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Could a new Antibody-Lowering drug ease autoimmune brain inflammation?

NCT ID NCT07583641

Disease control Sponsor: argenx 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Aug 25, 2026 · Updated 7 times

Summary

This Phase 2 trial tests efgartigimod PH20 SC, a drug that lowers harmful antibodies, in 170 adults and teens with autoimmune encephalitis (AIE). Participants receive either the drug or a placebo, and researchers measure changes in disability and symptoms over up to 3 years. The goal is to see if the drug can safely improve outcomes for people with this rare brain condition.

What this could mean

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

Active substance
efgartigimod PH20 SC (a drug that lowers harmful antibodies)
What this could lead to
If it works, this could point toward a new treatment option for autoimmune encephalitis, potentially reducing disability and improving daily function.
What could go wrong
This is an early Phase 2 trial with only 170 participants, so results may not apply to everyone. The drug may not work better than placebo, and side effects are still being studied.

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 170 people

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

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

May 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

12 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: * Is at least 12 years of age. * Meeting at least the criteria for possible AIE according to the Graus criteria. * Part A: Must not have received prior treatment for AIE with PLEX or Ig (participants may have received glucocorticoids); and must not have received PLEX or Ig for any other medical condition in the last 3 months \- Part B: Either completing Part A, or If directly entering Part B, must have received first-line treatment for AIE (i.e. corticosteroids, PLEX, and/or Ig) and have a CASE score of 3 or higher, or a score of 2 or higher in a single sub-item Exclusion Criteria: * Known anti-myelin oligodendrocyte glycoprotein (anti-MOG) antibody positivity. * Any medical condition that would interfere with an accurate assessment of clinical symptoms of AIE. * Recent major surgery (within 3 months of screening) or intention to have major surgery during the study, except for surgeries for AIE-related teratomas and thymomas. * History (within 12 months before screening) of current alcohol, drug (including recreational or prescribed cannabinoids), or medication abuse. * Psychiatric or cognitive impairment unrelated to AIE.

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Conditions

The condition(s) this trial relates to.

autoimmune disorder of the nervous system autoimmune encephalitis

As listed by the trial registrant

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

Autoimmune encephalitis (AE)

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

    2 sites. 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

  • Center for Neurosciences

    RECRUITING

    Tucson, Arizona, 85718, United States

  • Texas Institute for Neurological Disorders

    RECRUITING

    Sherman, Texas, 75092-7371, United States

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