Inebilizumab for Myasthenia Gravis
(MINT Trial)

Recruiting in Palo Alto (17 mi)

+113 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Viela Bio

Pivotal Trial (Near Approval)

Prior Safety Data

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.

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

I have been diagnosed with MG and tested positive for anti-AChR or anti-MuSK antibodies.

I am taking azathioprine, mycophenolate mofetil, or mycophenolic acid.

You have a score of 6 or higher on the MG-ADL test, and more than half of this score comes from non-eye-related items.

+3 more

Exclusion Criteria

I am not currently using high doses of corticosteroids or specific immune system medications.

I haven't taken cyclosporine, tacrolimus (except as a cream), or methotrexate in the last 4 weeks.

Participant Groups

The study tests Inebilizumab against a placebo in patients with Myasthenia Gravis. It's randomized (participants are assigned by chance), double-blind (neither the researchers nor participants know who gets what treatment), and placebo-controlled to compare effects accurately.

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Inebilizumab, (MuSK-Ab+) MGExperimental Treatment1 Intervention

Participants will receive inebilizumab administered IV on Days 1 and 15 of the RCP. Participants who elect to enter the OLP will receive inebilizumab administered IV on OLP Day 1, IV placebo on OLP Day 15 (to avoid potential unblinding), and inebilizumab IV on OLP Days 183, 365, 547, 729, and 911.

Group II: Inebilizumab, (AChR-Ab+) MGExperimental Treatment1 Intervention

Participants will receive inebilizumab administered intravenously (IV) on Days 1, 15, and 183 of the RCP. Participants who elect to enter the open label phase (OLP) will receive inebilizumab administered IV on OLP Days 1, IV placebo on OLP Day 15 (to avoid potential unblinding), and inebilizumab IV on OLP Days 183, 365, 547, 729, and 911.

Group III: Placebo, (MuSK-Ab+) MGPlacebo Group1 Intervention

Participants will receive placebo administered IV on Days 1 and 15 of the RCP. Participants who elect to enter the OLP will receive inebilizumab administered IV on OLP Days 1,15, 183, 365, 547, 729, and 911.

Group IV: Placebo, (AChR-Ab+) MGPlacebo Group1 Intervention

Participants will receive placebo administered IV on Days 1, 15, and 183 of the RCP. Participants who elect to enter the OLP will receive inebilizumab administered IV on OLP Days 1,15, 183, 365, 547, 729, and 911.

Inebilizumab is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Uplizna for: