An Open Label Clinical Study to Evaluate Tanruprubart (Also Commonly Known as ANX005) in Participants With Guillain-Barré Syndrome (FORWARD Study)
Purpose
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.
Condition
- Guillain-Barre Syndrome
Eligibility
- Eligible Ages
- Between 12 Years and 85 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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.
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.
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- N/A
- Intervention Model
- Single Group Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Tanruprubart |
Participants will receive a single 30 mg/kg intravenous (IV) infusion of tanruprubart on Day 1. |
|
Recruiting Locations
University of Kansas Medical Center
Kansas City, Kansas 66160
Kansas City, Kansas 66160
More Details
- Status
- Recruiting
- Sponsor
- Annexon, Inc.