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Could a new drug help keep myasthenia gravis symptoms at bay?

NCT ID NCT07673744

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 29, 2026 · Last updated Aug 21, 2026 · Updated 3 times

Summary

This study tests whether ublituximab, given as an infusion, can help adults with myasthenia gravis maintain symptom control after initial treatment with efgartigimod. Participants will receive either ublituximab or a placebo, and researchers will track how long it takes for symptoms to worsen. The goal is to see if ublituximab can delay or prevent flare-ups in this autoimmune disease.

What this could mean

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

Active substance
ublituximab (BRIUMVI)
What this could lead to
If successful, this could provide a new maintenance option to help people with myasthenia gravis stay stable longer and delay symptom worsening.
What could go wrong
This is an early phase 2 trial with only 120 participants, so results may not apply to everyone. The drug may cause side effects or fail to show benefit over placebo.

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 120 people

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

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Jan 2030

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: 1. Documentation of MG diagnosis. 2. Eligible for treatment with efgartigimod per effective local product label, confirmed by serological testing at screening. 3. MG-ADL score at the time of screening more than or equal to (≥) 6 and less than or equal to (≤) 10 with more than (\>) 50 percent (%) of this score attributed to non-ocular items, or an MG-ADL score ≥ 11. Exclusion Criteria: 1. Active chronic (or stable but treated with immune therapy) disease of the immune system other than MG (e.g., rheumatoid arthritis, scleroderma, Sjögren's syndrome, Crohn's disease, ulcerative colitis, etc.) or immunodeficiency syndrome (hereditary immune deficiency, drug-induced immune deficiency, etc.). 2. Lack of efficacy or observed safety concerns from prior neonatal Fc receptor (FcRn) treatment. 3. Prior treatment with B-cell depleting therapy, alemtuzumab, total lymphoid irradiation, bone marrow transplant, T-cell vaccination therapy, or natalizumab at any time prior to screening. 4. Participants with significantly impaired organ function. 5. History of life-threatening injection/infusion related reaction (IRR/ISR), hypersensitivity, or anaphylactic reaction with components of efgartigimod or ublituximab solutions, protocol-allowed rescue medications, or protocol required pre-treatment medications. 6. Unwillingness or inability to comply with study and/or follow-up procedures outlined in the protocol. Note: Other protocol-specified Inclusion/Exclusion criteria may apply.

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Conditions

The condition(s) this trial relates to.

myasthenia gravis

As listed by the trial registrant

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

Myasthenia gravis

How to take part

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

  1. The places running it

    5 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

    Colorado Springs, Colorado, 80919, United States

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Colorado Springs, Colorado, 80920, United States

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Clearwater, Florida, 33761, United States

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    Farmington Hills, Michigan, 48334, United States

  • TG Therapeutics Investigational Trial Site

    RECRUITING

    New Bern, North Carolina, 28562, United States

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