A Study to Test Whether Nerandomilast Helps People With Lung Fibrosis Related to Rheumatic Diseases
En dobbel blind, randomisert, placebokontrollert studie som evaluerer effektiviteten og sikkerheten til nerandomilast i løpet av 26 uker hos pasienter med systemisk autoimmun revmatiske sykdommer assosiert interstitielle lungesykdommer (SARD-ILD)
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.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Studietype
Registrering (Faktiske)
Fase
- Fase 3
Kontakter og plasseringer
Studiesteder
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New South Wales
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Camperdown, Sydney, New South Wales, Australia, 2050
- Royal Prince Alfred Hospital
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Darlinghurst, New South Wales, Australia, 2010
- St Vincent's Hospital Sydney
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Queensland
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Chermside, Queensland, Australia, 4032
- The Prince Charles Hospital
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Victoria
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Heidelberg, Victoria, Australia, 3084
- Austin Hospital
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Western Australia
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Murdoch, Western Australia, Australia, 6150
- Fiona Stanley Hospital
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Alabama
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Birmingham, Alabama, Forente stater, 35205
- University of Alabama at Birmingham
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Arizona
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Scottsdale, Arizona, Forente stater, 85259
- Mayo Clinic-Arizona
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California
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Los Angeles, California, Forente stater, 90095
- University of California Los Angeles
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San Diego, California, Forente stater, 92108
- Paradigm Clinical Research - San Diego
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Colorado
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Denver, Colorado, Forente stater, 80206
- National Jewish Health
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Connecticut
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New Haven, Connecticut, Forente stater, 06510
- Yale University School of Medicine
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Florida
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Brandon, Florida, Forente stater, 33511
- Meris Clinical Research-Brandon-69466
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Miami, Florida, Forente stater, 33125
- Miami VA Healthcare System
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Georgia
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Atlanta, Georgia, Forente stater, 30309
- Piedmont Physicians Pulmonary & Sleep Medicine of Buckhead
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Augusta, Georgia, Forente stater, 30912
- Augusta University
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Illinois
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Chicago, Illinois, Forente stater, 60611
- Northwestern University
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Chicago, Illinois, Forente stater, 60637
- The University of Chicago Medical Center
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Evanston, Illinois, Forente stater, 60201
- Northshore University Health System
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Kansas
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Kansas City, Kansas, Forente stater, 66160
- University of Kansas Medical Center
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Massachusetts
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Boston, Massachusetts, Forente stater, 02115
- Brigham and Women's Hospital
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Boston, Massachusetts, Forente stater, 02114
- Massachusetts General Hospital
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Minnesota
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Minneapolis, Minnesota, Forente stater, 55455
- University of Minnesota
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Rochester, Minnesota, Forente stater, 55902
- Mayo Clinic, Rochester
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Nebraska
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Omaha, Nebraska, Forente stater, 68198-1230
- University of Nebraska Medical Center
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New York
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Great Neck, New York, Forente stater, 11021
- Northwell Health
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New York, New York, Forente stater, 10017
- NYU Langone Health
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New York, New York, Forente stater, 10032
- New York Presbyterian Hospital -Columbia University
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North Carolina
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Salisbury, North Carolina, Forente stater, 28144
- Onsite Clinical Solutions
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Winston-Salem, North Carolina, Forente stater, 27103
- Southeastern Research Center-Winston Salem-69289
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Pennsylvania
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Philadelphia, Pennsylvania, Forente stater, 19140
- Temple Lung Center
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Pittsburgh, Pennsylvania, Forente stater, 15213
- University of Pittsburgh Medical Center
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Texas
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Houston, Texas, Forente stater, 77030
- The University of Texas Health Science Center at Houston
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San Antonio, Texas, Forente stater, 78229
- University of Texas Health Science Center at San Antonio
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Utah
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Salt Lake City, Utah, Forente stater, 84108
- University of Utah Health Sciences Center
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West Virginia
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Beckley, West Virginia, Forente stater, 25801
- Rheumatology and Pulmonary Clinic
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Wisconsin
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Madison, Wisconsin, Forente stater, 53792
- University of Wisconsin
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Angers, Frankrike, 49933
- HOP d'Angers
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Bordeaux, Frankrike, 33076
- HOP Pellegrin
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Lille, Frankrike, 59037
- Hôpital Claude Huriez
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Paris, Frankrike, 75014
- Hôpital Cochin
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Paris, Frankrike, 75018
- HOP Bichat
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Rennes, Frankrike, 35203
- HOP Sud
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Strasbourg, Frankrike, 67091
- HOP Civil
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Toulouse, Frankrike, 31059
- Hôpital Rangueil - CHU de Toulouse
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Brescia, Italia, 25123
- ASST degli Spedali Civili di Brescia
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Florence, Italia, 50134
- A. O. Universitaria Careggi
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Milan, Italia, 20132
- Ospedale San Raffaele S.r.l.
