Generalized Myasthenia Gravis
Conditions
Interventions
- Period 1: Induction Period
Period 1 (Week 0 to Week 12) is a randomized, 3-arm, parallel-group study designed to assess the safety and efficacy of batoclimab 340 mg subcutaneous (SC) once a week (QW
Sponsors
Yamazaki Kenji
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age >= 18 years of age at the Screening Visit. 2. Have mild to severe gMG by Myasthenia Gravis Foundation of America (MGFA) classification Class II, III, or IVa at the Screening Visit. 3. Have a QMG score >= 11 at the Screening and Baseline Visits. 4. Have a MG-ADL score of >= 5 at the Screening and Baseline Visits. 5. Additional inclusion criteria are defined in the protocol.
Exclusion criteria
Exclusion criteria: 1. Have experienced myasthenic crisis within 3 months of the Screening Visit. 2. Have had a thymectomy performed < 6 months prior to the Screening Visit or have a planned thymectomy during the study period. 3. Have any active or untreated malignant thymoma. 4. 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. 5. 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. 6. Additional exclusion criteria are defined in the protocol.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from Period 1 baseline in MG-ADL score to Week 12 for AChRAb+ participants (Timeframe: Period 1 baseline to Week 12) | — |
Countries
Argentina, Brazil, Canada, Georgia, Germany, Hungary, Italy, Japan, Mexico, Poland, Romania, Serbia, South Korea, Spain, UK, US
Contacts
Public ContactKenji Yamazaki
Syneos Health Japan K.K.
Outcome results
None listed