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
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
* Participant has systemic autoimmune rheumatic diseases associated interstitial lung diseases (SARD-ILD), defined as
* Diagnosis by a rheumatologist (or equally qualified medical physician) with at least 1 of the following SARDs: Rheumatoid arthritis (RA), systemic sclerosis (SSc) (participants must be anticentromere auto-antibody negative), idiopathic inflammatory myopathy (IIM), Sjögren's disease, or mixed connective tissue disease (MCTD) (participants must be anti-U1-ribonucleoprotein particle (RNP) auto-antibody positive)
* Presence of fibrotic interstitial lung disease (ILD) on high-resolution computed tomography (HRCT), defined as presence of reticular abnormality with traction bronchiectasis with or without honeycombing (HC), with disease extent \>10% on HRCT performed within 12 months of Visit 1 or, if historical scan is not available, on baseline HRCT taken prior to Visit 2, as confirmed by central review
* No lung function improvement and no clinically significant ILD improvement as a treatment response to immunosuppressant (IS) therapy according to both criteria:
* No improvement in absolute forced vital capacity (FVC) % predicted \>5% within the 15 months prior to Visit 1, as measured by 2 spirometry assessments that must be ≥3 months apart. (Note: 1: In the case of multiple PFTs over the 15 months prior to screening, exceptional values of absolute change in FVC % predicted \>5% are acceptable if the overall trend of FVC % predicted is declining or stable; note 2: Visit 1 spirometry may be used to fulfill the inclusion criterion if there is only 1 spirometry reading in the 15 months prior to Visit 1)
* No clinically significant improvement in ILD based on clinician's judgement (including symptoms, imaging/HRCT, or other assessments as considered relevant and documented by the Investigator)
* FVC ≥45% of predicted normal at Visit 1
* Diffusing capacity of the lungs for carbon monoxide (DLCO) ≥25% of predicted normal corrected for haemoglobin (Hb) within 3 months prior to or at Visit 1
* Participants must be on stable treatment with any IS agent for ≥6 months (or ≥3 months for participants with IIM-ILD) prior to visit 2, with the following specifications:
* If using prednisone, participants must be on stable dose for ≥4 weeks prior to Visit 2
* If using rituximab, participants must have completed their first cycle \>6 months prior to Visit 2
* If using nintedanib, participants must be on a stable dose for ≥12 weeks prior to Visit 2
* In the opinion of the Investigator, no change in background standard of care (SoC) treatment with immunosuppressant (IS), immunomodulator (IM), or nintedanib is planned
* Further inclusion criteria apply
Exclusion Criteria:
* Organising pneumonia as predominant pattern in the HRCT
* Prebronchodilator forced expiratory volume in 1 second (FEV1)/ forced vital capacity (FVC) \<0.7 at Visit 1
* Acute ILD exacerbation within 3 months prior to Visit 1 and/or during the screening period, based on Investigator judgement
* Active vasculitis, unstable or uncontrolled within 8 weeks prior to Visit 1 or during the screening period
* Any suicidal behaviour in the past 2 years
* Any suicidal ideation of type 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) in the past 3 months or at Visit 1, and/or at Visit 2
* Use of any of the following medications: cyclophosphamide within 6 months of Visit 1, pirfenidone within 8 weeks of Visit 1
* Further exclusion criteria apply
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
Recruiting
Mayo Clinic-Arizona
Scottsdale
Arizona
Recruiting
University of California Los Angeles
Los Angeles
California
Recruiting
Paradigm Clinical Research - San Diego
San Diego
California
Recruiting
National Jewish Health
Denver
Colorado
Recruiting
Yale University School of Medicine
New Haven
Connecticut
Recruiting
Meris Clinical Research-Brandon-69466
Brandon
Florida
Recruiting
Miami VA Healthcare System
Miami
Florida
Recruiting
Piedmont Physicians Pulmonary & Sleep Medicine of Buckhead
Atlanta
Georgia
Recruiting
Augusta University
Augusta
Georgia
Recruiting
Northwestern University
Chicago
Illinois
Recruiting
The University of Chicago Medical Center
Chicago
Illinois
Recruiting
Northshore University Health System
Evanston
Illinois
Recruiting
University of Kansas Medical Center
Kansas City
Kansas
Recruiting
Massachusetts General Hospital
Boston
Massachusetts
Recruiting
Brigham and Women's Hospital
Boston
Massachusetts
Recruiting
University of Minnesota
Minneapolis
Minnesota
Recruiting
Mayo Clinic, Rochester
Rochester
Minnesota
Recruiting
University of Nebraska Medical Center
Omaha
Nebraska
Recruiting
Northwell Health
Great Neck
New York
Recruiting
NYU Langone Health
New York
New York
Recruiting
Columbia University Medical Center-New York Presbyterian Hospital
New York
New York
Recruiting
Onsite Clinical Solutions
Salisbury
North Carolina
Recruiting
Southeastern Research Center-Winston Salem-69289
Winston-Salem
North Carolina
Recruiting
Temple Lung Center
Philadelphia
Pennsylvania
Recruiting
University of Pittsburgh Medical Center
Pittsburgh
Pennsylvania
Recruiting
The University of Texas Health Science Center at Houston
Houston
Texas
Recruiting
University of Texas Health Science Center at San Antonio
San Antonio
Texas
Recruiting
University of Utah Health Sciences Center
Salt Lake City
Utah
Recruiting
Rheumatology and Pulmonary Clinic
Beckley
West Virginia
Recruiting
University of Wisconsin
Madison
Wisconsin
Recruiting
Royal Prince Alfred Hospital
Camperdown, Sydney
New South Wales
Recruiting
St Vincent's Hospital Sydney
Darlinghurst
New South Wales
Recruiting
The Prince Charles Hospital
Chermside
Queensland
Recruiting
Austin Hospital
Heidelberg
Victoria
Recruiting
Fiona Stanley Hospital
Murdoch
Western Australia
Recruiting
Krems University Hospital
Krems
Austria
Completed
Klinikum Wels - Grieskirchen GmbH
Wels
Austria
Recruiting
Beijing Chao-Yang Hospital
Beijing
China
Recruiting
China-Japan Friendship Hospital
Beijing
China
Recruiting
+ 113 more sites — see the full list on the official registry below.
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.
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