Inebilizumab for Myasthenia Gravis

(MINT Trial)

Not currently recruiting at 143 trial locations

Overseen By Horizon Therapeutics

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Viela Bio

Must be taking: Corticosteroids, Azathioprine, Mycophenolate

Must not be taking: Cyclosporine, Tacrolimus, Methotrexate

Disqualifiers: High corticosteroids, High pyridostigmine, others

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 10

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests inebilizumab for individuals with myasthenia gravis, a condition that causes muscle weakness. The researchers aim to determine if inebilizumab can reduce symptoms compared to a placebo (a substance with no therapeutic effect). Participants will receive either inebilizumab or a placebo through an IV (intravenous) infusion. Ideal candidates for this trial have myasthenia gravis with anti-AChR or anti-MuSK antibodies and experience moderate to severe muscle weakness. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new treatment.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that inebilizumab has been tested for safety in treating generalized myasthenia gravis (gMG), a long-term autoimmune disorder. In a study with 238 participants, most tolerated inebilizumab well. A small number (5.6%) developed antibodies, indicating an immune reaction to the treatment.

The overall safety of inebilizumab was considered manageable, with side effects not too severe or difficult to handle. The FDA has already approved the treatment for another condition, suggesting it is relatively safe. However, individual reactions can vary. Prospective trial participants should discuss any concerns with their doctor. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for myasthenia gravis?

Researchers are excited about inebilizumab for myasthenia gravis because it offers a unique approach compared to standard treatments like acetylcholinesterase inhibitors, corticosteroids, and immunosuppressants. Unlike these traditional options, inebilizumab targets CD19, a protein on B cells, helping to reduce the number of cells that produce harmful antibodies. This new mechanism could mean more targeted treatment with potentially fewer side effects. Additionally, its administration via intravenous infusion provides a controlled delivery method that might improve its effectiveness and tolerability.

What evidence suggests that inebilizumab might be an effective treatment for myasthenia gravis?

In this trial, participants will receive either inebilizumab or a placebo to evaluate the treatment's effectiveness for myasthenia gravis. Research has shown that inebilizumab can significantly improve symptoms of this condition, where the immune system disrupts communication between nerves and muscles. Studies have found that patients taking inebilizumab experienced a greater reduction in their MG-ADL score, which measures daily life challenges, compared to those taking a placebo. One study noted a difference of -2.8 in symptom improvement when comparing inebilizumab to placebo, indicating significant benefits. Another study reported meaningful improvements in both MG-ADL and QMG scores, which evaluate muscle strength and abilities, over 26 weeks. These findings suggest that inebilizumab may effectively manage myasthenia gravis symptoms. ^{1 3 6 7 8}

Who Is on the Research Team?

MD

Principal Investigator

Amgen

Are You a Good Fit for This Trial?

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.

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Randomized Controlled Period (RCP)

Participants receive either inebilizumab or placebo administered intravenously on specified days

26 weeks

3 visits (in-person)

Open-label Period (OLP)

Participants who complete the RCP may opt into receiving inebilizumab for an extended period

156 weeks

7 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Inebilizumab
• IV Placebo

Trial Overview 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.

How Is the Trial Designed?

Group I: Inebilizumab, (MuSK-Ab+) MG Experimental Treatment 1 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+) MG Experimental Treatment 1 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+) MG Placebo Group 1 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+) MG Placebo Group 1 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:

• Neuromyelitis optica spectrum disorder (NMOSD) in adults who are anti-aquaporin-4 (AQP4) antibody positive

Approved in European Union as Uplizna for:

• Neuromyelitis optica spectrum disorder (NMOSD) in adults who are anti-aquaporin-4 (AQP4) antibody positive

Approved in Canada as Uplizna for:

• Neuromyelitis optica spectrum disorder (NMOSD) in adults who are anti-aquaporin-4 (AQP4) antibody positive

Who Is Running the Clinical Trial?

