A Study to Test Whether Nerandomilast Helps People With Lung Fibrosis Related to Rheumatic Diseases
Um estudo duplo cego, randomizado e controlado por placebo, avaliando a eficácia e a segurança do nerandomilast em 26 semanas em pacientes com doenças reumáticas autoimunes sistêmicas associadas a doenças pulmonares intersticiais (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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Estágio
- Fase 3
Contactos e Locais
Locais de estudo
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Berlin, Alemanha, 10117
- Charité - Universitätsmedizin Berlin
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Berlin, Alemanha, 13125
- Immanuel-Krankenhaus GmbH
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Bonn, Alemanha, 53127
- Universitätsklinikum Bonn AöR
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Braunschweig, Alemanha, 38126
- Städtisches Klinikum Braunschweig gGmbH
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Bremen, Alemanha, 28325
- Gesundheit Nord gGmbH | Klinikverbund Bremen
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Cologne, Alemanha, 51149
- Krankenhaus Porz am Rhein gGmbH
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Düsseldorf, Alemanha, 40225
- Universitätsklinikum Düsseldorf
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Essen, Alemanha, 45239
- Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
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Freiburg im Breisgau, Alemanha, 79106
- Universitätsklinikum Freiburg
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Gommern, Alemanha, 39245
- Helios Fachklinik Vogelsang-Gommern GmbH
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Hanover, Alemanha, 30625
- Medizinische Hochschule Hannover
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Herne, Alemanha, 44649
- St. Elisabeth Gruppe GmbH Katholische Kliniken Rhein-Ruhr
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Kirchheim unter Teck, Alemanha, 73230
- medius Kliniken gGmbH
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Konstanz, Alemanha, 78464
- Klinikum Konstanz
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Lübeck, Alemanha, 23538
- Universitätsklinikum Schleswig-Holstein, Campus Lübeck
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Minden, Alemanha, 32429
- Johannes Wesling Klinikum Minden
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München, Alemanha, 80336
- Klinikum der Universität München AÖR
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Regensburg, Alemanha, 93049
- Krankenhaus Barmherzige Brüder Regensburg
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New South Wales
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Camperdown, Sydney, New South Wales, Austrália, 2050
- Royal Prince Alfred Hospital
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Darlinghurst, New South Wales, Austrália, 2010
- St Vincent's Hospital Sydney
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Queensland
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Chermside, Queensland, Austrália, 4032
- The Prince Charles Hospital
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Victoria
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Heidelberg, Victoria, Austrália, 3084
- Austin Hospital
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Western Australia
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Murdoch, Western Australia, Austrália, 6150
- Fiona Stanley Hospital
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Beijing, China, 100730
- Peking Union Medical College Hospital
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Beijing, China, 100020
- Beijing Chao-Yang Hospital
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Beijing, China, 100029
- China-Japan Friendship Hospital
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Chengdu, China, 610041
- West China Hospital, Sichuan University
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Chengdu, China, 610072
- Sichuan Provincial People's Hospital
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Guangzhou, China, 510080
- Guangdong Provincial People's Hospital
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Hangzhou, China, 310009
- The Second Affiliated Hospital Zhejiang University School of Medicine
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Hangzhou, China, 310003
- The First Affiliated Hospital, Zhejiang University
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Luoyang, China, 471000
- The First Affiliated Hospital of Henan University of Science and Technology
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Macau, China, 999078
- University Hospital_Macau University of Science and Technology
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Nanchang, China, 330006
- The First Affiliated Hospital of Nanchang University
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Shanghai, China, 200040
- Huashan Hospital, Fudan University
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Tianjin, China, 30052
- Tianjin Medical University General Hospital
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Wuhan, China, 430030
- Tongji Hospital Affiliated Tongji Medical College Huazhong University of S & T
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Wuhan, China, 430022
- Union Hospital Tongji Medical College Huazhong University of Science and Technology
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Xiamen, China, 361003
- First Affiliated Hospital of Xiamen University
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Zhuzhou, China, 412007
