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

Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age12-85
SponsorAnnexon, Inc.

About this trial

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.

Eligibility criteria

Qualifiers

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.

Disqualifiers

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.

Trial design

Treatments tested in this trial

  • Tanruprubart

Treatment groups

30 Participants
are divided into 1 treatment group

Sponsors and collaborators