A Study of RVT-1401 in Myasthenia Gravis (MG) Patients
Summary
The purpose of the current study is to assess safety/tolerability and key pharmacodynamic (PD) effects that are considered to be associated with clinical benefit (reduction of total IgG and anti-AChR-IgG) in Myasthenia Gravis patients following treatment with RVT-1401 (also known as IMVT-1401) compared to placebo.
Timeline
- Start
- 2019-05-21
- Primary completion
- 2020-10-07
- Completion
- 2020-12-21
Outcome
Met primary endpoint
registry analysis (superiority test); Double-blind Treatment Period: Placebo vs Double-blind Treatment Period: RVT-1401 340 mg/Week; p <0.0001; Least square mean difference -56.33; ANCOVA NCT03863080 ↗
registry analysis (superiority test); Double-blind Treatment Period: Placebo vs Double-blind Treatment Period: RVT-1401 340 mg/Week; p <0.001; Least square mean difference -62.7; ANCOVA NCT03863080 ↗
registry analysis (superiority test); Double-blind Treatment Period: Placebo vs Double-blind Treatment Period: RVT-1401 340 mg/Week; p = 0.0009; Least square mean difference -62.58; ANCOVA NCT03863080 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Batoclimab | Monoclonal antibody | 340 mg | Subcutaneous |
| Subject | Batoclimab | Monoclonal antibody | 680 mg | Subcutaneous |