A Study to Test Whether Nerandomilast Helps People With Lung Fibrosis Related to Rheumatic Diseases
Condition(s) studied
Investigational drug(s) / intervention(s)
Nerandomilast: Nerandomilast
Placebo matching nerandomilast: Placebo matching nerandomilast
Study summary
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.
Eligibility
Primary outcome measure(s)
- Absolute change from baseline in quantitative interstitial lung disease (QILD) score [%] on high-resolution computed tomography (HRCT) at Week 26 — At baseline and 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.
Trial sites (153)
| Facility | City | Region | Status |
|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | |
| Mayo Clinic-Arizona | Scottsdale | Arizona | |
| University of California Los Angeles | Los Angeles | California | |
| Paradigm Clinical Research - San Diego | San Diego | California | |
| National Jewish Health | Denver | Colorado | |
| Yale University School of Medicine | New Haven | Connecticut | |
| Meris Clinical Research-Brandon-69466 | Brandon | Florida | |
| Miami VA Healthcare System | Miami | Florida | |
| Piedmont Physicians Pulmonary & Sleep Medicine of Buckhead | Atlanta | Georgia | |
| Augusta University | Augusta | Georgia | |
| Northwestern University | Chicago | Illinois | |
| The University of Chicago Medical Center | Chicago | Illinois | |
| Northshore University Health System | Evanston | Illinois | |
| University of Kansas Medical Center | Kansas City | Kansas | |
| Massachusetts General Hospital | Boston | Massachusetts | |
| Brigham and Women's Hospital | Boston | Massachusetts | |
| University of Minnesota | Minneapolis | Minnesota | |
| Mayo Clinic, Rochester | Rochester | Minnesota | |
| University of Nebraska Medical Center | Omaha | Nebraska | |
| Northwell Health | Great Neck | New York | |
| NYU Langone Health | New York | New York | |
| Columbia University Medical Center-New York Presbyterian Hospital | New York | New York | |
| Onsite Clinical Solutions | Salisbury | North Carolina | |
| Southeastern Research Center-Winston Salem-69289 | Winston-Salem | North Carolina | |
| Temple Lung Center | Philadelphia | Pennsylvania | |
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | |
| The University of Texas Health Science Center at Houston | Houston | Texas | |
| University of Texas Health Science Center at San Antonio | San Antonio | Texas | |
| University of Utah Health Sciences Center | Salt Lake City | Utah | |
| Rheumatology and Pulmonary Clinic | Beckley | West Virginia | |
| University of Wisconsin | Madison | Wisconsin | |
| Royal Prince Alfred Hospital | Camperdown, Sydney | New South Wales | |
| St Vincent's Hospital Sydney | Darlinghurst | New South Wales | |
| The Prince Charles Hospital | Chermside | Queensland | |
| Austin Hospital | Heidelberg | Victoria | |
| Fiona Stanley Hospital | Murdoch | Western Australia | |
| Krems University Hospital | Krems | Austria | |
| Klinikum Wels - Grieskirchen GmbH | Wels | Austria | |
| Beijing Chao-Yang Hospital | Beijing | China | |
| China-Japan Friendship Hospital | Beijing | China |
+ 113 more sites — see the full list on the official registry below.
More Boehringer Ingelheim trials in the Netherlands
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06806592 on ClinicalTrials.gov ↗ ← All trials in the Netherlands