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

NCT07673744 | Recruiting Phase 2 FDA Drug

• 2 other identifiers: TG1101-MG2012025-524630-26-00
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Time to Onset of a Clinical Worsening Event

  Up to Week 24

Secondary Outcomes (4)

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

  Up to Week 72

• Maximum Plasma Concentration (Cmax) of Ublituximab

  Up to Week 72

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

  Up to Week 72

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

  Baseline, Week 24

Study Arms (2)

Randomized controlled period (RCP)

EXPERIMENTAL

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

Open-label period (OLP): Ublituximab

EXPERIMENTAL

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

Drug: Ublituximab

Interventions

Placebo DRUG

Administered as an IV infusion.

Randomized controlled period (RCP)

Ublituximab DRUG

Administered as an IV infusion.

Also known as: BRIUMVI

Open-label period (OLP): Ublituximab; Randomized controlled period (RCP)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• TG Therapeutics, Inc.: lead

Study Sites (2)

TG Therapeutics Investigational Trial Site

Colorado Springs, Colorado, 80919, United States

RECRUITING

TG Therapeutics Investigational Trial Site

Clearwater, Florida, 33761, United States

RECRUITING

MeSH Terms

Conditions

Myasthenia Gravis

Interventions

ublituximab

Condition Hierarchy (Ancestors)

Paraneoplastic Syndromes, Nervous System; Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Paraneoplastic Syndromes; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Neurodegenerative Diseases; Neuromuscular Junction Diseases; Neuromuscular Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

TG Therapeutics Clinical Support Team

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 10, 2026
• First Posted: June 29, 2026
• Study Start: July 30, 2026
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): January 1, 2030
• Last Updated: July 17, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)