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

What this Trial Is About

Researchers are studying tanruprubart, also known as ANX005, in people aged 12 to 85 who have Guillain-Barré Syndrome (GBS). This open-label Phase 3 study aims to understand how the drug moves through and affects the body, as well as its early effectiveness and safety. The study is conducted in the United States, Canada, and Europe and is sponsored by Annexon, Inc. Participants will receive a single intravenous infusion of tanruprubart at a dose of 30 mg/kg on the first day of the study. There are no other treatment groups or placebo arms; all participants get the study drug. The trial focuses on monitoring drug levels and biological effects up to 15 days after infusion. During the study, researchers will measure how much tanruprubart is in the blood over time and the time to reach the highest concentration. They will also assess changes in a protein involved in the immune response and muscle strength scores up to one week after treatment. The total participation period includes assessments through day 15, with safety and efficacy monitored throughout.

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