Inebilizumab for Myasthenia Gravis

(MINT Trial)

Recruiting at 113 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

238 Participants Needed

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. ^{1 2 3 4 5}

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

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. England 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. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Long-term safety and efficacy of certolizumab pegol in combination with methotrexate in the treatment of rheumatoid arthritis: 5-year results from the RAPID 1 trial and open-label extension. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Certolizumab pegol in combination with dose-optimised methotrexate in DMARD-naïve patients with early, active rheumatoid arthritis with poor prognostic factors: 1-year results from C-EARLY, a randomised, double-blind, placebo-controlled phase III study. [2022]

4. England pubmed.ncbi.nlm.nih.gov

The first double-blind, randomised, parallel-group certolizumab pegol study in methotrexate-naive early rheumatoid arthritis patients with poor prognostic factors, C-OPERA, shows inhibition of radiographic progression. [2022]

5. England 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. [2022]