A Study to Test Whether Nerandomilast Helps People With Lung Fibrosis Related to Rheumatic Diseases
전신자가 면역 류마티스 질환과 관련된 환자에서 26 주 동안 Nerandomilast의 효능 및 안전성을 평가하는 이중 블라인드, 무작위 위약 대조 시험과 관련된 간질 폐 질환 (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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (실제)
등록
단계
단계
- 3단계
연락처 및 위치
연구 장소
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Heerlen, 네덜란드, 6419 PC
- Zuyderland Medisch Centrum
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Nieuwegein, 네덜란드, 3435 CM
- St. Antonius Ziekenhuis
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Rotterdam, 네덜란드, 3015
- Erasmus Medisch Centrum-ROTTERDAM-50697
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Nordbyhagen, 노르웨이, 1478
- Akershus Universitetssykehus HF
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Skien, 노르웨이, N-3710
- Sykehuset Telemark HF, Avd. Skien
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Seongnam, 대한민국, 13620
- Seoul National University Bundang Hospital
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Seoul, 대한민국, 03080
- Seoul National University Hospital
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Seoul, 대한민국, 04401
- Soonchunhyang University Hospital Seoul
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Seoul, 대한민국, 02447
- Kyung Hee University Hospital
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Berlin, 독일, 10117
- Charité - Universitätsmedizin Berlin
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Berlin, 독일, 13125
- Immanuel-Krankenhaus GmbH
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Bonn, 독일, 53127
- Universitätsklinikum Bonn AöR
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Braunschweig, 독일, 38126
- Städtisches Klinikum Braunschweig gGmbH
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Bremen, 독일, 28325
- Gesundheit Nord gGmbH | Klinikverbund Bremen
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Cologne, 독일, 51149
- Krankenhaus Porz am Rhein gGmbH
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Düsseldorf, 독일, 40225
- Universitätsklinikum Düsseldorf
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Essen, 독일, 45239
- Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
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Freiburg im Breisgau, 독일, 79106
- Universitätsklinikum Freiburg
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Gommern, 독일, 39245
- Helios Fachklinik Vogelsang-Gommern GmbH
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Hanover, 독일, 30625
- Medizinische Hochschule Hannover
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Herne, 독일, 44649
- St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr
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Kirchheim unter Teck, 독일, 73230
- medius Kliniken gGmbH
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Konstanz, 독일, 78464
- Klinikum Konstanz
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Lübeck, 독일, 23538
- Universitätsklinikum Schleswig-Holstein, Campus Lübeck
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Minden, 독일, 32429
- Johannes Wesling Klinikum Minden
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München, 독일, 80336
- Klinikum der Universität München AÖR
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Regensburg, 독일, 93049
- Krankenhaus Barmherzige Brüder Regensburg
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Chihuahua City, 멕시코, 31020
- Investigacion y Biomedicina de Chihuahua S.C.
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Guadalajara, 멕시코, 44160
- Centro Integral en Reumatologia, SA. de CV.
