A Study to Evaluate the Efficacy and Safety of Maintenance Ublituximab Following Induction With Efgartigimod Administration in Participants With Myasthenia Gravis (MG)
Purpose
The primary purpose of this study is to evaluate the efficacy of ublituximab in adult participants with MG responding to treatment with efgartigimod.
Condition
- Myasthenia Gravis
Eligibility
- Eligible Ages
- Over 18 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
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. |
|
Recruiting Locations
TG Therapeutics Investigational Trial Site
Colorado Springs, Colorado 80919
Colorado Springs, Colorado 80919
TG Therapeutics Investigational Trial Site
Clearwater, Florida 33761
Clearwater, Florida 33761
More Details
- Status
- Recruiting
- Sponsor
- TG Therapeutics, Inc.