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)

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07020819

Enrollment

Registered

2025-06-13

Start date

2025-09-12

Completion date

2028-06-30

Last updated

2026-05-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Guillain-Barre Syndrome

Keywords

Guillain-Barre Syndrome, GBS, ANX005, Tanruprubart, FORWARD study

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.

Interventions

DRUGTanruprubart

Solution for IV infusion.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

12 Years to 85 Years

Healthy volunteers

Inclusion 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.

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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

Countries

Denmark, United States

Contacts

CONTACTStudy Coordinator

clinicaltrials@annexonbio.com1-650-822-5500

STUDY_DIRECTORClinical Trials

Annexon, Inc.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 29, 2026