A Phase 3, Multicenter, Randomized, Placebo-Controlled, Double-Blind Study to Assess the Efficacy and Safety of IMVT-1402 in Patients With Mild to Severe Generalized Myasthenia Gravis
Immunovant Sciences GmbH
Summary
The purpose of the study is to assess the efficacy, safety and tolerability of IMVT-1402 in adult participants with mild to severe generalized myasthenia gravis.
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: * Participants with the ability to understand the requirements of the trial, provide written informed consent, and comply with the trial protocol procedures. * Have mild to severe gMG by Myasthenia Gravis Foundation of America (MGFA) classification of Class II, III, or IVa at the Screening Visit * Have an MG activities of daily living (MG-ADL) score of ≥ 6 at the Screening Visit and Baseline Visit (Day 1) Additional inclusion criteria are defined in the protocol. Exclusion Criteria: * Have experienced myasthenic crisis within 12 weeks prior to the Screening Visit. * Hav…
Interventions
- DrugIMVT-1402
• Dose 1 subcutaneous (SC) once weekly (QW) for 12 weeks (Period 1)
- DrugIMVT-1402
* Dose 2 SC QW for 12 weeks (Period 1) * Dose 2 SC QW for 14 weeks (Period 2) * Dose 2 SC QW for 52 weeks (Period 3)
- DrugPlacebo
• Placebo SC QW for 12 weeks (Period 1)
- DrugIMVT-1402
* Dose 1 SC QW for 14 weeks (Period 2) * Dose 1 SC QW for 52 weeks (Period 3)
Locations (81)
- Site Number - 1041Mobile, Alabama
- Site Number - 1017Phoenix, Arizona
- Site Number - 1025Scottsdale, Arizona
- Site Number - 1042Tucson, Arizona
- Site Number - 1010Carlsbad, California
- Site Number - 1028Irvine, California