RecruitingPhase 3NCT07020819
An Open Label Clinical Study to Evaluate Tanruprubart (Also Commonly Known as ANX005) in Participants With Guillain-Barré Syndrome (FORWARD Study)
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)
Sponsor
Annexon, Inc.
Enrollment
30 participants
Start Date
Sep 12, 2025
Study Type
INTERVENTIONAL
Conditions
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
Min Age: 12 YearsMax Age: 85 Years
Inclusion Criteria3
- 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 Criteria3
- 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.
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Interventions
DRUGTanruprubart
Solution for IV infusion.
Locations(9)
View Full Details on ClinicalTrials.gov
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NCT07020819
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