What side effects are associated with this type of intervention?

Common treatments for myositis, particularly those involving tyrosine kinase inhibitors like Nintedanib, can have several side effects. Nintedanib, which is used to reduce fibrosis and scarring in the lungs, has been associated with serious toxicities such as thrombocytopenia, anemia, neutropenia, diarrhea, fatigue, hypertension, and hepatic transaminitis. Other treatments for myositis, such as mycophenolate mofetil, can lead to opportunistic infections, including Mycobacterium xenopi abscess, pulmonary blastomycosis, and Legionella pneumonia. Patients undergoing these treatments should be closely monitored for these potential adverse effects.

What prior FDA approvals exist?

Currently, there are no FDA-approved treatments specifically for myositis that function similarly to nintedanib by inhibiting multiple tyrosine kinases to reduce fibrosis and scarring. However, treatments like mycophenolate mofetil and rituximab are used off-label for myositis, particularly when associated with interstitial lung disease. These treatments focus on immunosuppression and reducing inflammation rather than directly targeting fibrosis pathways.

What other types of research exist?

Promising novel alternatives to Nintedanib for Myositis patients include: 1) Reldesemtiv, which is currently in phase III trials and has shown trends favoring benefit in muscle strength and respiratory function. 2) Masitinib, a selective tyrosine kinase inhibitor that has shown a 27% slowing in the rate of functional decline in ALS patients, indicating potential neuroprotective and anti-inflammatory effects. Both treatments are still under investigation but show potential for managing fibrosis and related symptoms in Myositis patients.

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Tyrosine Kinase Inhibitor

Nintedanib for Interstitial Lung Disease (MINT Trial)

Verified Trial

Phase 4

Recruiting

Research Sponsored by Rohit Aggarwal, MD

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Do you live in the United States?

Do you have myositis or a blood test indicating myositis (or myositis antibodies)?

Must not have

Are you being evaluated for a lung transplant or have you had one in the past?

Do you currently require supplemental oxygen of 10L or more at rest?

Timeline

Screening 1 day

Treatment 24 weeks

Follow Up 52 weeks

Awards & highlights

Pivotal Trial

Drug Has Already Been Approved

Summary

This trial tests nintedanib, a drug that slows lung damage, in patients with myositis-associated interstitial lung disease. It works by blocking proteins that cause lung inflammation and scarring. Nintedanib has been approved for treating certain lung diseases and has shown positive results in various conditions.

Who is the study for?

This trial is for people living in the U.S. who have myositis-associated interstitial lung disease, can speak English or Spanish, and haven't used OFEV for treatment. It's not for those needing high levels of oxygen (10L+), planning major surgery within 6 months, undergoing evaluation or past recipients of a lung transplant, or women who are pregnant/lactating or planning pregnancy soon.

What is being tested?

The study tests if nintedanib can improve symptoms in patients with MA-ILD compared to a placebo alongside standard care. Participants will undergo physical exams, pulmonary function tests, CT scans, blood draws and use activity monitors; some activities may be done remotely via telemedicine.

What are the potential side effects?

Nintedanib may cause side effects like diarrhea, liver enzyme elevation leading to potential liver damage, bleeding risk increase due to its effect on clotting mechanisms and possible heart attack or stroke.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I have myositis or a positive test for myositis antibodies.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am being considered for or have had a lung transplant.

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I need more than 10L of oxygen at rest.

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I am not planning any major surgeries that require anesthesia in the next 6 months.

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I have used OFEV for my condition.

Timeline

Screening ~ 1 day1 visit

Treatment ~ 24 weeks1 visit

Follow Up ~ 52 weeks1 visit

Screening ~ 1 day

Treatment ~ 24 weeks

Follow Up ~52 weeks

This trial's timeline: 1 day for screening, 24 weeks for treatment, and 52 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change in Living with Pulmonary Fibrosis Symptoms and Impact Questionnaire (L-PF) Dyspnea score

Secondary study objectives

Absolute and relative change in Forced Vital Capacity (FVC) (mL) from baseline to 12 weeks

Absolute and relative change in Forced Vital Capacity (FVC) (mL) from baseline to 24 weeks

Absolute and relative change in Forced Vital Capacity FVC (%) from baseline to week 12

+13 more

Other study objectives

Absolute and relative change in DLCO

Absolute and relative change in FEV1

Adverse events (AEs) and tolerance

+16 more

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

Trial Design

2Treatment groups

Active Control

Placebo Group

Group I: Nintedanib plus Standard of CareActive Control2 Interventions

Nintedanib 150 mg BID + SOC Immunosuppressive Therapy for 12 weeks followed by open-label Nintedanib 150mg BID + SOC Immunosuppressive Therapy for additional 12 weeks.

Group II: Placebo plus Standard of Care, then Nintedanib plus Standard of CarePlacebo Group3 Interventions

Placebo twice a day (BID) plus standard of care (SOC) Immunosuppressive Therapy for 12 weeks followed by open-label Nintedanib 150 mg BID + SOC Immunosuppressive Therapy for additional 12 weeks.

0 / 6Eligibility criteria met

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 Myositis, such as Nintedanib, work by inhibiting multiple tyrosine kinases, which play a crucial role in the development of fibrosis and scarring in tissues. By targeting these pathways, these treatments help reduce the thickening, stiffness, and scarring of muscle tissues, which are hallmark features of Myositis. This is particularly important for Myositis patients as it can improve muscle function, reduce symptoms, and potentially slow disease progression, thereby enhancing their quality of life.

PDGFRα mediated survival of myofibroblasts inhibit satellite cell proliferation during aberrant regeneration of lacerated skeletal muscle.Angiotensin-converting-enzyme inhibitor prevents skeletal muscle fibrosis in myocardial infarction mice.Review of Recent Patents and Developments in Skeletal Muscle Regeneration.