Inebilizumab for Myasthenia Gravis
(MINT Trial)
Trial Summary
What is the purpose of this trial?
This trial tests a new treatment for Myasthenia Gravis in patients with specific antibodies. It aims to see if the new treatment improves muscle strength.
Will I have to stop taking my current medications?
The trial requires that you continue taking certain medications, like corticosteroids or specific immunosuppressive therapies, without increasing the dose before joining. However, you must stop using certain other medications, like cyclosporine, tacrolimus, and methotrexate, at least 4 weeks before starting the trial.
How is the drug Inebilizumab unique for treating Myasthenia Gravis?
Inebilizumab is unique because it targets and reduces the number of B cells, a type of immune cell, which can help in conditions like Myasthenia Gravis where the immune system mistakenly attacks the body's own tissues. This mechanism is different from other treatments that may not specifically target B cells.12345
Research Team
MD
Principal Investigator
Amgen
Eligibility Criteria
This trial is for people with Myasthenia Gravis, a condition causing muscle weakness. Participants must have certain antibodies and scores indicating moderate to severe symptoms. They should be on stable doses of specific treatments like corticosteroids or immunosuppressants but not others like cyclosporine or high-dose acetylcholinesterase inhibitors.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Randomized Controlled Period (RCP)
Participants receive either inebilizumab or placebo administered intravenously on specified days
Open-label Period (OLP)
Participants who complete the RCP may opt into receiving inebilizumab for an extended period
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- Inebilizumab
- IV Placebo
Inebilizumab is already approved in United States, European Union, Canada for the following indications:
- Neuromyelitis optica spectrum disorder (NMOSD) in adults who are anti-aquaporin-4 (AQP4) antibody positive
- Neuromyelitis optica spectrum disorder (NMOSD) in adults who are anti-aquaporin-4 (AQP4) antibody positive
- Neuromyelitis optica spectrum disorder (NMOSD) in adults who are anti-aquaporin-4 (AQP4) antibody positive
Find a Clinic Near You
Who Is Running the Clinical Trial?
Viela Bio
Lead Sponsor
Amgen
Lead Sponsor
Robert A. Bradway
Amgen
Chief Executive Officer since 2012
MBA from Harvard Business School
Paul Burton
Amgen
Chief Medical Officer since 2023
MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London
Viela Bio (acquired by Horizon Therapeutics)
Lead Sponsor