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

Last updated: May 27, 2026
Sponsor: Annexon, Inc.
Overall Status: Active - Recruiting

Phase

3

Condition

Neuropathy

Neurologic Disorders

Peripheral Neuropathy

Treatment

Tanruprubart

Clinical Study ID

NCT07020819
ANX005-GBS-05
2025-522664-32-00
  • Ages 12-85
  • All Genders

Study 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

Inclusion

Key Inclusion Criteria:

  • Diagnosis of GBS according to the National Institute of Neurological Disorders andStroke 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 ofinfusion on Day 1.

Exclusion

Key Exclusion Criteria:

  • Previous or intended treatment with either plasma exchange or IV immunoglobulin forGBS.

  • Diagnosis of a variant of GBS, including Miller Fisher syndrome, Bickerstaff'sencephalitis, and overlap syndromes.

Other protocol-defined criteria may apply.

Study Design

Total Participants: 30
Treatment Group(s): 1
Primary Treatment: Tanruprubart
Phase: 3
Study Start date:
September 12, 2025
Estimated Completion Date:
June 30, 2028

Connect with a study center

  • Aarhus University Hospital

    Aarhus, Aarhus N 8200
    Denmark

    Active - Recruiting

  • Aarhus University Hospital

    Aarhus 2624652, Aarhus N 8200
    Denmark

    Site Not Available

  • St. Joseph's Hospital & Medical Center - Barrow Neurological Institute

    Phoenix, Arizona 85013
    United States

    Active - Recruiting

  • HonorHealth Bob Bové Neuroscience Institute

    Scottsdale, Arizona 85251
    United States

    Active - Recruiting

  • HonorHealth Bob Bové Neuroscience Institute

    Scottsdale 5313457, Arizona 5551752 85251
    United States

    Site Not Available

  • Profound Research LLC

    Carlsbad, California 92011
    United States

    Active - Recruiting

  • Children's Hospital of Orange County

    Orange, California 92868
    United States

    Active - Recruiting

  • University of California Irvine

    Orange, California 92868
    United States

    Active - Recruiting

  • Children's Hospital of Orange County

    Orange 5379513, California 5332921 92868
    United States

    Active - Recruiting

  • University of California Irvine

    Orange 5379513, California 5332921 92868
    United States

    Site Not Available

  • University of Colorado Hospital

    Aurora, Colorado 80045
    United States

    Active - Recruiting

  • University of Colorado Hospital

    Aurora 5412347, Colorado 5417618 80045
    United States

    Site Not Available

  • Mayo Clinic Florida

    Jacksonville, Florida 32224
    United States

    Active - Recruiting

  • University of Kansas Medical Center

    Kansas City, Kansas 66160
    United States

    Active - Recruiting

  • Ochsner LSU Health

    Shreveport, Louisiana 71101
    United States

    Active - Recruiting

  • Ochsner LSU Health

    Shreveport 4341513, Louisiana 4331987 71101
    United States

    Site Not Available

  • University Massachusetts Chan Medical School

    Worcester, Massachusetts 01655
    United States

    Active - Recruiting

  • University Massachusetts Chan Medical School

    Worcester 4956184, Massachusetts 6254926 01655
    United States

    Site Not Available

  • Henry Ford Health

    Detroit, Michigan 48202
    United States

    Active - Recruiting

  • Henry Ford Health

    Detroit 4990729, Michigan 5001836 48202
    United States

    Site Not Available

  • Mayo Rochester

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • Mayo Rochester

    Rochester 5043473, Minnesota 5037779 55905
    United States

    Site Not Available

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