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New drug targets Antibody-Producing cells in brain inflammation

NCT ID NCT03993262

Disease control Sponsor: Jena University Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This phase 2 trial tests whether bortezomib, a drug that targets antibody-producing cells, can help people with severe autoimmune encephalitis. In this condition, the body's own antibodies attack the brain. The study will enroll 50 adults who have already tried another treatment (rituximab). Participants will receive either bortezomib or a placebo, along with dexamethasone, and be followed for 17 weeks to see if their symptoms improve.

What this could mean

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

Active substance
bortezomib
What this could lead to
If it works, this could provide a more targeted treatment for severe autoimmune encephalitis by directly attacking the cells that produce harmful antibodies.
What could go wrong
This is a small, early-phase trial with only 50 participants, so results may not apply to everyone. Bortezomib also has side effects like nerve damage and low blood cell counts.

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 50 people

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

Started

May 2020

Expected to finish

Dec 2026

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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: * Clinically diagnosed severe autoimmune encephalitis (defined as mRS ≥ 3) with autoantibodies to neuronal surface proteins in cerebrospinal fluid and / or serum * Pretreatment with rituximab * Age ≥18 years * signed informed consent * Women of childbearing potential (up to 2 years after menopause): negative pregnancy test Exclusion Criteria: * pregnancy/breast-feeding * acute infiltrative pulmonary and pericardial disease * malignant tumor under current chemotherapy * Simultaneous participation in another intervention study * Previous participation in this study * Known hypersensitivity to an ingredient of the investigational product * Continued therapy with glucocorticoids / rituximab during the study duration (last dose must be administered before the first dose of the investigational product)

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Conditions

The condition(s) this trial relates to.

autoimmune disease autoimmune disorder of the nervous system autoimmune encephalitis encephalitis

As listed by the trial registrant

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

Autoimmune encephalitis

How to take part

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

  1. The places running it

    17 sites. The list below names each one and where it is.

  2. 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 ↗

  3. 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

Locations

  • Charité - Universitätsmedizin Berlin, Klinik für Neurologie mit Experimenteller Neurologie

    RECRUITING

    Berlin, 10117, Germany

  • Klinik für Neurologie UKSH, Campus Kiel

    RECRUITING

    Kiel, 24105, Germany

  • Ludwig-Maximilians-Universität München, Klinikum Großhadern

    RECRUITING

    München, Bavaria, 81377, Germany

  • Medizinische Hochschule Hannover

    RECRUITING

    Hanover, Niedersachen, 30625, Germany

  • Ruhr-Universität Bochum, St. Josef Hospital, Klinik für Neurologie

    RECRUITING

    Bochum, 44791, Germany

  • University Hospital Düsseldorf, Clinic for Neurology

    RECRUITING

    Düsseldorf, 40225, Germany

  • University Hospital Frankfurt (Main), Clinic for Neurology

    RECRUITING

    Frankfurt, 60528, Germany

  • Universitätsklinikum Erlangen, Neurologische Klinik

    RECRUITING

    Erlangen, 91054, Germany

  • Universitätsklinikum Essen (AöR), Klinik für Neurologie

    RECRUITING

    Essen, 45147, Germany

  • Universitätsklinikum Jena, Sektion Translationale Neuroimmunologie, Klinik für Neurologie

    RECRUITING

    Jena, Germany, 07747, Germany

  • Universitätsklinikum Leipzig, Klinik und Poliklinik für Neurologie

    RECRUITING

    Leipzig, 04103, Germany

  • Universitätsklinikum Münster Klinik für Neurologie

    RECRUITING

    Münster, 48149, Germany

  • Universitätsklinikum Ulm, Klinik für Neurologie Neurologische Ambulanz

    RECRUITING

    Ulm, 89081, Germany

  • Universitätsklinikum Würzburg

    RECRUITING

    Würzburg, Bavaria, 97080, Germany

  • Universitätsmedizin Greifswald, Klinik und Poliklinik für Neurologie

    RECRUITING

    Greifswald, 17475, Germany

  • Universitätsmedizin Göttingen Georg-August-Universität, Klinik für Neurologie

    RECRUITING

    Göttingen, 37075, Germany

  • Universitätsmedizin Mainz, Klinik und Poliklinik für Neurologie

    RECRUITING

    Mainz, 55131, Germany

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