An Open-Label Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Efficacy, and Safety of a Single Dose of Tanruprubart (Also Commonly Known as ANX005) in Participants With Guillain-Barré Syndrome (GBS) (FORWARD Study)
Status: Recruiting
Location: See all (9) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 12
Maximum Age: 85
Healthy Volunteers: f
View:
• 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.
Locations
United States
Arizona
HonorHealth Bob Bové Neuroscience Institute
RECRUITING
Scottsdale
California
Children's Hospital of Orange County
RECRUITING
Orange
University of California Irvine
RECRUITING
Orange
Colorado
University of Colorado Hospital
RECRUITING
Aurora
Louisiana
Ochsner LSU Health
RECRUITING
Shreveport
Massachusetts
University Massachusetts Chan Medical School
RECRUITING
Worcester
Michigan
Henry Ford Health
RECRUITING
Detroit
Minnesota
Mayo Rochester
RECRUITING
Rochester
Other Locations
Denmark
Aarhus University Hospital
RECRUITING
Aarhus
Contact Information
Primary
Study Coordinator
clinicaltrials@annexonbio.com
1-650-822-5500
Time Frame
Start Date: 2025-09-12
Estimated Completion Date: 2028-06-30
Participants
Target number of participants: 30
Treatments
Experimental: Tanruprubart
Participants will receive a single 30 mg/kg intravenous (IV) infusion of tanruprubart on Day 1.
Related Therapeutic Areas
Sponsors
Leads: Annexon, Inc.