Ireland
--:--IST
Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
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 UK tracker
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
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 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)

FacilityCityRegionStatus
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
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 UK