Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Batoclimab weekly · 1 trial · 1 indication
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...
Batoclimab weekly is an investigational small molecule being developed for generalized myasthenia gravis, a chronic neuromuscular disorder. It is administered as a 680 mg subcutaneous injection on a weekly schedule. The drug is currently in Phase 3 clinical development and has not been approved by regulatory authorities.
Batoclimab weekly targets the neonatal Fc receptor (FCGRT) and acts as an inhibitor of this receptor. By blocking FCGRT, the drug is designed to reduce levels of pathogenic IgG antibodies that contribute to the autoimmune attack in generalized myasthenia gravis.
Batoclimab weekly is being developed by Immunovant, Inc., a biopharmaceutical company traded on Nasdaq under the ticker symbol IMVT. The company is conducting a Phase 3 clinical trial to evaluate the drug as induction and maintenance therapy for generalized myasthenia gravis.
Batoclimab weekly is in Phase 3 clinical development for generalized myasthenia gravis. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory agencies. The ongoing Phase 3 study is active but not recruiting participants.
Batoclimab weekly is being studied in a single Phase 3 clinical trial registered as NCT05403541. This randomized, double-blind, placebo-controlled study evaluates the efficacy and safety of batoclimab as induction and maintenance therapy in adults with generalized myasthenia gravis, with an enrollment target of 240 participants.
Yes, Batoclimab weekly is also known as Batoclimab 680 mg SC weekly. The name reflects the specific dosing regimen of 680 mg administered subcutaneously on a weekly basis. Both names refer to the same investigational drug being developed for generalized myasthenia gravis.