- Zhuzhou Central Hospital
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Seongnam, Coréia do Sul, 13620
- Seoul National University Bundang Hospital
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Seoul, Coréia do Sul, 03080
- Seoul National University Hospital
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Seoul, Coréia do Sul, 04401
- Soonchunhyang University Hospital Seoul
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Seoul, Coréia do Sul, 02447
- Kyung Hee University Hospital
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Barcelona, Espanha, 08035
- Hospital Universitari Vall d'Hebron
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Barcelona, Espanha, 08026
- Hospital Santa Creu i Sant Pau
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Bilbao, Espanha, 48013
- Hospital de Basurto
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Córdoba, Espanha, 14004
- Hospital Universitario Reina Sofía
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Huelva, Espanha, 21005
- Hospital Juan Ramón Jimenez
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L'Hospitalet de Llobregat, Espanha, 08907
- Hospital Universitari de Bellvitge
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Madrid, Espanha, 28040
- Fundación Jiménez Díaz
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Madrid, Espanha, 28041
- Hospital Universitario 12 de Octubre
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Madrid, Espanha, 28034
- Hospital Universitario Ramon Y Cajal
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Santiago de Compostela, Espanha, 15706
- Hospital Clínico de Santiago
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Seville, Espanha, 41009
- Hospital Universitario Virgen De La Macarena
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Seville, Espanha, 41013
- Hospital Virgen del Rocio
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Valencia, Espanha, 46017
- Hospital Dr. Peset
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Vigo, Espanha, 36312
- Complejo Hospitalario Universitario de Vigo
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Alabama
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Birmingham, Alabama, Estados Unidos, 35205
- University of Alabama at Birmingham
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Arizona
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Scottsdale, Arizona, Estados Unidos, 85259
- Mayo Clinic-Arizona
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California
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Los Angeles, California, Estados Unidos, 90095
- University of California Los Angeles
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San Diego, California, Estados Unidos, 92108
- Paradigm Clinical Research - San Diego
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Colorado
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Denver, Colorado, Estados Unidos, 80206
- National Jewish Health
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Connecticut
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New Haven, Connecticut, Estados Unidos, 06510
- Yale University School of Medicine
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Florida
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Brandon, Florida, Estados Unidos, 33511
- Meris Clinical Research-Brandon-69466
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Miami, Florida, Estados Unidos, 33125
- Miami VA Healthcare System
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Georgia
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Atlanta, Georgia, Estados Unidos, 30309
- Piedmont Physicians Pulmonary & Sleep Medicine of Buckhead
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Augusta, Georgia, Estados Unidos, 30912
- Augusta University
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Illinois
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Chicago, Illinois, Estados Unidos, 60611
- Northwestern University
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Chicago, Illinois, Estados Unidos, 60637
- The University of Chicago Medical Center
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Evanston, Illinois, Estados Unidos, 60201
- Northshore University Health System
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Kansas
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Kansas City, Kansas, Estados Unidos, 66160
- University of Kansas Medical Center
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Massachusetts
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Boston, Massachusetts, Estados Unidos, 02115
- Brigham and Women's Hospital
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Boston, Massachusetts, Estados Unidos, 02114
- Massachusetts General Hospital
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Minnesota
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Minneapolis, Minnesota, Estados Unidos, 55455
- University of Minnesota
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Rochester, Minnesota, Estados Unidos, 55902
- Mayo Clinic, Rochester
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Nebraska
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Omaha, Nebraska, Estados Unidos, 68198-1230
- University of Nebraska Medical Center
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New York
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Great Neck, New York, Estados Unidos, 11021
- Northwell Health
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New York, New York, Estados Unidos, 10017
- NYU Langone Health
