A Study to Evaluate the Efficacy and Safety of Maintenance Ublituximab Following Induction With Efgartigimod Administration in Participants With Myasthenia Gravis (MG)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ublituximab, Placebo.
- Who it may be relevant to
- Registry conditions: Myasthenia Gravis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
The primary purpose of this study is to evaluate the efficacy of ublituximab in adult participants with MG responding to treatment with efgartigimod.
Interventions
- Drug Ublituximab
Administered as an IV infusion. - Drug Placebo
Administered as an IV infusion.
Primary outcome measures
- Time to Onset of a Clinical Worsening Event [Time frame: Up to Week 24]
Secondary outcome measures (4)
- Number of Participants with Treatment-Emergent Adverse Events (TEAEs) [Time frame: Up to Week 72]
- Maximum Plasma Concentration (Cmax) of Ublituximab [Time frame: Up to Week 72]
- Proportion of Participants with Cluster of Differentiation 19 + (CD19+) B-cell Counts [Time frame: Up to Week 72]
- Change From Baseline in Myasthenia Gravis-Activities of Daily Living (MG-ADL) Total Score in RCP [Time frame: Baseline, Week 24]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Double blind
- Primary purpose
- Treatment
Study locations
United States · 2 centers
- TG Therapeutics Investigational Trial Site — Colorado Springs
- TG Therapeutics Investigational Trial Site — Clearwater
Identifiers
NCT: NCT07673744 · TG1101-MG201 · 2025-524630-26-00