A Study to Test Whether Nerandomilast Helps People With Lungfibrosis Related to Rheumatic Diseases
Start Date
9/13/2025
Completion Date
7/30/2027
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 Criteria
Age Range: 18 years to No maximum
Interventions
Nerandomilast
Placebo matching nerandomilast
Conditions
Locations
University of Alabama at Birmingham
Birmingham, Alabama 35205
United States
Mayo Clinic-Arizona
Scottsdale, Arizona 85259
United States
University of California Los Angeles
Los Angeles, California 90095
United States
Paradigm Clinical Research - San Diego
San Diego, California 92108
United States
National Jewish Health
Denver, Colorado 80206
United States
Yale University School of Medicine
New Haven, Connecticut 06510
United States
Meris Clinical Research-Brandon-69466
Brandon, Florida 33511
United States
Miami VA Healthcare System
Miami, Florida 33125
United States
Piedmont Physicians Pulmonary & Sleep Medicine of Buckhead
Atlanta, Georgia 30309
United States
Augusta University
Augusta, Georgia 30912
United States
Northwestern University
Chicago, Illinois 60611
United States
The University of Chicago Medical Center
Chicago, Illinois 60637
United States
Northshore University Health System
Evanston, Illinois 60201
United States
University of Kansas Medical Center
Kansas City, Kansas 66160
United States
LSU Health Sciences Center
New Orleans, Louisiana 70112
United States
Massachusetts General Hospital
Boston, Massachusetts 02114
United States
Brigham and Women's Hospital
Boston, Massachusetts 02115
United States
University of Minnesota
Minneapolis, Minnesota 55455
United States
Mayo Clinic, Rochester
Rochester, Minnesota 55902
United States
University of Nebraska Medical Center
Omaha, Nebraska 68198-1230
United States
Northwell Health
Great Neck, New York 11021
United States
NYU Langone Health
New York, New York 10017
United States
Columbia University Medical Center-New York Presbyterian Hospital
New York, New York 10032
United States
Onsite Clinical Solutions
Salisbury, North Carolina 28144
United States
Southeastern Research Center-Winston Salem-69289
Winston-Salem, North Carolina 27103
United States
Cleveland Clinic
Cleveland, Ohio 44195
United States
Temple Lung Center
Philadelphia, Pennsylvania 19140
United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania 15213
United States
The University of Texas Health Science Center at Houston
Houston, Texas 77030
United States
University of Texas Health Science Center at San Antonio
San Antonio, Texas 78229
United States
University of Utah Health Sciences Center
Salt Lake City, Utah 84108
United States
Rheumatology and Pulmonary Clinic
Beckley, West Virginia 25801
United States
University of Wisconsin
Madison, Wisconsin 53792
United States
Royal Prince Alfred Hospital
Camperdown, Sydney, New South Wales 2050
Australia
St Vincent's Hospital Sydney
Darlinghurst, New South Wales 2010
Australia
The Prince Charles Hospital
Chermside, Queensland 4032
Australia
Austin Hospital
Heidelberg, Victoria 3084
Australia
Fiona Stanley Hospital
Murdoch, Western Australia 6150
Australia
Krems University Hospital
Krems, 3500
Austria
AKH - Medical University of Vienna
Vienna, 1090
Austria
Klinikum Wels - Grieskirchen GmbH
Wels, 4600
Austria
Beijing Chao-Yang Hospital
Beijing, 100020
China
China-Japan Friendship Hospital
Beijing, 100029
China
Peking Union Medical College Hospital
Beijing, 100730
China
West China Hospital, Sichuan University
Chengdu, 610041
China
People's Hospital of Sichuan Province
Chengdu, 610072
China
Guangdong Provincial People's Hospital
Guangzhou, 510080
China
The First Affiliated Hospital, Zhejiang University
Hangzhou, 310003
China
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, 310009
China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, 471000
China
University Hospital_Macau University of Science and Technology
Macau, 999078
China
The First Affiliated Hospital of Nanchang University
Nanchang, 330006
China
Huashan Hospital, Fudan University
Shanghai, 200040
China
Tianjin Medical University General Hospital
Tianjin, 30052
China
Wuhan Union Hospital
Wuhan, 430022
China
Tongji Hospital Affiliated Tongji Medical College Huazhong University of S & T
Wuhan, 430030
China
First Affiliated Hospital of Xiamen University
Xiamen, 361003
China
Zhuzhou Central Hospital
Zhuzhou, 412007
China
HOP d'Angers
Angers, 49933
France
HOP Pellegrin
Bordeaux, 33076
France
Hôpital Claude Huriez
Lille, 59037
France
Hôpital Cochin
Paris, 75014
France
HOP Bichat
Paris, 75018
France
HOP Sud
Rennes, 35203
France
HOP Civil
Strasbourg, 67091
France
Hôpital Rangueil - CHU de Toulouse
Toulouse, 31059
France
Charité - Universitätsmedizin Berlin
Berlin, 10117
Germany
Immanuel-Krankenhaus GmbH
Berlin, 13125
Germany
Universitätsklinikum Bonn AöR
Bonn, 53127
Germany
Städtisches Klinikum Braunschweig gGmbH
Braunschweig, 38126
Germany
Gesundheit Nord gGmbH | Klinikverbund Bremen
Bremen, 28325
Germany
Krankenhaus Porz am Rhein gGmbH
Cologne, 51149
Germany
Universitätsklinikum Düsseldorf
Düsseldorf, 40225
Germany
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
Essen, 45239
Germany
Universitätsklinikum Freiburg
Freiburg im Breisgau, 79106
Germany
Helios Fachklinik Vogelsang-Gommern GmbH
Gommern, 39245
Germany
Medizinische Hochschule Hannover
Hanover, 30625
Germany
St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr
Herne, 44649
Germany
medius Kliniken gGmbH
Kirchheim unter Teck, 73230
Germany
Klinikum Konstanz
Konstanz, 78464
Germany
Universitätsklinikum Schleswig-Holstein, Campus Lübeck
Lübeck, 23538
Germany
Johannes Wesling Klinikum Minden
Minden, 32429
Germany
Klinikum der Universität München AÖR
München, 80336
Germany
Krankenhaus Barmherzige Brüder Regensburg
Regensburg, 93049
Germany
ASST degli Spedali Civili di Brescia
Brescia, 25123
Italy
A. O. Universitaria Careggi
Florence, 50134
Italy
Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico
Milan, 20122
Italy
Ospedale San Raffaele S.r.l.
Milan, 20132
Italy
Azienda Ospedaliera Universitaria di Padova
Padova, 35128
Italy
Fondazione IRCCS Policlinico S. Matteo
Pavia, 27100
Italy
AOU Policlinico Umberto I
Roma, 00161
Italy
Fujita Health University Hospital
Aichi, Toyoake, 470-1192
Japan
Hospital of the University of Occupational and Environmental Health
Fukuoka, Kitakyushu, 807-8556
Japan
Hiroshima University Hospital
Hiroshima, Hiroshima, 734-8551
Japan
Sapporo Medical University Hospital
Hokkaido, Sapporo, 060-8543
Japan
Hokkaido University Hospital
Hokkaido, Sapporo, 060-8648
Japan
Kagawa University Hospital
Kagawa, Kita-gun, 761-0793
Japan
St. Marianna University Hospital
Kanagawa, Kawasaki, 216-8511
Japan
Kitasato University Hospital
Kanagawa, Sagamihara, 252-0375
Japan
Kyoto University Hospital
Kyoto, Kyoto, 606-8507
Japan
Nagasaki University Hospital
Nagasaki, Nagasaki, 852-8501
Japan
Osaka Medical and Pharmaceutical University Hospital
Osaka, Takatsuki, 569-8686
Japan
Saitama Medical University Hospital
Saitama, Iruma-gun, 350-0495
Japan
Juntendo University Hospital
Tokyo, Bunkyo-Ku, 113-8431
Japan
Nippon Medical School Hospital
Tokyo, Bunkyo-ku, 113-8603
Japan
Keio University Hospital
Tokyo, Shinjuku-ku, 160-8582
Japan
Investigacion y Biomedicina de Chihuahua S.C.
Chihuahua City, 31020
Mexico
Centro Integral en Reumatologia, SA. de CV.
Guadalajara, 44160
Mexico
Soltmed Smo
Mexico City, 03650
Mexico
CITER Centro de Investigación y Tratamiento de las Enfermedades Reumaticas SA de CV
Mexico City, 06700
Mexico
Inst Nac de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, 14080
Mexico
Medical Care & Research SA de CV
Mérida, 97070
Mexico
Hospital Universitario Dr Jose Eleuterio Gonzalez
Monterrey, 64460
Mexico
Zuyderland Medisch Centrum
Heerlen, 6419 PC
Netherlands
St. Antonius Ziekenhuis
Nieuwegein, 3435 CM
Netherlands
Erasmus Medisch Centrum-ROTTERDAM-50697
Rotterdam, 3015
Netherlands
Akershus Universitetssykehus HF
Nordbyhagen, 1478
Norway
Sykehuset Telemark HF, Avd. Skien
Skien, N-3710
Norway
GCM Medical Group, PSC
San Juan, 00917
Puerto Rico
Seoul National University Bundang Hospital
Seongnam, 13620
South Korea
Kyung Hee University Hospital
Seoul, 02447
South Korea
Seoul National University Hospital
Seoul, 03080
South Korea
Soonchunhyang University Hospital Seoul
Seoul, 04401
South Korea
Hospital Santa Creu i Sant Pau
Barcelona, 08026
Spain
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Spain
Hospital de Basurto
Bilbao, 48013
Spain
Hospital Universitario Reina Sofía
Córdoba, 14004
Spain
Hospital Juan Ramón Jimenez
Huelva, 21005
Spain
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, 08907
Spain
Hospital Universitario Ramon Y Cajal
Madrid, 28034
Spain
Fundación Jiménez Díaz
Madrid, 28040
Spain
Hospital Universitario 12 de Octubre
Madrid, 28041
Spain
Hospital Clínico de Santiago
Santiago de Compostela, 15706
Spain
Hospital Universitario Virgen De La Macarena
Seville, 41009
Spain
Hospital Virgen del Rocío
Seville, 41013
Spain
Hospital Dr. Peset
Valencia, 46017
Spain
Complejo Hospitalario Universitario de Vigo
Vigo, 36312
Spain
Cantonal Hospital of Aarau
Aarau, CH-5001
Switzerland
Universitätsspital Basel
Basel, 4031
Switzerland
Hopitaux Universitaires de Geneve (HUG)
Geneva, 1205
Switzerland
Neuchatel Hospital Network
Neuchâtel, 2000
Switzerland
Kantonsspital St.Gallen
Sankt Gallen, 9007
Switzerland
University Hospital Zurich
Zurich, 8091
Switzerland
Antrim Area Hospital
Antrim, BT41 2RL
United Kingdom
Royal United Hospital, Bath
Bath, BA1 3NG
United Kingdom
Heartlands Hospital
Birmingham, B9 5SS
United Kingdom
Chapel Allerton Hospital
Leeds, LS7 4SA
United Kingdom
Royal Free Hospital
London, NW3 2QG
United Kingdom
St George's Hospital
London, SW17 0QT
United Kingdom
University College Hospital
London, WC1E 6BT
United Kingdom
Altnagelvin Area Hospital
Londonderry, BT47 6SB
United Kingdom
Luton & Dunstable University Hospital
Luton, LU4 8RB
United Kingdom
NIHR Lancashire Clinical Research Facility
Preston, PR2 9HT
United Kingdom
Northern General Hospital
Sheffield, S5 7AU
United Kingdom
Royal Cornwall Hospital
Truro, TR1 3LJ
United Kingdom
Southend University Hospital
Westcliffe-on-Sea, SS0 0RY
United Kingdom