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New York, New York, Estados Unidos, 10032
- New York Presbyterian Hospital -Columbia University
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North Carolina
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Salisbury, North Carolina, Estados Unidos, 28144
- Onsite Clinical Solutions
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Winston-Salem, North Carolina, Estados Unidos, 27103
- Southeastern Research Center-Winston Salem-69289
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19140
- Temple Lung Center
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Pittsburgh, Pennsylvania, Estados Unidos, 15213
- University of Pittsburgh Medical Center
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Texas
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Houston, Texas, Estados Unidos, 77030
- The University of Texas Health Science Center at Houston
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San Antonio, Texas, Estados Unidos, 78229
- University of Texas Health Science Center at San Antonio
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Utah
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Salt Lake City, Utah, Estados Unidos, 84108
- University of Utah Health Sciences Center
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West Virginia
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Beckley, West Virginia, Estados Unidos, 25801
- Rheumatology and Pulmonary Clinic
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Wisconsin
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Madison, Wisconsin, Estados Unidos, 53792
- University of Wisconsin
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Angers, França, 49933
- HOP d'Angers
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Bordeaux, França, 33076
- HOP Pellegrin
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Lille, França, 59037
- Hôpital Claude Huriez
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Paris, França, 75014
- Hôpital Cochin
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Paris, França, 75018
- HOP Bichat
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Rennes, França, 35203
- HOP Sud
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Strasbourg, França, 67091
- HOP Civil
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Toulouse, França, 31059
- Hôpital Rangueil - CHU de Toulouse
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Heerlen, Holanda, 6419 PC
- Zuyderland Medisch Centrum
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Nieuwegein, Holanda, 3435 CM
- St. Antonius Ziekenhuis
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Rotterdam, Holanda, 3015
- Erasmus Medisch Centrum-ROTTERDAM-50697
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Brescia, Itália, 25123
- ASST degli Spedali Civili di Brescia
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Florence, Itália, 50134
- A. O. Universitaria Careggi
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Milan, Itália, 20132
- Ospedale San Raffaele S.r.l.
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Milan, Itália, 20122
- Fondazione IRCCS Ca'Granda-Ospedale Maggiore Policlinico
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Padova, Itália, 35128
- Azienda Ospedaliera Universitaria di Padova
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Pavia, Itália, 27100
- Fondazione IRCCS Policlinico S. Matteo
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Roma, Itália, 00161
- AOU Policlinico Umberto I
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Aichi, Toyoake, Japão, 470-1192
- Fujita Health University Hospital
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Fukuoka, Kitakyushu, Japão, 807-8556
- Hospital of the University of Occupational and Environmental Health
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Hiroshima, Hiroshima, Japão, 734-8551
- Hiroshima University Hospital
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Hokkaido, Sapporo, Japão, 060-8543
- Sapporo Medical University Hospital
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Hokkaido, Sapporo, Japão, 060-8648
- Hokkaido University Hospital
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Kagawa, Kita-gun, Japão, 761-0793
- Kagawa University Hospital
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Kanagawa, Kawasaki, Japão, 216-8511
- St. Marianna University Hospital
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Kanagawa, Sagamihara, Japão, 252-0375
- Kitasato University Hospital
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Kyoto, Kyoto, Japão, 606-8507
- Kyoto University Hospital
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Nagasaki, Nagasaki, Japão, 852-8501
- Nagasaki University Hospital
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Osaka, Takatsuki, Japão, 569-8686
- Osaka Medical and Pharmaceutical University Hospital
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Saitama, Iruma-gun, Japão, 350-0495
- Saitama Medical University Hospital
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Tokyo, Bunkyo-Ku, Japão, 113-8431
- Juntendo University Hospital
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Tokyo, Bunkyo-ku, Japão, 113-8603
- Nippon Medical School Hospital
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Tokyo, Shinjuku-ku, Japão, 160-8582
- Keio University Hospital
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Chihuahua City, México, 31020
- Investigacion y Biomedicina de Chihuahua S.C.
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Guadalajara, México, 44160
- Centro Integral en Reumatologia, SA. de CV.
