NCT07020819

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for phase_3

Timeline
26mo left

Started Sep 2025

Typical duration for phase_3

Geographic Reach
2 countries

9 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress23%
Sep 2025Jun 2028

First Submitted

Initial submission to the registry

June 6, 2025

Completed
7 days until next milestone

First Posted

Study publicly available on registry

June 13, 2025

Completed
3 months until next milestone

Study Start

First participant enrolled

September 12, 2025

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2028

Last Updated

February 20, 2026

Status Verified

February 1, 2026

Enrollment Period

1.3 years

First QC Date

June 6, 2025

Last Update Submit

February 18, 2026

Conditions

Guillain-Barre Syndrome

Keywords

Guillain-Barre SyndromeGBSANX005TanruprubartFORWARD study

Outcome Measures

Primary Outcomes (2)

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

    Up to Day 15

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

    Up to Day 15

Secondary Outcomes (2)

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

    Baseline up to Day 15

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

    Baseline, Week 1

Study Arms (1)

Tanruprubart

EXPERIMENTAL

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

Drug: Tanruprubart

Interventions

TanruprubartDRUG

Solution for IV infusion.

Also known as: ANX005
Tanruprubart

Eligibility Criteria

Age12 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (9)

HonorHealth Bob Bové Neuroscience Institute

Scottsdale, Arizona, 85251, United States

RECRUITING

Children's Hospital of Orange County

Orange, California, 92868, United States

RECRUITING

University of California Irvine

Orange, California, 92868, United States

RECRUITING

University of Colorado Hospital

Aurora, Colorado, 80045, United States

RECRUITING

Ochsner LSU Health

Shreveport, Louisiana, 71101, United States

RECRUITING

University Massachusetts Chan Medical School

Worcester, Massachusetts, 01655, United States

RECRUITING

Henry Ford Health

Detroit, Michigan, 48202, United States

RECRUITING

Mayo Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Aarhus University Hospital

Aarhus, Aarhus N, 8200, Denmark

RECRUITING

Related Links

MeSH Terms

Conditions

Guillain-Barre Syndrome

Condition Hierarchy (Ancestors)

PolyradiculoneuropathyAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesPolyneuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesAutoimmune DiseasesImmune System DiseasesPost-Infectious DisordersChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Clinical Trials

    Annexon, Inc.

    STUDY DIRECTOR

Central Study Contacts

Study Coordinator

CONTACT

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

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2025

First Posted

June 13, 2025

Study Start

September 12, 2025

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

June 30, 2028

Last Updated

February 20, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

US(8)DK(1)