NCT04524273

Myasthenia Gravis Inebilizumab Trial

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 238 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 230 participants (188 acetylcholine receptor antibody positive \[AChR-Ab+\] and 42 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. 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. Study acquired from Horizon in 2023.

Conditions

• Myasthenia Gravis

Interventions

Type	Name	Description
DRUG	inebilizumab	Participants will receive IV inebilizumab
DRUG	IV Placebo	Participants will receive IV placebo matched to inebilizumab

Timeline

• Start date: 2020-10-15
• Primary completion: 2024-05-28
• Completion: 2027-11-29
• First posted: 2020-08-24
• Last updated: 2026-03-10
• Results posted: 2026-03-10

Locations

104 sites across 19 countries: United States, Argentina, Belarus, Brazil, Canada, China, Denmark, France, Germany, India, Italy, Japan, Poland, Russia, South Korea, Spain, Taiwan, Turkey (Türkiye), Ukraine

Regulatory

• FDA-regulated drug study