Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Claseprubart · 4 trials · 3 indications
The MG-ADL score is an 8-item patient reported outcome (PRO) instrument. The MG-ADL targets symptoms of disability across ocular, bulbar, respiratory, and axial symptoms. The item responses are scored from 0 to 3, and the total score of the MG-ADL is the sum of the 8 items and ranges from 0 to 24, with a higher score indicating more disability.
Adjusted INCAT scores range from 0-10 with a score of 10 indicating the greatest degree of disability. A relapse is defined as an increase of ≥1 point from baseline in adjusted INCAT score.
Incidence of treatment-emergent adverse events (TEAEs) and treatment emergent serious adverse events (SAEs)
Number of participants with TEAEs and treatment-emergent SAEs will be reported.
| Arm | Type | Description |
|---|---|---|
| Placebo | PLACEBO_COMPARATOR | Intravenous (IV) infusion of Placebo on Day 1 followed by subcutaneous (SC) injections of Placebo every 2 weeks (Q2W) starting at Week 1 (Day 8). |
| Claseprubart Q2W | EXPERIMENTAL | IV loading dose of claseprubart on Day 1 followed by SC injections of claseprubart Q2W starting at Week 1 (Day 8). |
| Claseprubart Every 4 weeks (Q4W) | EXPERIMENTAL | IV loading dose of claseprubart on Day 1 followed by SC injections of claseprubart or Placebo Q2W starting at Week 1 (Day 8), with doses alternating between claseprubart and placebo. |
| Claseprubart (Part A) | EXPERIMENTAL | Claseprubart intravenous (IV) loading dose on Day 1. Claseprubart subcutaneous (SC) once every 2 weeks for up to 13 weeks. |
| Claseprubart (Part B) | EXPERIMENTAL | Claseprubart SC once every 2 weeks for up to 52 weeks. |
| Placebo (Part B) | PLACEBO_COMPARATOR | Placebo SC once every 2 weeks for up to 52 weeks. |
| Claseprubart (Optional OLE) | EXPERIMENTAL | Claseprubart SC once every 2 weeks for up to 104 weeks. |
| Claseprubart 300 mg Q2W | EXPERIMENTAL | - |
| Claseprubart 600 mg Q2W | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Claseprubart | DRUG | IV loading dose on Day 1 |
| Placebo | DRUG | IV infusion on Day 1 |
Inclusion Criteria: 1. Must have given written informed consent before any study-related activities are carried out 2. Weight range between 40-130 kg at Screening 3. Diagnosis of gMG by the following tests: 1. Acetylcholine receptor antibody (AChR Ab) positive, and 2. One of the following: ...