Not recruitingRare disease

Study on the Long-Term Safety of Nintedanib for Children and Adolescents with Interstitial Lung Disease

Verified siteInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying the long-term safety of a medication called nintedanib in children and adolescents who have a condition known as Childhood Interstitial Lung Disease. This disease affects the lungs, causing inflammation and scarring, which can make it difficult to breathe. The purpose of the study is to understand how safe and tolerable nintedanib is when used over a long period, alongside the usual care these patients receive.

Participants in the study will take nintedanib in the form of a soft capsule, which is taken by mouth. The study will last for at least three years, during which time researchers will monitor the participants for any side effects or adverse reactions that may occur as a result of the treatment. The study aims to gather information on how often these side effects happen and how they affect the participants.

Throughout the study, participants will continue to receive their standard medical care for Childhood Interstitial Lung Disease, and the effects of adding nintedanib to their treatment will be closely observed. The goal is to ensure that the medication is safe for long-term use in young patients and to provide valuable information that could help improve treatment options for this condition in the future.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, the patient will be required to provide written informed consent and assent, if applicable. This is necessary to confirm understanding and agreement to participate in the trial.
Eligibility criteria include being between 6 to 17 years old, with specific age requirements in certain locations, and having a diagnosis of fibrosing interstitial lung disease confirmed by a recent high-resolution CT scan.
Step 2
Treatment initiation
The patient will begin treatment with nintedanib, which is administered orally in the form of a soft capsule.
The dosage and frequency of nintedanib will be determined by the study protocol and the patient's specific needs, under the supervision of the study team.
Step 3
Ongoing treatment and monitoring
The patient will continue to take nintedanib as prescribed, alongside any standard care treatments they are already receiving.
Regular monitoring will occur to assess the safety and tolerability of the treatment. This includes tracking any adverse events that may arise during the trial.
Step 4
Long-term follow-up
The trial is designed to last for at least 3 years, during which the patient will be regularly evaluated to ensure the treatment's safety and effectiveness.
The primary focus is on identifying any treatment emergent adverse events throughout the duration of the trial.
Step 5
Completion of the trial
Upon completion of the trial, the patient will undergo a final assessment to evaluate the overall impact of the treatment.
The study is expected to conclude by August 11, 2025, at which point all data will be analyzed to determine the long-term safety of nintedanib in treating fibrosing interstitial lung disease in children and adolescents.

Who can join the trial?

8 criteria

Children and adolescents aged 6 to 17 years old can join the study. In France, only those aged 12 to 17 years old can participate.
A signed and dated written informed consent is needed. This means that both the child and their guardian agree to join the study after understanding what it involves.
Both boys and girls can participate. Girls who can have children must agree to avoid pregnancy by either not having sex or using a very effective birth control method until 3 months after the last dose of the study drug.
Participants must have signs of a specific lung condition called **fibrosing ILD** on a special scan called **HRCT** within 12 months before joining the study. This will be checked by the study doctor and confirmed by another review.
Participants must have a lung function test result called **FVC** that is at least 25% of what is expected for their age and size.
Participants must have a significant lung disease, as determined by the study doctor, based on certain criteria like a specific score, worsening symptoms, or increased lung scarring on scans.
For those who were part of a previous study called InPedILD™, only the consent and birth control criteria apply, and they must have completed the previous study without stopping the treatment early.
For those who stopped treatment early in a previous study or completed a parent trial but couldn't join the extension trial within 12 weeks, the criteria for new patients apply, except for some specific conditions.

Who cannot join the trial?

10 criteria

Patients who have a different lung disease that is not related to **Childhood Interstitial Lung Disease**.
Patients who are not within the age range specified for the trial.
Patients who have a medical condition that could interfere with the trial or make it unsafe for them to participate.
Patients who are taking medications that might interact negatively with the trial treatment.
Patients who have had a recent surgery or medical procedure that could affect their participation.
Patients who are unable to follow the trial procedures or attend the required visits.
Patients who have a history of allergic reactions to the trial medication or similar drugs.
Patients who are currently participating in another clinical trial.
Patients who are pregnant or breastfeeding, as the trial may not be safe for them or their baby.
Patients who have a history of substance abuse that could interfere with the trial.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Centre Hospitalier Intercommunal Creteil
Verified
Creteil, France
Fakultni nemocnice Motol a Homolka
Verified
Prague, Czechia
Hippokration Hospital
Verified
Athens, Greece

Trial locations

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Investigated drugs

Nintedanib is a medication being studied for its long-term safety and tolerability in children and adolescents with clinically significant fibrosing Interstitial Lung Disease (ILD). It is taken orally and is used in addition to the standard care treatments for this condition. The main goal of the trial is to understand how safe and tolerable nintedanib is when used over a long period, specifically looking at any side effects that may occur during the trial.

Nintedanib

What is already known about the treatment

Nintedanib – Nintedanib is administered orally and is currently being studied in clinical trials for its long-term safety and tolerability in children and adolescents with significant fibrosing interstitial lung disease. It is primarily used to treat conditions involving lung fibrosis. Nintedanib works by inhibiting certain enzymes that contribute to the formation of fibrous tissue in the lungs, thereby slowing disease progression. It is classified as a tyrosine kinase inhibitor, which helps reduce inflammation and scarring in lung tissues.

Investigated diseases

Childhood Interstitial Lung Disease – This is a group of rare lung disorders that affect children, characterized by inflammation and scarring of the lung tissue. The disease can lead to difficulty in breathing and reduced oxygen levels in the blood. Symptoms often include chronic cough, rapid breathing, and fatigue. The progression of the disease can vary, with some children experiencing stable symptoms while others may have worsening respiratory issues. The exact cause of the disease is often unknown, and it can be associated with genetic factors or environmental exposures. The condition requires careful monitoring to manage symptoms and maintain lung function.