Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05403541 | Phase 3 Study to Assess the Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants With Generalized Myasthenia Gravis | PHASE3 | ACTIVE NOT_RECRUITING | 240 | — | — | Jun 27, 2022 | Feb 1, 2027 | Jun 5, 2026 | 93 | United States, Argentina +14 |
MG-ADL is an 8-item, participant-reported questionnaire that assesses gMG symptoms and their effects on activities of daily living. Each item is assessed on a 4-point scale where a score of 0 represents normal function and a score of 3 represents loss of ability to perform that function. Total score ranges from 0 to 24, with higher scores indicating greater functional impairment and disability.
| Arm | Type | Description |
|---|---|---|
| Batoclimab Induction Dose 1 (Period 1) | EXPERIMENTAL | - |
| Batoclimab Induction Dose 2 (Period 1) | EXPERIMENTAL | - |
| Placebo Induction Dose (Period 1) | PLACEBO_COMPARATOR | - |
| Batoclimab Maintenance Dose 1 (Period 2) | EXPERIMENTAL | - |
| Batoclimab Maintenance Dose 2 (Period 2) | EXPERIMENTAL | - |
| Placebo Maintenance Dose (Period 2) | PLACEBO_COMPARATOR | - |
| Name | Type | Description |
|---|---|---|
| Batoclimab 680 mg SC weekly | DRUG | Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody |
| Batoclimab 340 mg SC weekly | DRUG | Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody |
| Matching Placebo SC | DRUG | Placebo |
| Batoclimab 340 mg SC bi-weekly | DRUG | Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody |
Inclusion Criteria: 1. Are ≥ 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...