Tanruprubart (ANX005) treatment for Guillain-Barré syndrome (FORWARD)
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)
This study will test tanruprubart (ANX005) in adults and children with recent-onset Guillain-Barré syndrome to see if it is safe, how the drug behaves in the body, and whether it helps recovery.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 12 Years to 85 Years |
| Sex | All |
| Sponsor | Annexon, Inc. Industry-sponsored |
| Locations | 9 sites (Scottsdale, Arizona and 8 other locations) |
| Trial ID | NCT07020819 on ClinicalTrials.gov |
What this trial studies
This is an open-label Phase 3 trial of tanruprubart (ANX005) in adult and pediatric participants with Guillain-Barré syndrome, measuring pharmacokinetics, pharmacodynamics, early efficacy signals, and safety. Participants must have symptom onset within 10 days and a GBS disability score of 3, 4, or 5, and those who have received or plan to receive IV immunoglobulin or plasma exchange are excluded. The protocol enrolls patients across sites in the United States, Canada, and Europe, with infusions initiated on Day 1 and follow-up assessments to capture clinical course and laboratory markers. The design is open-label without a blinded control, focusing on drug behavior and safety in a population early in disease.
Who should consider this trial
Good fit: Adults and children diagnosed with GBS per NINDS criteria who have weakness onset within the past 10 days, a GBS disability score of 3–5, and who have not received IVIG or plasma exchange are ideal candidates.
Not a fit: Patients who have already received or plan to receive standard treatments like IVIG or plasma exchange, or those diagnosed with GBS variants (for example Miller Fisher syndrome), are not eligible and are unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the drug could provide a targeted therapy that limits immune-mediated nerve damage and speeds recovery from Guillain-Barré syndrome.
How similar studies have performed: Complement-targeting approaches such as ANX005 have shown promise in preclinical studies and early-phase trials for immune neuropathies, but large-scale definitive success in GBS has not yet been established.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Scottsdale, Arizona and 8 other locations
- HonorHealth Bob Bové Neuroscience Institute — Scottsdale, Arizona, United States (Recruiting)
- Children's Hospital of Orange County — Orange, California, United States (Recruiting)
- University of California Irvine — Orange, California, United States (Recruiting)
- University of Colorado Hospital — Aurora, Colorado, United States (Recruiting)
- Ochsner LSU Health — Shreveport, Louisiana, United States (Recruiting)
- University Massachusetts Chan Medical School — Worcester, Massachusetts, United States (Recruiting)
- Henry Ford Health — Detroit, Michigan, United States (Recruiting)
- Mayo Rochester — Rochester, Minnesota, United States (Recruiting)
- Aarhus University Hospital — Aarhus, Aarhus N, Denmark (Recruiting)
Study contacts
- Study coordinator: Study Coordinator
- Email: clinicaltrials@annexonbio.com
- Phone: 1-650-822-5500
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.