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

Phase 3

Not yet recruiting

• Conditions: Guillain-Barre Syndrome
• Interventions: Drug: Tanruprubart

• Registration Number: NCT07020819
• Lead Sponsor: Annexon, Inc.

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-06
• Study Start: 2025-06
• Study First Submitted: 2025-06-06
• Study First Submitted QC: 2025-06-06
• Last Update Submitted: 2025-06-06
• Study First Posted: 2025-06-13
• Last Update Posted: 2025-06-13
• Primary Completion: 2026-12
• Study Completion: 2028-06

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Area Under the Tanruprubart Serum Concentration-time Curve to the Last Sample (AUC0-t)	Up to Day 15
Observed Time to Maximum Observed Serum Concentration (Cmax) (Tmax) of Tanruprubart	Up to Day 15

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Free Component of Complement Complex (C1q) Protein Concentration in Serum	Baseline up to Day 15
Change from Baseline in Medical Research Council (MRC) Sumscore at Week 1	Baseline, Week 1