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Milan, Italia, 20122
- Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico
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Padova, Italia, 35128
- Azienda Ospedaliera Universitaria di Padova
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Pavia, Italia, 27100
- Fondazione IRCCS Policlinico S. Matteo
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Roma, Italia, 00161
- AOU Policlinico Umberto I
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Aichi, Toyoake, Japan, 470-1192
- Fujita Health University Hospital
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Fukuoka, Kitakyushu, Japan, 807-8556
- Hospital of the University of Occupational and Environmental Health
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Hiroshima, Hiroshima, Japan, 734-8551
- Hiroshima University Hospital
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Hokkaido, Sapporo, Japan, 060-8543
- Sapporo Medical University Hospital
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Hokkaido, Sapporo, Japan, 060-8648
- Hokkaido University Hospital
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Kagawa, Kita-gun, Japan, 761-0793
- Kagawa University Hospital
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Kanagawa, Kawasaki, Japan, 216-8511
- St. Marianna University Hospital
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Kanagawa, Sagamihara, Japan, 252-0375
- Kitasato University Hospital
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Kyoto, Kyoto, Japan, 606-8507
- Kyoto University Hospital
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Nagasaki, Nagasaki, Japan, 852-8501
- Nagasaki University Hospital
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Osaka, Takatsuki, Japan, 569-8686
- Osaka Medical and Pharmaceutical University Hospital
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Saitama, Iruma-gun, Japan, 350-0495
- Saitama Medical University Hospital
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Tokyo, Bunkyo-Ku, Japan, 113-8431
- Juntendo University Hospital
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Tokyo, Bunkyo-ku, Japan, 113-8603
- Nippon Medical School Hospital
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Tokyo, Shinjuku-ku, Japan, 160-8582
- Keio University Hospital
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Beijing, Kina, 100730
- Peking Union Medical College Hospital
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Beijing, Kina, 100020
- Beijing Chao-Yang Hospital
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Beijing, Kina, 100029
- China-Japan Friendship Hospital
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Chengdu, Kina, 610041
- West China Hospital, Sichuan University
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Chengdu, Kina, 610072
- Sichuan Provincial People's Hospital
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Guangzhou, Kina, 510080
- Guangdong Provincial People's Hospital
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Hangzhou, Kina, 310009
- The Second Affiliated Hospital Zhejiang University School of Medicine
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Hangzhou, Kina, 310003
- The First Affiliated Hospital, Zhejiang University
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Luoyang, Kina, 471000
- The First Affiliated Hospital of Henan University of Science and Technology
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Macau, Kina, 999078
- University Hospital_Macau University of Science and Technology
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Nanchang, Kina, 330006
- The First Affiliated Hospital of Nanchang University
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Shanghai, Kina, 200040
- Huashan Hospital, Fudan University
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Tianjin, Kina, 30052
- Tianjin Medical University General Hospital
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Wuhan, Kina, 430030
- Tongji Hospital Affiliated Tongji Medical College Huazhong University of S & T
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Wuhan, Kina, 430022
- Union Hospital Tongji Medical College Huazhong University of Science and Technology
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Xiamen, Kina, 361003
- First Affiliated Hospital of Xiamen University
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Zhuzhou, Kina, 412007
- Zhuzhou Central Hospital
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Chihuahua City, Mexico, 31020
- Investigacion y Biomedicina de Chihuahua S.C.
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Guadalajara, Mexico, 44160
- Centro Integral en Reumatologia, SA. de CV.
