AChR-Ab+ or MuSK-Ab+ generalized Myasthenia Gravis
Conditions
Interventions
(RCP: Randomized Controlled Period)
Treatment group 1: AChR-Ab positive population (active) - inebilizumab 300 mg administered intravenously (IV) on Days 1, 15, and 183 of the RCP
Treatment group 2: A
Sponsors
Cardona Ritsuko
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Diagnosis of MG with anti-AChR or anti-MuSK antibody. 2. MGFA Clinical Classification Class II, III, or IV. 3. MG-ADL score of 6 or greater at screening and at randomization with > 50% of this score attributed to non-ocular items. 4. QMG score of 11 or greater. 5. Participants must be on: a. Corticosteroids only, with no dose increase within 4 weeks prior to randomization, or b. One allowed non-steroidal immunosuppressive therapy (IST), with continuous use for at least 6 months prior to randomization and no dose increase within 4 months prior to randomization, or c. Combination of (1) corticosteroids with no dose increase within 4 weeks prior to randomization and (2) one allowed non-steroidal IST with continuous use for at least 6 months prior to randomization and no dose increase within 4 months prior to randomization. Allowed ISTs, alone or in combination with corticosteroids, are azathioprine, mycophenolate mofetil, and mycophenolic acid. Tacrolimus is allowed in Japan only, at a dose of <= 3 mg/day, with continued use for at least 6 months prior to randomization and no dose increase within 4 months prior to randomization.
Exclusion criteria
Exclusion criteria: 1. Receipt of the following medications within the 4 weeks prior to Day 1: a. Cyclosporine (except eye drops) b. Tacrolimus (except topical) (tacrolimus 40 mg/day or > 80 mg over a 2-day period [or equivalent dose of other corticosteroids]) b. Acetylcholinesterase inhibitors (pyridostigmine) > 480 mg/day or unstable dose in the 2 weeks prior to Day 1. c. Azathioprine > 3 mg/kg/day d. Mycophenolate mofetil > 3 g/day or mycophenolic acid > 1440 mg/day e. Any IST, alone or in combination with corticosteroids, except for azathioprine, mycophenolate mofetil, and mycophenolic acid.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary endpoint: Change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) score at Week 26 in the overall study population (ie, the AChR-Ab+ and MuSK-Ab+ populations). | — |
Secondary
| Measure | Time frame |
|---|---|
| Key secondary endpoints: 1. Change from baseline in Quantitative Myasthenia Gravis (QMG) score at Week 26 in the overall study population. 2. Change from baseline in MG-ADL score at Week 26 in the AChR-Ab+ population. 3. Change from baseline in QMG score at Week 26 in the AChR-Ab+ population. 4. Change from baseline in MG-ADL score at Week 26 in the MuSK-Ab+ population. 5. Change from baseline in QMG score at Week 26 in the MuSK-Ab+ population. Additional secondary endpoints: 1. The proportion of subjects with >= 3-point improvement in MG-ADL score at Week 26 and no use of rescue therapy between Day 28 and Week 26 in the overall study population, the AChR-Ab+ population, and the MuSK-Ab+ population and at Week 52 and no use of rescue therapy between Day 28 and Week 52 in the AChR-Ab+ population. 2. Change from baseline in MG-ADL score at Week 52 in the AChR-Ab+ population. 3. Change from baseline in QMG score at Week 52 in the AChR-Ab+ population. 4. Change from baseline in Myasthenia Gravis Composite (MGC) score at Week 26 in the overall study population, the AChR-Ab+ population, and the MuSK-Ab+ population and at Week 52 in the AChR-Ab+ population. 5. Change from baseline in Myasthenia Gravis Quality of Life-15 revised (MGQOL-15r) score at Week 26 in the overall study population, the AChR-Ab+ population, and the MuSK-Ab+ population and at Week 52 in the AChR-Ab+ population. 6. Patient Global Impression of Change score at Week 26 in the overall study population, the AChR-Ab+ population, and the MuSK-Ab+ population and at Week 52 in the AChR-Ab+ population. 7. Time to first MG exacerbation by Week 26 in the overall study population, the AChR-Ab+ population, and the MuSK-Ab+ population and by Week 52 in the AChR-Ab+ population. 8. The safety and tolerability of inebilizumab as measured by the incidence of treatment-emergent adverse events, adverse events of special interest, and treatment-emergent serious adverse events. Laboratory measurements will also be evaluate | — |
Countries
Argentina, Belarus, Brazil, Canada, China, Denmark, France, Germany, India, Italy, Japan, Poland, Russia, South Korea, Spain, Taiwan, Turkey, Ukraine, USA
Contacts
Public ContactRitsuko Cardona
Medpace Japan KK
Outcome results
None listed