Myasthenia Gravis Inebilizumab Trial

Summary

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

Timeline

Start

2020-10-15

Primary completion

2024-05-28

Completion

2029-06-07

Outcome

Met primary endpoint

registry analysis (superiority test); Overall: Placebo vs Overall: Inebilizumab 300 mg; p <0.0001; Difference in mean change -1.9 (95% CI -2.9 to -1.0) NCT04524273 ↗

paper Participants who received inebilizumab had a greater reduction in the MG-ADL score than those who received placebo PMID 40202593 ↗

release “The trial met its primary endpoint, with a statistically significant change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) score” amgen.com ↗

release “Key findings from MINT include: 6 Primary Endpoint: A 1.9-point difference in the MG-ADL score for UPLIZNA (-4.2) compared to placebo (-2.2) (p<0.0001)” amgen.com ↗

Publications

• Nowak RJ, Benatar M, Ciafaloni E, Howard JF Jr, Leite MI, Utsugisawa K, Vissing J, Rojavin M, Li Q, Tang F, Wu Y, Rampal N, Cheng S; MINT Investigators. A Phase 3 Trial of Inebilizumab in Generalized Myasthenia Gravis. N Engl J Med. 2025 Jun 19;392(23):2309-2320. doi: 10.1056/NEJMoa2501561. Epub 2025 Apr 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Inebilizumab	Monoclonal antibody	300 mg	Intravenous

Indications