What is the mechanism of action of this treatment?

Nintedanib, a tyrosine kinase inhibitor, works by blocking the signaling pathways that lead to fibrosis, which is crucial for slowing the progression of lung fibrosis in Interstitial Lung Disease (ILD) patients. This helps preserve lung function and improve quality of life. Similarly, pirfenidone, another antifibrotic agent, reduces the production of fibrotic proteins and inflammatory mediators. Both treatments aim to manage symptoms and slow disease progression, which is vital for maintaining respiratory function and delaying the need for more invasive treatments.

What side effects are associated with this type of intervention?

Nintedanib, a tyrosine kinase inhibitor used in the treatment of Interstitial Lung Disease (ILD), is generally well-tolerated but can cause side effects such as diarrhea, nausea, vomiting, liver enzyme elevation, and abdominal pain. Pirfenidone, another common treatment, may lead to gastrointestinal issues, skin rash, and photosensitivity. Glucocorticoids, often used in ILD, can cause weight gain, hypertension, diabetes, osteoporosis, and increased risk of infections. Patients should discuss these potential side effects with their healthcare provider to manage and mitigate them effectively.

What prior FDA approvals exist?

Nintedanib, a tyrosine kinase inhibitor, has been FDA-approved for the treatment of idiopathic pulmonary fibrosis (IPF) and other fibrosing interstitial lung diseases. Another FDA-approved drug for IPF is pirfenidone, which has antifibrotic and anti-inflammatory properties. Both drugs aim to slow disease progression and improve lung function. These treatments represent significant advancements in managing ILD, particularly for conditions involving lung fibrosis.

What other types of research exist?

Promising alternatives to Nintedanib for ILD patients include Pirfenidone, which has shown efficacy in slowing the progression of lung impairment in pulmonary fibrosis. Additionally, Nilotinib has demonstrated potent antifibrotic effects in preclinical models and may be a potential alternative. Further clinical trials and studies are needed to confirm their efficacy and safety in ILD patients.

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Tyrosine Kinase Inhibitor

Nintedanib for Interstitial Lung Disease

Phase 3

Waitlist Available

Research Sponsored by Boehringer Ingelheim

Eligibility Criteria Checklist

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

Must have

For new patients: Patients with clinically significant disease at Visit 2, as assessed by the investigator based on any of the following: Fan score ≥3, or Documented evidence of clinical progression over time based on either a 5-10% relative decline in FVC % predicted accompanied by worsening symptoms, or a ≥10% relative decline in FVC % predicted, or increased fibrosis on HRCT, or other measures of clinical worsening attributed to progressive lung disease (e.g. increased oxygen requirement, decreased diffusion capacity)

For new patients: Children and adolescents 6 to 17 years old at Visit 2

Must not have

For new patients: Female patients who are pregnant, nursing, or who plan to become pregnant while in the trial

For new patients: Patients not able or willing to adhere to trial procedures, including intake of study medication

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Pivotal Trial

No Placebo-Only Group

Summary

This trial tests the medicine nintedanib in children and teens with lung disease that causes scarring. The goal is to see if long-term use of nintedanib is safe and effective for them. Participants take the medicine and visit the study site for health check-ups. Nintedanib has been shown to slow disease progression and is well tolerated in patients.

Who is the study for?

This trial is for children and adolescents aged 6-17 with fibrosing interstitial lung disease. They must have participated in a prior study or meet specific health criteria, including normal organ function tests and not being on conflicting medications. Girls able to have children must use effective birth control.

What is being tested?

The trial evaluates the long-term safety of Nintedanib (Ofev®) in treating lung fibrosis in young patients. Participants will take Nintedanib capsules twice daily for at least six months, with regular visits to monitor their health.

What are the potential side effects?

Nintedanib may cause liver issues, gastrointestinal problems like diarrhea, nausea or vomiting, weight loss, high blood pressure, headache or dizziness. It can also affect blood clotting leading to bleeding risk.

Eligibility Criteria

Inclusion Criteria

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

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I have worsening lung disease symptoms or test results.

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I am between 6 and 17 years old.

Exclusion Criteria

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

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I am not pregnant, nursing, or planning to become pregnant during the trial.

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I am willing and able to follow the trial procedures and take the study medication.

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I have severe or uncontrolled high blood pressure, had a heart attack, or unstable angina recently.

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I have a high risk of bleeding due to genetic factors, medication use, recent significant bleeding events, or recent major injury/surgery.

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I have chronic liver disease.

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I weigh less than 13.5 kg.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

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

Awards & Highlights

Pivotal Trial

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

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Patients rolling over from the InPedILD® studyExperimental Treatment1 Intervention

Group II: Patients newly enrolled in this studyExperimental Treatment1 Intervention

0 / 8Eligibility 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

Nintedanib, a tyrosine kinase inhibitor, works by blocking the signaling pathways that lead to fibrosis, which is crucial for slowing the progression of lung fibrosis in Interstitial Lung Disease (ILD) patients. This helps preserve lung function and improve quality of life. Similarly, pirfenidone, another antifibrotic agent, reduces the production of fibrotic proteins and inflammatory mediators. Both treatments aim to manage symptoms and slow disease progression, which is vital for maintaining respiratory function and delaying the need for more invasive treatments.