Overview

A Study to Evaluate Long-term Safety of Nintedanib in Children and Adolescents With Interstitial Lung Disease (InPedILD™-ON)

Status:
Not yet recruiting

Trial end date:
2026-05-29

Target enrollment:

Participant gender:

Summary

This study is open to children and adolescents with interstitial lung disease (ILD) that causes lung fibrosis. This is a study for people who took part in a previous study (study 1199-0337, InPedILD™) and for people who are between 6 and 17 years old and have fibrosing ILD. This study tests a medicine called nintedanib. Nintedanib is already used to treat different types of lung fibrosis in adults. The purpose of the study is to find out how well long-term treatment with nintedanib is tolerated in children and adolescents. All participants take nintedanib capsules twice a day. Participants are in the study for at least 2 years or until nintedanib or other treatment options become available outside of this study. During the first 2 years, they visit the study site between 9 and 11 times. Afterwards, they visit the study site every 3 months. The doctors collect information on any health problems of the participants.

Phase:

Phase 3

Details

Lead Sponsor:

Boehringer Ingelheim

Treatments:

Nintedanib