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Monoclonal Antibodies

Inebilizumab for Myasthenia Gravis (MINT Trial)

Phase 3
Waitlist Available
Research Sponsored by Viela Bio
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of MG with anti-AChR or anti-MuSK antibody
MGFA Clinical Classification Class II, III, or IV
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Summary

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.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
While the side effects of Inebilizumab aren't detailed here, similar medications can cause infusion reactions, infections due to immune system suppression, liver issues, and potential allergic responses.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I have been diagnosed with MG and tested positive for anti-AChR or anti-MuSK antibodies.
Select...
My myasthenia gravis is moderate to severe.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Trial Design

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.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
The most common treatments for Myasthenia Gravis (MG) include immunotherapy, thymectomy, and symptomatic therapies. Immunotherapy targets the dysregulated immune system by using agents that suppress or modulate immune responses, thereby reducing the production of antibodies that attack the neuromuscular junction. Thymectomy, the surgical removal of the thymus gland, is believed to reduce the production of these harmful antibodies and has been shown to improve long-term remission rates. Symptomatic therapies, such as acetylcholinesterase inhibitors, increase the availability of acetylcholine at the neuromuscular junction, improving muscle strength. These treatments are crucial for MG patients as they aim to restore immune balance, alleviate symptoms, and achieve long-term remission, significantly improving quality of life.
Advances in the understanding of disease mechanisms of autoimmune neuromuscular junction disorders.Knowledge mapping of targeted immunotherapy for myasthenia gravis from 1998 to 2022: A bibliometric analysis.Therapeutic modalities in small cell lung cancer: a paradigm shift after decades of quiescence.

Find a Location

Who is running the clinical trial?

Viela BioLead Sponsor
12 Previous Clinical Trials
866 Total Patients Enrolled
AmgenLead Sponsor
1,420 Previous Clinical Trials
1,382,712 Total Patients Enrolled
Viela Bio (acquired by Horizon Therapeutics)Lead Sponsor
6 Previous Clinical Trials
708 Total Patients Enrolled

Media Library

Inebilizumab (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT04524273 — Phase 3
Myasthenia Gravis Research Study Groups: Placebo, (MuSK-Ab+) MG, Inebilizumab, (AChR-Ab+) MG, Placebo, (AChR-Ab+) MG, Inebilizumab, (MuSK-Ab+) MG
Myasthenia Gravis Clinical Trial 2023: Inebilizumab Highlights & Side Effects. Trial Name: NCT04524273 — Phase 3
Inebilizumab (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04524273 — Phase 3
~48 spots leftby Sep 2025
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