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

NCT07020819 · tracked via the Priya Life Science USA tracker

Sponsor

Annexon, Inc.

Phase

Phase 3

Started

2025-09-12

Last updated

2026-05-28

Condition(s) studied

Guillain-Barre Syndrome

Investigational drug(s) / intervention(s)

Tanruprubart

Tanruprubart: Solution for IV infusion.

Study 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

Sex

ALL

Min age

12 Years

Max age

85 Years

Healthy volunteers

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.

Primary outcome measure(s)

Area Under the Tanruprubart Serum Concentration-time Curve to the Last Sample (AUC0-t) — Up to Day 15
Observed Time to Maximum Observed Serum Concentration (Cmax) (Tmax) of Tanruprubart — Up to Day 15

Trial sites (13)

Facility	City	Region	Status
St. Joseph's Hospital & Medical Center - Barrow Neurological Institute	Phoenix	Arizona	Recruiting
HonorHealth Bob Bové Neuroscience Institute	Scottsdale	Arizona	Recruiting
Profound Research LLC	Carlsbad	California	Recruiting
Children's Hospital of Orange County	Orange	California	Recruiting
University of California Irvine	Orange	California	Recruiting
University of Colorado Hospital	Aurora	Colorado	Recruiting
Mayo Clinic Florida	Jacksonville	Florida	Recruiting
University of Kansas Medical Center	Kansas City	Kansas	Recruiting
Ochsner LSU Health	Shreveport	Louisiana	Recruiting
University Massachusetts Chan Medical School	Worcester	Massachusetts	Recruiting
Henry Ford Health	Detroit	Michigan	Recruiting
Mayo Rochester	Rochester	Minnesota	Recruiting
Aarhus University Hospital	Aarhus	Aarhus N	Recruiting

More Annexon, Inc. trials in the USA

An Open-label Extension Study of the Long-Term Safety of Vonaprument (ANX007) in Participants With Dry Age-Related Macular Degeneration (AMD) With Geographic Atrophy (GA) Starting soon

A Study Investigating the Efficacy and Safety of Intravitreal (IVT) Injections of Vonaprument (Formerly ANX007) in Participants With Dry Age-Related Macular Degeneration (AMD) With Geographic Atrophy (GA) Active, not recruiting

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07020819 on ClinicalTrials.gov ↗ ← All trials in the USA