A double blind, randomised, placebo-controlled trial evaluating efficacy and safety of oral nintedanib treatment for at least 52 weeks in patients with 'Systemic Sclerosis associated Interstitial Lung Disease' (SSc-ILD)
ID Number 16-0542Principal Investigator(s)
Maria L Padilla
Department(s) or Division(s)
Pulmonary, Critical Care and Sleep Medicine
The purpose of this study is to investigate how well the treatment with the study drug called nintedanib can demonstrate a slowing the rate of lung scarring (or fibrosis) and how well the study treatment has an effect on the skin thickening. In addition, this study will also investigate the safety of nintedanib and how well the body tolerates the study drug; it will evaluate how the subject feels about their condition; and when symptoms improve, occur, or get worse during the course of the study, using questionnaires, it will get participants' responses.
Subjects may qualify to take part in this research study, because they have systemic sclerosis (SSc) and associated Interstitial Lung Disease.
Subjects participation in this research study is expected to last between 56 and 104 weeks (between 1 and 2 years).
Subjects will be assigned to nintedanib or placebo by random choice. Subjects have a 50% chance to receive the study drug, nintedanib, or placebo. They will have an equal chance of being placed in either of the following groups:
- 150 mg nintedanib two times daily
- Placebo two times daily
The number of people expected to take part in this research study at this site is 10. The total number of people expected to take part in this research study is 80 subjects in the US and approximately 520 subjects will participate worldwide.
Recruiting Patients: Yes