A Study to Test Whether Nerandomilast Helps People With Lungfibrosis Related to Rheumatic Diseases
- Conditions
- Interstitial Lung DiseasesSystemic Autoimmune Rheumatic Diseases Associated Interstitial Lung Diseases
- Interventions
- Drug: Placebo matching nerandomilast
- Registration Number
- NCT06806592
- Lead Sponsor
- Boehringer Ingelheim
- Brief 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 26 weeks. Participants continue immunosuppressant treatment for their underlying rheumatic disease.
Participants are in the study for about 7.5 months. During this time, they visit the study site 8 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- NOT_YET_RECRUITING
- Sex
- All
- Target Recruitment
- 400
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Nerandomilast Nerandomilast Participants with SARD-ILDs will receive nerandomilast. Placebo Placebo matching nerandomilast Participants with SARD-ILDs will receive placebo.
- Primary Outcome Measures
Name Time Method Absolute change from baseline in quantitative interstitial lung disease (QILD) score [%] 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.
- Secondary Outcome Measures
Name Time Method Absolute change from baseline in quantitative lung fibrosis (QLF) score [%] at Week 26 At baseline and 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.Absolute change from baseline in quantitative ground glass opacity (QGGO) score [%] at Week 26 At baseline and 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.Absolute change from baseline in forced vital capacity (FVC) [mL] at Week 26 At baseline and 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).
Absolute change from baseline in living with pulmonary fibrosis (L-PF) Symptoms Dyspnoea domain score at Week 26 At baseline and at Week 26 L-PF is a self-administered 44 item patient reported outcome measure (PROM) with 2 modules: Symptoms (23 items) and Impacts (21 items). The Symptom module assesses 3 domains (dyspnoea, cough, and fatigue) in the past 24 h. The Impact questionnaire assesses impact related to dyspnoea, cough, energy, and global within the last week. Both modules have a 5-point Likert scale with varying response options. For the Symptoms module, a total Symptom score as well as Symptoms domain scores (dyspnoea, cough, and fatigue) are generated. The Impacts module yields a single Impacts score. Scoring is performed as a summary score, the mean of the dimension ratings multiplied by 100. The L-PF symptom module domain and total scores as well as the L-PF impact module total score range from 0 to 100, with higher scores indicating a greater impairment.
There are 5 additional questions pertaining to oxygen use at the end of the Symptoms module to serve interpretation of the L-PF scores.Absolute change from baseline in living with pulmonary fibrosis (L-PF) Symptoms Cough domain score at Week 26 At baseline and at Week 26 L-PF is a self-administered 44 item patient reported outcome measure (PROM) with 2 modules: Symptoms (23 items) and Impacts (21 items). The Symptom module assesses 3 domains (dyspnoea, cough, and fatigue) in the past 24 h. The Impact questionnaire assesses impact related to dyspnoea, cough, energy, and global within the last week. Both modules have a 5-point Likert scale with varying response options. For the Symptoms module, a total Symptom score as well as Symptoms domain scores (dyspnoea, cough, and fatigue) are generated. The Impacts module yields a single Impacts score. Scoring is performed as a summary score, the mean of the dimension ratings multiplied by 100. The L-PF symptom module domain and total scores as well as the L-PF impact module total score range from 0 to 100, with higher scores indicating a greater impairment.
