrome, Bickerstaff's encephalitis, and overlap syndromes.

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
  • Mayo Rochester accepting new patients
    Rochester Minnesota 55905 United States
  • Henry Ford Health accepting new patients
    Detroit Michigan 48202 United States

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