Recruiting

Phase 3

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

Sponsor:

Annexon, Inc.

Code:

NCT07020819

Conditions

Guillain-Barre Syndrome

Eligibility Criteria

Sex: All

Age: 12 - 70+

Healthy Volunteers: Not accepted

Interventions

Tanruprubart

Study Details

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.

Conditions

Guillain-Barre Syndrome

Study ID

NCT07020819

Start date

Sep 12, 2025

Status verified date

May, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Sex: All

Age: 12 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Tanruprubart

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

Interventions

Tanruprubart

Solution for IV infusion.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Study Coordinator

1-650-822-5500 clinicaltrials@annexonbio.com

Locations

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

Recruiting

Phoenix, Arizona, United States, 85013

HonorHealth Bob Bové Neuroscience Institute

Recruiting

Scottsdale, Arizona, United States, 85251

Profound Research LLC

Recruiting

Carlsbad, California, United States, 92011

Children's Hospital of Orange County

Recruiting

Orange, California, United States, 92868

University of California Irvine

Recruiting

Orange, California, United States, 92868

University of Colorado Hospital

Recruiting

Aurora, Colorado, United States, 80045

Mayo Clinic Florida

Recruiting

Jacksonville, Florida, United States, 32224

University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

Ochsner LSU Health

Recruiting

Shreveport, Louisiana, United States, 71101

University Massachusetts Chan Medical School

Recruiting

Worcester, Massachusetts, United States, 01655

Henry Ford Health

Recruiting

Detroit, Michigan, United States, 48202

Mayo Rochester

Recruiting

Rochester, Minnesota, United States, 55905

More Information

Sponsor

Annexon, Inc.

Last update posted

May 28, 2026

Last verified

May, 2026

Keywords

Guillain-Barre Syndrome
GBS
ANX005
Tanruprubart
FORWARD study

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Annexon, Inc. on 2026-05-28.