Viela Bio

Lead Sponsor

Trials

13

Recruited

1,100+

Amgen

Lead Sponsor

Trials

1,508

Recruited

1,433,000+

Founded

1980

Headquarters

Thousand Oaks, USA

Known For

Human Therapeutics

Top Products

Enbrel, Prolia, Neulasta, Otezla

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

Trials

7

Recruited

950+

Published Research Related to This Trial

In a 2-year study involving 556 patients with active rheumatoid arthritis, tocilizumab (TCZ) combined with methotrexate was effective in achieving sustained remission, with 50.4% of patients able to discontinue TCZ after reaching this state.

While most patients (84.0%) who stopped TCZ experienced a flare in their condition, they responded well to reintroduction of the drug, and minimal radiographic progression was observed, indicating that TCZ is both effective and relatively safe for long-term management of rheumatoid arthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Clinical and radiographic outcomes at 2 years and the effect of tocilizumab discontinuation following sustained remission in the second and third year of the ACT-RAY study. Huizinga, TW., Conaghan, PG., Martin-Mola, E., et al.[2022]

Patients treated with certolizumab pegol (CZP) showed significantly higher odds of achieving meaningful improvements in pain, physical function, and fatigue compared to control groups, with improvements being five times more likely for pain.

Improvements in physical function, fatigue, and pain were strongly associated with enhanced productivity at work and home, indicating that effective management of rheumatoid arthritis symptoms can lead to better overall life quality.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Physical function improvements and relief from fatigue and pain are associated with increased productivity at work and at home in rheumatoid arthritis patients treated with certolizumab pegol. Hazes, JM., Taylor, P., Strand, V., et al.[2022]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40202593/

A Phase 3 Trial of Inebilizumab in Generalized Myasthenia ... Participants who received inebilizumab had a greater reduction in the MG-ADL score than those who received placebo (least-squares mean change, - ...

2. amgen.com amgen.com/newsroom/press-releases/2025/03/uplizna-inebilizumabcdon-significantly-improves-generalized-myasthenia-gravis-symptoms-in-acetylcholine-receptor-autoantibodypositive-patients-over-52-weeks

UPLIZNA® (INEBILIZUMAB-CDON) SIGNIFICANTLY ... The trial demonstrated continued improvement in efficacy of UPLIZNA compared to placebo (adjusted difference, −2.8, 95% CI, −3.9 to −1.7) as ...

3. neurology.org neurology.org/doi/10.1212/WNL.0000000000211217

Phase 3 Myasthenia Gravis Inebilizumab Trial (MINT) The primary endpoint was achieved demonstrating a clinically meaningful improvement in MG-ADL score change in the inebilizumab group (−4.2) as ...

4. ajmc.com ajmc.com/view/mint-trial-26-week-data-show-inebilizumab-for-gmg-is-effective-and-safe

MINT Trial 26-Week Data Show Inebilizumab for gMG Is ... Key Takeaways. Inebilizumab showed significant efficacy in improving MG-ADL and QMG scores in gMG patients compared to placebo over 26 weeks.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04524273

NCT04524273 | Myasthenia Gravis Inebilizumab Trial This study is a phase 3, randomized, double-blind, placebo-controlled study, to be conducted at approximately 120 study sites.

6. amgen.com amgen.com/newsroom/press-releases/2024/10/amgen-presents-positive-phase-3-data-for-uplizna-inebilizumabcdon-in-generalized-myasthenia-gravis-gmg-at-aanem-2024

Press Releases The Phase 3 MINT trial evaluating the efficacy and safety of UPLIZNA (inebilizumab-cdon) for the treatment of adults with generalized myasthenia gravis (gMG), ...

7. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2020/761142s000lbl.pdf

UPLIZNA (inebilizumab-cdon) - accessdata.fda.gov In Study 1, treatment-emergent antibodies (those that appeared or significantly increased from baseline after administration of UPLIZNA), were detected in 5.6% ...

8. appliedclinicaltrialsonline.com appliedclinicaltrialsonline.com/view/uplizna-generalized-myasthenia-gravis-mint-trial

Uplizna Shows Significant Efficacy, Safety Treating ... Uplizna (inebilizumab) demonstrated significant short-term efficacy and a manageable safety profile in adult patients with generalized myasthenia gravis.