Clinical Trials in the UK / 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 UK tracker
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
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 UK
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