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Mexico City, 멕시코, 14080
- Inst Nac de Ciencias Medicas y Nutricion Salvador Zubiran
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Mexico City, 멕시코, 03650
- Soltmed Smo
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Mexico City, 멕시코, 06700
- CITER Centro de Investigación y Tratamiento de las Enfermedades Reumaticas SA de CV
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Monterrey, 멕시코, 64460
- Hospital Universitario Dr Jose Eleuterio Gonzalez
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Mérida, 멕시코, 97070
- Medical Care & Research SA de CV
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Alabama
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Birmingham, Alabama, 미국, 35205
- University of Alabama at Birmingham
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Arizona
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Scottsdale, Arizona, 미국, 85259
- Mayo Clinic-Arizona
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California
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Los Angeles, California, 미국, 90095
- University of California Los Angeles
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San Diego, California, 미국, 92108
- Paradigm Clinical Research - San Diego
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Colorado
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Denver, Colorado, 미국, 80206
- National Jewish Health
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Connecticut
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New Haven, Connecticut, 미국, 06510
- Yale University School of Medicine
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Florida
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Brandon, Florida, 미국, 33511
- Meris Clinical Research-Brandon-69466
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Miami, Florida, 미국, 33125
- Miami VA Healthcare System
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Georgia
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Atlanta, Georgia, 미국, 30309
- Piedmont Physicians Pulmonary & Sleep Medicine of Buckhead
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Augusta, Georgia, 미국, 30912
- Augusta University
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Illinois
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Chicago, Illinois, 미국, 60611
- Northwestern University
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Chicago, Illinois, 미국, 60637
- The University of Chicago Medical Center
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Evanston, Illinois, 미국, 60201
- Northshore University Health System
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Kansas
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Kansas City, Kansas, 미국, 66160
- University of Kansas Medical Center
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Massachusetts
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Boston, Massachusetts, 미국, 02115
- Brigham and Women's Hospital
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Boston, Massachusetts, 미국, 02114
- Massachusetts General Hospital
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Minnesota
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Minneapolis, Minnesota, 미국, 55455
- University of Minnesota
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Rochester, Minnesota, 미국, 55902
- Mayo Clinic, Rochester
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Nebraska
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Omaha, Nebraska, 미국, 68198-1230
- University of Nebraska Medical Center
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New York
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Great Neck, New York, 미국, 11021
- Northwell Health
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New York, New York, 미국, 10017
- NYU Langone Health
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New York, New York, 미국, 10032
- New York Presbyterian Hospital -Columbia University
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North Carolina
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Salisbury, North Carolina, 미국, 28144
- Onsite Clinical Solutions
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Winston-Salem, North Carolina, 미국, 27103
- Southeastern Research Center-Winston Salem-69289
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Pennsylvania
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Philadelphia, Pennsylvania, 미국, 19140
- Temple Lung Center
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Pittsburgh, Pennsylvania, 미국, 15213
- University of Pittsburgh Medical Center
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Texas
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Houston, Texas, 미국, 77030
- The University of Texas Health Science Center at Houston
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San Antonio, Texas, 미국, 78229
- University of Texas Health Science Center at San Antonio
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Utah
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Salt Lake City, Utah, 미국, 84108
- University of Utah Health Sciences Center
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West Virginia
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Beckley, West Virginia, 미국, 25801
- Rheumatology and Pulmonary Clinic
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Wisconsin
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Madison, Wisconsin, 미국, 53792
- University of Wisconsin
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Aarau, 스위스, CH-5001
- Cantonal Hospital of Aarau
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Basel, 스위스, 4031
- Universitätsspital Basel
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Geneva, 스위스, 1205
- Hopitaux Universitaires de Geneve (HUG)
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Neuchâtel, 스위스, 2000
- Neuchatel Hospital Network
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Sankt Gallen, 스위스, 9007
