A Study to Find Out How Nerandomilast is Tolerated, Handled by the Body, and if it Helps Children and Adolescents With Interstitial Lung Disease (FIBRONEER-chILD)
Start Date
7/22/2026
Completion Date
4/14/2031
Summary
This study is open to children and adolescents aged 2 to 17 years with interstitial lung disease (ILD). Nerandomilast has just been approved in some countries to help adults with a lung condition called idiopathic pulmonary fibrosis. The purpose of this study is to understand how nerandomilast is tolerated and handled by the body and whether nerandomilast also helps children and adolescents with ILD. For participants aged 6 to 17 years when joining, the study has 2 parts. In the first part, participants are put into 1 of 2 groups randomly, which means by chance. One group gets nerandomilast and the other group placebo. Placebo looks like nerandomilast but does not contain any medicine. Participants are twice as likely to be in the nerandomilast group. They take tablets twice a day for 6 months. After these 6 months, in the second part of this study, they get nerandomilast for at least 2 years regardless of what they got in the first part. Young participants aged 2 to 5 years when joining get nerandomilast from the start. They receive tablets twice a day for at least 2 and a half years. Depending on when a person joins, the study lasts between 2 and a half years and up to 5 years. During this time, participants may visit the study site about 18 to 30 times. Study doctors collect blood samples to check participants' health and to find out how their body handles the study medicine. Doctors also check the function of the lungs, body growth, and how participants feel. The study doctors also regularly check participants' health and take note of any changes. For participants aged 6 to 17 years, the results are compared between the groups to see whether nerandomilast treatment helps children and adolescents.
Eligibility Criteria
Age Range: 2 years to 17 years
Interventions
Nerandomilast
Placebo
Conditions
Locations
Children's Hospital Los Angeles
Los Angeles, California 90027
United States
Children's Hospital Colorado
Aurora, Colorado 80045
United States
Johns Hopkins Hospital
Baltimore, Maryland 21287
United States
Boston Children's Hospital
Boston, Massachusetts 02115
United States
University of Minnesota
Minneapolis, Minnesota 55454
United States
Nationwide Children's Hospital
Columbus, Ohio 43205
United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania 19104
United States
Fundacion Respirar
CABA, 1426
Argentina
Hospital de Pediatria Prof. Dr. Juan P. Garrahan
CABA, C1245AAM
Argentina
Women's and Children's Hospital
North Adelaide, South Australia 5006
Australia
Brussels - UNIV HUDERF
Brussels, 1020
Belgium
Serviços Medicos Respirar Sul Fluminense
Barra Mansa, 27323240
Brazil
Associação dos Funcionários Públicos do Estado do Rio Grande do Sul - Hospital Ernesto Dorneles
Porto Alegre, 90160-093
Brazil
IMIP Pernambuco
Recife, 50070-550
Brazil
Centro de Pesquisa Clinica do Instituto da Crianca - HCFMUSP
São Paulo, 5403-900
Brazil
Alberta Children's Hospital
Calgary, Alberta T3B 6A8
Canada
The Hospital for Sick Children
Toronto, Ontario M5G 1X8
Canada
Beijing Children's Hospital, Capital Medical University
Beijing, 100045
China
Hunan Provincial People's Hospital (The First Affiliated Hospital of Hunan Normal University)
Changsha, 410005
China
The Children's Hospital of Fudan University
Shanghai, 201102
China
University Hospital Motol
Prague, 150 00
Czechia
Aarhus University Hospital
Aarhus N, 8200
Denmark
HUS Lasten ja nuorten sairaudet, Kliinisen tutkimuksen yksikkö
Helsinki, PL 281, 00029
Finland
Tampere University Hospital
Tampere, 33520
Finland
HOP Femme Mère Enfant
Bron, 69677
France
HOP Intercommunal
Créteil, 94000
France
HOP Timone
Marseille, 13387
France
HOP Armand-Trousseau
Paris, 75012
France
HOP Necker - Enfants Malades
Paris, 75015
France
Charité - Universitätsmedizin Berlin
Berlin, 13353
Germany
Hamburger Zentrum für Kinder- und Jugendrheumatologie
Hamburg, 22081
Germany
Medizinische Hochschule Hannover
Hanover, 30625
Germany
Aristotle University, Thessaloniki
Thessaloniki, 54642
Greece
Istituto G. Gaslini
Genova, 16147
Italy
Ospedale Pediatrico Bambino Gesù
Roma, 00165
Italy
Fukuoka Children's Hospital
Fukuoka, Fukuoka, 813-0017
Japan
Osaka Women's and Children's Hospital
Osaka, Izumi, 594-1101
Japan
National Center for Child Health and Development
Tokyo, Setagaya-ku, 157-8535
Japan
Centro de Investigacion Clinica y Medicina Traslacional (CIMeT)
Guadalajara, 44340
Mexico
Clinical Research Institute S.C.
Tlalnepantla, 54055
Mexico
Amsterdam University Medical Center
Amsterdam, 1105 AZ
Netherlands
University Clinical Center of the Medical University of Warsaw
Warsaw, 02 091
Poland
ULS de Santa Maria, E.P.E
Lisbon, 1649-035
Portugal
Seoul National University Hospital
Seoul, 03080
South Korea
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Spain
Hospital Virgen del Rocío
Seville, 41013
Spain
Birmingham Children's Hospital
Birmingham, B4 6NH
United Kingdom
King's College Hospital
London, SE5 9RS
United Kingdom