Guillain-Barre SyndromePhase 3NCT07020819
An Open Label Clinical Study to Evaluate Tanruprubart (Also Commonly Known as ANX005) in Participants With Guillain-Barré Syndrome (FORWARD Study)
A Phase 3 study testing Tanruprubart in people with Guillain-Barre Syndrome, run by Annexon, Inc. at 28 sites in 5 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 85 years
- Conditions the study is for
- Guillain-Barre Syndrome
- What is being tested?
- Tanruprubart
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 28 sitesin 5 countries
- Study dates
- 12 Sep 2025to 30 Jun 2028
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Previous or planned treatment with either plasma exchange or IV immunoglobulin within 90 days of Day 1.
- Diagnosis of any form of GBS that does not involve weakness of the extremities.
- Other protocol-defined criteria may apply.
Trial locations and contacts
28 sites in 5 countries. Contact the study team or a site near you to ask about taking part.
28 sites in 5 countries
United States20 sites, 20 recruiting
- Recruiting
University of Michigan
Ann Arbor, Michigan, 48109
- Recruiting
University of Colorado Hospital
Aurora, Colorado, 80045
- Recruiting
Profound Research LLC
Carlsbad, California, 92011
- Recruiting
University of Virginia Department of Neurology
Charlottesville, Virginia, 22903
- Recruiting
Cleveland Clinic
Cleveland, Ohio, 44195
- Recruiting
Henry Ford Health
Detroit, Michigan, 48202
- Recruiting
Duke University
Durham, North Carolina, 27710
- Recruiting
Mayo Clinic Florida
Jacksonville, Florida, 32224
- Recruiting
University of Kansas Medical Center
Kansas City, Kansas, 66160
- Recruiting
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, 03756
- Recruiting
Loma Linda
Loma Linda, California, 92354
- Recruiting
Children's Hospital of Orange County
Orange, California, 92868
- Recruiting
University of California Irvine
Orange, California, 92868
- Recruiting
Stanford University
Palo Alto, California, 94304
- Recruiting
St. Joseph's Hospital & Medical Center - Barrow Neurological Institute (Dignity Health)
Phoenix, Arizona, 85013
- Recruiting
Mayo Rochester
Rochester, Minnesota, 55905
- Recruiting
HonorHealth Bob Bové Neuroscience Institute
Scottsdale, Arizona, 85251
- Recruiting
Ochsner LSU Health
Shreveport, Louisiana, 71101
- Recruiting
Georgetown
Washington D.C., District of Columbia, 20007
- Recruiting
University Massachusetts Chan Medical School
Worcester, Massachusetts, 01655
United Kingdom3 sites, 3 recruiting
- Recruiting
Queen Elizabeth Hospital
Edgbaston, Birmingham, B15 2WB
- Recruiting
Queen Elizabeth University Hospital
Glasgow, G51 4TF
- Recruiting
University of Oxford - West Wing John Radcliffe Hospital
Oxford, OX3 9DU
Denmark2 sites, 2 recruiting
- Recruiting
Aarhus University Hospital
Aarhus, Aarhus N, 8200
- Recruiting
Righospitalet - Copenhagen Neuromuscular Center
Østerbro, Copenhagen, 2100
Spain2 sites, 2 recruiting
- Recruiting
Hospital Universitario de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
- Recruiting
Hospital Universitario Infanta Sofia
San Sebastián de los Reyes, Madrid, 28702
France1 site, 1 recruiting
- Recruiting
Hospital Bicêtre
Le Kremlin-Bicêtre, Cedex, 94725
About this study
Official title: An Open-Label Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Efficacy, and Safety of a Single Dose of ANX005 in Participants With Guillain-Barré Syndrome
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
- Being tested
- Tanruprubart
- Keywords
- Guillain-Barre Syndrome, GBS, ANX005, Tanruprubart, FORWARD study
- Medical subject headings
- Guillain-Barre Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TanruprubartDrug
Also called ANX005
Solution for IV infusion.
| Study group | Role | What they receive |
|---|---|---|
| Tanruprubart | Experimental | Participants will receive a single 30 mg/kg intravenous (IV) infusion of tanruprubart on Day 1. Receives: Drug: Tanruprubart |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Tanruprubart Serum Concentration-time Curve to the Last Sample (AUC0-t)
Measured: Up to Day 15
Observed Time to Maximum Observed Serum Concentration (Cmax) (Tmax) of Tanruprubart
Measured: Up to Day 15
Secondary outcomes (2)
Change From Baseline in Free Component of Complement Complex (C1q) Protein Concentration in Serum
Measured: Baseline up to Day 15
Change from Baseline in Medical Research Council (MRC) Sumscore at Week 1
Measured: Baseline, Week 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start12 Sep 2025
- Primary completion31 May 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Guillain-Barre SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Annexon, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Annexon, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07020819
- Sponsor's protocol ID
- ANX005-GBS-05
- Other IDs
- 2025-522664-32-00, 2025
- Status last verified
- Oct 2026
- First submitted
- 6 Jun 2025
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No