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Could an immune drug ease schizophrenia symptoms?

NCT ID NCT07680946

Disease control Sponsor: TG Therapeutics, 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 02, 2026 · Last updated Aug 27, 2026 · Updated 4 times

Summary

This phase 2 trial tests whether ublituximab, an immune-modulating drug, can reduce symptoms in people with treatment-resistant schizophrenia. Participants receive the drug by IV infusion, and researchers measure changes in symptom scores over time. The goal is to see if targeting the immune system might help when standard antipsychotics fail.

What this could mean

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

Active substance
ublituximab (also known as BRIUMVI)
What this could lead to
If successful, this could point toward a new treatment option for people with schizophrenia who do not respond to standard antipsychotics.
What could go wrong
This is an early phase 2 trial with only 60 participants, so results may not apply to everyone. The drug may cause infusion reactions or infections, and its effect on schizophrenia symptoms is unproven.

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 60 people

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

Started

Jul 2026

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 to 60 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.

Inclusion Criteria: 1. Primary diagnosis of schizophrenia. 2. Treatment-resistant. 3. Requires antipsychotic treatment and is currently receiving "standard of care". 4. PANSS total score between 80 and 120, inclusive at screening and baseline. Exclusion Criteria 1. Any primary Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) disorder other than schizophrenia. 2. Ongoing clozapine treatment. 3. Risk for suicidal behavior. 4. Any severe or uncontrolled medical condition that could affect the participant's ability to participate. Note: Other protocol-specified Inclusion/Exclusion criteria may apply

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Conditions

The condition(s) this trial relates to.

schizophrenia

As listed by the trial registrant

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

Schizophrenia

How to take part

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

  1. The places running it

    2 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

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Little Rock, Arkansas, 72204, United States

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Richardson, Texas, 75080, United States

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