At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 444 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 'Systemic Sclerosis Associated Interstitial Lung Disease' (SSc-ILD)
In Brief
A Phase 3 clinical trial evaluating Nintedanib for Lung Diseases, Interstitial. Completed, enrolled 444 participants across 159 sites in 30 countries.
Detailed Summary
The main objective is to assess long term safety of treatment with oral nintedanib in patients with Systemic Sclerosis associated Interstitial Lung Disease (SSc-ILD).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLung Diseases, Interstitial
CountriesArgentina, Australia, Austria, Belgium, Brazil, Canada, Chile, China, Czechia, Denmark, Finland, France, Germany, Greece, India, Israel, Italy, Japan, Malaysia, Mexico, Netherlands, Norway, Poland, Portugal, Spain, Sweden, Switzerland, Thailand, United Kingdom, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201820192020202120222023202420252026
First PostedOct 2017
Enrollment StartNov 2017
Primary CompletionJan 2023
TodayJul 2026
First PostedOct 18, 2017
Enrollment StartNov 27, 2017
Primary CompletionJan 25, 2023
TodayJul 2, 2026
Enrollment to primary: 5.2 yearsPosted 8.7 years ago
Interventions
Nintedanibdrug
Administered twice daily