Phase 3 Study to Assess Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants with Generalized Myasthenia Gravis (gMG)
Key facts
- Where
- Budapest VIII és Kistarcsa, MagyarországSee the 2 sites
- Phase
- 3. fázis
Where in Magyarország
- Semmelweis UniversityBudapest VIII, MagyarországNo longer taking part
- Kistarcsai Flor Ferenc KorhazKistarcsa, MagyarországNo longer taking part
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
- Immunovant Sciences GmbH
- Trial code
- EU 2024-512258-91-00
- Record updated
- 2026. június 5.
- Original description
To evaluate the efficacy of batoclimab 680 mg SC QW or 340 mg SC QW compared to placebo as Induction Therapy in AChRAb+ participants as assessed by change in the Myasthenia Gravis Activities of Daily Living (MG-ADL) score.Read full original descriptionShow less
A Phase 3, Multi-center, Randomized, Quadruple-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants with Generalized Myasthenia Gravis (gMG)
To evaluate the efficacy of batoclimab 680 mg SC QW or 340 mg SC QW compared to placebo as Induction Therapy in AChRAb+ participants as assessed by change in the Myasthenia Gravis Activities of Daily Living (MG-ADL) score.
Inclusion: Are ≥ 18 years of age at the Screening Visit; Have mild to severe gMG by Myasthenia Gravis Foundation of America (MGFA) classification Class II, III, or IVa at the Screening Visit; Have a QMG score ≥ 11 at the Screening and Baseline Visits; Have a MG-ADL score of ≥ 5 at the Screening and Baseline Visits; Additional inclusion criteria are defined in the protocol.
Exclusion: Have had a thymectomy performed < 6 months prior to the Screening Visit or have a planned thymectomy during the study period; Have received any agent or therapy (exclusive of those identified within inclusion criteria) with immunosuppressive properties (e.g., stem cell therapy, chemotherapies, etc.) within the past year; Have used anti-FcRn treatment within 3 months prior to the Screening Visit or have a documented history of non-response to prior anti-FcRn treatment; Have any active or untreated malignant thymoma; Have experienced myasthenic crisis within 3 months of the Screening Visit; Additional exclusion criteria are defined in the protocol.