Adults 18 years of age and older or above legal age with lung fibrosis related to systemic autoimmune rheumatic disease can participate in this study. People can only take part if they show no improvement in lung function after standard treatment with immunosuppressant medicine. The main purpose of this study is to find out how a medicine called nerandomilast affects the lungs in people with systemic autoimmune rheumatic disease. Participants are put into 2 groups randomly, which means by chance. One group takes nerandomilast tablets and the other group takes placebo tablets. Placebo tablets look like nerandomilast tablets but do not contain any medicine. Participants take a tablet 2 times a day for at least 26 weeks and up to 1 year. Participants continue immunosuppressant treatment for their underlying rheumatic disease. Participants are in the study for about 7.5 to 13 months depending on when they join the study. During this time, they visit the study site about 9 to 10 times. At study visits, participants have lung function tests. At select visits, chest imaging is performed. Participants fill in questionnaires about their symptoms and quality of life. The results between the 2 groups are compared to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
400
Nerandomilast
Placebo matching nerandomilast
University of Alabama at Birmingham
Birmingham, Alabama, United States
NOT_YET_RECRUITINGMayo Clinic-Arizona
Scottsdale, Arizona, United States
NOT_YET_RECRUITINGUniversity of California Los Angeles
Los Angeles, California, United States
NOT_YET_RECRUITINGParadigm Clinical Research - San Diego
San Diego, California, United States
RECRUITINGAbsolute change from baseline in quantitative interstitial lung disease (QILD) score [%] on high-resolution computed tomography (HRCT) at Week 26
QILD will be assessed via quantitative high-resolution computed tomography (qHRCT). QILD are quantitative measures of different radiological patterns associated with lung fibrosis. QLF is a measure of reticulation with architectural distortion. QGGO is a measure of ground glass opacities (i.e. hazy or cloudy areas) within the lung. QHC is a measure of HC within the lung. QILD is the sum of QLF, QGGO, and QHC. Quantification of HRCT scans will be performed centrally via a machine learning algorithm. QILD \[%\] is the QILD volume \[mL\] as a percent of the total lung volume. A higher QILD percentage or volume indicates a higher extent of disease.
Time frame: At baseline and at Week 26
Absolute change from baseline in quantitative lung fibrosis (QLF) score [%] on HRCT at Week 26
QLF will be assessed via qHRCT. QLF are quantitative measures of different radiological patterns associated with lung fibrosis. QLF is a measure of reticulation with architectural distortion. Quantification of HRCT scans will be performed centrally via a machine learning algorithm. QILD \[%\] is the QILD volume \[mL\] as a percent of the total lung volume. A higher QILD percentage or volume indicates a higher extent of disease.
Time frame: At baseline and at Week 26
Absolute change from baseline in quantitative ground glass opacity (QGGO) score [%] on HRCT at Week 26
QGGO will be assessed via qHRCT. QGGO are quantitative measures of different radiological patterns associated with lung fibrosis. QGGO is a measure of ground glass opacities (i.e. hazy or cloudy areas) within the lung. Quantification of HRCT scans will be performed centrally via a machine learning algorithm. A higher QGGO percentage or volume indicates a higher extent of disease.
Time frame: At baseline and at Week 26
Absolute change from baseline in vascular volume [%] on HRCT at Week 26
Time frame: At baseline and at Week 26
Absolute change from baseline in forced vital capacity (FVC) [mL] at Week 26
FVC will be assessed using standardised spirometry equipment which will be provided centrally with supplies of precalibrated disposable flow sensors. Spirometry will be conducted with the participant in a seated position. It is preferable that the same trained individual (i.e. PFT specialist or pulmonologist) performs the PFTs for a given participant. The best of 3 efforts will be defined as the highest FVC obtained on any of three blows meeting the 2019 American Thoracic Society/European Respiratory Society (ATS/ERS) criteria (with a maximum of eight attempts). Predicted normal values will be calculated according to global lung function initiative (GLI).
Time frame: At baseline and at Week 26
Absolute change from baseline in supplemental oxygen use over the whole trial for oxygen users at baseline
Time frame: At baseline and at Week 52
Time to first supplemental oxygen use during the trial for oxygen non-users at baseline
Time frame: Up to Week 52
Occurrence of infection-related adverse events (AEs) from baseline over the duration of the trial
Time frame: Up to 1 year
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National Jewish Health
Denver, Colorado, United States
RECRUITINGYale University School of Medicine
New Haven, Connecticut, United States
NOT_YET_RECRUITINGMeris Clinical Research-Brandon-69466
Brandon, Florida, United States
NOT_YET_RECRUITINGMiami VA Healthcare System
Miami, Florida, United States
RECRUITINGPiedmont Physicians Pulmonary & Sleep Medicine of Buckhead
Atlanta, Georgia, United States
RECRUITINGAugusta University
Augusta, Georgia, United States
NOT_YET_RECRUITING...and 147 more locations