Tanruprubart (ANX005) treatment for Guillain-Barré syndrome (FORWARD)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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.

Where it's running

• St. Joseph's Hospital & Medical Center - Barrow Neurological Institute (Dignity Health)
  Phoenix, Arizona, United States Recruiting
• HonorHealth Bob Bové Neuroscience Institute
  Scottsdale, Arizona, United States Recruiting
• Profound Research LLC
  Carlsbad, California, United States Recruiting
• Loma Linda
  Loma Linda, California, United States Recruiting
• Children's Hospital of Orange County
  Orange, California, United States Recruiting
• University of California Irvine
  Orange, California, United States Recruiting

Study contacts

• Study coordinator: Study Coordinator
• Email: clinicaltrials@annexonbio.com
• Phone: 1-650-822-5500

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Breathing support options for adults with Guillain-Barré respiratory failure

  This will test whether high-velocity nasal cannula or bi-level noninvasive ventilation works better for adults with Guillain-Barré syndrome who have severe breathing problems.

  Recruiting at 2 sites Assiut University · Asyut, Assuit and 1 other locations · NCT06996509

• Comparing early and late tracheostomy in patients with Guillain-Barre syndrome

  This study is testing if doing a tracheostomy sooner rather than later can help patients with Guillain-Barre syndrome who need breathing support recover faster and have better outcomes.

  Recruiting Meir Medical Center · Kfar Saba · NCT06612242

• Identifying biomarkers for autoimmune diseases affecting the nervous system

  This study is trying to find specific markers in the blood of people with autoimmune diseases affecting the nervous system, like Multiple Sclerosis, to help with early diagnosis and better treatment options.

  Recruiting Tongji Hospital · Wuhan · NCT06502015

• Observational study on Guillain-Barre Syndrome at a single center

  This study looks at the experiences of adults with Guillain-Barre Syndrome over the last 15 years to see how often it occurs, what symptoms they have, and how different treatments affect their recovery.

  Recruiting University Hospital, Basel, Switzerland · Basel · NCT04829526

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.