There are 5 additional questions pertaining to oxygen use at the end of the Symptoms module to serve interpretation of the L-PF scores.Occurrence of infection-related adverse events (AEs) from baseline to Week 26 At baseline and at Week 26
Related Research Topics
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Trial Locations
- Locations (139)
HOP Sud
🇫🇷Rennes, France
HOP Civil
🇫🇷Strasbourg, France
HOP Rangueil
🇫🇷Toulouse, France
Charite Universitätsmedizin Berlin KöR
🇩🇪Berlin, Germany
Immanuel-Krankenhaus GmbH
🇩🇪Berlin, Germany
Universitätsklinikum Bonn AöR
🇩🇪Bonn, Germany
Kitasato University Hospital
🇯🇵Kanagawa, Sagamihara, Japan
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
University of California Los Angeles
🇺🇸Los Angeles, California, United States
National Jewish Health
🇺🇸Denver, Colorado, United States
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
Miami VA Healthcare System
🇺🇸Miami, Florida, United States
Augusta University
🇺🇸Augusta, Georgia, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Evanston Hospital
🇺🇸Evanston, Illinois, United States
University of Kansas Medical Center
🇺🇸Kansas City, Kansas, United States
LSU Health Sciences Center
🇺🇸New Orleans, Louisiana, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
University of Minnesota
🇺🇸Minneapolis, Minnesota, United States
University of Nebraska Medical Center
🇺🇸Omaha, Nebraska, United States
NYU Langone Health
🇺🇸New York, New York, United States
Columbia University Medical Center-New York Presbyterian Hospital
🇺🇸New York, New York, United States
Onsite Clinical Solutions
🇺🇸Salisbury, North Carolina, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Temple Lung Center
🇺🇸Philadelphia, Pennsylvania, United States
University of Pittsburgh Medical Center
🇺🇸Pittsburgh, Pennsylvania, United States
The University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States
University of Utah Health Sciences Center
🇺🇸Salt Lake City, Utah, United States
Rheumatology and Pulmonary Clinic
🇺🇸Beckley, West Virginia, United States
University of Wisconsin
🇺🇸Madison, Wisconsin, United States
Royal Prince Alfred Hospital
🇦🇺Camperdown, Sydney, New South Wales, Australia
St Vincent's Hospital Sydney
🇦🇺Darlinghurst, New South Wales, Australia
The Prince Charles Hospital
🇦🇺Chermside, Queensland, Australia
Austin Hospital
🇦🇺Heidelberg, Victoria, Australia
Fiona Stanley Hospital
🇦🇺Murdoch, Western Australia, Australia
Krems University Hospital
🇦🇹Krems, Austria
Klinikum Wels - Grieskirchen GmbH
🇦🇹Wels, Austria
AKH - Medical University of Vienna
🇦🇹Vienna, Austria
HOP d'Angers
🇫🇷Angers, France
Beijing Chao-Yang Hospital
🇨🇳Beijing, China
China-Japan Friendship Hospital
🇨🇳Beijing, China
Peking Union Medical College Hospital
🇨🇳Beijing, China
West China Hospital
🇨🇳Chengdu, China
People's Hospital of Sichuan Province
🇨🇳Chengdu, China
Guangdong Provincial People's Hospital
🇨🇳Guangzhou, China
The First Affiliated Hospital, Zhejiang University
🇨🇳Hangzhou, China
The First Affiliated Hospital of Henan University of Science and Technology
🇨🇳Luoyang, China
The Second Affiliated Hospital Zhejiang University School of Medicine
🇨🇳Hangzhou, China
University Hospital_Macau University of Science and Technology
🇨🇳Macau, China
The First Affiliated Hospital of Nanchang University
🇨🇳Nanchang, China
Huashan Hospital, Fudan University
🇨🇳Shanghai, China
HOP Pellegrin
🇫🇷Bordeaux, France
Tianjin Medical University General Hospital
🇨🇳Tianjin, China
Tongji Hospital Affiliated Tongji Medical College Huazhong University of S & T
🇨🇳Wuhan, China
First Affiliated Hospital of Xiamen University
🇨🇳Xiamen, China
Zhuzhou Central Hospital
🇨🇳Zhuzhou, China
Wuhan Union Hospital
🇨🇳Wuhan, China
HOP Claude Huriez
🇫🇷Lille, France
HOP Cochin
🇫🇷Paris, France
HOP Bichat
🇫🇷Paris, France
Städtisches Klinikum Braunschweig gGmbH
🇩🇪Braunschweig, Germany
Gesundheit Nord gGmbH | Klinikverbund Bremen
🇩🇪Bremen, Germany
Technische Universität Dresden
🇩🇪Dresden, Germany
Universitätsklinikum Düsseldorf
🇩🇪Düsseldorf, Germany
Universitätsklinikum Erlangen
🇩🇪Erlangen, Germany
Universitätsklinikum Freiburg
🇩🇪Freiburg, Germany
Helios Fachklinik Vogelsang-Gommern GmbH
🇩🇪Gommern, Germany
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr
🇩🇪Herne, Germany
medius Kliniken gGmbH
🇩🇪Kirchheim unter Teck, Germany
Klinikum Konstanz
🇩🇪Konstanz, Germany
Krankenhaus Porz am Rhein gGmbH
🇩🇪Köln, Germany
Universitätsklinikum Schleswig-Holstein, Campus Lübeck
🇩🇪Lübeck, Germany
Johannes Wesling Klinikum Minden
🇩🇪Minden, Germany
Klinikum der Universität München AÖR
🇩🇪München, Germany
Krankenhaus Barmherzige Brüder Regensburg
🇩🇪Regensburg, Germany
ASST degli Spedali Civili di Brescia
🇮🇹Brescia, Italy
A. O. Universitaria Careggi
🇮🇹Frienze, Italy
Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico
🇮🇹Milano, Italy
IRCCS San Raffaele
🇮🇹Milano, Italy
Azienda Ospedaliera Policlinico di Modena
🇮🇹Modena, Italy
Università degli Studi Padova
🇮🇹Padova, Italy
Fondazione IRCCS Policlinico S. Matteo
🇮🇹Pavia, Italy
Fujita Health University Hospital
🇯🇵Aichi, Toyoake, Japan
Hospital of the University of Occupational and Environmental Health
🇯🇵Fukuoka, Kitakyushu, Japan
Hiroshima University Hospital
🇯🇵Hiroshima, Hiroshima, Japan
Sapporo Medical University Hospital
🇯🇵Hokkaido, Sapporo, Japan
Hokkaido University Hospital
🇯🇵Hokkaido, Sapporo, Japan
Kagawa University Hospital
🇯🇵Kagawa, Kita-gun, Japan
St. Marianna University Hospital
🇯🇵Kanagawa, Kawasaki, Japan
Kyoto University Hospital
🇯🇵Kyoto, Kyoto, Japan
Nagasaki University Hospital
🇯🇵Nagasaki, Nagasaki, Japan
Osaka Medical and Pharmaceutical University Hospital
🇯🇵Osaka, Takatsuki, Japan
Saitama Medical University Hospital
🇯🇵Saitama, Iruma-gun, Japan
Juntendo University Hospital
🇯🇵Tokyo, Bunkyo-Ku, Japan
Nippon Medical School Hospital
🇯🇵Tokyo, Bunkyo-ku, Japan
Keio University Hospital
🇯🇵Tokyo, Shinjuku-ku, Japan
Seoul National University Bundang Hospital
🇰🇷Seongnam, Korea, Republic of
Kyung Hee University Hospital
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Soonchunhyang University Hospital Seoul
🇰🇷Seoul, Korea, Republic of
Investigacion y Biomedicina de Chihuahua S.C.
🇲🇽Chihuahua, Mexico
Soltmed Smo
🇲🇽Ciudad de Mexico, Mexico
CITER Centro de Investigación y Tratamiento de las Enfermedades Reumaticas SA de CV
🇲🇽Ciudad de Mexico, Mexico
Centro Integral en Reumatologia, SA. de CV.
🇲🇽Guadalajara, Mexico
Medical Care & Research SA de CV
🇲🇽Merida, Mexico
Inst Nac de Ciencias Medicas y Nutricion Salvador Zubiran
🇲🇽Mexico City, Mexico
Hospital Universitario Dr Jose Eleuterio Gonzalez
🇲🇽Monterrey, Mexico
Zuyderland Medisch Centrum
🇳🇱Heerlen, Netherlands
St. Antonius ziekenhuis, locatie Nieuwegein
🇳🇱Nieuwegein, Netherlands
Erasmus Medisch Centrum-ROTTERDAM-50697
🇳🇱Rotterdam, Netherlands
Akershus Universitetssykehus HF
🇳🇴Nordbyhagen, Norway
Sykehuset Telemark HF, Avd. Skien
🇳🇴Skien, Norway
Hospital Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Hospital Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital de Basurto
🇪🇸Bilbao, Spain
Hospital Universitario Reina Sofía-Córdoba-40500
🇪🇸Córdoba, Spain
Hospital de Bellvitge
🇪🇸L'Hospitalet de Llobregat, Spain
Hospital Ramón y Cajal
🇪🇸Madrid, Spain
Fundación Jiménez Díaz
🇪🇸Madrid, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Hospital Clínico de Santiago
🇪🇸Santiago de Compostela, Spain
Hospital Virgen del Rocío
🇪🇸Sevilla, Spain
Hospital Dr. Peset
🇪🇸Valencia, Spain
Complejo Hospitalario Universitario de Vigo
🇪🇸Vigo, Spain
Cantonal Hospital of Aarau
🇨🇭Aarau, Switzerland
University Hospital Basel
🇨🇭Basel, Switzerland
Hopitaux Universitaires de Geneve (HUG)
🇨🇭Geneve, Switzerland
Neuchatel Hospital Network
🇨🇭Neuchatel, Switzerland
Kantonsspital St.Gallen
🇨🇭St. Gallen, Switzerland
University Hospital Zurich
🇨🇭Zürich, Switzerland
Antrim Area Hospital
🇬🇧Antrim, United Kingdom
Heartlands Hospital
🇬🇧Birmingham, United Kingdom
Altnagelvin Area Hospital
🇬🇧Londonderry, United Kingdom
St George's Hospital-London-26733
🇬🇧London, United Kingdom
Royal Brompton Hospital
🇬🇧London, United Kingdom
Royal Hallamshire Hospital
🇬🇧Sheffield, United Kingdom
Royal Cornwall Hospital
🇬🇧Truro, United Kingdom