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Recruiting
NCT07020819
An Open Label Clinical Study to Evaluate Tanruprubart (Also Commonly Known as ANX005) in Participants With Guillain-Barré Syndrome (FORWARD Study)
Conditions: Guillain-Barre Syndrome
Sex: All
Ages: 8 Years – 85 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 30
Sponsor: Annexon, Inc.
Location: St. Joseph's Hospital & Medical Center - Barrow Neurological Institute (Dignity Health) Phoenix Arizona
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 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 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.
Source: ClinicalTrials.gov (NCT07020819). StuddyBuddy aggregates publicly available trial information.