Myasthenia Gravis Inebilizumab Trial (MINT)

Myasthenia Gravis Inebilizumab Trial (MINT)

ClinicalTrials.gov ID: NCT04524273
Sponsor: Viela Bio (acquired by Horizon Therapeutics)
Information provided b:y Viela Bio (acquired by Horizon Therapeutics) (Responsible Party)
Last Update Posted: 2023-08-07

Brief Summary:
Randomized, double-blind, placebo-controlled, Phase 3, parallel-group study with optional open-label extension.

Detailed Description:
This study is a phase 3, randomized, double-blind, placebo-controlled study, to be conducted at approximately 120 study sites. Approximately 270 participants (188 acetylcholine receptor antibody positive [AChR-Ab+] and 82 muscle-specific tyrosine kinase antibody positive [MuSK-Ab+]) will be enrolled. Participants with Myasthenia Gravis (MG) who are positive for anti-AChR or anti-MuSK antibodies will be enrolled and analyzed separately as 2 populations: (1) AChR-Ab+ and (2) MuSK-Ab+. Patients who do not have anti-AChR or anti-MuSK antibodies will not be enrolled. Patients with Myasthenia Gravis Foundation of America (MGFA) classification II, III, or IV disease, Myasthenia Gravis Activities of Daily Living (MG-ADL) score at screening and randomization between 6 and 10 with > 50% of this score attributed to non-ocular items, or an MG-ADL score >=11, Quantitative Myasthenia Gravis (QMG) score >= 11 at the time of screening and randomization, and use of a corticosteroid and/or non-steroidal immunosuppressant will be included in the study.

All subjects who complete the randomized controlled period (RCP) will have the option to enroll in a 3-year (156 weeks) open-label period.

OFFICIAL TITLE
A Randomized, Double-blind, Multicenter, Placebo-controlled Phase 3 Study With Open-label Period to Evaluate the Efficacy and Safety of Inebilizumab in Adults With Myasthenia Gravis

INTERVENTION / TREATMENT
Drug: inebilizumab
Drug: IV Placebo

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