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

Part of paid clinical trials in Colorado Springs, Colorado.

Sponsor
TG Therapeutics, Inc.
Study ID
NCT07673744
Phase
PHASE2
Status
Recruiting
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Conditions

  • Myasthenia Gravis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Ublituximab — DRUG
    Administered as an IV infusion.
  • Placebo — DRUG
    Administered as an IV infusion.

Study Details

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

Key Dates

Start date
Jul 30, 2026
Status verified
Jun 2026
Primary completion
Jul 1, 2028
Completion
Jan 1, 2030

Study Design

Enrollment
120 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

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.

Primary Outcome Measure

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

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
TG Therapeutics Investigational Trial SiteColorado SpringsColorado80919-
TG Therapeutics Investigational Trial SiteClearwaterFlorida33761-

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TG Therapeutics Investigational Trial Site· Colorado Springs, COTG Therapeutics Investigational Trial Site· Clearwater, FL

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