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Mexico City, México, 14080
- Inst Nac de Ciencias Medicas y Nutricion Salvador Zubiran
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Mexico City, México, 03650
- Soltmed Smo
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Mexico City, México, 06700
- CITER Centro de Investigación y Tratamiento de las Enfermedades Reumaticas SA de CV
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Monterrey, México, 64460
- Hospital Universitario Dr Jose Eleuterio Gonzalez
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Mérida, México, 97070
- Medical Care & Research SA de CV
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Nordbyhagen, Noruega, 1478
- Akershus Universitetssykehus HF
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Skien, Noruega, N-3710
- Sykehuset Telemark HF, Avd. Skien
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San Juan, Porto Rico, 00917
- GCM Medical Group, PSC
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Antrim, Reino Unido, BT41 2RL
- Antrim Area Hospital
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Bath, Reino Unido, BA1 3NG
- Royal United Hospital, Bath
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Birmingham, Reino Unido, B9 5SS
- Heartlands Hospital
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Leeds, Reino Unido, LS7 4SA
- Chapel Allerton Hospital
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London, Reino Unido, NW3 2QG
- Royal Free Hospital
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London, Reino Unido, SW17 0QT
- St George's Hospital
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London, Reino Unido, WC1E 6BT
- University College Hospital
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Londonderry, Reino Unido, BT47 6SB
- Altnagelvin Area Hospital
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Luton, Reino Unido, LU4 8RB
- Luton & Dunstable University Hospital
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Preston, Reino Unido, PR2 9HT
- NIHR Lancashire Clinical Research Facility
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Sheffield, Reino Unido, S5 7AU
- Northern General Hospital
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Truro, Reino Unido, TR1 3LJ
- Royal Cornwall Hospital
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Westcliffe-on-Sea, Reino Unido, SS0 0RY
- Southend University Hospital
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Aarau, Suíça, CH-5001
- Cantonal Hospital of Aarau
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Basel, Suíça, 4031
- Universitätsspital Basel
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Geneva, Suíça, 1205
- Hopitaux Universitaires de Geneve (HUG)
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Neuchâtel, Suíça, 2000
- Neuchatel Hospital Network
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Sankt Gallen, Suíça, 9007
- Kantonsspital St.Gallen
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Zurich, Suíça, 8091
- University Hospital Zurich
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Krems, Áustria, 3500
- Krems University Hospital
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Wels, Áustria, 4600
- Klinikum Wels - Grieskirchen GmbH
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
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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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Nerandomilast
Participants with SARD-ILDs will receive nerandomilast. |
Nerandomilast
Outros nomes:
|
|
Comparador de Placebo: Placebo
Participants with SARD-ILDs will receive placebo. |
Placebo matching nerandomilast |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Absolute change from baseline in quantitative interstitial lung disease (QILD) score [%] on high-resolution computed tomography (HRCT) at Week 26
Prazo: 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
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
Mudança absoluta da linha de base no volume vascular [%] no HRCT na semana 26
Prazo: Na linha de base e na semana 26
|
Na linha de base e na semana 26
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Mudança absoluta da linha de base no uso suplementar de oxigênio em todo o estudo para usuários de oxigênio na linha de base
Prazo: Na linha de base e na semana 52
|
Na linha de base e na semana 52
|
|
|
Hora de primeiro uso suplementar de oxigênio durante o estudo para não usuários de oxigênio na linha de base
Prazo: Até a semana 52
|
Até a semana 52
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Ocorrência de eventos adversos relacionados à infecção (EAs) da linha de base ao longo da duração do estudo
Prazo: Até 1 ano
|
Até 1 ano
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|
Absolute change from baseline in quantitative lung fibrosis (QLF) score [%] on HRCT at Week 26
Prazo: 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
Prazo: 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
Prazo: 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
|
Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Links úteis
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Estimado)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 1305-0046
- U1111-1305-5857 (Identificador de registro: WHO International Clinical Trials Registry Platform (ICTRP))
- 2024-512849-17-00 (Identificador de registro: CTIS (EU))
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
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.
Prazo de Compartilhamento de IPD
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.
Critérios de acesso de compartilhamento IPD
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.
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CSR
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .