An Open Label Clinical Study to Evaluate Tanruprubart (Also Commonly Known as ANX005) in Participants With Guillain-Barré Syndrome (FORWARD Study)

Annexon

Status and phase: Not yet enrolling; Phase 3

Conditions: Guillain-Barre Syndrome

Treatments: Drug: Tanruprubart

Study type: Interventional

Funder types: Industry

Identifiers

NCT07020819

ANX005-GBS-05

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 12 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Tanruprubart

Experimental group

Description:

Participants will receive a single 30 mg/kg intravenous (IV) infusion of tanruprubart on Day 1.

Treatment:

Drug: Tanruprubart