Home › NCT07020819
An Open Label Clinical Study to Evaluate Tanruprubart (Also Commonly Known as ANX005) in Participants With Guillain-Barré Syndrome (FORWARD Study)
RecruitingPhase 3
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)
Who can join
Ages 12 to 85 · All sexes
Full eligibility criteria
Key Inclusion Criteria: * 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. Key Exclusion Criteria: * 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.
About the study
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.
What is being tested
- Tanruprubart (drug)
Sponsor: Annexon, Inc. · Participants: 30 · Started: Sep 12, 2025
Contact the study team
- Study Coordinator · Phone: 1-650-822-5500
Official record on ClinicalTrials.gov — NCT07020819
Locations in the U.S.
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.