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NCT07020819PHASE3Recruiting

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

Annexon, Inc.

Start Date

9/12/2025

Completion Date

6/30/2028

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.

Eligibility Criteria

Age Range: 12 years to 85 years

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.

Interventions

DRUG

Tanruprubart

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Conditions

Guillain-Barre Syndrome

Locations

St. Joseph's Hospital & Medical Center - Barrow Neurological Institute

Phoenix, Arizona 85013

United States

HonorHealth Bob Bové Neuroscience Institute

Scottsdale, Arizona 85251

United States

Profound Research LLC

Carlsbad, California 92011

United States

Children's Hospital of Orange County

Orange, California 92868

United States

University of California Irvine

Orange, California 92868

United States

University of Colorado Hospital

Aurora, Colorado 80045

United States

Mayo Clinic Florida

Jacksonville, Florida 32224

United States

University of Kansas Medical Center

Kansas City, Kansas 66160

United States

Ochsner LSU Health

Shreveport, Louisiana 71101

United States

University Massachusetts Chan Medical School

Worcester, Massachusetts 01655

United States

Henry Ford Health

Detroit, Michigan 48202

United States

Mayo Rochester

Rochester, Minnesota 55905

United States

Aarhus University Hospital

Aarhus, Aarhus N 8200

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