A study to evaluate whether inebilizumab is safe and effective in adult with Myasthenia Gravis.
- Conditions
- Health Condition 1: G700- Myasthenia gravis
- Registration Number
- CTRI/2020/12/030162
- Lead Sponsor
- Viela Bio Inc acquired by Horizon Therapeutics
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) Profile scoreTimepoint: Week 26
- Secondary Outcome Measures
Name Time Method Change in QMG scores <br/ ><br>Proportion of participants with both greater then equal 3-point improvement in MG-ADL & did not initiate rescue therapy <br/ ><br>Change in MG ADL at Week 26 <br/ ><br>Time to first gMG exacerbation <br/ ><br>Change in MGC score <br/ ><br>Change in Myasthenia Gravis Quality of Life-15, revised MGQOL-15r score <br/ ><br>Change in PGIC score <br/ ><br>Number of participants with TEAEs AESIs & TESAEs during the RCP & OLP <br/ ><br>Timepoint: Week 26 for the overall study, the AChR-Ab & for the MuSK. <br/ ><br>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.