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New hope for GBS: Single-Dose drug enters final testing

NCT ID NCT07020819

Disease control Sponsor: Annexon, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a single dose of tanruprubart (ANX005) in 30 adults and children with Guillain-Barré syndrome (GBS), a rare nerve disorder that causes weakness. The goal is to see how the drug works in the body, its early effects, and its safety. Participants must have GBS symptoms for 10 days or less and have not received standard treatments like plasma exchange or IV immunoglobulin.

Why investors are watching

Annexon is running a Phase 3 trial of its drug tanruprubart (ANX005) in 30 people with Guillain-Barré syndrome, a rare nerve disease. For a micro-cap company, this single readout can determine whether the drug works well enough to move toward approval, making the result a major event for the company's future.

If it works: If the trial shows the drug is safe and improves symptoms in these patients, Annexon could have a viable treatment for a disease with few options. That positive data might support further development and eventual regulatory approval.

If it fails: The trial could fail to show meaningful benefit, or safety problems could emerge, which would likely set the program back. Trials in small patient groups often miss their goals, so a disappointing result is a real possibility for a company this size.

AI-written from the trial record. Speculative, and not investment advice.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 30 people

The number the study aims to enrol. It can still change while the study runs.

Started

Sep 2025

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

Guillain-Barre syndrome

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Guillain-Barre syndrome

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    13 sites in 2 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Aarhus University Hospital

    RECRUITING

    Aarhus, Aarhus N, 8200, Denmark

  • Children's Hospital of Orange County

    RECRUITING

    Orange, California, 92868, United States

  • Henry Ford Health

    RECRUITING

    Detroit, Michigan, 48202, United States

  • HonorHealth Bob Bové Neuroscience Institute

    RECRUITING

    Scottsdale, Arizona, 85251, United States

  • Mayo Clinic Florida

    RECRUITING

    Jacksonville, Florida, 32224, United States

  • Mayo Rochester

    RECRUITING

    Rochester, Minnesota, 55905, United States

  • Ochsner LSU Health

    RECRUITING

    Shreveport, Louisiana, 71101, United States

  • Profound Research LLC

    RECRUITING

    Carlsbad, California, 92011, United States

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

    RECRUITING

    Phoenix, Arizona, 85013, United States

  • University Massachusetts Chan Medical School

    RECRUITING

    Worcester, Massachusetts, 01655, United States

  • University of California Irvine

    RECRUITING

    Orange, California, 92868, United States

  • University of Colorado Hospital

    RECRUITING

    Aurora, Colorado, 80045, United States

  • University of Kansas Medical Center

    RECRUITING

    Kansas City, Kansas, 66160, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.