Tests ublituximab after efgartigimod in adults with myasthenia gravis
Tests ublituximab as maintenance treatment in adults with myasthenia gravis responding to efgartigimod.
Plain-language title generated from the registry record
Registry title: A Study to Evaluate the Efficacy and Safety of Maintenance Ublituximab Following Induction With Efgartigimod Administration in Participants With Myasthenia Gravis (MG)
Key facts
- Where
- Cracow, Katowice, Kielce, Lodz, Lublin, Poznan, Zabrze, and Zory, PolandSee the 8 sites
- Phase
- Phase 2
Where in Poland
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Szpital Uniwersytecki W KrakowieCracow, PolandNot yet recruiting
- Neurologia Śląska Centrum MedyczneKatowice, PolandNot yet recruiting
- Resmedica Sp. z o.o.Kielce, PolandNot yet recruiting
- Amicare Sp. z o.o. S.K.Lodz, PolandNot yet recruiting
- Indywidualna Praktyka Lekarska Prof. Dr hab Konrad RejdakLublin, PolandNot yet recruiting
- Ilkowski I Partnerzy sp.p. LekarzyPoznan, PolandNot yet recruiting
- Wielospecjalistyczne Centrum Medyczne "Ibismed" s.c.Zabrze, PolandNot yet recruiting
- ProNeuro Centrum MedyczneZory, PolandNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- TG Therapeutics, Inc.
- Trial code
- NCT07673744EU 2025-524630-26-00
- Record updated
- 29 October 2026
- Original description
The primary purpose of this study is to evaluate the efficacy of ublituximab in adult participants with MG responding to treatment with efgartigimod.Read full original descriptionShow less
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
The primary purpose of this study is to evaluate the efficacy of ublituximab in adult participants with MG responding to treatment with efgartigimod.
Inclusion: 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: 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; 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; Participants with significantly impaired organ function; 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.