Health Condition 1: G700- Myasthenia gravis
Conditions
Interventions
Intervention1: Inebilizumab: Intravenous 300mg inebilizumab
AChR-Ab+ subject will receive inebilizumab at RCP Days 1, 15, and 183. MuSK-Ab+ subject will receive inebilizumab at RCP Days 1 and 15. Participants who elect to enter the open label phase (OLP) will
AChR-Ab+ subject will receive placebo at RCP Days 1, 15, and 183. MuSK-Ab+ subject will receive placebo at RCP Days 1 and 15. Participants who elect to enter the open label phase (OLP) will receive in
Sponsors
Horizon Therapeutics Ireland DAC a wholly owned subsidiary of Amgen Inc
Eligibility
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 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.
Exclusion criteria
Exclusion criteria: 1. Receipt within the 4 weeks prior to Day 1 a. Cyclosporine (except eye drops) b. Tacrolimus (except topical) c. Methotrexate 2. Current use of: a. Corticosteroids (Prednisone > 40 milligram (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/kilogram (kg)/day d. Mycophenolate mofetil > 3 grams/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 |
|---|---|
| Change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) Profile scoreTimepoint: Week 26 | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in QMG scores Proportion of participants with both greater then equal 3-point improvement in MG-ADL & did not initiate rescue therapy Change in MG ADL at Week 26 Time to first gMG exacerbation Change in MGC score Change in Myasthenia Gravis Quality of Life-15, revised MGQOL-15r score Change in PGIC score Number of participants with TEAEs AESIs & TESAEs during the RCP & OLP Timepoint: Week 26 for the overall study, the AChR-Ab & for the MuSK. Between Day 28 & Week 52 for AChR-Ab & Day 28 & Week 26 for the overall study the AChR Ab & for the MuSK Ab.Week 26 for the overall study, the AChR-Ab, & for the MuSK-Ab.Week 52 for AChR-Ab population & Week 26 for the overall study, the AChR-Ab, & for the MuSK-Ab.Until Week 156 the overall study population, the AChR-Ab, & for the MuSK-Ab. | — |
Countries
Argentina, Belarus, Brazil, Canada, China, Denmark, France, Germany, India, Italy, Japan, Poland, Republic of Korea, Russian Federation, Spain, Taiwan, Turkey, Ukraine, United States of America
Contacts
Public ContactSupriya Parui
Medpace Clinical Research India Pvt. Ltd
Outcome results
None listed