- Kantonsspital St.Gallen
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Zurich, 스위스, 8091
- University Hospital Zurich
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Barcelona, 스페인, 08035
- Hospital Universitari Vall d'Hebron
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Barcelona, 스페인, 08026
- Hospital Santa Creu i Sant Pau
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Bilbao, 스페인, 48013
- Hospital de Basurto
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Córdoba, 스페인, 14004
- Hospital Universitario Reina Sofía
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Huelva, 스페인, 21005
- Hospital Universitario Juan Ramón Jimenez
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L'Hospitalet de Llobregat, 스페인, 08907
- Hospital Universitari de Bellvitge
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Madrid, 스페인, 28040
- Fundación Jiménez Díaz
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Madrid, 스페인, 28041
- Hospital Universitario 12 de Octubre
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Madrid, 스페인, 28034
- Hospital Universitario Ramon Y Cajal
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Santiago de Compostela, 스페인, 15706
- Hospital Clínico de Santiago
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Seville, 스페인, 41009
- Hospital Universitario Virgen De La Macarena
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Seville, 스페인, 41013
- Hospital Universitario Virgen del Rocio
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Valencia, 스페인, 46017
- Hospital Dr. Peset
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Vigo, 스페인, 36312
- Complejo Hospitalario Universitario de Vigo
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Antrim, 영국, BT41 2RL
- Antrim Area Hospital
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Bath, 영국, BA1 3NG
- Royal United Hospital, Bath
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Birmingham, 영국, B9 5SS
- Heartlands Hospital
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Leeds, 영국, LS7 4SA
- Chapel Allerton Hospital
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London, 영국, NW3 2QG
- Royal Free Hospital
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London, 영국, SW17 0QT
- St George's Hospital
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London, 영국, WC1E 6BT
- University College Hospital
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Londonderry, 영국, BT47 6SB
- Altnagelvin Area Hospital
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Luton, 영국, LU4 8RB
- Luton & Dunstable University Hospital
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Preston, 영국, PR2 9HT
- NIHR Lancashire Clinical Research Facility
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Sheffield, 영국, S5 7AU
- Northern General Hospital
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Truro, 영국, TR1 3LJ
- Royal Cornwall Hospital
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Westcliffe-on-Sea, 영국, SS0 0RY
- Southend University Hospital
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Krems, 오스트리아, 3500
- Krems University Hospital
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Wels, 오스트리아, 4600
- Klinikum Wels - Grieskirchen GmbH
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Brescia, 이탈리아, 25123
- ASST degli Spedali Civili di Brescia
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Florence, 이탈리아, 50134
- A. O. Universitaria Careggi
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Milan, 이탈리아, 20132
- Ospedale San Raffaele S.r.l.
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Milan, 이탈리아, 20122
- Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico
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Padova, 이탈리아, 35128
- Azienda Ospedaliera Universitaria di Padova
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Pavia, 이탈리아, 27100
- Fondazione IRCCS Policlinico S. Matteo
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Roma, 이탈리아, 00161
- AOU Policlinico Umberto I
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Aichi, Toyoake, 일본, 470-1192
- Fujita Health University Hospital
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Fukuoka, Kitakyushu, 일본, 807-8556
- Hospital of the University of Occupational and Environmental Health
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Hiroshima, Hiroshima, 일본, 734-8551
- Hiroshima University Hospital
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Hokkaido, Sapporo, 일본, 060-8543
- Sapporo Medical University Hospital
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Hokkaido, Sapporo, 일본, 060-8648
- Hokkaido University Hospital
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Kagawa, Kita-gun, 일본, 761-0793
- Kagawa University Hospital
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Kanagawa, Kawasaki, 일본, 216-8511
- St. Marianna University Hospital
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Kanagawa, Sagamihara, 일본, 252-0375
- Kitasato University Hospital
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Kyoto, Kyoto, 일본, 606-8507
- Kyoto University Hospital
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Nagasaki, Nagasaki, 일본, 852-8501
- Nagasaki University Hospital
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Osaka, Takatsuki, 일본, 569-8686
- Osaka Medical and Pharmaceutical University Hospital
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Saitama, Iruma-gun, 일본, 350-0495
- Saitama Medical University Hospital
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Tokyo, Bunkyo-Ku, 일본, 113-8431
- Juntendo University Hospital
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Tokyo, Bunkyo-ku, 일본, 113-8603
- Nippon Medical School Hospital
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Tokyo, Shinjuku-ku, 일본, 160-8582
- Keio University Hospital
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Beijing, 중국, 100730
- Peking Union Medical College Hospital
