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NCT Number: NCT07673744

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

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

TG Therapeutics Investigational Trial Site, Colorado Springs, Colorado, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Documentation of MG diagnosis.
  • Eligible for treatment with efgartigimod per effective local product label, confirmed by serological testing at screening.
  • 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

  • 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.).
  • Lack of efficacy or observed safety concerns from prior neonatal Fc receptor (FcRn) treatment.
  • 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.
  • Participants with significantly impaired organ function.
  • 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.
  • 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.

Treatment and study plan

Ublituximab

Drug

Administered as an IV infusion.

Other names: BRIUMVI

Placebo

Drug

Administered as an IV infusion.

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

    Time frame: Baseline, Week 24

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

TG Therapeutics Clinical Support Team

CONTACT

[email protected]

1-877-575-8489

Sponsors and collaborators

Lead sponsor

TG Therapeutics, Inc.

Industry

Registry information

Official study title

A Phase 2, Randomized, Double-blind, Multicenter, Placebo-controlled Study to Evaluate the Efficacy and Safety of Maintenance Ublituximab Treatment Following Induction With Efgartigimod Administration in Adults With Myasthenia Gravis

Important dates

Study start
2026
Primary completion
2028
Study completion
2030
First posted
Jun 29, 2026
Registry last updated
Jul 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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