Recruiting
Phase 2

Ublituximab with Efgartigimod

Sponsor:

TG Therapeutics, Inc.

Code:

NCT07673744

Conditions

Myasthenia Gravis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Ublituximab

Placebo

Study Details

Brief summary:

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

Conditions

Myasthenia Gravis

Study ID

NCT07673744

Start date

Jul 30, 2026

Status verified date

Aug, 2026

Completion date

Jan 1, 2030

Anticipated

Primary completion date

Jul 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

120 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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.

experimental: Open-label period (OLP): Ublituximab

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

Interventions

Ublituximab

Administered as an IV infusion.

Placebo

Administered as an IV infusion.

Primary outcome measure

  • Time to Onset of a Clinical Worsening Event [ Time Frame: Up to Week 24 ]

Central Contacts and Locations

Central contacts

TG Therapeutics Clinical Support Team

1-877-575-8489clinicalsupport@tgtxinc.com

Locations

TG Therapeutics Investigational Trial Site

Recruiting

Colorado Springs, Colorado, United States, 80919

TG Therapeutics Investigational Trial Site

Recruiting

Colorado Springs, Colorado, United States, 80920

TG Therapeutics Investigational Trial Site

Recruiting

Clearwater, Florida, United States, 33761

TG Therapeutics Investigational Trial Site

Recruiting

Farmington Hills, Michigan, United States, 48334

TG Therapeutics Investigational Trial Site

Recruiting

New Bern, North Carolina, United States, 28562

More Information

Sponsor

TG Therapeutics, Inc.

Last update posted

Aug 21, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by TG Therapeutics, Inc. on 2026-08-21.