NCT03820726

A Follow-up Study Investigating Long Term Treatment With Nintedanib in Patients With Progressive Fibrosing Interstitial Lung Disease (PF-ILD)

An Open-label Extension Trial of the Long Term Safety of Nintedanib in Patients With Progressive Fibrosing Interstitial Lung Disease (PF-ILD)

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 435 (actual)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main objective is to assess long term tolerability and safety of treatment with oral nintedanib in patients with Progressive Fibrosing Interstitial Lung Disease (PF-ILD) who have complete (and did not prematurely discontinue trial medication in) the phase III parent trial, INBUILD® (trial 1199.247).

Conditions

• Lung Diseases, Interstitial

Interventions

Type	Name	Description
DRUG	Nintedanib	Bid

Timeline

• Start date: 2019-04-16
• Primary completion: 2022-08-30
• Completion: 2022-08-30
• First posted: 2019-01-29
• Last updated: 2023-09-13
• Results posted: 2023-09-13

Locations

121 sites across 15 countries: United States, Argentina, Belgium, Canada, Chile, China, France, Germany, Italy, Japan, Poland, Russia, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study