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.
Children and adolescents 2 to <18 years old at Visit 2.
Participants with evidence of fibrosing ILD on high-resolution computed tomography (HRCT) within 12 months of Visit 1 as assessed by the investigator and confirmed by central review.
For children ≥6 years: Participants with forced vital capacity (FVC) % predicted ≥25% at Visit 2.
Fan score ≥3, or
Previous treatment with nerandomilast.
Participants treated with other oral/systemic PDE4 and non-selective PDE inhibitors within 30 days before Visit 1.
Participants treated with pirfenidone in the 8 weeks prior to Visit 1.
Unstable pulmonary arterial hypertension (PAH).
Parallel
Nerandomilast
DrugNerandomilast
Placebo
DrugPlacebo
Area under the concentration curve (AUC) T,SS based on sampling at steady state using rich sampling in participants from 6 years to less than 18 years and sparse sampling in participants younger than 6 years
Occurrence of a treatment-emergent adverse event
Absolute change from baseline in oxygen saturation (SpO2) [%] on room air at rest
Absolute change from baseline in height [cm]
Absolute change from baseline in pediatric quality of life inventory (PedsQL™)
Health-related quality of life will be assessed in children using the PedsQL™ questionnaire. For younger children who are unable to perform self-assessment, a parent proxy may be required. The score ranges from 0-100, a higher score indicates a better health related quality of life.
Occurrence of a treatment-emergent adverse event (Yes/No) over the whole trial
Click on the lead sponsor to view all of their trials.