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Mexico City, Mexico, 14080
- Inst Nac de Ciencias Medicas y Nutricion Salvador Zubiran
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Mexico City, Mexico, 03650
- Soltmed Smo
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Mexico City, Mexico, 06700
- CITER Centro de Investigación y Tratamiento de las Enfermedades Reumaticas SA de CV
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Monterrey, Mexico, 64460
- Hospital Universitario Dr Jose Eleuterio Gonzalez
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Mérida, Mexico, 97070
- Medical Care & Research SA de CV
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Heerlen, Nederland, 6419 PC
- Zuyderland Medisch Centrum
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Nieuwegein, Nederland, 3435 CM
- St. Antonius Ziekenhuis
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Rotterdam, Nederland, 3015
- Erasmus Medisch Centrum-ROTTERDAM-50697
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Nordbyhagen, Norge, 1478
- Akershus Universitetssykehus HF
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Skien, Norge, N-3710
- Sykehuset Telemark HF, Avd. Skien
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San Juan, Puerto Rico, 00917
- GCM Medical Group, PSC
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Barcelona, Spania, 08035
- Hospital Universitari Vall d'Hebron
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Barcelona, Spania, 08026
- Hospital Santa Creu i Sant Pau
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Bilbao, Spania, 48013
- Hospital de Basurto
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Córdoba, Spania, 14004
- Hospital Universitario Reina Sofía
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Huelva, Spania, 21005
- Hospital Juan Ramón Jimenez
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L'Hospitalet de Llobregat, Spania, 08907
- Hospital Universitari de Bellvitge
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Madrid, Spania, 28040
- Fundación Jiménez Díaz
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Madrid, Spania, 28041
- Hospital Universitario 12 de Octubre
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Madrid, Spania, 28034
- Hospital Universitario Ramon Y Cajal
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Santiago de Compostela, Spania, 15706
- Hospital Clínico de Santiago
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Seville, Spania, 41009
- Hospital Universitario Virgen De La Macarena
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Seville, Spania, 41013
- Hospital Virgen del Rocio
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Valencia, Spania, 46017
- Hospital Dr. Peset
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Vigo, Spania, 36312
- Complejo Hospitalario Universitario de Vigo
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Antrim, Storbritannia, BT41 2RL
- Antrim Area Hospital
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Bath, Storbritannia, BA1 3NG
- Royal United Hospital, Bath
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Birmingham, Storbritannia, B9 5SS
- Heartlands Hospital
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Leeds, Storbritannia, LS7 4SA
- Chapel Allerton Hospital
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London, Storbritannia, NW3 2QG
- Royal Free Hospital
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London, Storbritannia, SW17 0QT
- St George's Hospital
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London, Storbritannia, WC1E 6BT
- University College Hospital
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Londonderry, Storbritannia, BT47 6SB
- Altnagelvin Area Hospital
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Luton, Storbritannia, LU4 8RB
- Luton & Dunstable University Hospital
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Preston, Storbritannia, PR2 9HT
- NIHR Lancashire Clinical Research Facility
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Sheffield, Storbritannia, S5 7AU
- Northern General Hospital
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Truro, Storbritannia, TR1 3LJ
- Royal Cornwall Hospital
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Westcliffe-on-Sea, Storbritannia, SS0 0RY
- Southend University Hospital
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Aarau, Sveits, CH-5001
- Cantonal Hospital of Aarau
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Basel, Sveits, 4031
- Universitätsspital Basel
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Geneva, Sveits, 1205
- Hopitaux Universitaires de Geneve (HUG)
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Neuchâtel, Sveits, 2000
- Neuchatel Hospital Network
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Sankt Gallen, Sveits, 9007
- Kantonsspital St.Gallen
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Zurich, Sveits, 8091
- University Hospital Zurich
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Seongnam, Sør -Korea, 13620
- Seoul National University Bundang Hospital
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Seoul, Sør -Korea, 03080
- Seoul National University Hospital
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Seoul, Sør -Korea, 04401
- Soonchunhyang University Hospital Seoul
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Seoul, Sør -Korea, 02447
- Kyung Hee University Hospital
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Berlin, Tyskland, 10117
- Charité - Universitätsmedizin Berlin
