Condition: Fibrosing Interstitial Lung Disease · Sponsor: Boehringer Ingelheim
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 stud…
This description comes directly from the study's public registry record.
Boehringer Ingelheim · 1-800-243-0127 · clintriage.rdg@boehringer-ingelheim.com
Always discuss trial participation with your own doctor first.
| Children's Hospital Los Angeles | Los Angeles, California, United States | Not Yet Recruiting |
| Children's Hospital Colorado | Aurora, Colorado, United States | Not Yet Recruiting |
| Johns Hopkins Hospital | Baltimore, Maryland, United States | Not Yet Recruiting |
| Boston Children's Hospital | Boston, Massachusetts, United States | Not Yet Recruiting |
| University of Minnesota | Minneapolis, Minnesota, United States | Not Yet Recruiting |
| Nationwide Children's Hospital | Columbus, Ohio, United States | Not Yet Recruiting |
| Children's Hospital of Philadelphia | Philadelphia, Pennsylvania, United States | Not Yet Recruiting |
| Fundacion Respirar | CABA, Argentina | Not Yet Recruiting |
| Hospital de Pediatria Prof. Dr. Juan P. Garrahan | CABA, Argentina | Not Yet Recruiting |
| Women's and Children's Hospital | North Adelaide, South Australia, Australia | Not Yet Recruiting |
| Brussels - UNIV HUDERF | Brussels, Belgium | Not Yet Recruiting |
| Serviços Medicos Respirar Sul Fluminense | Barra Mansa, Brazil | Not Yet Recruiting |
+ 36 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT07366034