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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05556096 | Safety and Efficacy of ALXN1720 in Adults With Generalized Myasthenia Gravis | PHASE3 | ACTIVE NOT_RECRUITING | 261 | — | — | Nov 21, 2022 | Aug 31, 2027 | Apr 21, 2026 | 132 | United States, Argentina +20 |
| Arm | Type | Description |
|---|---|---|
| ALXN1720 | EXPERIMENTAL | Participants will receive a weight-based initial (loading) dose of ALXN1720 on Day 1, followed by weight-based maintenance treatment with ALXN1720 on Day 8 and once every week (Q1W) thereafter for a total of 26 weeks. Following this randomized controlled treatment (RCT) period, all participants will receive ALXN1720 in an open-label extension (OLE) period of 105 weeks. |
| Placebo | PLACEBO_COMPARATOR | Participants will receive placebo during the 26-week RCT period, after which they will enter the OLE period of the study and receive ALXN1720. |
| Name | Type | Description |
|---|---|---|
| ALXN1720 | COMBINATION_PRODUCT | Combination product consisting of syringe prefilled with ALXN1720. |
| Placebo | COMBINATION_PRODUCT | Combination product consisting of syringe prefilled with placebo. |
Inclusion Criteria: * Diagnosis of MG with generalized muscle weakness meeting the clinical criteria defined by Myasthenia Gravis Foundation of America (MGFA) Class II, III or IV * Positive serological test for autoantibodies against AChR Exclusion Criteria: * History of thymectomy, or any other ...