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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 between day 28 and week 52 for achr-ab+ population and day 28 and week 26 for the overall study population, the achr-ab+ population, and for the musk-ab+ population

Awards & highlights

MINT Trial Summary

This trial is testing a new medication against a placebo (inactive) medication to see if the new medication is effective. The trial is well-designed, and participants have an equal chance of receiving the new medication or the placebo.

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.Check my eligibility

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.See study design

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.

MINT Trial 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.

MINT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ between day 28 and week 52 for achr-ab+ population and day 28 and week 26 for the overall study population, the achr-ab+ population, and for the musk-ab+ population

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~between day 28 and week 52 for achr-ab+ population and day 28 and week 26 for the overall study population, the achr-ab+ population, and for the musk-ab+ population

This trial's timeline: 3 weeks for screening, Varies for treatment, and between day 28 and week 52 for achr-ab+ population and day 28 and week 26 for the overall study population, the achr-ab+ population, and for the musk-ab+ population for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) Profile score.

Secondary outcome measures

Change in MG-ADL at Week 26

Change in Myasthenia Gravis Composite (MGC) score.

Change in Myasthenia Gravis Quality of Life-15, revised (MGQOL-15r) score.

+5 more

MINT 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.

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

Viela BioLead Sponsor

12 Previous Clinical Trials

891 Total Patients Enrolled

AmgenLead Sponsor

1,370 Previous Clinical Trials

1,377,450 Total Patients Enrolled

Viela Bio (acquired by Horizon Therapeutics)Lead Sponsor

6 Previous Clinical Trials

733 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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

At how many different locations is this trial taking place?

"There are 25 sites running this trial, Great Neck, Pittsburgh and Minneapolis being three of them. Patients should select the location nearest to them to avoid extensive travel if they choose to participate."

Answered by AI

What have been the inebilizumab-related hospitalization rates?

"Inebilizumab has been studied in multiple Phase 3 clinical trials, so its safety profile is well-understood and it received a score of 3."

Answered by AI

Is this research looking for new participants?

"From what is publicly available on clinicaltrials.gov, this research study is still recruiting patients. The trial was initially posted on August 30th 2020 with the most recent update being from October 18th 2022."

Answered by AI

Has there been research like this conducted before?

"In total, there have been 17 clinical trials for inebilizumab since the year 2020. The most recent one is still ongoing and taking place across 48 cities and 28 countries. Viela Bio (now Horizon Therapeutics) sponsored the first trial which involved 270 patients. This initial study completed its Phase 3 drug approval process in 2020."

Answered by AI

How many individuals are involved in this research?

"The sponsor of this trial, Viela Bio (now under Horizon Therapeutics), needs to enroll 270 eligible patients from various locations. For example, one site is at Viela Bio Investigative Site - 1020 in Great Neck, New york and another is at Viela Bio Investigative Site - 1008 in Pittsburgh, Pennsylvania."

Answered by AI

Could you provide a summary of other inebilizumab-related research?

"inebilizumab was first studied in the year 2020 at Viela Bio Investigative Site - 3003. Since then there are a total of 17 completed studies. There are 3 active clinical trials as of now, with a significant proportion taking place in Great Neck, New york."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Myasthenia Gravis Inebilizumab Trial

2020. "Myasthenia Gravis Inebilizumab Trial". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04524273.

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