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Clinical Trials in France / NCT07020819
Recruiting Phase 3

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 France tracker
Sponsor
Annexon, Inc
Phase
Phase 3
Started
2025-09-12
Last updated
2026-10-19

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
8 Years
Max age
85 Years
Healthy volunteers
No
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 planned treatment with either plasma exchange or IV immunoglobulin within 90 days of Day 1. * Diagnosis of any form of GBS that does not involve weakness of the extremities. 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 (28)

FacilityCityRegionStatus
St. Joseph's Hospital & Medical Center - Barrow Neurological Institute (Dignity Health) Phoenix Arizona Recruiting
HonorHealth Bob Bové Neuroscience Institute Scottsdale Arizona Recruiting
Profound Research LLC Carlsbad California Recruiting
Loma Linda Loma Linda California Recruiting
Children's Hospital of Orange County Orange California Recruiting
University of California Irvine Orange California Recruiting
Stanford University Palo Alto California Recruiting
University of Colorado Hospital Aurora Colorado Recruiting
Georgetown Washington D.C. District of Columbia 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
University of Michigan Ann Arbor Michigan Recruiting
Henry Ford Health Detroit Michigan Recruiting
Mayo Rochester Rochester Minnesota Recruiting
Dartmouth Hitchcock Medical Center Lebanon New Hampshire Recruiting
Duke University Durham North Carolina Recruiting
Cleveland Clinic Cleveland Ohio Recruiting
University of Virginia Department of Neurology Charlottesville Virginia Recruiting
Aarhus University Hospital Aarhus Aarhus N Recruiting
Righospitalet - Copenhagen Neuromuscular Center Østerbro Copenhagen Recruiting
Hospital Bicêtre Le Kremlin-Bicêtre Cedex Recruiting
Hospital Universitario de Bellvitge L'Hospitalet de Llobregat Barcelona Recruiting
Hospital Universitario Infanta Sofia San Sebastián de los Reyes Madrid Recruiting
Queen Elizabeth Hospital Edgbaston Birmingham Recruiting
Queen Elizabeth University Hospital Glasgow United Kingdom Recruiting
University of Oxford - West Wing John Radcliffe Hospital Oxford United Kingdom Recruiting

More Annexon, Inc. trials in France

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 France