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RecruitingNCT07673744Updated Oct 29, 2026

A Study to Evaluate the Efficacy and Safety of Maintenance Ublituximab Following Induction With Efgartigimod Administration in Participants With Myasthenia Gravis (MG)

A Phase 2 interventional study of Ublituximab and Placebo in Myasthenia Gravis, sponsored by TG Therapeutics, Inc.. Recruiting at 7 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-29.

Sponsored by TG Therapeutics, Inc. · Phase 2, Interventional, and Treatment

Updated Oct 29, 2026Start date moved1 site addedGo to Updates ↓
Phase
Phase 2
Study type
Interventional
Enrollment
120
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

The primary purpose of this study is to evaluate the efficacy of ublituximab in adult participants with MG responding to treatment with efgartigimod.

02

Conditions studied

  • Myasthenia Gravis

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03

In context

Myasthenia Gravis

330 studies on the registry are indexed under Myasthenia Gravis; 144 are open to participants now.

This study's planned enrollment of 120 is above the median of 44 across 217 interventional studies indexed under Myasthenia Gravis.

Browse Myasthenia Gravis studies →

Lead sponsor

TG Therapeutics, Inc. is the lead sponsor of 40 studies on the registry; 9 are open to participants now.

Of its 16 completed or terminated interventional studies of FDA-regulated products, 9 (56%) have results posted.

Browse TG Therapeutics, Inc. studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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), , 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.

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
120 participants (estimated)

Study arms

  • Experimental
    Randomized controlled period (RCP)

    Responder participants from efgartigimod induction period will be randomised 1:1 ratio to receive either ublituximab or ublituximab matching-placebo intravenous (IV) infusion.

    Drug: Ublituximab · Drug: Placebo

  • Experimental
    Open-label period (OLP): Ublituximab

    Non-responder participants from efgartigimod induction period will receive ublituximab IV infusion.

    Drug: Ublituximab

Interventions

  • DrugUblituximab

    Administered as an IV infusion.

    Also known as: BRIUMVI

  • DrugPlacebo

    Administered as an IV infusion.

06

What researchers measure

Primary outcomes

  1. Time to Onset of a Clinical Worsening Event

    Time frame: Up to Week 24

Secondary outcomes

  1. Number of Participants with Treatment-Emergent Adverse Events (TEAEs)

    Time frame: Up to Week 72

  2. Maximum Plasma Concentration (Cmax) of Ublituximab

    Time frame: Up to Week 72

  3. Proportion of Participants with Cluster of Differentiation 19 + (CD19+) B-cell Counts

    Time frame: Up to Week 72

  4. Change From Baseline in Myasthenia Gravis-Activities of Daily Living (MG-ADL) Total Score in RCP

    The MG-ADL scale focuses on relevant symptoms and functional performance of activities of daily living in participants with MG. The total score varies between 0-24, with higher score indicating more severe disease.

    Time frame: Baseline, Week 24

07

Study locations

7 of 7 sites recruiting
  • TG Therapeutics Investigational Trial Site
    Colorado Springs, Colorado 80919, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Colorado Springs, Colorado 80920, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Clearwater, Florida 33761, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Maitland, Florida 32751, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Farmington Hills, Michigan 48334, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    New Bern, North Carolina 28562, United States
    Recruiting
  • TG Therapeutics Investigational Trial Site
    Greenville, South Carolina 29605, United States
    Recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Nov 2026; primary completion for Jul 2028, 20 months later.

Of 22 phase 2 interventional studies under Myasthenia Gravis, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 13 and three quarters within 30. This study's planned 20 months is above that.

Start moved once since we started tracking on Sep 25, 2026: Oct 2026 → Nov 2026, on Oct 29, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Jun 10, 2026
First posted
Jun 29, 2026
StartEst.
Nov 1, 2026was Oct 2026
Primary completionEst.
Jul 1, 2028
CompletionEst.
Jan 1, 2030
Last update
Oct 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Sites
1 site added
Show site
  • TG Therapeutics Investigational Trial Site · Maitland, United States
Oct 29, 2026
Start date
Oct 1, 2026→Nov 1, 2026
Oct 29, 2026
Show all 1 update
  1. Oct 29, 2026
    1 site added
    Show site
    • TG Therapeutics Investigational Trial Site · Maitland, United States
    Start date Oct 1, 2026→Nov 1, 2026
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07673744
Lead sponsor
TG Therapeutics, Inc.
Responsible party
Sponsor
First posted
Jun 29, 2026
Start date
Nov 1, 2026 (estimated)
Primary completion
Jul 1, 2028 (estimated)
Completion
Jan 1, 2030 (estimated)
Last update
Oct 29, 2026

Study contacts

TG Therapeutics Clinical Support Team
Contact
clinicalsupport@tgtxinc.com
1-877-575-8489

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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