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RecruitingNCT07020819Updated Oct 26, 2026

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

A Phase 3 interventional study of Tanruprubart in Guillain-Barre Syndrome, sponsored by Annexon, Inc.. Recruiting at 30 sites in 5 countries. Open to participants aged 8 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-10-26.

Sponsored by Annexon, Inc. · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Sep 2025; still recruiting 1 year 1 month later.
Updated Oct 26, 2026First sites in France, Spain and United KingdomPrimary completion moved+3 moreGo to Updates ↓
Phase
Phase 3
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
8 Years to 85 Years
Sex
All
01

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.

02

Conditions studied

  • Guillain-Barre Syndrome

Keywords

  • Guillain-Barre Syndrome
  • GBS
  • ANX005
  • Tanruprubart
  • FORWARD study
03

In context

Guillain-Barre Syndrome

96 studies on the registry are indexed under Guillain-Barre Syndrome; 28 are open to participants now.

This study's planned enrollment of 30 is below the median of 50 across 43 interventional studies indexed under Guillain-Barre Syndrome.

Browse Guillain-Barre Syndrome studies →

Lead sponsor

Annexon, Inc. is the lead sponsor of 16 studies on the registry; 2 are open to participants now.

Of its 8 completed or terminated interventional studies of FDA-regulated products, 3 (38%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Oct 19, 2026. See what changed

Ages eligible
8 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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 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.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Tanruprubart

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

    Drug: Tanruprubart

Interventions

  • DrugTanruprubart

    Solution for IV infusion.

    Also known as: ANX005

06

What researchers measure

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

07

Study locations

30 of 30 sites recruiting
08

References and documents

Related links

Individual participant data

Plan to share: No

09

Updates

2 registry updates since Sep 25, 2026
Sites
18 sites added, 1 site removed — first sites in France, Spain and United Kingdom
Show 18 added (11 United States, 3 United Kingdom, 2 Spain, 1 Denmark, 1 France)
  • St. Joseph's Hospital & Medical Center - Barrow Neurological Institute (Dignity Health) · Phoenix, United States
  • Loma Linda · Loma Linda, United States
  • Stanford University · Palo Alto, United States
  • Georgetown · Washington D.C., United States
  • University of Michigan · Ann Arbor, United States
  • Dartmouth Hitchcock Medical Center · Lebanon, United States
  • Duke University · Durham, United States
  • Cleveland Clinic · Cleveland, United States
  • University of Virginia Department of Neurology · Charlottesville, United States
  • Righospitalet - Copenhagen Neuromuscular Center · Østerbro, Denmark
  • Hospital Bicêtre · Le Kremlin-Bicêtre, France
  • Hospital Universitario de Bellvitge · L'Hospitalet de Llobregat, Spain
  • Hospital Universitario Infanta Sofia · San Sebastián de los Reyes, Spain
  • Queen Elizabeth Hospital · Edgbaston, United Kingdom
  • Queen Elizabeth University Hospital · Glasgow, United Kingdom
  • University of Oxford - West Wing John Radcliffe Hospital · Oxford, United Kingdom
  • Albany Medical Center · Albany, United States
  • Children's Hospital of Philadelphia · Philadelphia, United States
Show 1 removed
  • St. Joseph's Hospital & Medical Center - Barrow Neurological Institute · Phoenix, United States
across 2 updates, Oct 19, 2026 – Oct 26, 2026
Primary completion
Dec 31, 2026→May 31, 2027
Oct 19, 2026
Eligibility
Minimum age 12 Years→8 Years; 2 criteria edited
What changed in the criteria
  • EditedPrevious or intendedplanned treatment with either plasma exchange or IV immunoglobulin for GBSwithin 90 days of Day 1.
  • ChangedBefore Diagnosis of a variant of GBS, including Miller Fisher syndrome, Bickerstaff's encephalitis, and overlap syndromes.Now Diagnosis of any form of GBS that does not involve weakness of the extremities.
Oct 19, 2026
Show all 2 updates
  1. Oct 26, 2026
    2 sites added
    Show 2 added (2 United States)
    • Albany Medical Center · Albany, United States
    • Children's Hospital of Philadelphia · Philadelphia, United States
  2. Oct 19, 2026
    16 sites added, 1 site removed — first sites in France, Spain and United Kingdom
    Show 16 added (9 United States, 3 United Kingdom, 2 Spain, 1 Denmark, 1 France)
    • St. Joseph's Hospital & Medical Center - Barrow Neurological Institute (Dignity Health) · Phoenix, United States
    • Loma Linda · Loma Linda, United States
    • Stanford University · Palo Alto, United States
    • Georgetown · Washington D.C., United States
    • University of Michigan · Ann Arbor, United States
    • Dartmouth Hitchcock Medical Center · Lebanon, United States
    • Duke University · Durham, United States
    • Cleveland Clinic · Cleveland, United States
    • University of Virginia Department of Neurology · Charlottesville, United States
    • Righospitalet - Copenhagen Neuromuscular Center · Østerbro, Denmark
    • Hospital Bicêtre · Le Kremlin-Bicêtre, France
    • Hospital Universitario de Bellvitge · L'Hospitalet de Llobregat, Spain
    • Hospital Universitario Infanta Sofia · San Sebastián de los Reyes, Spain
    • Queen Elizabeth Hospital · Edgbaston, United Kingdom
    • Queen Elizabeth University Hospital · Glasgow, United Kingdom
    • University of Oxford - West Wing John Radcliffe Hospital · Oxford, United Kingdom
    Show 1 removed
    • St. Joseph's Hospital & Medical Center - Barrow Neurological Institute · Phoenix, United States
    Primary completion Dec 31, 2026→May 31, 2027
    Eligibility Minimum age 12 Years→8 Years; 2 criteria edited
    What changed in the criteria
    • EditedPrevious or intendedplanned treatment with either plasma exchange or IV immunoglobulin for GBSwithin 90 days of Day 1.
    • ChangedBefore Diagnosis of a variant of GBS, including Miller Fisher syndrome, Bickerstaff's encephalitis, and overlap syndromes.Now Diagnosis of any form of GBS that does not involve weakness of the extremities.
    + 2 other changes: identifiers and verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07020819
Lead sponsor
Annexon, Inc.
Responsible party
Sponsor
First posted
Jun 13, 2025
Start date
Sep 12, 2025
Primary completion
May 31, 2027 (estimated)
Completion
Jun 30, 2028 (estimated)
Last update
Oct 26, 2026

Study contacts

Study Coordinator
Contact
clinicaltrials@annexonbio.com
1-650-822-5500
Clinical Trials
study director · Annexon, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Tanruprubart

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