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Berlin, Tyskland, 13125
- Immanuel-Krankenhaus GmbH
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Bonn, Tyskland, 53127
- Universitätsklinikum Bonn AöR
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Braunschweig, Tyskland, 38126
- Städtisches Klinikum Braunschweig gGmbH
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Bremen, Tyskland, 28325
- Gesundheit Nord gGmbH | Klinikverbund Bremen
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Cologne, Tyskland, 51149
- Krankenhaus Porz am Rhein gGmbH
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Düsseldorf, Tyskland, 40225
- Universitätsklinikum Düsseldorf
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Essen, Tyskland, 45239
- Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
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Freiburg im Breisgau, Tyskland, 79106
- Universitätsklinikum Freiburg
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Gommern, Tyskland, 39245
- Helios Fachklinik Vogelsang-Gommern GmbH
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Hanover, Tyskland, 30625
- Medizinische Hochschule Hannover
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Herne, Tyskland, 44649
- St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr
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Kirchheim unter Teck, Tyskland, 73230
- medius Kliniken gGmbH
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Konstanz, Tyskland, 78464
- Klinikum Konstanz
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Lübeck, Tyskland, 23538
- Universitätsklinikum Schleswig-Holstein, Campus Lübeck
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Minden, Tyskland, 32429
- Johannes Wesling Klinikum Minden
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München, Tyskland, 80336
- Klinikum der Universität München AÖR
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Regensburg, Tyskland, 93049
- Krankenhaus Barmherzige Brüder Regensburg
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Krems, Østerrike, 3500
- Krems University Hospital
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Wels, Østerrike, 4600
- Klinikum Wels - Grieskirchen GmbH
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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)
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FVC ≥45% of predicted normal at Visit 1
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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
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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
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If using nintedanib, participants must be on a stable dose for ≥12 weeks prior to Visit 2
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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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Nerandomilast
Participants with SARD-ILDs will receive nerandomilast. |
Nerandomilast
Andre navn:
|
|
Placebo komparator: Placebo
Participants with SARD-ILDs will receive placebo. |
Placebo matching nerandomilast |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Absolute change from baseline in quantitative interstitial lung disease (QILD) score [%] on high-resolution computed tomography (HRCT) at Week 26
Tidsramme: 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. |
At baseline and at Week 26
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Absolutt endring fra baseline i vaskulært volum [%] på HRCT i uke 26
Tidsramme: Ved baseline og i uke 26
|
Ved baseline og i uke 26
|
|
|
Absolutt endring fra baseline i supplerende oksygenbruk over hele forsøket for oksygenbrukere ved baseline
Tidsramme: Ved baseline og i uke 52
|
Ved baseline og i uke 52
|
|
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Tid til første supplerende oksygenbruk under forsøket for ikke-brukere ved oksygen ved baseline
Tidsramme: Opp til uke 52
|
Opp til uke 52
|
|
|
Forekomst av infeksjonsrelaterte bivirkninger (AES) fra baseline i løpet av forsøket
Tidsramme: Opptil 1 år
|
Opptil 1 år
|
|
|
Absolute change from baseline in quantitative lung fibrosis (QLF) score [%] on HRCT at Week 26
Tidsramme: 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. |
At baseline and at Week 26
|
|
Absolute change from baseline in quantitative ground glass opacity (QGGO) score [%] on HRCT at Week 26
Tidsramme: 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. |
At baseline and at Week 26
|
|
Absolute change from baseline in forced vital capacity (FVC) [mL] at Week 26
Tidsramme: 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). |
At baseline and at Week 26
|
Samarbeidspartnere og etterforskere
Sponsor
Publikasjoner og nyttige lenker
Hjelpsomme linker
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 1305-0046
- U1111-1305-5857 (Registeridentifikator: WHO International Clinical Trials Registry Platform (ICTRP))
- 2024-512849-17-00 (Registeridentifikator: CTIS (EU))
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Once the criteria in section "time frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
IPD-delingstidsramme
One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
Tilgangskriterier for IPD-deling
For study documents -upon signing of a "Document Sharing Agreement". For study data -1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- CSR
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Studerer et amerikansk FDA-regulert enhetsprodukt
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