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Beijing, 중국, 100020
- Beijing Chao-Yang Hospital
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Beijing, 중국, 100029
- China-Japan Friendship Hospital
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Chengdu, 중국, 610041
- West China Hospital, Sichuan University
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Chengdu, 중국, 610072
- Sichuan Provincial People's Hospital
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Guangzhou, 중국, 510080
- Guangdong Provincial People's Hospital
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Hangzhou, 중국, 310009
- The Second Affiliated Hospital Zhejiang University School of Medicine
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Hangzhou, 중국, 310003
- The First Affiliated Hospital, Zhejiang University
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Luoyang, 중국, 471000
- The First Affiliated Hospital of Henan University of Science and Technology
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Macau, 중국, 999078
- University Hospital_Macau University of Science and Technology
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Nanchang, 중국, 330006
- The First Affiliated Hospital of Nanchang University
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Shanghai, 중국, 200040
- Huashan Hospital, Fudan University
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Tianjin, 중국, 30052
- Tianjin Medical University General Hospital
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Wuhan, 중국, 430030
- Tongji Hospital Affiliated Tongji Medical College Huazhong University of S & T
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Wuhan, 중국, 430022
- Union Hospital Tongji Medical College Huazhong University of Science and Technology
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Xiamen, 중국, 361003
- First Affiliated Hospital of Xiamen University
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Zhuzhou, 중국, 412007
- Zhuzhou Central Hospital
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San Juan, 푸에르토 리코, 00917
- GCM Medical Group, PSC
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Angers, 프랑스, 49933
- HOP d'Angers
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Bordeaux, 프랑스, 33076
- HOP Pellegrin
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Lille, 프랑스, 59037
- Hôpital Claude Huriez
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Paris, 프랑스, 75014
- Hôpital Cochin
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Paris, 프랑스, 75018
- HOP Bichat
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Rennes, 프랑스, 35203
- HOP Sud
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Strasbourg, 프랑스, 67091
- HOP Civil
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Toulouse, 프랑스, 31059
- Hôpital Rangueil - CHU de Toulouse
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New South Wales
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Camperdown, Sydney, New South Wales, 호주, 2050
- Royal Prince Alfred Hospital
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Darlinghurst, New South Wales, 호주, 2010
- St Vincent's Hospital Sydney
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Queensland
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Chermside, Queensland, 호주, 4032
- The Prince Charles Hospital
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Victoria
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Heidelberg, Victoria, 호주, 3084
- Austin Hospital
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Western Australia
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Murdoch, Western Australia, 호주, 6150
- Fiona Stanley Hospital
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
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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
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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
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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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
팔의 수
무기와 개입
참가자 그룹 / 팔참가자 그룹 / 팔 |
개입 / 치료개입 / 치료 |
|---|---|
|
실험적: Nerandomilast
Participants with SARD-ILDs will receive nerandomilast. |
Nerandomilast
다른 이름들:
|
|
위약 비교기: Placebo
Participants with SARD-ILDs will receive placebo. |
Placebo matching nerandomilast |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Absolute change from baseline in quantitative interstitial lung disease (QILD) score [%] on high-resolution computed tomography (HRCT) at Week 26
기간: 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
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
26 주에 HRCT에서 혈관 부피 [%]의 기준선에서 절대 변화
기간: 기준선 및 26 주차
|
기준선 및 26 주차
|
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|
기준선의 산소 사용자에 대한 전체 시험에서 보충 산소 사용에서 기준선에서 절대 변화
기간: 기준선 및 52 주차
|
기준선 및 52 주차
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기준선에서 산소 비 사용자에 대한 시험 중 첫 번째 보충 산소 사용 시간
기간: 최대 52 주
|
최대 52 주
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시험 기간 동안 기준선에서 감염 관련 부작용 (AES) 발생
기간: 최대 1 년
|
최대 1 년
|
|
|
Absolute change from baseline in quantitative lung fibrosis (QLF) score [%] on HRCT at Week 26
기간: 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
기간: 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
기간: 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
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공동 작업자 및 조사자
간행물 및 유용한 링크
유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- 1305-0046
- U1111-1305-5857 (레지스트리 식별자: WHO International Clinical Trials Registry Platform (ICTRP))
- 2024-512849-17-00 (레지스트리 식별자: CTIS (EU))
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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 공유 기간
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.
IPD 공유 액세스 기준
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 공유 지원 정보 유형
- 연구_프로토콜
- 수액
- CSR
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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