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Can a second antibody drug help Guillain-Barré patients walk again sooner?

NCT ID NCT07821762

Disease control Sponsor: argenx Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 16, 2026 · Last updated Sep 17, 2026 · Updated 1 time

Summary

Guillain-Barré syndrome (GBS) is a rare condition where the immune system attacks nerves, causing weakness that can progress to paralysis. Standard treatment is intravenous immunoglobulin (IVIg), but recovery is often slow. This phase 2 trial tests whether adding an experimental drug called empasiprubart to IVIg helps adults with GBS regain the ability to walk without assistance by week 4. About 63 participants will be randomly assigned to receive either empasiprubart or a placebo, both given by IV infusion alongside IVIg. Researchers will track walking ability, time spent in intensive care, and side effects over 15 months.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
empasiprubart, an experimental antibody drug given alongside standard IVIg therapy
What this could lead to
If it works, adding empasiprubart to standard IVIg could help people with Guillain-Barré syndrome regain the ability to walk sooner and spend less time in intensive care.
What could go wrong
This is a small phase 2 trial with about 63 participants, so any benefit seen may not hold up in larger studies. Empasiprubart is experimental, and combining it with IVIg could cause side effects that outweigh the benefits.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 63 people

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

Expected to start

Dec 2026

An estimate. Start dates often move.

Expected to finish

Mar 2029

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

18 years and older

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.

Inclusion Criteria: * At least 18 years old * Clinically diagnosed with Guillain-Barré syndrome (GBS) according to NINDS (National Institute of Neurological Disorders and Stroke) diagnostic criteria * GBS-related weakness beginning within 7 days before the first study treatment * GBS Disability Scale (GBS-DS) score of 3, 4, or 5 at screening and baseline * Was able to walk approximately 10 m or more without assistance before the onset of GBS symptoms * Agrees to receive antibiotic prophylaxis against N. meningitidis and S. pneumoniae for the first 90 days of the study or until a completed vaccination schedule against these bacterial pathogens per local guidelines has been shown. Exclusion Criteria: * History of a previous GBS episode or diagnosis of an atypical GBS variant * Clinical diagnosis of systemic lupus erythematosus (SLE) or known complement deficiency * Autoimmune or neuromuscular diseases or medical conditions (eg, clinically significant renal, hepatic, cardiac, pulmonary, hematologic, or neurological conditions or clinically significant laboratory abnormalities) that would interfere with an accurate assessment of clinical symptoms of GBS, confound the study results, or put the participant at undue risk * IVIg therapy contraindications or another medical condition that, in the opinion of the investigator, would make IVIg administration unsafe * Recent treatment with IVIg or plasma exchange (PLEX), or recent use of certain immune-modulating or immunosuppressive therapies

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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-Barré syndrome (GBS)

How to take part

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  1. The study's own enquiry address

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  2. The official record

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    Open the record ↗

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Contacts and locations

Study contacts

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