At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 435 enrolled
Drug / intervention
Nintedanibdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
An Open-label Extension Trial of the Long Term Safety of Nintedanib in Patients With Progressive Fibrosing Interstitial Lung Disease (PF-ILD)
In Brief
A Phase 3 clinical trial evaluating Nintedanib for Lung Diseases, Interstitial. Completed, enrolled 435 participants across 121 sites in 15 countries.
Detailed 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).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLung Diseases, Interstitial
CountriesArgentina, Belgium, Canada, Chile, China, France, Germany, Italy, Japan, Poland, Russia, South Korea, Spain, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
20192020202120222023202420252026
First PostedJan 2019
Enrollment StartApr 2019
Primary CompletionAug 2022
TodayJul 2026
First PostedJan 29, 2019
Enrollment StartApr 16, 2019
Primary CompletionAug 30, 2022
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 7.4 years ago
Interventions
Nintedanibdrug
Bid