NCT05285982

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

An Open-label Trial of the Long-term Safety and Tolerability of Nintedanib Per os, on Top of Standard of Care, Over at Least 3 Years, in Children and Adolescents With Clinically Significant Fibrosing Interstitial Lung Disease (InPedILD®-ON)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 54 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

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 called InPedILD (study 1199-0337) and for people who are between 6 and 17 years old (in France, between 12 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 coming from the previous study are in this study for at least 3 years or until nintedanib or other treatment options become available outside of this study. New participants are in the study until the overall end of study meaning for at least 1.5 years. Participants visit the study site about 15 times for a study participation of 3 years. Afterwards, they visit the study site every 3 months. The doctors collect information on any health problems of the participants.

Conditions

• Lung Diseases, Interstitial

Interventions

Type	Name	Description
DRUG	Nintedanib (Ofev®)	Nintedanib soft capsules administered orally with doses ranged from 50 to 150 mg bid depending on body weight

Timeline

• Start date: 2022-04-06
• Primary completion: 2025-08-13
• Completion: 2025-08-13
• First posted: 2022-03-18
• Last updated: 2026-03-04
• Results posted: 2026-03-04

Locations

28 sites across 17 countries: United States, Argentina, Belgium, Brazil, Canada, Czechia, Finland, France, Germany, Greece, Italy, Mexico, Norway, Poland, Portugal, Spain, United Kingdom

Regulatory

• FDA-regulated drug study