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NCT Number: NCT07020819

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

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.

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Key information

Conditions

Guillain-Barre Syndrome Autoimmune Diseases Autoimmune Diseases of the Nervous System Chronic Disease Demyelinating Diseases Disease Attributes Immune System Diseases Nervous System Diseases Neuromuscular Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Polyneuropathies Polyradiculoneuropathy Post-Infectious Disorders

Age range

12 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Aarhus University Hospital, Aarhus, Aarhus N, Denmark

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tanruprubart

Drug

Solution for IV infusion.

Other names: ANX005

Primary outcomes

  1. Area Under the Tanruprubart Serum Concentration-time Curve to the Last Sample (AUC0-t)

    Time frame: Up to Day 15

  2. Observed Time to Maximum Observed Serum Concentration (Cmax) (Tmax) of Tanruprubart

    Time frame: Up to Day 15

Secondary outcomes

  1. Change From Baseline in Free Component of Complement Complex (C1q) Protein Concentration in Serum

    Time frame: Baseline up to Day 15

  2. Change from Baseline in Medical Research Council (MRC) Sumscore at Week 1

    Time frame: Baseline, Week 1

Study contacts

Contact information is provided by the study sponsor or research team.

Study Coordinator

CONTACT

[email protected]

1-650-822-5500

Sponsors and collaborators

Lead sponsor

Annexon, Inc.

Industry

Registry information

Official study title

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)

Important dates

Study start
2025
Primary completion
2026
Study completion
2028
First posted
Jun 13, 2025
Registry last updated
May 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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