This research study will evaluate safety and how well the study drug, nintedanib improve symptoms in participants with myositis associated interstitial lung disease (MA-ILD). Interstitial lung disease is a disorder caused by the abnormal accumulation of cells structures between air sacs of the lungs resulting in thickening, stiffness and scarring of the tissues of the lung.
This study will enroll a total of 134 participants across 15 clinical sites located in the United States. A subset of participants will be enrolled remotely via telemedicine utilizing certified mobile home research nurses and various remote monitoring devices.
The research visits may include a physical exam, vital signs (such as blood pressure, heart rate, etc.), pulmonary function tests (PFT and/or home spirometry), Computerized Tomography (or CT) scans of the chest, blood draws, wearing a physical activity monitor and completing questionnaires. Some of these events may be done at home, at a local facility or remotely (via telemedicine).
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Subject has provided written informed consent
✓. Approval from local treating physician (done at pre-screening only for remote patients as well as for local site patients not actively being managed at the local site).
✓. Subject lives in the United States
✓. Adult: Age ≥ 18 years
✓. Subject can speak, read, and understand English or Spanish
✓. Subject is willing and capable of performing all study procedures.
✓. Validity/repeatability of home spirometry confirmed by PFT lab technician/MD through telemedicine as per American Thoracic Society guidelines.
✓. Men and women of reproductive potential must agree to use 2 reliable methods of birth control during the trial period.
Exclusion criteria
✕. Planned major surgical procedures within the trial period of 24 weeks.
What they're measuring
1
Change in Living with Pulmonary Fibrosis Symptoms and Impact Questionnaire (L-PF) Dyspnea score
. Women who are pregnant, nursing, or who plan to become pregnant while in the trial.
✕. Women of childbearing potential\* not willing or able to use at least two highly effective methods of birth control.
✕. For females of reproductive potential: use of highly effective contraception for at least 1 month before study drug administration and agreement to use such a method during study participation and for an additional 28 days after the end of study drug administration.
✕. For males of reproductive potential\*\*: use of condoms or other methods to ensure effective contraception with a partner
✕. Severe lung disease is defined by the following within the last 6 months before the screening:
✕. FVC ≤40 percent predicted
✕. DLCO \<30% of percent predicted (corrected for Hb)